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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.

In-depth guide 19 sources Updated

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.

Compiled from 19 indexed sources, updated . Cited findings carry an evidence tier; passages written from general knowledge are marked editorial synthesis. Nothing here is medical or dosing advice. What changed

New diabetes medications approved in 2026

US approvals for type 2 diabetes from January to October 2026, with the evidence each one rests on.

New type 2 diabetes medications and indications approved by the FDA in 2026
DateMedicine (company)What is newEvidence base
4 Feb 2026Ozempic 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 2026Awiqli, 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 2026Mounjaro, 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

Type 2 diabetes drugs in late-stage development, October 2026
DrugTypeStatusReported result
OrforglipronOral GLP-1 agonistSubmitted to FDA for type 2 diabetes, Q2 2026 [5]HbA1c -1.91 vs -1.47 for oral semaglutide 14 mg [10]
RetatrutideGIP, GLP-1 and glucagon agonist, weekly injectionPhase 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]
CagriSemaAmylin analogue plus semaglutide, weekly injectionPhase 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.

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.

  1. 1
    FDA Approves Ozempic Tablets
    nn-ozempic-tablets · · manufacturer
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
    The ADA/EASD type 2 diabetes consensus 2026: What's new?
    dotn-ada-easd-2026 · · other
Show the remaining 7 sources
  1. 13
  2. 14
  3. 15
  4. 16
  5. 17
  6. 18
  7. 19

Last reviewed and what changed

  1. · 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.