Obesity Drug Pipeline: What's Approved and What's Not

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Only one of the next obesity drugs has been approved by FDA, and it isn’t a peptide. The rest are experimental, with timelines that come from the companies. This guide sorts what is approved from what is only promised.

The short answer

As of Nov. 5, 2026, orforglipron (Foundayo) is the only drug on this list that FDA has approved, and it is not a peptide. FDA approved it on April 1, 2026, for weight reduction in adults with obesity, or with overweight and a weight-related condition.

CagriSema, retatrutide, survodutide and mazdutide are experimental and not FDA-approved. Expected decision dates come from the companies, not from FDA.

Weight-loss percentages come from different trials with different populations and lengths, and should not be compared directly.

How this guide is built

This is an explainer, not a ranking. We report each drug’s status from FDA’s Drugs@FDA data and its label, the best published trials, and what the companies say about their plans, and we mark which is which. Drugs@FDA shows approved products, not pending applications, so it cannot tell us whether an application is under review. We give no doses. For the drugs that are already approved for weight, see our guides to peptides for weight loss, semaglutide, tirzepatide and liraglutide.

What is the status of each drug?

Sources: Drugs@FDA (searched Nov. 5, 2026) and the company statements linked in each section below. A company’s expected date is not an FDA decision. Approved drugs for weight loss that serve as the reference point are semaglutide (Wegovy), tirzepatide (Zepbound), liraglutide (Saxenda and generics) and setmelanotide, which is approved only for specific rare forms of obesity, some genetic and one acquired (hypothalamic obesity).

Is orforglipron a peptide, and what is it approved for?

It is not a peptide. Its label gives its chemical formula, and the trial report describes it as a “small-molecule, nonpeptide” drug. It acts on the same GLP-1 receptor as semaglutide (FDA label; NEJM). It is taken as a once-daily pill.

• Approved use. With a reduced-calorie diet and more physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity, or adults with overweight and at least one weight-related condition. It is not approved for type 2 diabetes, sleep apnea, cardiovascular risk or people under 18. There are trials in some of these, but the label does not list them (FDA label).
• Best evidence. In ATTAIN-1, 3,127 adults without diabetes were randomized for 72 weeks. Weight fell 7.5%, 8.4% and 11.2% across three doses, against 2.1% on placebo. With the highest dose, 54.6% lost at least 10% of body weight, compared with 12.9% on placebo. The trial was funded by Lilly.
• Safety. The label carries the boxed warning on thyroid C-cell tumors that other GLP-1 drugs carry, and it says using it with another GLP-1 drug is not recommended. The most common side effects were gastrointestinal, and the label lists hair loss among those reported in at least 5% of people. About 8% stopped treatment because of side effects, against 3% on placebo.
• What we did not find. A head-to-head trial against semaglutide or tirzepatide. One indirect comparison with oral semaglutide favored semaglutide; several of its authors work for or own shares in Novo Nordisk, which makes semaglutide. An indirect comparison is not a trial.

What about CagriSema?

CagriSema combines cagrilintide, an experimental peptide, with semaglutide. It is not FDA-approved as of Nov. 5, 2026.

• Trials. In REDEFINE 1, 3,417 adults without diabetes were randomized for 68 weeks: weight fell 20.4% on CagriSema and 3.0% on placebo, and gastrointestinal side effects were reported by 79.6% vs 39.9%. In REDEFINE 2, 1,206 people with type 2 diabetes lost 13.7% vs 3.4% over 68 weeks.
• Regulatory timeline, from the company. Novo Nordisk’s nine-month report lists a “US decision” for CagriSema in the fourth quarter of 2026 and says the company is “preparing for the US launch of CagriSema in early 2027, subject to regulatory approval.” The report does not give a filing date or an FDA decision date. In an October release, Novo said it submitted CagriSema to FDA in December 2025.
• Company-reported head-to-head results. Novo has announced results against tirzepatide, but none is peer-reviewed. In REDEFINE 4, an open-label trial against the highest tirzepatide dose, Novo said CagriSema did not meet its primary endpoint. In REIMAGINE 5, in people with type 2 diabetes, Novo said CagriSema produced more weight loss than tirzepatide. The comparison was with tirzepatide 5 mg in an open-label trial. The Mounjaro label starts at 2.5 mg and goes up to 15 mg; its glycemic-control trials tested 5, 10 and 15 mg (Mounjaro label).
• Not yet published. The REDEFINE 9 and REIMAGINE 5 results come from company announcements and have not been published in a peer-reviewed journal.

What about retatrutide?

Retatrutide is an experimental injectable peptide from Lilly that is not FDA-approved. For the full story, see our retatrutide guide and tirzepatide vs retatrutide.

• Trials. TRIUMPH-1 enrolled 2,339 adults with obesity and no diabetes for 80 weeks: weight fell 17.6%, 23.7% and 25.0% across three dose arms, against 3.9% on placebo. In TRIUMPH-2, 1,152 people with obesity and type 2 diabetes lost 11.9%, 16.8% and 18.8%, against 5.1%.
• Why the headline number can differ. Lilly’s announcement of TRIUMPH-1 gave 28.3%, which assumes everyone stayed on treatment (“efficacy estimand”). The journal reports 25.0% for all randomized participants. We use the journal figure (Lilly).
• Side effects. In TRIUMPH-2, nausea rose with dose (14%, 21% and 28% vs 8%), and an abnormal skin sensation called dysesthesia was reported by up to 7% vs 1%. There were 6 deaths on retatrutide and 1 on placebo, which the investigators attributed to unrelated causes. Long-term safety is not established.
• Regulatory timeline, from the company. Lilly said on Sept. 29, 2026 that it plans to submit an application in the first quarter of 2027. That is a company plan.
• Compounding. FDA says retatrutide “cannot be used in compounding under federal law,” and that it is not a component of an FDA-approved drug (FDA).

What about survodutide?

Survodutide is an experimental weekly injectable peptide from Boehringer Ingelheim that targets the glucagon and GLP-1 receptors. It is not FDA-approved, and we did not verify that an application has been filed. We have found no company date for a decision.

• Trials. In SYNCHRONIZE-1, 725 adults with obesity and no diabetes were randomized for 76 weeks. Weight fell 12.2% and 13.0% across two doses, against 5.4% on placebo. Gastrointestinal symptoms were reported by 80.9% and 89.7%, against 47.9%. The trial was funded by the company.
• Liver. In SYNCHRONIZE-MASLD, a 216-person, 48-week trial in people with obesity and fatty liver disease, more people on survodutide had at least a 30% drop in liver fat on imaging than on placebo. That is an imaging result, not a clinical outcome, and the paper has an author correction we did not read.
• Not yet published. We found no published results for SYNCHRONIZE-2 (type 2 diabetes) or the cardiovascular outcomes trial, and the registry shows no posted results.

What about mazdutide?

Mazdutide is an experimental weekly injectable peptide that targets the GLP-1 and glucagon receptors. It is not FDA-approved. The phase 3 trials were run by Innovent Biologics in China, and we did not verify an approval in China or anywhere else.

• Chinese phase 3 trials. In GLORY-1, 610 Chinese adults with overweight or obesity lost about 11% to 14% over 48 weeks, while the placebo group’s weight barely changed. In GLORY-2, 461 Chinese adults with moderate to severe obesity lost 16.65% vs 1.50% over 60 weeks, with vomiting reported by 53.1% vs 1.3%.
• The only published U.S. data we found. In a 179-person phase 2 trial in the U.S., funded by Eli Lilly, weight fell 7.3% to 18.1% at 32 weeks across doses, compared with 0.9% on placebo. These are efficacy-estimand results, which assume people stayed on treatment. At the highest dose, 20% of participants stopped treatment because of side effects, mostly gastrointestinal. The study was published online in August 2026.
• Caution. Most of the phase 3 evidence comes from Chinese adults, and results in one population do not automatically carry over to another.

Why can’t the weight-loss percentages be compared?

Weight-loss percentages come from different trials with different populations and lengths, and should not be compared directly. These are some of the differences behind the numbers above:

• Length. The trials above report results from 32 weeks to 80 weeks, which are not the same measurement.
• Who was enrolled. Adults without diabetes, adults with type 2 diabetes, Chinese adults and U.S. adults, with different starting weights.
• How the result was counted. Some figures include everyone randomized. Others assume everyone stayed on treatment (“efficacy estimand”). The two can differ for the same trial: 28.3% against 25.0% in TRIUMPH-1.
• Dose arms. Several trials report two or three dose arms, and we give ranges.
• Who ran the trial. Most were funded by the company that makes the drug.

A direct comparison needs a trial that compares the drugs head to head, with the same people and analysis. For the approved drugs, see semaglutide vs tirzepatide.

Are the “research peptide” versions of these drugs the same?

Products sold online under these names as ‘research peptides’ are not the drugs tested in trials; FDA has called them unapproved new drugs. FDA’s warning letters to online sellers have named retatrutide, survodutide, mazdutide and cagrilintide as products it considers unapproved new drugs, including letters dated Aug. 24, 2026 and Mar. 31, 2026. In those letters, FDA said the “research use” label did not change its conclusion. No letter we found names orforglipron. We do not name sellers or link to them. See our guide to what “research use only” means, our tracker of FDA warning letters, and what FDA says about compounded GLP-1 drugs.

Which claims are not supported?

• “Orforglipron is an oral peptide.” It is a small molecule.
• “Orforglipron is Ozempic in a pill.” It is a different drug. Oral semaglutide is sold as Rybelsus and Ozempic tablets.
• “CagriSema is approved” or “launches in 2027.” It is not approved, and Novo’s launch plan is “subject to regulatory approval.”
• “Retatrutide is approved” or “available legally.” It is not approved, and FDA says it cannot be compounded.
• “Mazdutide is approved.” Not in the U.S. We did not verify approval elsewhere.
• “Drug X beats tirzepatide.” The head-to-head results for CagriSema are from company announcements, with different tirzepatide doses.
• “The research peptide is the same drug as the trial drug.” FDA calls those products unapproved.

What should you ask your doctor?

• Is an FDA-approved weight-management drug an option for me, given my health history?
• Do I have a personal or family history of medullary thyroid carcinoma or MEN 2?
• If I read about an experimental drug, is there an approved option, or a trial I could ask about?
• If I am offered a product sold under one of these names, is it FDA-approved, and who makes it?

We do not give doses, and we do not recommend products or sellers.

Frequently asked questions

Which obesity drug did FDA approve most recently?

Orforglipron (Foundayo), on April 1, 2026, for weight reduction in adults. It is a small-molecule pill and not a peptide.

Is CagriSema approved?

No. As of Nov. 5, 2026, it is not FDA-approved. Novo Nordisk expects a U.S. decision in the fourth quarter of 2026, which is a company date, not an FDA one.

When will retatrutide be approved?

We do not know. Lilly says it plans to submit an application in the first quarter of 2027, which is a company plan. Retatrutide is not FDA-approved.

Is survodutide or mazdutide approved?

No. Neither is FDA-approved, and Drugs@FDA lists no product for either.

Which of these drugs causes the most weight loss?

The percentages come from different trials with different populations and lengths and should not be compared directly. Only a head-to-head trial can answer it.

Related guides

• Retatrutide: What Published Trials Show, and Its Status
• Tirzepatide vs Retatrutide: Approved vs Investigational
• Best Peptides for Weight Loss: What the Evidence Shows
• Best Peptides for Type 2 Diabetes: What the Evidence Shows
• Compounded GLP-1 Drugs: What FDA Says

From Best Peptides Today

1. Is Retatrutide FDA-Approved? Status and What Is MissingNov. 5, 2026
2. Mazdutide's US Phase 2 Trial: What a 179-Person Study ShowsNov. 5, 2026
3. CagriSema Awaits an FDA Decision. Here Is What the Trials Show, and What Only Novo Has SaidOct. 31, 2026

Sources we checked

1. Drugs@FDA record, NDA 220934 (orforglipron, Foundayo)FDA. Accessed November 5, 2026.
2. Foundayo prescribing information (FDA label PDF, rev. 07/2026)FDA. Accessed November 5, 2026.
3. Drugs@FDA (searched Nov. 5, 2026; no product listed as CagriSema, cagrilintide, retatrutide, survodutide or mazdutide)FDA. Accessed November 5, 2026.
4. ATTAIN-1: orforglipron in obesity, Wharton 2025, NEJM (PubMed)PubMed. Accessed November 5, 2026.
5. Indirect comparison of orforglipron and oral semaglutide (PubMed)PubMed. Accessed November 5, 2026.
6. REDEFINE 1: CagriSema in obesity, NEJM (PubMed)PubMed. Accessed November 5, 2026.
7. REDEFINE 2: CagriSema in obesity with type 2 diabetes, NEJM (PubMed)PubMed. Accessed November 5, 2026.
8. Novo Nordisk nine-month financial report 2026 (company announcement No 65/2026, Nov. 4, 2026)Press release. Accessed November 5, 2026.
9. Novo Nordisk news release (Oct. 20, 2026): CagriSema post hoc analysis and FDA submissionPress release. Accessed November 5, 2026.
10. Novo Nordisk news release (Sept. 2026): REIMAGINE 5 and REDEFINE 9Press release. Accessed November 5, 2026.
11. Novo Nordisk news release (Feb. 23, 2026): REDEFINE 4 (via BioSpace)Press release. Accessed November 5, 2026.
12. Mounjaro prescribing information (FDA label PDF, rev. 08/2026)FDA. Accessed November 5, 2026.
13. TRIUMPH-1: retatrutide in obesity, NEJM (PubMed)PubMed. Accessed November 5, 2026.
14. TRIUMPH-2: retatrutide in obesity with type 2 diabetes, Lancet (PubMed)PubMed. Accessed November 5, 2026.
15. Lilly news release (May 21, 2026): TRIUMPH-1Press release. Accessed November 5, 2026.
16. Lilly news release (Sept. 29, 2026): TRIUMPH-2 and submission plansPress release. Accessed November 5, 2026.
17. SYNCHRONIZE-1: survodutide in obesity, le Roux 2026, NEJM (PubMed)PubMed. Accessed November 5, 2026.
18. SYNCHRONIZE-MASLD: survodutide, Kaplan 2026, Nature Medicine (PubMed)PubMed. Accessed November 5, 2026.
19. GLORY-1: mazdutide in Chinese adults, Ji 2025, NEJM (PubMed)PubMed. Accessed November 5, 2026.
20. GLORY-2: mazdutide in Chinese adults, Gao 2026, JAMA (PubMed)PubMed. Accessed November 5, 2026.
21. Mazdutide US phase 2 trial, Hsia 2026, Lancet Diabetes Endocrinol (PubMed)PubMed. Accessed November 5, 2026.
22. FDA: FDA's concerns with unapproved GLP-1 drugs used for weight lossFDA. Accessed November 5, 2026.
23. FDA Warning Letter 733652 (Aug. 24, 2026)FDA. Accessed November 5, 2026.
24. FDA Warning Letter 721805 (Mar. 31, 2026)FDA. Accessed November 5, 2026.
25. Best Peptides Today: FDA warning letters that name peptide drugs (tracker)Other. Accessed November 5, 2026.

Written and maintained by the Best Peptides For Editorial Team. How we rate evidence.