New diabetes medications: what has been approved recently, and what is coming
The new type 2 diabetes medications approved in 2026, from the Ozempic pill to two once-weekly insulins, the late-stage drugs behind them, and a plain answer to what is replacing metformin.
At a glance
- Topic
- Type 2 diabetes medicines
- Topic guide
- Diabetes medications
- Sources
- 19 cited, numbered at the bottom; each [n] mark links to its source
- Updated
The new diabetes medications approved in the United States in 2026 are the Ozempic pill, a new oral semaglutide tablet (4 February) [1]; two once-weekly basal insulins, Awiqli (26 March) [2] and Onswik (September) [3]; and a new cardiovascular indication for Mounjaro (28 August) [4]. Lilly's oral orforglipron has been submitted for type 2 diabetes but not yet approved for it [5].
Nothing has replaced metformin. What changed is the order: the October 2026 ADA/EASD consensus advocates earlier use, potentially from diagnosis, of SGLT2 inhibitors and GLP-1-based medicines to protect the heart and kidneys [6]. This page sits under the diabetes medications guide, which covers every class; it describes what was approved and how guidelines frame the choice, not what any individual should take.
New diabetes medications approved in 2026
US approvals for type 2 diabetes from January to October 2026, with the evidence each one rests on.
| Date | Medicine (company) | What is new | Evidence base |
|---|---|---|---|
| 4 Feb 2026 | Ozempic pill, semaglutide tablets 1.5, 4 and 9 mg (Novo Nordisk) | A new oral formulation; also indicated to reduce major cardiovascular events [1] | Matched to the earlier 3, 7 and 14 mg oral semaglutide doses [1] |
| 26 Mar 2026 | Awiqli, insulin icodec (Novo Nordisk) | First once-weekly basal insulin for adults with type 2 diabetes [2] | Four ONWARDS trials, about 2,680 adults [2] |
| 28 Aug 2026 | Mounjaro, tirzepatide (Lilly) | New indication: lowering the risk of major cardiovascular events [4] | SURPASS-CVOT, 13,299 adults, against dulaglutide [4] |
| Sep 2026 (announced 24 Sep) | Onswik, insulin efsitora alfa (Lilly) | Second once-weekly basal insulin [3] | QWINT programme, more than 3,400 adults [3] |
Two of these are new molecules (the two weekly insulins), one is a new formulation of a known medicine, and one is a new use for an existing drug. That is typical: much of what counts as a new diabetes drug in a given year is a new form, dose or indication of a class already in use.
Is there a new pill for type 2 diabetes?
Yes, two, at different stages.
The Ozempic pill (approved)
On 4 February 2026 the FDA approved Ozempic as the name for semaglutide tablets in 1.5 mg, 4 mg and 9 mg strengths for adults with type 2 diabetes [1]. The active ingredient is the same semaglutide as in Rybelsus, available since 2019; Novo says the new tablets have higher bioavailability and give comparable therapeutic value to the original 3, 7 and 14 mg doses [1]. The label covers improving blood sugar alongside diet and exercise and reducing the risk of major cardiovascular events in adults at high risk [1]. Novo announced US availability from 4 May 2026 [7]. The semaglutide record covers the molecule.
Orforglipron (submitted for diabetes)
Orforglipron, sold for weight management as Foundayo since its approval on 1 April 2026 [8], is a non-peptide GLP-1 pill. Lilly submitted it to the FDA for type 2 diabetes in the second quarter of 2026 [5]; no decision on that application had been announced by the date of this page. In ACHIEVE-1, in 559 adults with early type 2 diabetes on diet and exercise alone, HbA1c fell by 1.24 to 1.48 points over 40 weeks against 0.41 on placebo [9]. In ACHIEVE-3, a head-to-head trial in 1,698 adults on metformin, orforglipron lowered HbA1c by 1.71 and 1.91 points against 1.23 and 1.47 for oral semaglutide 7 and 14 mg over 52 weeks [10].
The pill most people mean when they search for diabetes tablets is still one of the older oral classes; the glucose pills page covers those.
What is the new drug replacing metformin?
No drug has replaced metformin. The guidelines changed when other medicines are brought in.
No new drug has replaced metformin, and no new class does what metformin does by the same mechanism. What has changed is the sequence. For years metformin was the usual first medicine, with others added later if blood sugar stayed high. Current guidance brings two other classes in earlier, sometimes first, for people with specific conditions, because those classes protect the heart and kidneys in addition to lowering glucose.
The ADA Standards of Care 2026 recommend, for adults with type 2 diabetes and chronic kidney disease, an SGLT2 inhibitor or a GLP-1 receptor agonist with demonstrated benefit, irrespective of HbA1c, to slow kidney disease and reduce cardiovascular events [11]. A new 2026 recommendation adds a dual GIP/GLP-1 receptor agonist for adults with type 2 diabetes, obesity and heart failure with preserved ejection fraction, again irrespective of HbA1c [11]. For established atherosclerotic cardiovascular disease, the Standards call for a medicine with proven cardiovascular benefit, such as a GLP-1 receptor agonist or SGLT2 inhibitor [11].
The ADA/EASD consensus report of October 2026 goes further. It advocates earlier use, potentially from diagnosis, of SGLT2 inhibitors and/or GLP-1-based therapies to protect organs and improve long-term outcomes, and earlier combination of the two in people who also have cardiovascular disease, chronic kidney disease or heart failure [6]. A primary-care summary of the report notes that it treats metformin as less of a required first step than UK NICE guidance does, because the heart and kidney benefits of these classes do not depend on metformin [12].
So the accurate answer to "what is replacing metformin" is: for people with heart disease, kidney disease, heart failure or obesity, SGLT2 inhibitors and GLP-1-based medicines are now recommended early and alongside, or sometimes ahead of, metformin; metformin itself remains in use. How a clinician weighs these depends on the person's conditions, other medicines, cost and tolerance. The comparison with insulin is covered in metformin vs insulin, and an SGLT2 example in Jardiance for type 2 diabetes.
Medicines similar to metformin
People searching for a medicine similar to metformin usually mean one of three things, and each has a different answer.
- Another tablet that lowers blood sugar without causing low blood sugar on its own. SGLT2 inhibitors, DPP-4 inhibitors and oral semaglutide all fit that description, and the ADA Standards discuss each as a glucose-lowering option [11].
- Something with organ protection. That is where SGLT2 inhibitors and GLP-1-based medicines differ from metformin: the guidelines recommend them for kidney and cardiovascular benefit irrespective of HbA1c [11][6].
- Something that also helps with weight. The consensus lists weight management among the fundamentals of type 2 diabetes care [6], and a summary of it describes high-dose semaglutide and tirzepatide as the most effective weight-loss medicines it considers [12].
None of these is a drop-in substitute. Each class has its own side effects, cautions and costs, and the choice is made with a clinician who knows the rest of the person's health. The type 2 diabetes treatments page lays out the classes side by side.
Once-weekly insulins: Awiqli and Onswik
The two new insulins of 2026 change how often basal insulin is injected, from daily to once a week. Awiqli (insulin icodec), approved on 26 March 2026 as a 700 units/mL injection, was compared with daily basal insulin in four ONWARDS trials in about 2,680 adults with type 2 diabetes and met its HbA1c endpoint [2]. Onswik (insulin efsitora alfa), announced as approved on 24 September 2026, was evaluated in more than 3,400 adults in the QWINT programme [3].
Both are approved for adults with type 2 diabetes only, alongside diet and exercise [2][3]. Onswik's prescribing information warns of low blood sugar (hypoglycemia), as insulin labels do [3]. A weekly insulin is a different product from a daily one, with its own dose-adjustment rules set out in its label, so a switch is a prescribing decision rather than a like-for-like swap.
Late-stage diabetes drugs: what is coming
| Drug | Type | Status | Reported result |
|---|---|---|---|
| Orforglipron | Oral GLP-1 agonist | Submitted to FDA for type 2 diabetes, Q2 2026 [5] | HbA1c -1.91 vs -1.47 for oral semaglutide 14 mg [10] |
| Retatrutide | GIP, GLP-1 and glucagon agonist, weekly injection | Phase 3; first head-to-head result 28 Oct 2026 [13] | HbA1c -2.2 vs -1.8 for Ozempic 2 mg; weight 19.5% to 20.9% vs 9.4% [13] |
| CagriSema | Amylin analogue plus semaglutide, weekly injection | Phase 3 diabetes trials published June 2026; filed for weight management only [14][15] | Weight -13.7% vs -3.4% in adults with type 2 diabetes [16] |
Retatrutide had its first head-to-head diabetes result in October 2026: in TRANSCEND-T2D-2, 1,298 adults on metformin with or without an SGLT2 inhibitor were assigned to retatrutide 9 mg, 12 mg or Ozempic 2 mg for 80 weeks [13]. These are company topline figures, not yet peer reviewed. Lilly plans its first retatrutide filing, for obesity, in the first quarter of 2027 [5]. See the retatrutide record.
CagriSema was tested in type 2 diabetes in three REIMAGINE trials published in June 2026: on diet and exercise, on metformin, and on basal insulin [17][14][18]. Its weight-management filing is under FDA review [19]; the trials and dates are on CagriSema news and approval timeline, and the wider obesity pipeline on new weight-loss drugs. Tirzepatide, already approved, now carries the cardiovascular indication described above.
More in this topic
This guide is part of Diabetes medications.
- Type 2 diabetes treatments: how treatment is chosen, step by step, in current guidelinesType 2 diabetes treatment starts with nutrition, activity and education, adds medicines chosen by heart, kidney and weight goals, and moves to injections such as GLP-1 drugs and insulin when needed. This is the sequence the 2026 ADA Standards describe.
- Prediabetes medication: what the prevention trials showedNo medicine is approved in the US specifically for prediabetes. Metformin has the longest record, cutting diabetes onset by 31% in the Diabetes Prevention Program, less than lifestyle change did; semaglutide and tirzepatide showed larger effects in people with obesity.
- Metformin vs insulin: how much each lowers A1C, and how they differMetformin lowers A1C by about 1.1 percentage points on its own; insulin can lower it as far as needed but brings low blood sugar and weight gain. Here is what the trials measured for each, and when the 2026 ADA Standards use one, the other, or both.
- Hypoglycemic drugs: the glucose-lowering classes, and the medicines that raise blood sugarHypoglycemic drugs, also called antihyperglycemic or antidiabetic agents, are the medicines that lower blood sugar. Here they are classified in one table with the classes that can cause hypoglycemia, and a second table lists common drugs that increase blood sugar.
- Jardiance for type 2 diabetes: how empagliflozin works and what its trials foundJardiance is empagliflozin, a once-daily SGLT2 inhibitor tablet, not insulin. It lowers A1C by roughly 0.7 to 0.9 points against placebo, and its heart and kidney trials earned it approvals for heart failure and chronic kidney disease as well as diabetes.
- Glucose pills: glucose tablets for lows versus pills that lower blood sugarGlucose tablets raise blood sugar to treat a low; diabetes pills lower it. The two meanings, the ADA's 15-15 rule, grams per tablet, and which diabetes pills make lows more likely.
- Can type 2 diabetes be cured? What remission trials showThere is no cure for type 2 diabetes, but trials show remission: normal HbA1c off all glucose-lowering drugs. What diet, surgery and GLP-1 studies achieved, and how long it lasted.
Questions people ask
What is the new drug replacing metformin?
None. Metformin remains in use. Guidelines now recommend SGLT2 inhibitors and GLP-1-based medicines earlier, potentially from diagnosis, especially for people with heart disease, kidney disease or heart failure [6][11].
Is there a new pill for type 2 diabetes?
The Ozempic pill, semaglutide tablets 1.5, 4 and 9 mg, was approved on 4 February 2026 [1]. Orforglipron, an oral GLP-1 already approved for weight management, was submitted for type 2 diabetes in Q2 2026 [5].
What are the newest diabetes medications?
In 2026: the Ozempic pill [1], the once-weekly insulins Awiqli [2] and Onswik [3], and Mounjaro's new cardiovascular indication [4].
Is there a once-weekly insulin?
Yes, two in the US as of 2026: Awiqli (insulin icodec), approved 26 March 2026 [2], and Onswik (insulin efsitora alfa), announced as approved on 24 September 2026 [3]. Both are for adults with type 2 diabetes.
What medicine is similar to metformin?
No other medicine works the same way. Other tablets that lower glucose without causing low blood sugar on their own include SGLT2 inhibitors, DPP-4 inhibitors and oral semaglutide [11]; the choice between them is made with a clinician.
Sources
Numbered in the order they are first cited. The bracketed numbers in the text link straight to these.
- 1FDA Approves Ozempic Tablets
nn-ozempic-tablets· · manufacturer - 2
- 3
- 4FDA approves tirzepatide to cut CV risk in type 2 diabetes
pt-mounjaro-cv· · other - 5
- 6
- 7Novo Nordisk's Ozempic pill, the only FDA-approved oral peptide GLP-1 medication for adults with type 2 diabetes, soon to be available in the US
nn-ozempic-pill-launch· · manufacturer - 8FDA approves Lilly's Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions
lilly-foundayo-approval· · manufacturer - 9Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes.
pmid-40544435· · peer-reviewed - 10
- 119. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2026.
ada-soc-2026-s9· · peer-reviewed - 12The ADA/EASD type 2 diabetes consensus 2026: What's new?
dotn-ada-easd-2026· · other
Show the remaining 7 sources
- 13Lilly's retatrutide delivered greater A1C reduction and more than double the weight loss of Ozempic's highest approved dose in head-to-head trial
lilly-transcend-t2d-2· · manufacturer - 14
- 15
- 16Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes.
pmid-40544432· · peer-reviewed - 17
- 18
- 19
Last reviewed and what changed
- · Written: 2026 US approvals for type 2 diabetes (Ozempic pill, Awiqli, Onswik, Mounjaro CV indication), new pills, the metformin question answered from ADA Standards 2026 and the October 2026 ADA/EASD consensus, and late-stage drugs.