Status as of 14 September 2026

What Are the New GLP-1 Drugs in 2026? Approved, Filed and in Trials

As of 14 September 2026, three new GLP-1 products have reached patients since late 2025: Eli Lilly's Foundayo (orforglipron), approved by the FDA on 1 April 2026; Novo Nordisk's Wegovy pill (oral semaglutide), approved by the FDA on 22 December 2025; and Novo Nordisk's Wegovy HD, approved by the FDA on 19 March 2026. One candidate, Novo Nordisk's CagriSema, is filed and awaiting an FDA decision. Lilly's retatrutide, Boehringer Ingelheim's survodutide, Amgen's MariTide, Novo Nordisk's zenagamtide and Viking's VK2735 are in Phase 3 and not approved anywhere. This page dates fast, so every status below carries its source and the date it was checked.

· Educational content — not medically reviewed

The short answer

The new GLP-1 drugs of 2026 approved as of 14 September 2026 are Eli Lilly's Foundayo (orforglipron), approved by the FDA on 1 April 2026, Novo Nordisk's Wegovy pill (oral semaglutide), approved on 22 December 2025, and Novo Nordisk's Wegovy HD, approved on 19 March 2026. CagriSema is filed with the FDA awaiting a decision. Retatrutide, survodutide, MariTide, zenagamtide and VK2735 remain in Phase 3, approved nowhere.

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Key takeaways

  • Approved: Foundayo (orforglipron, Eli Lilly) by the FDA on 1 April 2026 and the MHRA on 10 August 2026; the Wegovy pill (oral semaglutide, Novo Nordisk) by the FDA on 22 December 2025 and the European Commission on 15 July 2026; Wegovy HD (semaglutide, Novo Nordisk) by the FDA on 19 March 2026.
  • Filed, not decided: CagriSema (cagrilintide plus semaglutide, Novo Nordisk), submitted to the FDA on 18 December 2025, with Novo Nordisk's 4 August 2026 half-year report anticipating a US decision in the fourth quarter of 2026. Lilly also submitted Foundayo for type 2 diabetes in the US, per its 5 August 2026 results release.
  • In Phase 3, not filed anywhere: retatrutide (Lilly, BLA planned for the first quarter of 2027), survodutide (Boehringer Ingelheim), MariTide (Amgen), zenagamtide, formerly amycretin (Novo Nordisk), and VK2735 (Viking Therapeutics).
  • Approved in China only: mazdutide (Innovent Biologics), cleared by the NMPA for weight management on 27 June 2025 and for type 2 diabetes on 19 September 2025. It has no FDA, EMA or MHRA approval.
  • What is not known: long-term safety beyond the trial windows, how any of the filed or Phase 3 candidates will be labeled, and whether any will be approved at all. A press release is not a label.
  • Nothing here is a recommendation. Whether any approved product is right for a given person is a decision for that person's prescriber and pharmacist.

Three approvals since December 2025

The Wegovy pill (FDA, 22 December 2025), Wegovy HD (FDA, 19 March 2026) and Foundayo (FDA, 1 April 2026) are the only new GLP-1 products a US prescriber can actually write for as of 14 September 2026. Everything else on this page is investigational.

One application on the FDA's desk

CagriSema, Novo Nordisk's once-weekly amylin-plus-GLP-1 combination, was submitted on 18 December 2025. Novo Nordisk expects a US decision in the fourth quarter of 2026. No PDUFA date has been made public by the company or the agency.

Phase 3 is not approval

Retatrutide, survodutide, MariTide, zenagamtide and VK2735 have Phase 3 programs running. A positive topline release from a sponsor tells you a trial met its endpoint; it does not tell you what a regulator will conclude, when, or with what warnings.

Built to be re-checked

Each entry names its regulator, its source document and the date. The last section lists exactly which items are likely to change before the end of 2026, so you can verify rather than trust a page that was accurate on the day it was written.

The status board, as of 14 September 2026

The new GLP-1 drugs of 2026 sort into four bins, and the bin matters more than the brand name. Approved means a named regulator has issued a marketing authorisation and a prescriber in that jurisdiction can write for it. Filed means a sponsor has submitted an application and the regulator has not decided. Phase 3 means pivotal trials are running or reporting and no application has been submitted anywhere. Approved elsewhere means a regulator outside the US, EU and UK has authorised it and the FDA, EMA and MHRA have not.

Approved: Foundayo (orforglipron), an oral small-molecule GLP-1 receptor agonist from Eli Lilly, approved by the FDA on 1 April 2026 for weight management and by the UK's MHRA on 10 August 2026 for weight management and type 2 diabetes. The Wegovy pill (oral semaglutide), a once-daily peptide tablet from Novo Nordisk, approved by the FDA on 22 December 2025 and by the European Commission on 15 July 2026. Wegovy HD, the higher-strength once-weekly semaglutide injection from Novo Nordisk, approved by the FDA on 19 March 2026; Novo Nordisk's same-day announcement stated the strength was already approved in the EU and UK, and the European Commission approved a single-dose pen for it on 15 July 2026.

Filed: CagriSema (cagrilintide plus semaglutide), Novo Nordisk, submitted to the FDA on 18 December 2025. Foundayo for type 2 diabetes, Eli Lilly, submitted to the FDA per Lilly's 5 August 2026 second-quarter release.

Phase 3: retatrutide (Eli Lilly), survodutide (Boehringer Ingelheim, licensed from Zealand Pharma), MariTide (Amgen), zenagamtide, formerly amycretin (Novo Nordisk), and VK2735 (Viking Therapeutics).

Approved elsewhere: mazdutide (Innovent Biologics), approved by China's NMPA on 27 June 2025 for weight management and on 19 September 2025 for type 2 diabetes.

Every one of those sentences has a date attached because every one of them can change. If you are reading this after the fourth quarter of 2026, the CagriSema line is the first thing to re-check, and the last section says where.

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Approved: Foundayo, the Wegovy pill and Wegovy HD

Foundayo is orforglipron, a once-daily oral GLP-1 receptor agonist from Eli Lilly. It is a small molecule rather than a peptide, which is the reason its label carries no food or water conditions; the pharmacokinetic detail behind that is on the Foundayo reference page. Lilly's 1 April 2026 announcement states the FDA approved it for adults with obesity, or overweight with a weight-related condition, and reports an average weight loss of 12.4% at the highest dose in its trials. That figure is Lilly's, from Lilly's release, and it is a trial average rather than a promise to any individual. The MHRA authorised Foundayo on 10 August 2026 for both weight management and type 2 diabetes, the first authorisation in Europe. No EMA opinion had been published as of 14 September 2026.

The Wegovy pill is oral semaglutide, a once-daily peptide tablet from Novo Nordisk. The FDA approved it on 22 December 2025 to reduce excess body weight, maintain weight reduction and reduce the risk of major adverse cardiovascular events, per Novo Nordisk's company announcement, which cites a 16.6% mean weight loss in the OASIS 4 trial when treatment was adhered to. Because it is a peptide, its absorption looks nothing like Foundayo's, and the label conditions differ accordingly; the oral Wegovy reference page transcribes what the label states. The European Commission approved it on 15 July 2026, following a CHMP positive opinion in May 2026, and Novo Nordisk's release lists prior approvals in the US, UK, UAE and Bahrain.

Wegovy HD is the higher-strength once-weekly semaglutide injection. Novo Nordisk announced FDA approval on 19 March 2026 under a Commissioner's National Priority Voucher, citing a 20.7% mean weight loss in the STEP UP trial, and said US launch was planned for April 2026. The Wegovy HD reference page records what the label states about that strength and deliberately publishes no escalation path to it.

A reader should notice what these three have in common: two are the same molecule as products that already existed, and one is a genuinely new molecule. Whether that distinction matters for a given person is a prescriber's question, not this page's. The general mechanism shared across the class is covered in how GLP-1 medications work.

Filed and waiting: CagriSema and Foundayo for type 2 diabetes

CagriSema is the candidate most likely to change status before this year ends. It is a once-weekly injection combining cagrilintide, a long-acting amylin receptor agonist, with semaglutide, the GLP-1 receptor agonist already sold as Wegovy and Ozempic. Novo Nordisk announced on 18 December 2025 that it had submitted a New Drug Application to the FDA for weight management in adults with obesity, or overweight with a weight-related condition, based on the REDEFINE 1 and REDEFINE 2 trials. That release reports a 20.4% body weight reduction versus 3.0% for placebo in REDEFINE 1 over 68 weeks using the treatment policy estimand. Novo Nordisk's half-year report of 4 August 2026 lists a US decision as an anticipated milestone for the fourth quarter of 2026.

Two things are not known about CagriSema. First, no PDUFA target date has been published by either Novo Nordisk or the FDA, so fourth quarter is company guidance rather than a calendar entry. Second, Novo Nordisk's first-quarter report of 6 May 2026 stated that a CagriSema co-formulation development project had been terminated for portfolio reasons, while the clinical program and the filed application continued. What that means for the product as eventually labeled is not something the report spells out, and this page will not guess. The same company has also filed nothing for CagriSema with the EMA that it has announced publicly as of 14 September 2026.

Foundayo's second indication is the other pending file. Lilly's 8 June 2026 release on the ACHIEVE-2, ACHIEVE-3 and ACHIEVE-5 type 2 diabetes trials said the company planned to submit by the end of the second quarter under a Commissioner's National Priority Voucher, and Lilly's 5 August 2026 second-quarter results release lists the US submission for type 2 diabetes as completed. No decision date has been announced. Foundayo is already approved for weight management in the US, so this is a label expansion rather than a new product, but a prescriber cannot rely on an indication that does not yet appear on the label.

In Phase 3, approved nowhere: retatrutide, survodutide, MariTide and the rest

Retatrutide is Eli Lilly's once-weekly injectable triple agonist, acting at the GIP, GLP-1 and glucagon receptors. Lilly's 21 May 2026 release on TRIUMPH-1 reported average weight loss of 28.3% at the highest dose over 80 weeks, against 2.2% on placebo, and its 23 July 2026 release on TRIUMPH-2 and TRIUMPH-3 reported 20.8% and 22.6% respectively at the highest doses over 80 weeks. Lilly stated in both that release and its 5 August 2026 results that it plans to submit a Biologics License Application to the FDA in the first quarter of 2027. That is the whole regulatory story: no application exists yet, in any country. Lilly's own releases note discontinuation rates due to adverse events ranging up to 11.6% across doses in TRIUMPH-2, which is the kind of detail a future label will address and a press release cannot.

Survodutide is a once-weekly glucagon and GLP-1 receptor dual agonist developed by Boehringer Ingelheim under licence from Zealand Pharma. Boehringer Ingelheim's April 2026 topline release on SYNCHRONIZE-1 reported weight loss of up to 16.6% on average after 76 weeks using the efficacy estimand, against 3.2% on placebo; Zealand Pharma's 7 June 2026 release confirms the April topline and the same figures, and added a 19% discontinuation rate due to gastrointestinal adverse events versus 2.9% on placebo. Survodutide holds FDA Breakthrough Therapy designation, granted in September 2024 for MASH with fibrosis, not for obesity, per Zealand Pharma's 7 June 2026 release; that designation does not constitute a filing, and no obesity filing has been announced with any regulator.

MariTide, maridebart cafraglutide, is Amgen's antibody-peptide conjugate that antagonises the GIP receptor while activating the GLP-1 receptor, designed for monthly or less frequent injection. Amgen's 11 May 2026 feature on the molecule describes it as an investigational medicine in the Phase 3 MARITIME program and gives no readout date and no regulatory timeline. No Phase 3 results have been published as of 14 September 2026.

Zenagamtide, the proposed name for what Novo Nordisk had called amycretin, is a single-molecule GLP-1 and amylin receptor agonist in both injectable and oral forms. Novo Nordisk's 6 May 2026 first-quarter report states the AMAZE Phase 3 program in obesity was initiated, and its 5 June 2026 release on Phase 2b diabetes data says a Phase 3 program in type 2 diabetes is planned for the second half of 2026. VK2735, Viking Therapeutics' GLP-1 and GIP dual agonist, completed enrolment of its VANQUISH-1 and VANQUISH-2 Phase 3 trials, per Viking's 26 March 2026 announcement, with the studies expected to complete in 2027.

Mazdutide is the outlier. Innovent Biologics' glucagon and GLP-1 dual agonist was approved by China's NMPA on 27 June 2025 for weight management and on 19 September 2025 for type 2 diabetes, per Innovent's releases. It is a marketed medicine in China and an unapproved one everywhere else.

What is not known about any of them

The most important gap is time. The longest trial figure quoted on this page is 104 weeks, from a retatrutide extension Lilly reported on 21 May 2026, and most of the pivotal figures are 68 to 80 weeks. What happens over five or ten years on a triple agonist, an amylin combination or a monthly antibody conjugate is not known, because nobody has been on one that long. The labels for the approved products carry the warnings their trials and post-marketing data support; the investigational products have no label at all.

The second gap is the difference between a sponsor's release and a regulator's conclusion. Every efficacy number above comes from the company that makes the drug, describing its own trial in its own words. Those numbers are real, they are from named trials, and they are also the most favourable honest framing available. Regulators see the full dataset, including the parts that do not make the headline, and they sometimes reach different conclusions about who a drug is for.

The third gap is comparison. None of the Phase 3 candidates has been approved on the basis of beating an existing product, and a number that looks larger in one trial than another was measured in a different population, over a different duration, against a different comparator. Reading a 28% next to a 20% and concluding something about two drugs is exactly the inference the trial designs do not support. The semaglutide versus tirzepatide comparison shows how careful even a same-class comparison has to be with two approved products.

The fourth gap is access. Approval says nothing about coverage, supply or price in any country, and this page quotes no prices because it cannot verify them for any reader. Novo Nordisk and Lilly have both announced launch timing for their approved products; whether a given pharmacy has stock is a question for that pharmacy.

And the fifth gap is the one that governs the rest: none of this tells any person what they should take. Whether to start, switch or stay is a decision that turns on medical history, tolerance, other medications and what a prescriber judges, none of which is visible from a status board.

How to re-check this page, and what to log if your prescription changes

Because this page is a snapshot, here is how to check whether it has gone stale. For US approval status, the primary source is the product's prescribing information on DailyMed, which is the National Library of Medicine's copy of the FDA-approved label; a product with no DailyMed entry is not approved in the US, whatever a press release says. For the EU, the EMA's medicines pages publish the CHMP opinion and the Commission decision. For the UK, the MHRA publishes authorisations on GOV.UK. For pending applications, the sponsor's quarterly results and company announcements are the only public record of timing, and Novo Nordisk, Lilly, Boehringer Ingelheim, Amgen and Viking all publish theirs.

The specific items most likely to change between 14 September 2026 and the end of the year, in rough order: an FDA decision on CagriSema, which Novo Nordisk guides to the fourth quarter; an FDA decision on Foundayo for type 2 diabetes, which was submitted under a priority voucher; an EMA opinion on Foundayo, which had not appeared as of this writing; further TRIUMPH readouts from Lilly, which said in its 21 May 2026 TRIUMPH-1 release that more results from the program would be shared later in 2026; and the start of zenagamtide's Phase 3 diabetes program. Retatrutide's filing is guided to the first quarter of 2027, so a claim that it has been approved before then should be treated as wrong until a label exists.

If any of this reaches you as an actual prescription, the tracking problem is simpler than the pipeline. A new molecule with a new cadence, a switch from a weekly injection to a daily tablet, or a move to a higher strength of the same molecule are the three transitions these approvals create, and the guide to keeping your record through a medication switch covers what to write down on the day the change happens. A daily oral is its own discipline, described in the oral GLP-1 pill tracker guide.

GLP-1 Tracker, a free iPhone app from an independent developer with no connection to any manufacturer, is the practical layer for that: it logs each dose with its date and time, records side effects with the day they landed, keeps weight as a trend, and stores all of it on your device with no account. It logs a daily tablet or a weekly injection the same way, and it takes no position on which is better. That question stays with your prescriber and pharmacist, and the log exists so that conversation starts from a record rather than a memory.

Frequently asked questions

Which new GLP-1 drugs are approved in 2026?

As of 14 September 2026, three: Foundayo (orforglipron, Eli Lilly), approved by the FDA on 1 April 2026 and by the MHRA on 10 August 2026; the Wegovy pill (oral semaglutide, Novo Nordisk), approved by the FDA on 22 December 2025 and by the European Commission on 15 July 2026; and Wegovy HD (higher-strength semaglutide, Novo Nordisk), approved by the FDA on 19 March 2026. Mazdutide is approved in China only.

Is CagriSema approved?

No. Novo Nordisk submitted CagriSema, a once-weekly combination of cagrilintide and semaglutide, to the FDA on 18 December 2025 for weight management. The company's half-year report of 4 August 2026 anticipates a US decision in the fourth quarter of 2026. No target action date has been made public, and no approval in any country had been announced as of 14 September 2026.

Is retatrutide approved or filed anywhere?

Neither. Retatrutide is Eli Lilly's investigational triple agonist acting at GIP, GLP-1 and glucagon receptors. Lilly reported positive Phase 3 results from TRIUMPH-1 on 21 May 2026 and from TRIUMPH-2 and TRIUMPH-3 on 23 July 2026, and stated it plans to submit a Biologics License Application to the FDA in the first quarter of 2027. Until a label exists it is not available by prescription in any country.

What is survodutide and where is it in development?

Survodutide is a once-weekly glucagon and GLP-1 receptor dual agonist developed by Boehringer Ingelheim under licence from Zealand Pharma. Boehringer Ingelheim reported in April 2026 that the Phase 3 SYNCHRONIZE-1 trial met its co-primary endpoints, with up to 16.6% average weight loss over 76 weeks using the efficacy estimand, figures Zealand Pharma's 7 June 2026 release repeats. Its FDA Breakthrough Therapy designation, granted in September 2024, is for MASH with fibrosis, not for obesity, per the same Zealand Pharma release, and no obesity application has been filed with any regulator as of 14 September 2026.

What is MariTide?

MariTide, maridebart cafraglutide, is Amgen's investigational antibody-peptide conjugate that blocks the GIP receptor while activating the GLP-1 receptor, designed for monthly or less frequent injection. It is in the Phase 3 MARITIME program. Amgen's 11 May 2026 feature describes it as investigational and gives no readout date or regulatory timeline, and no Phase 3 results had been published as of 14 September 2026.

How is Foundayo different from the Wegovy pill?

Both are once-daily oral GLP-1 receptor agonists approved by the FDA for weight management, but they are different molecules. Foundayo is orforglipron, a small molecule from Eli Lilly whose label carries no food or water conditions. The Wegovy pill is oral semaglutide, a peptide from Novo Nordisk, whose label does carry such conditions because peptides absorb poorly from the gut. Which, if either, suits a given person is a prescriber's decision.

Why do the weight-loss percentages on this page differ so much between drugs?

Because they come from different trials with different populations, durations and comparators, reported by the sponsors themselves. A figure from an 80-week trial in adults without diabetes is not comparable to one from a 68-week trial or one in adults with type 2 diabetes. Every figure here is a sponsor-reported average from a named trial, and none of them supports a conclusion that one drug is better than another for an individual.

How do I check whether this page is out of date?

Look for the product on DailyMed, which carries the FDA-approved prescribing information; if there is no entry, it is not approved in the US. For the EU, check the EMA medicines pages; for the UK, MHRA notices on GOV.UK. For pending applications, the sponsor's most recent quarterly results release is the only public record of timing. The items most likely to change soon are the CagriSema decision and Foundayo's type 2 diabetes decision.

Whatever you are prescribed, keep the record in one place

GLP-1 Tracker is a free iPhone app that logs each dose, side effect and weigh-in on your device, with no account and no manufacturer behind it. It tracks tablets and injections alike and never advises on what to take.

This page is for general education only and is not medical advice, diagnosis or treatment. GLP-1 Tracker is a tracking tool, not a medical device. Always consult your healthcare provider about your medication, dosing and health decisions. Brand names are trademarks of their respective owners and are not affiliated with this app.