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GLP-1 pipeline

The GLP-1 pipeline in 2026: approved drugs and what is in trials

GLP-1 drugs went from one hormone target to two, and the next generation adds a third, or pairs GLP-1 with amylin or glucagon. This guide maps what is approved, what is still in trials and how the mechanisms differ, with status labels taken from our peptide database.

Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated 6 min read
Approved in the US
Semaglutide, tirzepatide, orforglipron
Newest approval
Orforglipron (Foundayo)
1 Apr 2026 · oral
Latest phase 3 read-out
Retatrutide TRIUMPH-1
Published 29 Sep 2026
Filed with FDA
CagriSema

The hormones behind the drugs

GLP-1 (glucagon-like peptide-1) is a gut hormone released after eating. It increases insulin release when blood sugar is high, slows stomach emptying and acts on appetite centres in the brain. Drugs that mimic it, called GLP-1 receptor agonists, lower blood sugar and body weight.

  • GIP is a second gut hormone with a related role. Adding it to GLP-1 is the idea behind tirzepatide.
  • Glucagon normally raises blood sugar, but activity at its receptor also affects energy use and the liver. It is the third target in retatrutide and the second in survodutide and mazdutide.
  • Amylin is a hormone released with insulin that also signals fullness. Cagrilintide is an amylin analog, paired with semaglutide in CagriSema.

Approved in the United States

FDA-approved GLP-1-based drugs covered on this site
DrugTargetsFormStatus
SemaglutideGLP-1Weekly injection; daily tabletFDA approved (Ozempic, Wegovy, Rybelsus)
TirzepatideGLP-1 + GIPWeekly injectionFDA approved (Mounjaro, Zepbound)
OrforglipronGLP-1 (small molecule)OralFDA approved (Foundayo, Apr 2026)

Orforglipron is worth singling out: it is a small-molecule pill, not a peptide, so it does not need the absorption enhancer that oral semaglutide uses. It was approved on 1 Apr 2026 under the brand name Foundayo.

Each approved drug has an FDA label that sets its doses and warnings. Our pages for semaglutide and tirzepatide cite the label rather than restate it from memory.

In trials or under review

Investigational GLP-1-based drugs we track
DrugTargetsStatus
RetatrutideGLP-1 + GIP + glucagonInvestigational · phase 3
CagriSemaAmylin + GLP-1 (combination)Investigational · filed with FDA
CagrilintideAmylinInvestigational (CagriSema component)
SurvodutideGLP-1 + glucagonInvestigational · phase 3
MazdutideGLP-1 + glucagonInvestigational in the US (approved in China)

Dated read-outs, filings and expected decisions we hold a source for are listed below. Dates marked as estimated are the registry's own estimates and can move. Where a sponsor has not stated a decision date, we say so rather than guess. Each entry is on the trial tracker only with a primary source, such as a registry entry, a publication or a company statement.

  • Retatrutide: TRIUMPH-1 (NEJM) and TRIUMPH-2 (Lancet) phase 3 papers were published in 2026. Lilly states it plans to submit a Biologics License Application to the FDA in the first quarter of 2027. That is a submission plan, not a decision date.
  • CagriSema: Novo Nordisk announced on 18 Dec 2025 that it had submitted a New Drug Application to the FDA. Novo states the FDA is expected to review it in 2026 and gives no decision date. REIMAGINE 2 headline results were announced by the company on 2 Feb 2026. ClinicalTrials.gov estimates REDEFINE 3 primary completion in Sep 2027.
  • Cagrilintide alone: the RENEW 1 and RENEW 2 phase 3 trials started on 5 Nov 2025, with primary completion estimated by the registry for May 2027.
  • Survodutide: SYNCHRONIZE-1 and SYNCHRONIZE-2 reached primary completion on 2 Dec and 12 Dec 2025, and both were published in NEJM in 2026. We have no sourced filing or decision date.
  • Mazdutide: China's regulator approved it for chronic weight management, announced by Innovent on 27 Jun 2025. We have no sourced US filing or decision date.
  • Orforglipron: approved by the FDA on 1 Apr 2026 for obesity. Lilly reported a US submission for type 2 diabetes on 5 Aug 2026, with no decision date given.

The drug drawing the most search interest is retatrutide, up 172% year over year in our keyword data. Our retatrutide explainer covers it in depth.

Pills vs injections

Peptides are broken down in the gut, so most GLP-1 drugs are injected. Oral semaglutide gets around this with an absorption enhancer and strict dosing conditions, while orforglipron avoids the problem by not being a peptide at all. For people who prefer not to inject, the arrival of an approved small-molecule pill is the biggest practical change of 2026.

Compounded versions

Compounded semaglutide and tirzepatide became widely available during drug shortages. What pharmacies may compound depends on shortage status and compounding rules, which have changed over time. The legal hub and the telehealth comparison track the current position, and our legal status guide explains how compounding rules work.

  • Shortage ended: FDA determined the tirzepatide injection shortage resolved on 19 Dec 2024 (re-evaluating an earlier 2 Oct 2024 determination) and the semaglutide injection shortage resolved on 21 Feb 2025. FDA had listed both as in shortage since 2022, and set time-limited enforcement dates for compounders after each decision.
  • 6 Feb 2026: FDA announced its intent to restrict GLP-1 active ingredients intended for non-approved compounded drugs that are mass-marketed as alternatives to approved drugs.
  • 30 Apr 2026: FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk substances. Comments were open until 29 Jun 2026, and FDA said it would consider them before a final determination. We have not found a final determination.
  • Retatrutide and cagrilintide: FDA states they cannot be used in compounding under federal law.
Investigational drugs are not available legally outside trials. Products sold online as retatrutide, survodutide or other unapproved GLP-1 drugs are research-labelled chemicals with no verified identity or purity. They are not the trial drugs.

How to read pipeline news

GLP-1 headlines move markets and search trends, and they are easy to misread. A few distinctions help:

  • Phase 2 vs phase 3. Phase 2 trials are smaller and test doses; phase 3 trials are the large studies a regulator relies on. Weight-loss figures from phase 2 often change in phase 3.
  • Top-line vs published results. A company press release reports selected numbers. The peer-reviewed paper adds the full safety data, dropouts and methods. We cite the paper.
  • Filed vs approved. A filing starts the FDA review. Approval can take many months and is not guaranteed.
  • Approved somewhere vs approved in the US. Mazdutide's approval in China does not make it available or legal as a medicine in the US.
  • Average vs individual results. Trial results are averages across many people; individual responses vary widely.

When we report a trial result, we show the trial name, phase, size, duration and the publication it comes from, so you can judge it the same way.

What to watch next

  • An FDA filing for retatrutide (Lilly's stated plan is the first quarter of 2027).
  • An FDA decision on CagriSema.
  • Any survodutide regulatory filing (SYNCHRONIZE-1 and SYNCHRONIZE-2 are already published).
  • Whether mazdutide is filed in the US.

Each of these will appear in the legal tracker and the trial tracker with its date and source when it happens. To compare any two drugs as they stand today, use compare.

Common questions

Which GLP-1 drugs are approved in the US?

Among the drugs covered here, semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound) and orforglipron (Foundayo, approved 1 Apr 2026).

What is the difference between a dual and a triple agonist?

A dual agonist activates two hormone receptors, such as GLP-1 and GIP for tirzepatide. A triple agonist such as retatrutide also activates the glucagon receptor.

Is there a GLP-1 pill?

Yes. Oral semaglutide (Rybelsus) is a tablet, and orforglipron (Foundayo), approved in April 2026, is an oral small-molecule GLP-1 drug.

Keep going

Semaglutide · FDA approved (Ozempic, Wegovy, Rybelsus)Tirzepatide · FDA approved (Mounjaro, Zepbound)Orforglipron · FDA approved (Foundayo, Apr 2026)Retatrutide · Investigational · phase 3

Sources

  1. 1Lilly reports second-quarter 2026 financial results (retatrutide: planned BLA submission in Q1 2027; orforglipron type 2 diabetes submission)Eli Lilly (press release) · 2026sec.govAccessed 2 Oct 2026
  2. 2Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity (TRIUMPH-1)The New England Journal of Medicine · 2026PMID 42814954Accessed 2 Oct 2026
  3. 3Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2)The Lancet · 2026PMID 42810372Accessed 2 Oct 2026
  4. 4Novo Nordisk files for FDA approval of CagriSema (18 Dec 2025; states FDA review expected in 2026)Novo Nordisk (press release) · 2025Accessed 2 Oct 2026
  5. 5NCT05669755 (REDEFINE 3), study recordClinicalTrials.gov · 2026clinicaltrials.govAccessed 2 Oct 2026
  6. 6NCT07220642 (RENEW 1), study recordClinicalTrials.gov · 2026clinicaltrials.govAccessed 2 Oct 2026
  7. 7NCT07220759 (RENEW 2), study recordClinicalTrials.gov · 2026clinicaltrials.govAccessed 2 Oct 2026
  8. 8NCT06066515 (SYNCHRONIZE-1), study recordClinicalTrials.gov · 2025clinicaltrials.govAccessed 2 Oct 2026
  9. 9NCT06066528 (SYNCHRONIZE-2), study recordClinicalTrials.gov · 2025clinicaltrials.govAccessed 2 Oct 2026
  10. 10Survodutide Once Weekly for the Treatment of Adults with Obesity (SYNCHRONIZE-1)The New England Journal of Medicine · 2026PMID 42253238Accessed 2 Oct 2026
  11. 11Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes (SYNCHRONIZE-2)The New England Journal of Medicine · 2026PMID 42820639Accessed 2 Oct 2026
  12. 12Innovent announces mazdutide approved by China's NMPA for chronic weight management (27 Jun 2025)Innovent (press release via PR Newswire) · 2025Accessed 2 Oct 2026
  13. 13FDA approves first new molecular entity under National Priority Voucher program (Foundayo, orforglipron)U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  14. 14FDA clarifies policies for compounders as national GLP-1 supply begins to stabilizeU.S. Food and Drug Administration · 2025fda.govAccessed 2 Oct 2026
  15. 15FDA intends to take action against non-FDA-approved GLP-1 drugs (6 Feb 2026)U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  16. 16FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on 503B bulks list (30 Apr 2026)U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  17. 17FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026

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