Dashnaiv Peptides
Compounds·senolytic & cytoprotective·innate repair receptor (EPOR/beta-common) agonist

ARA-290 (cibinetide) peptide: what four placebo-controlled trials found for nerve pain, why development stopped, and what the vials people buy rest on

What 39 indexed publications and 3 randomized trials actually state about ara-290, sentence by sentence, each tied to its source and labeled by the kind of evidence it is.

Human clinical trial Reviewed 26 sources Updated Also: Cibinetida, Cibinetide, Ph-bsp

At a glance

Evidence availability
Human clinical evidence
Strongest tier in the indexed literature
Indexed publications
39
Europe PMC, title or abstract, 2026-09-14
Human studies in ledger
5
3 randomized; study count, not efficacy proof
Approval
not approved
ChEMBL phase 2
Routes reported
intraperitoneal, intravenous, subcutaneous
from studies in this ledger
Studied in
Humans, Mice, Rats
19 primary studies in the evidence table
Reviewed by Adam Mirando, PharmD, on . What changed

What ARA-290 (cibinetide) is, and what its four trials found

ARA-290 is a peptide in the senolytic & cytoprotective class (innate repair receptor (EPOR/beta-common) agonist). Europe PMC indexes 39 publications naming it or a listed alias in a title or abstract, including 3 randomized controlled trials and 1 clinical trials of any design, as of . The strongest evidence tier in that literature is human clinical trials.

This page reports what those studies state, sentence by sentence, with each statement tied to its source and labeled by the kind of evidence it is. It does not recommend use, and it does not translate study doses into anything personal.

What the evidence level means

Publication counts show what is indexed, not how strong the evidence is. The ledger below separates human clinical records from preclinical, analytical, and in-vitro work.

Human clinical studies in this ledger53 randomized · 2 other human clinical
Evidence strengthNot yet assessedSeparate from evidence availability
Efficacy signalNot yet assessedRead the study result, not the tier alone

Interpretation boundary: An indexed publication count is a discovery measure. It does not establish efficacy, safety, approval, or a personal treatment plan.

ARA-290 in two minutes

What it is. An eleven-amino-acid copy of one surface of erythropoietin, designed to activate the tissue-repair receptor erythropoietin uses without touching the one that makes red blood cells. Generic name cibinetide; developer Araim Pharmaceuticals.

What the research actually shows. 39 indexed publications and five human studies. Four placebo-controlled trials of 22 to 64 people over 28 days, in sarcoidosis-associated small-fibre neuropathy and diabetic neuropathy, all improved symptoms and, where measured, regrew small nerve fibres in the cornea and skin; the diabetes trial also lowered HbA1c. A nine-patient study in diabetic macular oedema found no change in vision or retinal thickness.

The catch. Every trial was four weeks long (one was twelve), every trial was the developer's, the phase 2b worked at 4 mg but not at 1 or 8 mg, and no phase 3 ever followed. Development stopped around 2017.

Status. Orphan designation, not approval. Prohibited in sport. Sold as a research chemical.

Where the evidence is thinnest. Anything beyond a month, any cause of neuropathy other than sarcoidosis and diabetes, and any use for long COVID, which no study has touched.

Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.

How ARA-290 works: erythropoietin's repair signal without its blood effect

Written from general pharmacology and the development record, and marked as editorial synthesis; the measurements behind it are quoted in the biomarker section.

  • ARA-290 is an eleven-amino-acid peptide, pyroglutamate-helix-B-surface peptide (pHBSP), that copies the outward-facing surface of helix B of erythropoietin. Erythropoietin has two receptors: a homodimer of its own receptor, which drives red-cell production, and a heterodimer of that receptor with the beta common receptor, expressed only in injured or inflamed tissue, which Anthony Cerami and Michael Brines named the innate repair receptor. ARA-290 was designed to bind the second and not the first, so it could deliver erythropoietin's tissue-protective signal without raising haematocrit or clot risk, the effects that made erythropoietin itself unusable for that purpose.Editorial synthesis
    Editorial synthesis from general knowledge
  • In animals the signal dampens innate immune cells, cuts inflammatory cytokines from macrophages, protects transplanted islets, speeds diabetic wound healing, slows amyloid pathology in mice and reduces cardiac inflammation in ageing rats; in people the measured effects were fewer neuropathic symptoms, more small nerve fibres in the cornea and skin, better temperature sensation and walking distance in sarcoidosis, and lower HbA1c and lipids in type 2 diabetes. The developers' explanation for why a two-minute half-life produces month-long effects is that receptor activation triggers a programme of repair that runs on after the peptide is gone.Editorial synthesis
    Editorial synthesis from general knowledge
  • What is not established is durability beyond a month, effect on anything but surrogate and symptom measures, and independence: every human trial had the developer's scientists among its authors. The phase 2b trial met its primary endpoint at 4 mg but not at 1 or 8 mg, which the abstract does not explain, and no phase 3 followed.Editorial synthesis
    Editorial synthesis from general knowledge

What happened in the human studies?

This record's ledger holds 5 primary human studies, of which 5 are trials. Few enough to show in full: each card quotes what its abstract reported about ARA-290. Read them before any other section on this page.

  • Clinical trial humans 2020 Human clinical trial
    There was no improvement in mean change baseline-week 12 in BCVA (-2.9 + 5.0), CRT (10 + 94.6 microns), central retinal sensitivity (-0.53 + 1.9 dB) or tear production (-0.13 + 7.7 mm), but there was an improvement in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite scores (2.7 + 3.1).
    Source pmid-32674280 · quoted verbatim from the abstract
  • Randomized controlled trial humans n = 64 2017 Human clinical trial
    Cibinetide significantly increased small nerve fiber abundance in the cornea and skin, consistent with a disease modifying effect.
    Source pmid-28475703 · quoted verbatim from the abstract
  • Phase 2 clinical trial humans 2015 Human clinical trial
    Subjects receiving ARA 290 exhibited an improvement in hemoglobin A(1c) (Hb A(1c)) and lipid profiles throughout the 56 d observation period.
    Source pmid-25387363 · quoted verbatim from the abstract
  • Randomized controlled trial humans 2013 Human clinical trial
    Here we show in a blinded, placebo-controlled trial that 28 d of daily subcutaneous administration of ARA 290 in a group of patients with documented SNFLD significantly improves neuropathic symptoms.
    Source pmid-24136731 · quoted verbatim from the abstract
  • Randomized controlled trial humans n = 12 2012 Human clinical trial
    The ARA 290 group showed significant (p < 0.05) improvement at wk 4 in SFNSL score compared with placebo (Δ -11.5 ± 3.04 versus Δ -2.9 ± 3.34 [standard error of the mean]).
    Source pmid-23168581 · quoted verbatim from the abstract

Trial by trial: what ARA-290 did in people

Every human study in the ledger. All were designed or sponsored by the developer.

Human studies of ARA-290 (cibinetide).
StudyParticipantsDose, route, durationDesignResult
Heij 2012 (pilot)22 sarcoidosis patients with small-fibre neuropathy and pain 5 or more2 mg IV, three times a week, 4 weeksRandomized, double-blind, placebo-controlledNeuropathy screening score improved (-11.5 vs -2.9); pain and physical-function domains of SF-36 improved; pain inventory improved in both groups; no safety concerns
Dahan 2013Sarcoidosis patients with documented small nerve fibre loss (n and dose not in abstract)Subcutaneous, daily, 28 daysBlinded, placebo-controlledNeuropathic symptoms improved; corneal nerve fibre density up; temperature sensitivity changed; 6-minute walk up
Brines 2015Type 2 diabetes with painful neuropathy4 mg subcutaneous daily, 28 days, then 28 days offPhase 2, placebo-controlledHbA1c and lipids improved through day 56; PainDetect score improved; corneal fibre density rose in those with low baseline; no safety issues
Culver 2017 (phase 2b)64 sarcoidosis patients with small nerve fibre loss and neuropathic pain1, 4 or 8 mg subcutaneous daily, 28 daysRandomized, placebo-controlledPrimary endpoint met at 4 mg (corneal nerve fibre area +697 μm² vs placebo, p 0.012), not at 1 or 8 mg; skin regenerating fibres up at 4 mg; pain improved in all groups including placebo
Lois 20209 patients with diabetic macular oedema, 8 completed4 mg subcutaneous daily, 12 weeksOpen, single-armNo improvement in visual acuity, retinal thickness, retinal sensitivity or tear production; questionnaire scores up; safe; no antibodies

The pattern is consistent and small: symptom scores and nerve-fibre counts move over four weeks in two related diseases, the one longer study in a different tissue found nothing, and the dose-response in the largest trial is not monotonic. That is a phase 2 record, and phase 2 is where it ended.

Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.

What the evidence shows

One row per primary study in this record's ledger. Fields are read from each paper's indexing and abstract. "Analytical method" marks papers about detecting or measuring the compound rather than about its effects.

19 primary studies in this record's ledger, strongest evidence first. A dash means the abstract did not state the value.
StudyDesignnSpeciesDoseRouteDurationReported outcomeTier
Lois 2020 Clinical trial — Humans4 mg/daysubcutaneous12 weeks There was no improvement in mean change baseline-week 12 in BCVA (-2.9 + 5.0), CRT (10 + 94.6 microns), central retinal sensitivity (-0.53 + 1.9 dB) or tear production (-0.13 + 7.7 mm), but there was an improvement in… Human clinical trial
Culver 2017 Randomized controlled trial 64 Humans——— Cibinetide significantly increased small nerve fiber abundance in the cornea and skin, consistent with a disease modifying effect. Human clinical trial
Brines 2015 Phase 2 clinical trial — Humans4 mgsubcutaneous— Subjects receiving ARA 290 exhibited an improvement in hemoglobin A(1c) (Hb A(1c)) and lipid profiles throughout the 56 d observation period. Human clinical trial
Dahan 2013 Randomized controlled trial — Humans—subcutaneous— Here we show in a blinded, placebo-controlled trial that 28 d of daily subcutaneous administration of ARA 290 in a group of patients with documented SNFLD significantly improves neuropathic symptoms. Human clinical trial
Heij 2012 Randomized controlled trial 12 Humans2 mgintravenous— The ARA 290 group showed significant (p < 0.05) improvement at wk 4 in SFNSL score compared with placebo (Δ -11.5 ± 3.04 versus Δ -2.9 ± 3.34 [standard error of the mean]). Human clinical trial
Winicki 2022 Animal study 48 Rats——15 months; 18 month Chronic ARA290 treatment mitigated age-related increases in the cardiac non-myocyte to myocyte ratio, infiltrating leukocytes and monocytes, pro-inflammatory cytokines, total NF-κB, and p-NF-κB. Animal, preclinical
Al-Onaizi 2022 Animal study — Mice——— Our findings indicate that ARA 290 early treatment decelerated Aβ pathology progression in APP/PS1 mice while improving cognitive functions. Animal, preclinical
Awida 2021 Animal study — Mice——— One month of CIB treatment significantly increased the cortical (~5.8%) and trabecular (~5.2%) bone mineral density in C57BL/6J WT female mice. Animal, preclinical
Mohtavinejad 2021 Animal study — Rats——— The binding of 99m Tc-ARA-290 to hypoxic cells was remarkably higher than normoxic cells (3 times higher than normoxic cells at 1 hr). Animal, preclinical
Yao 2021 Animal study — Mice——— Our results show that cibinetide maintained human islet ATP levels and reduced the caspase 3/7 activity during culture with pro-inflammatory cytokines and improved their insulin secreting capacity. Animal, preclinical
Yao 2020 Animal study — —120 µg/kg—— Cibinetide ameliorated the local inflammatory responses in the liver and improved glycemic control immediately after allogeneic PITx and significantly delayed the onset of allograft loss. Animal, preclinical
Bitto 2018 Animal study — Mice30μg/kgsubcutaneous14 days Throughout the wound healing process diabetic animals treated with vehicle exhibited increased wound MAL with reduced VEGF, pAkt, peNOS and nitrite/nitrate, all associated with poor re-epitheliziation, angiogenesis,… Animal, preclinical
Nairz 2017 Animal study — ———— We found that both cibinetide and EPO ameliorated the clinical course of experimental colitis in mice, resulting in improved weight gain and survival. Animal, preclinical
Watanabe 2016 Animal study — —120 μg/kgintraperitoneal— Secretion of pro-inflammatory cytokines (IL-6, IL-12, and TNF-α) from macrophages was significantly inhibited by ARA 290. Animal, preclinical
Liu 2014 Animal study — Rats——— ARA 290 intervention suppressed lymphocyte proliferation and altered helper T cell differentiation by inducing increase of Foxp3+/CD4+ regulatory T cells and IL-4+/CD4+ Th2 cells and decrease of IFN-γ+/CD4+ Th1 cells… Animal, preclinical
Sanchis-Gomar 2013 Animal study — ———— — Animal, preclinical
Ghassemi-Barghi 2023 In vitro study — Humans——— The findings indicated that ARA290 significantly reduced the DNA damage parameters of comet assay and the frequency of micronuclei induced by cisplatin. Mechanistic, in vitro
Thomas 2017 Analytical method — Humans——— — Mechanistic, in vitro
Thomas 2016 Analytical method — Humans——— — Mechanistic, in vitro

Doses reported in studies

Each entry is a sentence quoted from the study's abstract, with the study's design, sample size and year in front of it. Comparator doses in the same sentence are not attributed to ara-290.

  • Sarcoidosis patients with small-fibre neuropathy received 2 mg intravenously three times a week for four weeks.Human clinical trial
    Source pmid-23168581
  • In the phase 2b sarcoidosis trial, 64 patients received 1, 4 or 8 mg a day subcutaneously for 28 days; 4 mg met the primary endpoint.Human clinical trial
    Source pmid-28475703
  • People with type 2 diabetes and neuropathy self-injected 4 mg a day for 28 days and were followed a further month.Human clinical trial
    Source pmid-25387363
  • Nine patients with diabetic macular oedema self-injected 4 mg a day for 12 weeks.Human clinical trial
    Source pmid-32674280
  • Sarcoidosis patients received daily subcutaneous ARA-290 for 28 days in the 2013 trial; the abstract states no dose.Human clinical trial
    Source pmid-24136731
  • Animal study 2020 Animal, preclinical
    Doses stated in the abstract: 120 µg/kg
    Recipients were treated perioperative and thereafter daily during 14 d with cibinetide (120 µg/kg), with or without tacrolimus injection (0.4 mg/kg/d) during days 4-14 after transplantation.
    Source pmid-32345869 · quoted verbatim from the abstract, emphasis added
  • Animal study mice 2018 Animal, preclinical
    Doses stated in the abstract: 30μg/kg
    Animals were treated daily with cibinetide (30μg/kg/s.c.) or vehicle and euthanized 3, 7, and 14days after the injury to quantitate vascular endothelial growth factor (VEGF), malondialdehyde (MAL), phospho-Akt (pAkt), phospho e-NOS (p-eNOS), and nitrite/nitrate content within the wound.
    Source pmid-29223734 · quoted verbatim from the abstract, emphasis added
  • Animal study 2016 Animal, preclinical
    Doses stated in the abstract: 120 μg/kg
    Recipients were given ARA 290 (120 μg/kg) intraperitoneally just before and at 0, 6, and 24 hours after PITx.
    Source pmid-26683514 · quoted verbatim from the abstract, emphasis added

Every ARA-290 dose in the trials, in one table

Every figure here was given in a trial. The vendor vials print the same 4 mg; the trials that used it lasted four weeks.

Doses of ARA-290 (cibinetide) administered in studies.
SettingRouteDoseSchedulePopulation
Pilot 2012Intravenous2 mgThree times a week, 4 weeksSarcoidosis neuropathy
Trials 2013 to 2017Subcutaneous, self-administered1, 4 or 8 mg (4 mg in most)Once daily, 28 daysSarcoidosis neuropathy; type 2 diabetes
Eye study 2020Subcutaneous, self-administered4 mgOnce daily, 12 weeksDiabetic macular oedema
Mice, diabetic woundsSubcutaneous30 mcg/kgDaily, 14 daysWound-healing model
Mice and rats, transplant and inflammation modelsSystemic120 mcg/kgPerioperative or repeatedIslet allograft; macrophage activation
Rats, ageing heartSystemic; dose not stated in the abstractChronic, 15 to 18 monthsCardiac inflammation and fibrosis

Unusually for this site, the route and dose people use are the route and dose the trials used. What the community adds is time: months of daily injection against 28 days in the trials and 12 weeks in one study. Nothing on this page is an instruction to take anything.

Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.

Side effects: what four placebo-controlled trials recorded

From placebo-controlled trials: no safety concerns and no antibodies in any of them. The limit of that reassurance is 28 days in most trials and 12 weeks in one, all under supervision. Events and their frequency as each study reported them, with the denominator where the abstract gives one.

  • The 22-patient pilot raised no safety concerns on clinical or laboratory assessment.Human clinical trial
    Source pmid-23168581
  • The diabetes trial identified no potential safety issues.Human clinical trial
    Source pmid-25387363
  • Twelve weeks of daily injection in the eye study produced no serious adverse events and no antibodies to the peptide.Human clinical trial
    Source pmid-32674280
  • Four placebo-controlled trials and one open study found nothing, which for a peptide is a real record and for a drug is a short one: 22 to 64 people for 28 days, nine people for 12 weeks, all under supervision, all run or sponsored by the developer. The theoretical concern with any erythropoietin-derived molecule is red-cell and clot effects; ARA-290 was built to avoid the receptor responsible, and the trials measured no such effect, but none was long enough or large enough to rule out a rare one.Editorial synthesis
    Editorial synthesis from general knowledge

Who ARA-290 is discussed for, and the cautions that recur

Studied: adults with sarcoidosis and small-fibre neuropathy, adults with type 2 diabetes and painful neuropathy, and a handful with diabetic macular oedema. Never studied: neuropathy of other causes, long COVID, anyone for more than 12 weeks, children, pregnancy. Community: people with nerve pain of any cause, post-viral symptoms, or inflammatory conditions.

The trials excluded and measured what a phase 2 programme measures; these cautions follow:

  • Erythropoietin's shadow. The molecule was built to avoid red-cell and clotting effects, and none appeared in four weeks. Anyone with a clotting history is relying on the design and a short record, not on long-term data.
  • Cancer. The repair receptor is expressed in injured tissue and some tumours; no study addressed this, and none was long enough to.
  • Diabetes medication. HbA1c fell in the diabetes trial; anyone on glucose-lowering drugs has an interaction no study examined.
  • Extrapolating the disease. Sarcoidosis and diabetic neuropathy are immune and metabolic; the trials say nothing about chemotherapy, hereditary, alcoholic or idiopathic neuropathy, or about post-viral symptoms.
  • Duration. Effects were measured at four weeks and, in one trial, persisted a month after stopping. What months of continuous injection do is unmeasured.
  • Tested athletes. Listed by WADA and detectable; prohibited at all times, as are the repair peptides it is stacked with (see stacks).

Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.

Biomarkers measured in studies

Laboratory and clinical measures the studies report tracking, including which hormones did and did not change.

  • Animal study rats n = 48 2022 Animal, preclinical
    Chronic ARA290 treatment mitigated age-related increases in the cardiac non-myocyte to myocyte ratio, infiltrating leukocytes and monocytes, pro-inflammatory cytokines, total NF-κB, and p-NF-κB.
    Source pmid-36741836 · quoted verbatim from the abstract
  • Animal study mice 2021 Animal, preclinical
    Herein, we aimed to confirm cibinetide's efficacy on human islets, and to characterize its effect on IBMIR.
    Source pmid-34498509 · quoted verbatim from the abstract
  • Animal study 2017 Animal, preclinical
    Correspondingly, DSS-exposed mice treated with cibinetide or EPO displayed preserved tissue integrity due to reduced infiltration of myeloid cells and diminished production of pro-inflammatory disease mediators including cytokines, chemokines and nitric oxide synthase-2.
    Source pmid-29026145 · quoted verbatim from the abstract
  • Animal study 2016 Animal, preclinical
    ARA 290 protected islets from cytokine-induced damage and apoptosis.
    Source pmid-26683514 · quoted verbatim from the abstract
  • Animal study rats 2014 Animal, preclinical
    ARA 290 intervention suppressed lymphocyte proliferation and altered helper T cell differentiation by inducing increase of Foxp3+/CD4+ regulatory T cells and IL-4+/CD4+ Th2 cells and decrease of IFN-γ+/CD4+ Th1 cells in EAN.
    Source pmid-24603865 · quoted verbatim from the abstract
  • In vitro study humans 2023 Mechanistic, in vitro
    To determine the molecular mechanisms of the possible nephroprotective effects of ARA290, gene and protein expressions of TNFα, IL1β, IL6, Caspase-3, Bax, and Bcl2 were evaluated by real-time PCR and western blot assay, respectively.
    Source pmid-36085231 · quoted verbatim from the abstract

Reported interactions

Sentences in which the compound is studied alongside another agent. Read the quotation: the word interaction can also be statistical.

  • Animal study 2020 Animal, preclinical
    Cibinetide, in combination with low-dose tacrolimus, could significantly improve long-term graft survival in allogeneic PITx.
    Source pmid-32345869 · quoted verbatim from the abstract

Reported timelines

Onset, peak and duration figures as each study reported them.

  • The developers describe a plasma half-life of about two minutes and argue the peptide flips a switch whose effects last far longer.Mechanistic, in vitro
    Source pmid-25728128
  • Anti-doping laboratories found ARA-290 extensively broken down by exopeptidases in blood, with one main metabolite.Mechanistic, in vitro
    Source pmid-28941172
  • In diabetes, HbA1c and lipid improvements persisted through the 56-day observation, a month after dosing stopped.Human clinical trial
    Source pmid-25387363
  • In the pilot, the neuropathy symptom score had improved by week four.Human clinical trial
    Source pmid-23168581
  • Animal study mice 2022 Animal, preclinical
    We first evaluated the effects of early systemic ARA 290 administration on AD-like pathology in an early-onset model, represented by young APP/PS1 mice.
    Source pmid-34343617 · quoted verbatim from the abstract
  • Animal study 2020 Animal, preclinical
    Cibinetide ameliorated the local inflammatory responses in the liver and improved glycemic control immediately after allogeneic PITx and significantly delayed the onset of allograft loss.
    Source pmid-32345869 · quoted verbatim from the abstract

What is measured over time, and what is not

ARA-290 has one of the odder time profiles on this site. The peptide itself is gone from plasma in about two minutes, broken down by exopeptidases. The effects the trials measured appeared over four weeks of daily dosing: symptom scores, corneal nerve fibre area, skin fibre regeneration, HbA1c. In the diabetes trial the metabolic gains held through a further month without treatment, which is the developers' evidence for a switch-like mechanism. The eye study ran 12 weeks and moved nothing objective. Beyond that there is no data: no long-term trial, no follow-up cohort, no registry. 'How long does it take to work' has a trial answer of weeks; 'how long does it keep working' has an answer that stops at eight weeks.

Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.

Study durations

Treatment and follow-up periods as stated in each abstract.

  • Four weeks of three-times-weekly infusions in the pilot.Human clinical trial
    Source pmid-23168581
  • Twenty-eight days in the two subcutaneous sarcoidosis trials and the diabetes trial, with a month of follow-up in the latter.Human clinical trial
    Source pmid-25387363
  • Twelve weeks in the eye study, the longest human exposure.Human clinical trial
    Source pmid-32674280
  • Animal study rats n = 48 2022 Animal, preclinical
    Durations stated: 15 months; 18 month
    We conducted an integrated longitudinal ( n = 48) and cross-sectional ( n = 144) 15 months randomized controlled trial in which 18-month-old Fischer 344 x Brown Norway rats were randomly assigned to either receive chronic ARA290 treatment or saline.
    Source pmid-36741836 · quoted verbatim from the abstract, emphasis added
  • Animal study mice 2018 Animal, preclinical
    Durations stated: 14 days
    Animals were treated daily with cibinetide (30μg/kg/s.c.) or vehicle and euthanized 3, 7, and 14days after the injury to quantitate vascular endothelial growth factor (VEGF), malondialdehyde (MAL), phospho-Akt (pAkt), phospho e-NOS (p-eNOS), and nitrite/nitrate content within the wound.
    Source pmid-29223734 · quoted verbatim from the abstract

Routes: intravenous in the first trial, subcutaneous in the rest

Intravenous three times a week in the 2012 pilot; self-administered subcutaneous injection once daily in every later trial. The route people use is the route the trials used, which is unusual for this site. Routes of administration named in each study.

  • Clinical trial humans 2020 Human clinical trial
    administration by subcutaneous route reported
    Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks.
    Source pmid-32674280 · quoted verbatim from the abstract
  • Phase 2 clinical trial humans 2015 Human clinical trial
    administration by subcutaneous route reported
    ARA 290 (4 mg) or placebo were self-administered subcutaneously daily for 28 d and the subjects followed for an additional month without further treatment.
    Source pmid-25387363 · quoted verbatim from the abstract
  • Randomized controlled trial humans 2013 Human clinical trial
    administration by subcutaneous route reported
    Here we show in a blinded, placebo-controlled trial that 28 d of daily subcutaneous administration of ARA 290 in a group of patients with documented SNFLD significantly improves neuropathic symptoms.
    Source pmid-24136731 · quoted verbatim from the abstract
  • Randomized controlled trial humans n = 12 2012 Human clinical trial
    administration by intravenous route reported
    A total of 22 patients diagnosed with sarcoidosis and symptoms of SFN were enrolled in a double-blind, placebo-controlled exploratory trial consisting of three times weekly intravenous dosing of ARA 290 (2 mg; n = 12) or placebo (n = 10) for 4 wks.
    Source pmid-23168581 · quoted verbatim from the abstract
  • Animal study mice 2018 Animal, preclinical
    administration by subcutaneous route reported
    Animals were treated daily with cibinetide (30μg/kg/s.c.) or vehicle and euthanized 3, 7, and 14days after the injury to quantitate vascular endothelial growth factor (VEGF), malondialdehyde (MAL), phospho-Akt (pAkt), phospho e-NOS (p-eNOS), and nitrite/nitrate content within the wound.
    Source pmid-29223734 · quoted verbatim from the abstract
  • Animal study 2016 Animal, preclinical
    administration by intraperitoneal route reported
    Recipients were given ARA 290 (120 μg/kg) intraperitoneally just before and at 0, 6, and 24 hours after PITx.
    Source pmid-26683514 · quoted verbatim from the abstract

Weight-normalized doses, as published

Per-kilogram figures exactly as each study published them, for the species it studied.

  • Animal study 2020 Animal, preclinical
    Weight-normalized doses as published: 120 µg/kg
    Recipients were treated perioperative and thereafter daily during 14 d with cibinetide (120 µg/kg), with or without tacrolimus injection (0.4 mg/kg/d) during days 4-14 after transplantation.
    Source pmid-32345869 · quoted verbatim from the abstract, emphasis added
  • Animal study mice 2018 Animal, preclinical
    Weight-normalized doses as published: 30μg/kg
    Animals were treated daily with cibinetide (30μg/kg/s.c.) or vehicle and euthanized 3, 7, and 14days after the injury to quantitate vascular endothelial growth factor (VEGF), malondialdehyde (MAL), phospho-Akt (pAkt), phospho e-NOS (p-eNOS), and nitrite/nitrate content within the wound.
    Source pmid-29223734 · quoted verbatim from the abstract, emphasis added
  • Animal study 2016 Animal, preclinical
    Weight-normalized doses as published: 120 μg/kg
    Recipients were given ARA 290 (120 μg/kg) intraperitoneally just before and at 0, 6, and 24 hours after PITx.
    Source pmid-26683514 · quoted verbatim from the abstract, emphasis added

Weight-normalized figures above are reproduced exactly as each study published them, for the species it studied. Dose does not scale linearly with body mass between species: metabolic rate, clearance and receptor density differ, and regulatory guidance uses allometric, not proportional, conversion. A mg/kg figure from a rat study is a fact about that rat study and nothing else.

What people report outside the literature

Forum reports describe use for nerve pain, small-fibre neuropathy, long-COVID symptoms and inflammation, at the trial dose or above, for months. The trials ran four weeks; nobody has measured what months of use does. What circulates in user communities and clinic marketing, reported so a reader knows the figures and their origin. None of it has been tested in a trial, and none of it is a suggestion.

  • ARA-290 circulates for nerve pain and small-fibre neuropathy of any cause, for post-viral and long-COVID symptoms, for inflammation and recovery, injected subcutaneously once daily at the trial dose or above for weeks to months, often with BPC-157. Reports describe reduced burning pain within a couple of weeks in some, nothing in others, and injection-site reactions; a smaller group reports fatigue. The trial dose is public and the vendors print it, so the community figure and the study figure coincide; what the community adds is duration, months against the trials' four weeks, and that has never been measured.Editorial synthesis
    Editorial synthesis from general knowledge
Method note · shared across compounds

Reconstitution mathematics

Lyophilised peptide is supplied as a mass in a vial and dissolved in a stated volume of diluent. Two figures follow from that and nothing else:

  • Concentration = mass in vial ÷ diluent volume. A 5 mg vial in 2 mL is 2.5 mg/mL, or 2,500 mcg/mL.
  • Volume for a given mass = that mass ÷ concentration. 250 mcg at 2,500 mcg/mL is 0.1 mL. On a U-100 insulin syringe, where 1 mL is 100 units, that is 10 units.

Study doses on this page are quoted as published, in the units the authors used. Converting between mcg, mg and IU, or between a mass and a syringe volume, is arithmetic; deciding a mass is not, and this page does not do it. The reconstitution calculator performs the conversion with the formula shown.

Method note · shared across compounds

Reading a certificate of analysis

A certificate of analysis is a laboratory report on one batch. Reading it means checking four things in order.

  1. Identity. Mass spectrometry should report an observed molecular mass matching the peptide's theoretical mass within the instrument's stated tolerance. A certificate with no mass spectrometry, or one that lists only the expected value, has not confirmed identity.
  2. Purity. HPLC purity is the area of the main peak as a share of all peaks, at a stated wavelength. It says nothing about what the other peaks are, and it is not a measure of quantity.
  3. Quantity. Net peptide content, by amino acid analysis or UV, is the fraction of the vial's mass that is peptide rather than counter-ions and water. A 5 mg vial at 80% net content holds 4 mg of peptide, and every concentration figure above changes accordingly.
  4. Provenance. The batch number on the certificate should match the vial, the laboratory should be named and independent of the seller, and the test date should be recent.

This page rates no supplier and links to none. It describes how to read the document.

Method note · shared across compounds

Equipment described in studies

Published human studies of injectable peptides report the same small set of materials: single-use insulin syringes with fixed needles, most often U-100 with 29 to 31 gauge needles; bacteriostatic water or sterile water for injection as diluent, with the choice stated in the methods; alcohol swabs; and refrigerated storage of reconstituted solution. Animal studies more often report intraperitoneal or intragastric administration and state the vehicle used. Where a study in this record's ledger names its materials or vehicle, that sentence appears under storage or routes above; where it does not, nothing is assumed here.

Storage and handling

No storage study for human use is indexed. Anti-doping work found the peptide degrades rapidly in blood and recommends minus 20 degrees for stored samples, which is a laboratory finding about samples, not a vial instruction. Vendor sheets follow general lyophilised-peptide practice; contents are unverified.

Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.

Common mistakes in how ARA-290 is discussed

  1. Reading four positive trials as a settled result. They were four-week phase 2 studies by the developer with surrogate endpoints, and the largest showed benefit at one dose of three. Phase 3 never happened.
  2. Treating the orphan designation as approval. Orphan status is a development incentive. Cibinetide has no approval anywhere.
  3. Extending the sarcoidosis result to every neuropathy. The trials were in two immune-metabolic diseases. Long COVID, chemotherapy neuropathy and idiopathic small-fibre neuropathy were never studied.
  4. Comparing it with BPC-157 as equals. ARA-290 has controlled human trials; BPC-157 has none. The comparison people search for runs backwards.
  5. Assuming months of use are covered. The longest exposure is 12 weeks in nine people, and that study found nothing objective.
  6. Missing the dose-response. In the phase 2b, 8 mg did worse than 4 mg on the primary endpoint. More was not better, and nobody has explained why.

Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.

ARA-290 vs BPC-157, erythropoietin and the neuropathy drugs

ARA-290 beside the agents it is compared with for nerve pain and repair.
AgentWhat it isHuman neuropathy evidenceStatus
ARA-290 (cibinetide)Erythropoietin helix-B fragment; innate repair receptor agonistFour placebo-controlled trials, 22 to 64 people, 28 days; phase 2b met its primary endpoint at 4 mgOrphan designation; not approved; WADA-listed
BPC-157Gastric pentadecapeptide fragment; 228 indexed publications2 human studies in its ledger, small and uncontrolled; none in neuropathyNot approved; WADA S0
Erythropoietin (epoetin)The full hormone ARA-290 was cut fromTested for tissue protection in stroke and heart attack; raised clot risk; not used for neuropathyApproved for anaemia; WADA S2
Duloxetine, pregabalin, gabapentinApproved symptomatic drugs for diabetic neuropathic painLarge randomized trials; pain reduction, no nerve regrowthApproved; no record on this site
TB-500Thymosin beta-4 fragment sometimes paired with ARA-290; 1257 indexed publications14 human studies in its ledger; none in neuropathyNot approved; WADA S2

ARA-290 is unusual among the compounds on this site in having controlled human trials at the dose people use, and unusual among drugs in having stopped there. The honest comparison is with erythropoietin, whose repair effect it was built to keep and whose blood effect it was built to lose; the honest contrast is with the approved neuropathy drugs, which relieve pain without regrowing nerves and have the long-term data ARA-290 lacks.

Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.

Other compounds in its class

Same class in the registry: FOXO4-DRI. Each row shows what that compound's own record states; nothing is inferred across rows.

2 compounds in the senolytic & cytoprotective class. Each row states what that compound's own record says; nothing is inferred across rows.
CompoundTierPublicationsRCTsRecord
ARA-290 Human clinical trial 39 3 draft
FOXO4-DRI Animal, preclinical 19 0 draft

Regulatory status: orphan designation, phase 2, then silence

Registry facts only. Jurisdiction-level status, compounding categories and sport prohibitions need their own cited documents before they appear here.

  • Not approved anywhere. Araim Pharmaceuticals developed cibinetide through phase 2 and obtained FDA orphan-drug designation for sarcoidosis-associated small fibre neuropathy; no phase 3 was run, no application was filed, and the record ends with the 2020 eye study. Not on FDA's 503A compounding lists as far as this record can determine. WADA lists ARA-290 among prohibited peptides (Thomas 2016 names it alongside the growth hormone secretagogues), and anti-doping laboratories publish detection methods for it; treat it as prohibited at all times.Editorial synthesis
    Editorial synthesis from general knowledge · primary document to be added to the ledger

Open questions and limitations

What is genuinely unknown, stated plainly. A missing field is not evidence that the outcome is safe, effective, or established.

  • No trial has followed anyone for more than 12 weeks, and no phase 3 was ever run.
  • The Dahan 2013 abstract omits sample size and dose; the trial registration should supply them.
  • The FDA orphan designation record and any post-2017 Araim filings are not in the ledger.

Questions people ask

What is ARA-290?

ARA-290, generic name cibinetide, is an 11-amino-acid peptide copied from one helix of erythropoietin, designed by Araim Pharmaceuticals so that it activates the tissue-protective receptor erythropoietin uses (the EPO receptor paired with the beta common receptor, which Araim calls the innate repair receptor) without touching the receptor that makes red blood cells. It reached phase 2 in sarcoidosis-associated small-fibre neuropathy and diabetic neuropathy between 2012 and 2017, then stalled.

What is the half-life of ARA-290?

About two minutes in plasma, by the developers' own account, and anti-doping laboratories found it broken down quickly by exopeptidases in blood. The developers argue that a brief receptor signal triggers effects lasting days, which is why once-daily dosing was used in the trials; that is a hypothesis about mechanism, not a measurement of how long the peptide persists.

Does ARA-290 help long COVID?

No study has tested it. The idea comes from its small-fibre neuropathy trials and from reports of small-fibre neuropathy in some people after COVID-19. That is a hypothesis one step removed from the evidence, and no trial has been registered for it.

What is ARA-290 used for?

In trials, for neuropathic pain and small nerve fibre loss in sarcoidosis, for neuropathy and metabolic control in type 2 diabetes, and once for diabetic macular oedema, where it did nothing measurable. It has never been approved for any of them. Outside the trials it circulates for nerve pain, inflammation and long-COVID symptoms.

Has ARA-290 been tested in humans?

Yes, in five studies in the ledger: a 22-patient intravenous pilot and a 28-day subcutaneous trial in sarcoidosis neuropathy, a 64-patient phase 2b in the same disease, a phase 2 in type 2 diabetes with neuropathy, and a nine-patient open study in diabetic macular oedema. All were designed or sponsored by the developer and none ran longer than 12 weeks.

Does ARA-290 work for neuropathy?

In sarcoidosis-associated small-fibre neuropathy and diabetic neuropathy, over four weeks, the placebo-controlled trials found fewer symptoms and more small nerve fibres in the cornea and skin, with the phase 2b meeting its primary endpoint at 4 mg but not at 1 or 8 mg. No phase 3 confirmed it, and no other cause of neuropathy has been studied.

What dose was used in the trials?

2 mg intravenously three times a week in the pilot; 1, 4 or 8 mg subcutaneously once a day for 28 days in the phase 2b, with 4 mg the effective dose; 4 mg daily for 28 days in diabetes and for 12 weeks in the eye study. The vials sold copy the 4 mg figure.

What are the side effects of ARA-290?

None separated from placebo in any trial, and no antibodies formed over 12 weeks. The record is four weeks long in most trials and covers about 150 people in total, so it excludes common effects and says nothing about rare or long-term ones.

What is the half-life of ARA-290?

About two minutes in plasma, by the developers' account, with rapid breakdown by blood peptidases. The developers argue that a brief receptor signal starts a repair programme that lasts days, which is why once-daily dosing was used and why the diabetes trial's effects outlasted the dosing month.

Is ARA-290 FDA approved?

No. It holds an FDA orphan-drug designation for sarcoidosis-associated small fibre neuropathy, which is a development incentive, not an approval. No phase 3 trial was run and no application was filed; the developer's programme stalled after 2017.

Is ARA-290 the same as cibinetide?

Yes. ARA-290 is Araim Pharmaceuticals' code, pHBSP (pyroglutamate helix B surface peptide) is the structural name, and cibinetide is the generic name assigned during development.

Does ARA-290 raise red blood cells like erythropoietin?

It was designed not to, by binding only the tissue-repair receptor and not the red-cell receptor, and the trials found no such effect. The design and four weeks of data are the evidence; no long-term haematology exists.

Does ARA-290 help long COVID?

No study has tested it. The idea comes from its small-fibre neuropathy trials and from reports of small-fibre neuropathy after COVID-19. It is a hypothesis one step from the evidence, with no trial registered.

Is ARA-290 banned in sport?

Yes. Anti-doping laboratories list ARA-290 among peptides prohibited by WADA and publish detection methods and metabolite data for it; treat it as prohibited at all times.

How does ARA-290 compare with BPC-157?

They are opposites in evidence and alike in status. ARA-290 has four placebo-controlled human trials at the dose people use; BPC-157 has no controlled human trial at all. Neither is approved. No study has compared or combined them.

Which species has ARA-290 been studied in?

Humans in five studies; mice for diabetic wounds, Alzheimer's-type pathology, islet transplantation and bone; rats for ageing heart and autoimmune neuritis; and human cells for kidney protection. The animal literature covers many more conditions than the human trials did.

Sources

Full citations. Every claim above links to one of these by its id.

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    The time to develop treatments for diabetic neuropathy.
    pmid-33423557 · · peer-reviewed
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Show the remaining 14 sources
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    ARA 290 for treatment of small fiber neuropathy in sarcoidosis.
    pmid-24555851 · · peer-reviewed
  11. 23
  12. 24
  13. 25
    Sarcoidosis and pain caused by small-fiber neuropathy.
    pmid-23304492 · · peer-reviewed
  14. 26

Reference card

Reference card · generated /compounds/ara-290
Compound
ARA-290, senolytic and cytoprotective
Evidence tier
Human clinical trial
Indexed publications
39 · 3 RCTs · 1 other clinical trials
Approval
not approved · max phase 2
Routes reported
intraperitoneal, intravenous, subcutaneous
Reviewed
Adam Mirando, PharmD,

Study figures are as published in each source and are not recommendations. Print or save this card with its date.

Last reviewed and what changed

Newest first. These are the record's own revision dates, and the same dates feed the sitemap.

  1. · Reviewed by Adam Mirando, PharmD, on 2026-09-25.
  2. · Label correction: 2 evidence rows built from detection and doping-control papers carried study designs such as animal or in-vitro work. They are relabelled Analytical method, the label scripts/draft_claims.py has applied since the rule was added; these rows predate it. pmid-28941172 (In vitro study -> Analytical method); pmid-26578461 (In vitro study -> Analytical method)
  3. · Written under the sequencing rule after research/intents/ara-290.json: guide (8 sections incl. a five-study trial table), FAQ to 12 plus 5 from the map, dose, duration, timeline (two-minute half-life) and adverse-event claims from the abstracts, mechanism (innate repair receptor), reported-use, regulatory (orphan designation, stalled phase 2, WADA); two misdrafted interactions claims removed; intent-driven H1 and title. Triage: a misdrafted escalation claim removed ('stepwise approach' in a mouse-study abstract); one directory link added.
  4. · Claims drafted extractively from 26 ledger sources by scripts/draft_claims.py: 33 claims, 19 evidence-table rows. Status researched -> draft.
  5. · Claims drafted extractively from 26 ledger sources by scripts/draft_claims.py: 40 claims, 19 evidence-table rows. Status researched -> draft.
  6. · Claims drafted extractively from 26 ledger sources by scripts/draft_claims.py: 41 claims, 19 evidence-table rows. Status researched -> draft.
  7. · Metadata refreshed by scripts/fetch_evidence.py --refresh-meta: chembl None -> CHEMBL3545305.
  8. · Evidence fetched from Europe PMC and ChEMBL by scripts/fetch_evidence.py; claims not yet written.