Tesamorelin
What 115 indexed publications and 22 randomized trials actually state about tesamorelin, sentence by sentence, each tied to its source and labeled by the kind of evidence it is.
At a glance
What it is
Tesamorelin is a peptide in the ghrh analogs class (GHRH receptor agonist, stabilised GHRH analog). Europe PMC indexes 115 publications naming it or a listed alias in a title or abstract, including 22 randomized controlled trials and 7 clinical trials of any design, as of . The strongest evidence tier in that literature is an approved medicine with a regulator-reviewed label.
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.
Interpretation boundary: An indexed publication count is a discovery measure. It does not establish efficacy, safety, approval, or a personal treatment plan.
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.
| Study | Design | n | Species | Dose | Route | Duration | Reported outcome | Tier |
|---|---|---|---|---|---|---|---|---|
| Stewart 2026 | Clinical trial | 22 | Humans | 1 mg | — | 10 weeks | Low-dose GHRH treatment was not directly linked with significant changes in study measures. | Human clinical trial |
| Russo 2024 | Randomized controlled trial | 38 | Humans | 2 mg once daily | — | — | Tesamorelin led to significant declines in visceral fat (median [interquartile range]: -25 [-93, -2] vs. 14 [3, 41] cm 2 , P = 0.001), hepatic fat (-4.2% [-12.3%, -2.7%] vs. -0.5% [-3.9%, 2.7%], P = 0.01), and… | Human clinical trial |
| Stanley 2021 | Randomized controlled trial | — | Humans | — | — | — | Circulating concentrations of 13 proteins were significantly decreased, and no proteins increased, by tesamorelin. | Human clinical trial |
| Fourman 2021 | Randomized controlled trial | 58 | Humans | — | — | — | Individuals with fibrosis had higher NAFLD Activity Score (NAS) (mean ± standard deviation [SD], 3.6 ± 2.0 vs 2.0 ± 0.8; P Conclusions In this longitudinal study of HIV-associated NAFLD, high rates of hepatic fibrosis… | Human clinical trial |
| Fourman 2020 | Randomized controlled trial | — | Humans | — | — | — | Using gene set enrichment analysis, we found that tesamorelin increased hepatic expression of hallmark gene sets involved in oxidative phosphorylation and decreased hepatic expression of gene sets contributing to… | Human clinical trial |
| Stanley 2019 | Randomized controlled trial | 61 | Humans | 2 mg once daily; 2 mg daily | — | 12 months; 6 month | Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of -4·1% (95% CI -7·6 to -0·7, p=0·018), corresponding to a -37% (95% CI -67 to -7,… | Human clinical trial |
| Adrian 2019 | Randomized controlled trial | 193 | Humans | — | — | 26 weeks | In models adjusted for baseline differences and treatment arm, tesamorelin was associated with significantly greater increases in density of four truncal muscle groups (coefficient 1.56-4.86 Hounsfield units; all p… | Human clinical trial |
| Braun 2017 | Randomized controlled trial | — | Humans | 2mg | — | — | Log 10 FGF21 tended to decrease in the tesamorelin group compared to placebo (p=0.06). | Human clinical trial |
| Clemmons 2017 | Randomized controlled trial | 53 | Humans | 2 mg | — | 12 week; 12 weeks | Total cholesterol (-0.3±0.6 mmol/L) and non-HDL cholesterol (-0.3±0.5 mmol/L) significantly decreased from baseline to Week 12 in the tesamorelin 2 mg group (p Conclusions Treatment of type 2 diabetic patients with… | Human clinical trial |
| González-Sales 2015 | Phase 1 clinical trial | 41 | Humans | — | subcutaneous | — | Within the range of the values evaluated no covariates were significantly associated with GH or IGF-1 model parameters. | Human clinical trial |
| González-Sales 2015 | Randomized controlled trial | — | Humans | — | subcutaneous | — | The fraction of tesamorelin absorbed by a first-order process is 13.1 % higher on day 14 compared with day 1. | Human clinical trial |
| Stanley 2014 | Randomized controlled trial | 28 | Humans | 2 mg; 9 mg/d | subcutaneous | 6 months; 2 weeks | Tesamorelin significantly reduced visceral adipose tissue (mean change, -34 cm2 [95% CI, -53 to -15 cm2] with tesamorelin vs 8 cm2 [95% CI, -14 to 30 cm2] with placebo; treatment effect, -42 cm2 [95% CI, -71 to -14… | Human clinical trial |
| Baker 2012 | Randomized controlled trial | 152 | Humans | — | subcutaneous | 20 weeks; 10 week | Treatment with GHRH increased insulin like growth factor 1 levels by 117 %(P.001), which remained within the physiological range, and reduced percent body fat by 7.4%(P.001). | Human clinical trial |
| Makimura 2012 | Randomized controlled trial | — | Humans | — | subcutaneous | 12 months | VAT [-16 ± 9 vs.19 ± 9 cm(2), tesamorelin vs. placebo; treatment effect (95% confidence interval): -35 (-58, -12) cm(2); P = 0.003], cIMT (-0.03 ± 0.01 vs. 0.01 ± 0.01 mm; -0.04 (-0.07, -0.01) mm; P = 0.02), log… | Human clinical trial |
| Stanley 2011 | Randomized controlled trial | 273 | Humans | 2 mg | subcutaneous | — | At baseline, VAT was significantly associated with PAI-1 antigen (ρ = 0.36, P Conclusion In HIV patients with abdominal adiposity, tesamorelin may have a modest beneficial effect on adiponectin and fibrinolytic markers… | Human clinical trial |
| Falutz 2008 | Randomized controlled trial | 273 | Humans | 2 mg | subcutaneous | 26 weeks; 52 weeks | The change in VAT was sustained at -18% over 52 weeks of treatment (P Conclusion Treatment with tesamorelin was generally well tolerated and resulted in sustained decreases in VAT and triglycerides over 52 weeks… | Human clinical trial |
| Falutz 2005 | Randomized controlled trial | — | Humans | — | subcutaneous | — | TH9507 resulted in dose-related physiological increases in IGF-I (P Conclusions TH9507 reduced truncal fat, improved the lipid profile and did not increase glucose levels in HIV-infected patients with central fat… | Human clinical trial |
| Erlandson 2026 | Human study | — | Humans | — | — | 24 weeks; 24 week | Study findings will be disseminated through peer-reviewed publications and scientific conferences and may inform future interventions to improve physical function among older adults living with HIV. | Observational, human |
| Mihalache 2025 | Human study | — | Humans | — | — | — | Ten drugs were found to have significant overreporting of CTS, including idursulfase (ROR=51.2, 95% CI=39.0-67.2), galsulfase (ROR=26.8, 95% CI=17.2-41.7), laronidase (ROR=20.9, 95% CI=14.4-30.3), tesamorelin… | Observational, human |
| Thomas 2022 | Animal study | — | Swine | — | — | — | In contrast to urine, blood analysis essentially relies on the detection of intact peptide hormones, and the expected concentrations are commonly higher in blood samples than in urine. | Animal, preclinical |
| Uçaktürk 2026 | In vitro study | — | Humans | — | — | — | — | Mechanistic, in vitro |
| Cristea 2023 | In vitro study | — | — | — | — | — | — | 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 tesamorelin.
- Doses stated in the abstract: 1 mg
In a double-blind, placebo-controlled pilot trial, we assessed 22 subjects with baseline cognition ranging from normal cognition to mild cognitive impairment before and after 10 weeks of treatment with low-dose tesamorelin (1 mg; GHRH analog) or placebo.
Sourcepmid-42382101· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 2 mg once daily
We leveraged a randomized double-blind trial of 61 PWH and metabolic dysfunction-associated steatotic liver disease to evaluate the efficacy and safety of tesamorelin 2 mg once daily vs. identical placebo among participants on INSTI-based regimens at baseline.
Sourcepmid-38905488· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 2 mg once daily; 2 mg daily
Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily.
Sourcepmid-31611038· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 2mg
Methods 50 HIV-infected men and women with increased abdominal adiposity participated in this randomized, placebo-controlled trial of tesamorelin, 2mg vs. identical placebo daily for six months.
Sourcepmid-29031905· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 2 mg
Total cholesterol (-0.3±0.6 mmol/L) and non-HDL cholesterol (-0.3±0.5 mmol/L) significantly decreased from baseline to Week 12 in the tesamorelin 2 mg group (p Conclusions Treatment of type 2 diabetic patients with tesamorelin for 12 weeks did not alter insulin response or glycemic control.
Sourcepmid-28617838· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 2 mg; 9 mg/d; 5-13 mg/d
Participants were randomized to receive tesamorelin, 2 mg (n=28), or placebo (n=22), subcutaneously daily for 6 months.
Sourcepmid-25038357· quoted verbatim from the abstract, emphasis added
Adverse events and frequency
Events and their frequency as each study reported them, with the denominator where the abstract gives one.
-
Tesamorelin was well tolerated with a similar frequency of adverse events, including hyperglycemia, between groups.
Sourcepmid-38905488· quoted verbatim from the abstract -
Individuals in the tesamorelin group experienced more localised injection site complaints than those in the placebo group, though none were judged to be serious.
Sourcepmid-31611038· quoted verbatim from the abstract -
Tesamorelin was generally well tolerated.
Sourcepmid-18690162· quoted verbatim from the abstract
Study durations
Treatment and follow-up periods as stated in each abstract.
- Durations stated: 10 weeks
In a double-blind, placebo-controlled pilot trial, we assessed 22 subjects with baseline cognition ranging from normal cognition to mild cognitive impairment before and after 10 weeks of treatment with low-dose tesamorelin (1 mg; GHRH analog) or placebo.
Sourcepmid-42382101· quoted verbatim from the abstract, emphasis added - Durations stated: 12 months; 6 month
Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily.
Sourcepmid-31611038· quoted verbatim from the abstract, emphasis added - Durations stated: 26 weeks
Differences between muscle area and density before and after 26 weeks of tesamorelin or placebo treatment were compared and linear regression models were adjusted for baseline and treatment arm.
Sourcepmid-31237318· quoted verbatim from the abstract, emphasis added - Durations stated: 12 week; 12 weeks
No significant differences were observed between groups in relative insulin response over the 12-week treatment period.
Sourcepmid-28617838· quoted verbatim from the abstract - Durations stated: 6 months; 2 weeks
Participants were randomized to receive tesamorelin, 2 mg (n=28), or placebo (n=22), subcutaneously daily for 6 months.
Sourcepmid-25038357· quoted verbatim from the abstract, emphasis added - Durations stated: 20 weeks; 10 week
Participants self-administered daily subcutaneous injections of tesamorelin (Theratechnologies Inc),a stabilized analog of human GHRH (1 mg/d), or placebo 30 minutes before bedtime for 20 weeks.
Sourcepmid-22869065· quoted verbatim from the abstract, emphasis added
Routes studied
Routes of administration named in each study.
- administration by subcutaneous route reported
A total of 41 subjects in Phase I trials receiving subcutaneous daily doses of 1 or 2 mg of tesamorelin during 14 consecutive days were included in this analysis.
Sourcepmid-25895899· quoted verbatim from the abstract - administration by subcutaneous route reported
A total of 38 HIV-infected patients and healthy subjects receiving subcutaneous tesamorelin doses of 1 or 2 mg administered daily during 14 consecutive days were included in the analysis.
Sourcepmid-25358450· quoted verbatim from the abstract - administration by subcutaneous route reported
Participants were randomized to receive tesamorelin, 2 mg (n=28), or placebo (n=22), subcutaneously daily for 6 months.
Sourcepmid-25038357· quoted verbatim from the abstract - administration by subcutaneous route reported
Participants self-administered daily subcutaneous injections of tesamorelin (Theratechnologies Inc),a stabilized analog of human GHRH (1 mg/d), or placebo 30 minutes before bedtime for 20 weeks.
Sourcepmid-22869065· quoted verbatim from the abstract - administration by subcutaneous route reported
IGF-I increased (86 ± 21 vs. -6 ± 8 μg/liter; 92 (+52, +132) μg/liter; P Conclusion Among obese subjects with relative reductions in GH, tesamorelin selectively reduces VAT without significant effects on sc adipose tissue and improves triglycerides, C-reactive protein, and cIMT, without aggravating glucose.
Sourcepmid-23015655· quoted verbatim from the abstract - administration by subcutaneous route reported
Design and methods Four hundred and ten HIV-infected patients with abdominal adiposity were randomized to 2 mg tesamorelin (n = 273) or placebo (n = 137) subcutaneously daily for 26 weeks.
Sourcepmid-21516030· quoted verbatim from the abstract
Biomarkers measured in studies
Laboratory and clinical measures the studies report tracking, including which hormones did and did not change.
-
This study used proteomics and gene set enrichment analysis to assess effects of a GH releasing hormone (GHRH) analog, tesamorelin, on circulating immune markers and liver tissue in people with human immunodeficiency virus (HIV) (PWH) and nonalcoholic fatty liver disease (NAFLD).
Sourcepmid-33852720· quoted verbatim from the abstract -
We leveraged a randomized trial of the growth hormone-releasing hormone analogue tesamorelin to treat NAFLD in HIV.
Sourcepmid-32270862· quoted verbatim from the abstract -
In a recent randomized placebo-controlled trial, we demonstrated that the growth hormone-releasing hormone analog tesamorelin reduced liver fat and prevented fibrosis progression in HIV-associated NAFLD over 1 year.
Sourcepmid-32701508· quoted verbatim from the abstract -
Tesamorelin, a growth hormone-releasing hormone analogue, decreases visceral adipose tissue in people living with HIV, however, the effects on skeletal muscle fat and area are unknown.
Sourcepmid-31237318· quoted verbatim from the abstract -
Tesamorelin, a growth hormone releasing hormone agonist, reduces liver fat in HIV-infected individuals.
Sourcepmid-29031905· quoted verbatim from the abstract -
The objective of this study was to determine whether tesamorelin, a stabilized growth hormone-releasing hormone analogue, would alter insulin sensitivity or control of diabetes.
Sourcepmid-28617838· quoted verbatim from the abstract
Reported timelines
Onset, peak and duration figures as each study reported them.
-
In a double-blind, placebo-controlled pilot trial, we assessed 22 subjects with baseline cognition ranging from normal cognition to mild cognitive impairment before and after 10 weeks of treatment with low-dose tesamorelin (1 mg; GHRH analog) or placebo.
Sourcepmid-42382101· quoted verbatim from the abstract -
Differences between muscle area and density before and after 26 weeks of tesamorelin or placebo treatment were compared and linear regression models were adjusted for baseline and treatment arm.
Sourcepmid-31237318· quoted verbatim from the abstract
Storage and stability
Stability and storage conditions as reported.
-
The objective of this study was to determine whether tesamorelin, a stabilized growth hormone-releasing hormone analogue, would alter insulin sensitivity or control of diabetes.
Sourcepmid-28617838· quoted verbatim from the abstract -
Participants self-administered daily subcutaneous injections of tesamorelin (Theratechnologies Inc),a stabilized analog of human GHRH (1 mg/d), or placebo 30 minutes before bedtime for 20 weeks.
Sourcepmid-22869065· quoted verbatim from the abstract
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.
Reading a certificate of analysis
A certificate of analysis is a laboratory report on one batch. Reading it means checking four things in order.
- 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.
- 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.
- 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.
- 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.
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.
Other compounds in its class
Same class in the registry: CJC-1295, Sermorelin. Each row shows what that compound's own record states; nothing is inferred across rows. Head-to-head evidence, where any exists, is on the comparison pages: Sermorelin vs Tesamorelin, Ipamorelin vs Tesamorelin.
| Compound | Tier | Publications | RCTs | Record |
|---|---|---|---|---|
| Tesamorelin | Approved label | 115 | 22 | draft |
| CJC-1295 | Human clinical trial | 37 | 1 | draft |
| Sermorelin | Approved label | 579 | 39 | draft |
Studied in combination
Whether any indexed study tested Tesamorelin together with the compounds it is commonly combined with. A count of zero is the finding, not a gap in this page.
- No indexed study tested Tesamorelin with Ipamorelin. Tesamorelin + ipamorelin
Regulatory status
Registry facts only. Jurisdiction-level status, compounding categories and sport prohibitions need their own cited documents before they appear here.
- Registry entry
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 study in this record's ledger reports weight-normalized doses for Tesamorelin.
- No study in this record's ledger reports dose-escalation schedules for Tesamorelin.
- No study in this record's ledger reports interactions with other agents for Tesamorelin.
- No study in this record's ledger reports exclusion criteria for Tesamorelin.
Questions people ask
Has Tesamorelin been tested in humans?
Yes. Europe PMC indexes 7 clinical trials and 22 randomized controlled trials naming Tesamorelin or a listed alias in the title or abstract. The evidence table above lists the ones in this record's ledger with their design and sample size; check the study name, since an alias can refer to a different formulation of the same molecule.
What kind of evidence exists for Tesamorelin?
The strongest tier is approved label: an approved medicine with a regulator-reviewed label. Every claim on this page carries its own tier, because a compound with one human trial and forty animal studies is described by both facts, not the better one.
Is Tesamorelin an approved medicine?
ChEMBL records CHEMBL1237026 at maximum clinical phase 4, first approved 2010. Approval status differs by jurisdiction and is pending human review on this record.
Which species has Tesamorelin been studied in?
Studies in this record's ledger report work in: Humans, Swine. Findings in one species do not transfer to another, and weight-normalized doses in particular do not scale linearly between them.
Sources
Full citations. Every claim above links to one of these by its id.
- 1Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH): a clinical trial protocol.
pmid-42419889· · peer-reviewed - 2
- 3
- 4Carpal Tunnel Syndrome Attributed to Medication Use: A Pharmacovigilance Study.
pmid-40510111· · peer-reviewed - 5Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors.
pmid-38905488· · peer-reviewed - 6Cationic exchange SPE combined with triple quadrupole UHPLC-MS/MS for detection of GHRHs in urine samples.
pmid-37806509· · peer-reviewed - 7Probing for peptidic drugs (2-10 kDa) in doping control blood samples.
pmid-38716080· · peer-reviewed - 8Non-Alcoholic Steatohepatitis (NASH) - A Review of a Crowded Clinical Landscape, Driven by a Complex Disease.
pmid-34588764· · peer-reviewed - 9
- 10
- 11Effects of tesamorelin on hepatic transcriptomic signatures in HIV-associated NAFLD.
pmid-32701508· · peer-reviewed - 12Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial.
pmid-31611038· · peer-reviewed
Show the remaining 15 sources
- 13
- 14Fibroblast growth factor 21 decreases after liver fat reduction via growth hormone augmentation.
pmid-29031905· · peer-reviewed - 15Cardiovascular risk and dyslipidemia among persons living with HIV: a review.
pmid-28793863· · peer-reviewed - 16
- 17Therapeutic augmentation of the growth hormone axis to improve outcomes following peripheral nerve injury.
pmid-27192539· · peer-reviewed - 18Population pharmacokinetic and pharmacodynamic analysis of tesamorelin in HIV-infected patients and healthy subjects.
pmid-25895899· · peer-reviewed - 19Population pharmacokinetic analysis of tesamorelin in HIV-infected patients and healthy subjects.
pmid-25358450· · peer-reviewed - 20
- 21Growth hormone in the aging male.
pmid-24054930· · peer-reviewed - 22
- 23
- 24How to diagnose a lipodystrophy syndrome.
pmid-22748602· · peer-reviewed - 25
- 26
- 27
Reference card
- Compound
- Tesamorelin, ghrh analogs
- Evidence tier
- Approved label
- Indexed publications
- 115 · 22 RCTs · 7 other clinical trials
- Approval
- approved (2010) · ATC H01AC06
- Routes reported
- subcutaneous
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.
- · Claims drafted extractively from 27 ledger sources by scripts/draft_claims.py: 31 claims, 22 evidence-table rows. Status researched -> draft.
- · Claims drafted extractively from 27 ledger sources by scripts/draft_claims.py: 39 claims, 22 evidence-table rows. Status researched -> draft.
- · Metadata refreshed by scripts/fetch_evidence.py --refresh-meta: tier human-clinical-trial -> approved-label; chembl None -> CHEMBL1237026.
- · Evidence fetched from Europe PMC and ChEMBL by scripts/fetch_evidence.py; claims not yet written.