What’s Coming in 2027: Weight-Loss Treatments Awaiting FDA Decisions

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Retatrutide: an investigational triple agonist (not FDA approved) Investigational: not FDA approvedPrescriptionInjection

Weight-loss treatments awaiting FDA decisions in 2027: CagriSema, retatrutide, survodutide, MariTide and more, with filing dates, trial results and price changes. Investigational; checked Oct 7, 2026.

By marketing Updated October 7, 2026 Facts checked October 7, 2026

Fact-checked against FDA labels and official sources; not yet reviewed by a licensed clinician. This page is education, not medical advice. Talk to your doctor before starting, stopping or changing any treatment.

Key takeaways

  • CagriSema has been under FDA review since December 2025; Novo still expects a decision in Q4 2026 (company-reported). No decision as of Oct 7, 2026.[1]
  • Lilly plans to submit retatrutide in Q1 2027 (company-reported); on a standard FDA clock, a decision would come about a year later.[6]
  • The FDA aims to act on a standard new-drug application within 10 months of its 60-day filing date, or 6 months with priority review.[20]
  • Survodutide, MariTide and VK2735 are in Phase 3 with no FDA filing announced; their decisions are unlikely before late 2027 or 2028.[12]
  • Already set for 2027: Wegovy list price of $675 a month from January 1, and the Medicare GLP-1 Bridge through December 31.[23]

In short: The next FDA decisions on weight-loss medicines are close. CagriSema, a weekly combination injection from Novo Nordisk, has been under FDA review since December 2025, with a decision the company expects in the fourth quarter of 2026, so it may land late this year or slip into 2027. Lilly plans to apply for retatrutide in early 2027, and several other drugs finish their main trials during 2027 but will not reach a decision until later. None of these is approved today. Checked on October 7, 2026.

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This page is our yearly look ahead. It lists the weight-loss treatments with an FDA decision pending or likely in the next 12 to 18 months, what the trials showed, and the dated changes to price and coverage already set for 2027. For every candidate in development, including early-stage drugs, see our emerging medications tracker. For what you can use today, see our comparison of every FDA-approved weight-loss medication. This is general education, not advice about any treatment.

The 2027 outlook in four numbers

Checked on October 7, 2026

How an FDA decision date is set

It helps to know the clock before reading any “coming soon” headline. For a brand-new medicine, the FDA first takes up to 60 days to decide whether the application is complete enough to review. Under the user-fee goals the agency has agreed with industry for 2023 to 2027, it then aims to act on a standard application within 10 months and a priority one within 6 months of that 60-day filing date. That is why a drug submitted in a given month usually gets its decision about a year later, or about eight months later with priority review.

There is now a faster lane. Under the Commissioner’s National Priority Voucher program, launched in 2025, the FDA’s target is a decision within about two months. The first new medicine approved this way was Foundayo (orforglipron), the daily weight-loss pill, on April 1, 2026: 50 days after filing and 294 days ahead of its original goal date of January 20, 2027. A voucher can therefore move a decision forward by most of a year, which makes any forecast less certain.

From last trial to pharmacy shelf

  1. Phase 3 resultsThe company reports topline results, then full papers in journals.
  2. ApplicationThe company submits a new drug application (NDA) or biologics license application (BLA).
  3. Filing reviewUp to 60 days for the FDA to accept the application for review.
  4. ReviewGoal of 10 months (standard), 6 months (priority) or about 2 months (national priority voucher).
  5. Decision and labelApproval with a label, a request for more data, or a refusal. Launch, price and coverage follow.

The status board

The table lists candidates in the order their FDA decision could come, based on public information. It is not a ranking, and later rows are further from a decision.

Treatment (company)What it isStage on Oct 7, 2026FDA applicationEarliest decision
CagriSema (Novo Nordisk)Weekly injection: amylin analogue cagrilintide plus semaglutidePhase 3 complete (REDEFINE 1, 2, 4, 5)Filed December 2025 (reported)Q4 2026, company expectation; could move into 2027
Foundayo for type 2 diabetes (Lilly)Daily pill already approved for weight management; new diabetes usePhase 3 complete (ACHIEVE program)Planned by end of Q2 2026 under a priority voucher (reported); no decision foundNot announced
Retatrutide (Lilly)Weekly injection acting on GIP, GLP-1 and glucagon receptorsPhase 3: four trials reported; head-to-head vs tirzepatide due Nov 2026 (registry estimate)Planned Q1 2027 (reported)Late 2027 or 2028 on a standard clock; sooner only with a voucher
Survodutide (Boehringer Ingelheim)Weekly injection acting on glucagon and GLP-1 receptorsPhase 3: SYNCHRONIZE-1 and -2 reported; heart-safety trial completed June 2026None announcedNot before late 2027
MariTide (Amgen)Monthly or less frequent injection (antibody-peptide)Phase 3: MARITIME-1 (3,853 adults) primary completion Jan 2027 (registry estimate)None announced2028 or later
VK2735 (Viking)Weekly injection acting on GIP and GLP-1 receptorsPhase 3: VANQUISH 1 primary completion July 2027 (registry estimate)None announced2028 or later
Eloralintide (Lilly), zenagamtide (Novo Nordisk)Amylin-based injections; zenagamtide was previously called amycretinPhase 3 recruiting; main trials list completion 2028-2029NoneNot before 2028
INVESTIGATIONAL except Foundayo, which is approved for weight management only. Sources: company releases (reported), ClinicalTrials.gov and openFDA, checked 2026-10-07. “Earliest decision” for rows without a filing is our estimate from the FDA review clock, not a company date.

CagriSema: the decision closest to happening

CagriSema pairs semaglutide, the ingredient in Wegovy, with cagrilintide, a long-acting version of amylin, a hormone that helps signal fullness. In REDEFINE 1, published in 2025, 3,417 adults without diabetes lost 20.4% of their body weight on average over 68 weeks, compared with 3.0% on placebo, counting everyone who started. People with type 2 diabetes lost 13.7% vs 3.4% in REDEFINE 2. In an open-label head-to-head trial against tirzepatide, REDEFINE 4, Novo reported that CagriSema did not meet its goal of showing it was at least as effective (20.2% vs 23.6% at 84 weeks, treatment-regimen estimand). Digestive side effects were common, affecting 79.6% vs 39.9% on placebo in REDEFINE 1, mostly mild to moderate and temporary.

Novo filed with the FDA in December 2025 and, in its September 30, 2026 announcement, still said it expects a decision in the fourth quarter of 2026. We found no FDA decision as of October 7. If approved, the label would set who it is for and its warnings; price and coverage would follow. Our CagriSema explainer has every trial in detail.

Retatrutide: the application to watch in 2027

Retatrutide produced the largest average weight losses reported so far in a medicine trial. In TRIUMPH-1, published in the New England Journal of Medicine in September 2026, 2,339 adults with obesity lost 25.0% on the highest dose over 80 weeks vs 3.9% on placebo, counting everyone randomized. Lilly says it plans to submit retatrutide to the FDA in the first quarter of 2027. On a standard clock, that points to a decision in late 2027 or early 2028; Lilly has not said whether it will use a priority voucher. A head-to-head trial against tirzepatide, TRIUMPH-5, lists its primary completion for November 2026, so those results could arrive before the application. Our retatrutide results explainer covers the side effects, including the skin-sensation effect called dysesthesia.

Weight loss in each candidate's main Phase 3 trial vs placeboValues in %
Weight loss in each candidate's main Phase 3 trial vs placebo
ItemInvestigational drug, highest dosePlacebo
CagriSema, REDEFINE 1, 68 wk20.4%3%
Retatrutide, TRIUMPH-1, 80 wk25%3.9%
Survodutide, SYNCHRONIZE-1, 76 wk16.6%3.2%

INVESTIGATIONAL. Different trials, people and lengths: not a ranking. CagriSema and retatrutide figures count everyone randomized; the survodutide figure is company-reported and assumes everyone stayed on treatment (efficacy estimand), which gives higher numbers.

Source: Garvey WT et al., NEJM 2025 (REDEFINE 1); Jastreboff AM et al., NEJM 2026 (TRIUMPH-1); Boehringer Ingelheim release, April 28, 2026 (SYNCHRONIZE-1) (checked on October 7, 2026)

Read those bars with care. They come from separate trials with different lengths, and the survodutide number is measured in the more generous way. Our guide on how to read a weight-loss study headline explains why the same trial can produce two different percentages. For context, people in the trials behind today’s leading approved medicines lost 14.9% with semaglutide 2.4 mg over 68 weeks (STEP 1) and 20.9% with tirzepatide 15 mg over 72 weeks (SURMOUNT-1).

Further out: survodutide, MariTide, VK2735 and amylin drugs

Survodutide from Boehringer Ingelheim works on glucagon and GLP-1 receptors. On April 28, 2026, the company reported that in SYNCHRONIZE-1, 725 adults without diabetes lost up to 16.6% vs 3.2% on placebo over 76 weeks (efficacy estimand, company-reported), and 85.1% lost at least 5%. In SYNCHRONIZE-2, published in 2026, 752 adults with type 2 diabetes lost 8.2% and 9.8% on the two doses vs 3.9% on placebo, counting everyone randomized. Its heart-safety trial, with 5,531 participants, lists completion in June 2026. The company has not announced an FDA filing, so a decision before late 2027 is unlikely.

MariTide (maridebart cafraglutide) from Amgen is designed to be injected once a month or less often. In its Phase 2 trial, published in 2025, adults with obesity lost 12.3% to 16.2% at 52 weeks vs 2.5% on placebo. Its main Phase 3 trial, MARITIME-1, has enrolled 3,853 adults and lists primary completion in January 2027, so results could be one of the big news items of 2027, but a decision would come later. VK2735 from Viking, a weekly GIP and GLP-1 injection with an oral version in earlier testing, has a 4,500-person Phase 3 trial listed to complete in July 2027.

Several amylin-based medicines are in Phase 3: eloralintide from Lilly (ENLIGHTEN-1, completion listed March 2028), zenagamtide from Novo Nordisk (the AMAZE program, previously called amycretin) and petrelintide (Zealand with Roche). These are at least two years from any decision. Our muscle-preserving weight-loss drugs page follows a different branch of research, drugs meant to protect lean mass during weight loss.

Already decided: what is changing in 2027 for approved medicines

Some 2027 changes are already on the calendar. Novo Nordisk announced on February 24, 2026, that the US list price of Wegovy and Ozempic will be $675 a month for all doses from January 1, 2027, roughly half of Wegovy’s earlier list price; it said its direct self-pay prices are not affected. The list price matters most for people whose costs are tied to it, such as those on high-deductible plans. Our Wegovy cost guide has the current self-pay prices.

For people with Medicare, the Medicare GLP-1 Bridge, which began on July 1, 2026, runs through December 31, 2027, with a $50 copay for Foundayo, Wegovy (injection and tablets) and the Zepbound KwikPen when used for weight management. CMS says it extended the program through 2027 to collect more data; it has not said what replaces it in 2028. Medicare open enrollment runs from October 15 to December 7 each year. Our GLP-1 coverage guide explains the rules.

Foundayo itself may gain a second use. Lilly said on June 8, 2026, that it planned to submit Foundayo for type 2 diabetes by the end of the second quarter under a priority voucher, after three ACHIEVE trials. As of October 7, the FDA record shows only the April approval for weight management and an August labeling update, so the diabetes use is not approved.

Devices: two arrivals to know about

On the device side, the newest approval has already happened: the FDA approved the swallowable Allurion gastric balloon on February 20, 2026, and the company reported treating its first US commercial patients in April. The Epitomee capsule, cleared in September 2024, is in a pre-launch program with selected US clinics. Our list of weight-loss devices the FDA has authorized covers both, with their trial results.

What a new approval would and would not change

New medicines bring more choice, but several things stay the same. With every approved GLP-1 medicine so far, weight tends to return after stopping, and our guide on life after a GLP-1 covers what helps. Strength training and enough protein remain important on any strong weight-loss medicine to protect muscle; see muscle loss on GLP-1 medicines. A new label will define who a drug is for, and a launch price and insurance coverage usually lag behind approval.

If you are weighing whether to wait for a new drug, it may help to bring our printable questions to ask before starting a GLP-1 to your clinician, and to compare today’s options with Find My Options. Any FDA decision on the drugs above will appear first in our monthly news roundup, and this page will be updated.

Records in this article

Investigational: not FDA approvedPrescriptionInjectionRetatrutide: an investigational triple agonist (not FDA approved)Injection · WeeklyFDA approved for weight managementPrescriptionInjectionWegovy (semaglutide): uses, side effects, cost and FDA statusSemaglutide: one ingredient, several brands · Injection · WeeklyFDA approved for weight managementPrescriptionInjectionZepbound (tirzepatide): uses, side effects, cost and FDA statusTirzepatide: how the dual GIP/GLP-1 drug works (Zepbound, Mounjaro) · Injection · Weekly

Related guides

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Questions to ask a professional

  • Would any of the drugs expected soon be likely to suit someone like me, or is an approved option better now?
  • If I start an approved medicine today, could I switch later if something new is approved?
  • Am I eligible for a clinical trial of any of these candidates?
  • How would my insurance or Medicare cover a newly approved medicine?

Frequently asked questions

What new weight-loss drugs are coming in 2027?

The closest is CagriSema, under FDA review since December 2025 with a decision Novo expects in Q4 2026, which could slip into 2027. Lilly plans to submit retatrutide in Q1 2027. Survodutide, MariTide and VK2735 are in Phase 3 without an announced filing. None is approved as of October 7, 2026.

When will retatrutide be approved?

Nobody knows yet, and it may not be. Lilly plans to apply in the first quarter of 2027. A standard FDA review of a new medicine aims to finish about 12 months after submission, which points to late 2027 or early 2028.

Is CagriSema approved yet?

No. As of October 7, 2026, the FDA has not announced a decision. Novo Nordisk filed in December 2025 and says it expects a decision in the fourth quarter of 2026.

Will weight-loss drugs get cheaper in 2027?

Some list prices change: Novo Nordisk announced a Wegovy and Ozempic list price of $675 a month from January 1, 2027. What you pay depends on your insurance or self-pay program. The Medicare GLP-1 Bridge, with a $50 copay, runs through December 31, 2027.

Should I wait for a new drug instead of starting one now?

That is a decision for you and your clinician. Approved medicines with strong evidence are available today, and new drugs will take time to be approved, priced and covered. Our questions-to-ask checklist can help with that conversation.

References

  1. Novo’s investigational obesity and diabetes drug CagriSema reduces “food noise” and shows benefits in organ and bone health (EASD 2026). Novo Nordisk A/S, 2026. (accessed October 7, 2026) News (reported facts only)
  2. CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity; the primary endpoint was not achieved (company announcement). Novo Nordisk A/S, 2026. (accessed October 7, 2026) News (reported facts only)
  3. Garvey WT, Bluher M, Osorto Contreras CK, et al.. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1). New England Journal of Medicine, 2025. doi:10.1056/NEJMoa2502081 · PMID 40544433 · NCT05567796 (accessed October 7, 2026) Randomized trial
  4. Davies MJ, Bajaj HS, Broholm C, et al.. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2). New England Journal of Medicine, 2025. doi:10.1056/NEJMoa2502082 · PMID 40544432 · NCT05394519 (accessed October 7, 2026) Randomized trial
  5. Jastreboff AM, Kaplan LM, Davies MJ, et al.. Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity (TRIUMPH-1). New England Journal of Medicine, 2026. doi:10.1056/NEJMoa2604169 · PMID 42814954 · NCT05929066 (accessed October 7, 2026) Randomized trial
  6. Lilly’s triple agonist, retatrutide, delivered substantial weight loss and A1C reduction (BLA planned Q1 2027). Eli Lilly and Company (press release), 2026. (accessed October 7, 2026) News (reported facts only)
  7. TRIUMPH-5: retatrutide compared with tirzepatide in adults with obesity (NCT06662383). ClinicalTrials.gov (NLM). NCT06662383 (accessed October 7, 2026) Government page
  8. Survodutide achieved significant weight loss of 16.6% in Phase III SYNCHRONIZE-1 (company-reported). Boehringer Ingelheim (press release), 2026. (accessed October 7, 2026) News (reported facts only)
  9. Wharton S, le Roux CW, Startseva E, et al.. Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes (SYNCHRONIZE-2). New England Journal of Medicine, 2026. doi:10.1056/NEJMoa2607219 · PMID 42820639 · NCT06066528 (accessed October 7, 2026) Randomized trial
  10. ClinicalTrials.gov: SYNCHRONIZE-CVOT, survodutide cardiovascular safety (5,531 participants; completed 2026-06). U.S. National Library of Medicine. NCT06077864 (accessed October 7, 2026) Government page
  11. Jastreboff AM, Ryan DH, Bays HE, et al.. Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity: A Phase 2 Trial. New England Journal of Medicine, 2025. doi:10.1056/NEJMoa2504214 · PMID 40549887 · NCT05669599 (accessed October 7, 2026) Randomized trial
  12. ClinicalTrials.gov: MARITIME-1 (3,853 enrolled; primary completion 2027-01-21, estimated). U.S. National Library of Medicine. NCT06858839 (accessed October 7, 2026) Government page
  13. ClinicalTrials.gov: VANQUISH 1, VK2735 Phase 3 (primary completion 2027-07, estimated). U.S. National Library of Medicine. NCT07104500 (accessed October 7, 2026) Government page
  14. ClinicalTrials.gov: ENLIGHTEN-1, eloralintide Phase 3 (primary completion 2028-03, estimated). U.S. National Library of Medicine. NCT07321886 (accessed October 7, 2026) Government page
  15. ClinicalTrials.gov: AMAZE 1, Phase 3 (primary completion 2029-06, estimated). U.S. National Library of Medicine. NCT07339423 (accessed October 7, 2026) Government page
  16. Drugs@FDA: FDA-approved drugs (searched for cagrilintide; openFDA drugsfda dataset updated 2026-10-06). U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
  17. Drugs@FDA: Foundayo, NDA 220934. U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
  18. Foundayo delivered superior A1C control and weight loss in three pivotal type 2 diabetes trials (submission planned, company-reported). Eli Lilly and Company (press release), 2026. (accessed October 7, 2026) News (reported facts only)
  19. FDA Approves First New Molecular Entity Under National Priority Voucher Program. U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page
  20. PDUFA Reauthorization Performance Goals and Procedures, Fiscal Years 2023 Through 2027. U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
  21. FDA press announcements (September 15 to October 5, 2026 listing). U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
  22. Novo Nordisk announces significant reduction in US list price for Wegovy, Ozempic and Rybelsus. Novo Nordisk (press release), 2026. (accessed October 7, 2026) News (reported facts only)
  23. Medicare GLP-1 Bridge: information for providers. Centers for Medicare and Medicaid Services. (accessed October 7, 2026) Government page
  24. Joining a plan (Open Enrollment: October 15 to December 7). Medicare.gov (CMS). (accessed October 7, 2026) Government page
  25. PMA P250023: Allurion Gastric Balloon System (approved 2026-02-20). U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page
  26. 510(k) K240544: Epitomee, cleared 2024-09-13 (indications and RESET trial summary). U.S. Food and Drug Administration, 2024. (accessed October 7, 2026) Government page
  27. Wilding JPH, Batterham RL, Calanna S, et al.. Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1). New England Journal of Medicine, 2021. doi:10.1056/NEJMoa2032183 · PMID 33567185 · NCT03548935 (accessed October 7, 2026) Randomized trial
  28. Jastreboff AM, Aronne LJ, Ahmad NN, et al.. Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1). New England Journal of Medicine, 2022. doi:10.1056/NEJMoa2206038 · PMID 35658024 · NCT04184622 (accessed October 7, 2026) Randomized trial
  29. FDA’s concerns with unapproved GLP-1 drugs used for weight loss. U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page

Facts checked on October 7, 2026

Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.

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