Status Hub · Last checked October 12, 2026

Obesity Drug Approval Status 2026: FDA Tracker

Track which obesity drugs are approved, filed, or still in Phase 3, then click through to each drug-specific status page for the current yes-or-no answer and primary-source timeline.

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Fact-checked · Reviewed by Remy Research Editorial Board
Update History ▾
October 17, 2026: Replaced the bare accessdata.fda.gov labeling link with the Drugs@FDA pages for Wegovy injection (NDA 215256), Wegovy tablets (NDA 218316), Zepbound (NDA 217806) and Foundayo (NDA 220934).
October 12, 2026: Re-checked approvals against Drugs@FDA and FDA’s 2026 novel approvals list. Replaced the “four approved” count with the full list of FDA-approved incretin medicines (adding Saxenda and generic liraglutide) and noted the non-incretin drugs; moved petrelintide to Phase 3 (ZUPREME program announced September 22, 2026; ZUPREME-2 on October 7); replaced “five drugs in Phase 3” with “at least ten programs” and added MariTide, eloralintide and EloraTZP, cagrilintide on its own and elecoglipron; corrected the AMAZE 12 start date, the EC 7.2 mg approval dates and the mazdutide Phase 3 description; added the VK2735 maintenance study, the oral VK2735 SUNRISE trial postings and the UAE approvals; fixed leftover link text. Split the Viking reference into its two releases (VANQUISH-2 enrollment; first-quarter 2026 results) so each is cited once. Corrected the May 12 maintenance lines (ATTAIN-MAINTAIN tested Foundayo alone after Wegovy or Zepbound; SURMOUNT-MAINTAIN tested stepping Zepbound down to 5 mg) and labelled the SURMOUNT-1 and EloraTZP figures by estimand. Relabelled the retatrutide status link as “retatrutide approval status”.
October 11, 2026: Corrected the TRIUMPH-2 Lancet reference to its published title and pages, linked the Viking VANQUISH-2 enrollment release directly, and added all listed references to the structured-data citations.
October 10, 2026: Added the TRIUMPH-2 full results (The Lancet, September 29, 2026) alongside the July 23 topline, with estimands labelled.
October 7, 2026: Added the Wegovy HD 7.2 mg FDA approval (March 19, 2026) and EC approvals (July 15, 2026); recorded TRIUMPH-2 and TRIUMPH-3 toplines (July 23, 2026) and Lilly’s planned Q1 2027 BLA; added REIMAGINE 5 and REDEFINE 9 (September 21, 2026), SYNCHRONIZE-2 (October 1, 2026) and the Foundayo MHRA authorisation (August 10, 2026); corrected the SYNCHRONIZE-1 topline month to April 2026; labelled the TRIUMPH-1 estimand.
July 15, 2026: Flipped the retatrutide ADA reference to past tense (presented June 6, 2026) and qualified the 2026-filing / ~2027-launch guidance as unconfirmed (no NDA filed as of July 2026).
July 10, 2026: Replaced the elecoglipron ADA preview with verified VISTA/SOLSTICE outcomes and Phase 3 status.
June 21, 2026: US-market SEO/AEO refresh — title, meta, H1, and hub freshness aligned to “obesity drug approval status 2026” and compound-specific status queries; no regulatory delta.
June 15, 2026: Tightened the title, description, and direct-answer hub summary around live U.S. approval-status queries while preserving the current approval-stage facts and linked drug-specific source pages.
June 14, 2026: Refreshed the title, description, social metadata, schema headline, and H1 while preserving the approval-status facts and RUO framing.
May 28, 2026: Confirmed TRIUMPH-1 read out (May 21, no longer pending) and added Lilly’s FDA-submission-in-2026 / launch-~2027 guidance; clarified VK2735 subcutaneous Phase 3 status (VANQUISH-1 & -2 fully enrolled, readouts 2027).
May 25, 2026: Re-checked primary sources for TRIUMPH-1, Foundayo FDA approval, CagriSema NDA status, SYNCHRONIZE-1, VK2735 ECO, and oral Wegovy CHMP; refreshed visible freshness and schema to May 25. Added routing to the master Approval Trackers hub.
May 23, 2026: Tracker rows refreshed — retatrutide TRIUMPH-1 pivotal topline (May 21, 28.3% at 80wk, 30.3% at 104wk); CagriSema REDEFINE-4 head-to-head vs tirzepatide failed non-inferiority (Feb 23, 20.2% vs 23.6%); survodutide SYNCHRONIZE-1 Phase 3 readout (16.6% at 76wk); Wegovy 7.2mg pen + oral Wegovy EMA CHMP positive (May 22); amycretin AMAZE-12 Phase 3 launched.
May 20, 2026: Re-verified approval landscape (4 FDA-approved drugs, CagriSema NDA pending) and updated "as of" date stamps to current review
May 18, 2026: Added May 2026 research update: AstraZeneca’s elecoglipron (AZD5004) Ph2 success and the 2025 CVOT Summit consensus report (Schnell et al, Cardiovasc Diabetol, PMID 42092956).
April 14, 2026: Reframed the tracker as the cluster status hub, tightened status-page routing, and refreshed hub freshness signals
April 9, 2026: Foundayo (orforglipron) FDA approval added; zenagamtide updated to Phase 3; tracker table refreshed
March 28, 2026: CagriSema REDEFINE data update, petrelintide ZUPREME-1 results added
March 9, 2026: Initial publication
TL;DR — Hub Summary

As of October 12, 2026, the FDA-approved incretin medicines for weight management are Saxenda (daily liraglutide 3 mg, the first, approved December 2014), Wegovy (injectable + oral semaglutide, plus the 7.2 mg Wegovy HD dose approved March 19, 2026), Zepbound (tirzepatide), and Foundayo (orforglipron, approved April 1, 2026). CagriSema remains the closest pending FDA decision, while retatrutide, survodutide, and zenagamtide anchor the late-stage pipeline. This page is the landscape view; the master collection is the Approval Trackers hub.

Key Takeaways
2026 Catalyst Summary — What Landed (updated October 2026)

Retatrutide TRIUMPH-1 (May 21): Phase 3 pivotal topline — 28.3% at 80 weeks on 12 mg (n=2,339); up to 30.3% at 104 weeks in BMI ≥35 extension; 45.3% achieved ≥30% loss; 11.3% discontinuation on 12 mg. The 28.3% figure is the efficacy estimand; the NEJM paper (September 29, 2026) reports up to 25% under the treatment-regimen estimand. Detailed data were presented at ADA on June 6, 2026. TRIUMPH-2 and TRIUMPH-3 (July 23, 2026): TRIUMPH-2 (T2D, 80 weeks) showed 12.7% / 19.1% / 20.8% at 4 / 9 / 12 mg vs 4.0% placebo (efficacy estimand; full results in The Lancet, September 29, 2026: −11.9% / −16.8% / −18.8% vs −5.1% by the treatment-regimen estimand); TRIUMPH-3 (severe obesity with established CVD, 80 weeks) showed 21.6% / 22.6% at 9 / 12 mg vs 3.2%. Lilly says it will file for US approval no later than Q1 2027 (Lilly release). Retatrutide remains investigational; researchers sourcing it for in-vitro work can compare the verified UAE retatrutide formats and batch COAs on the Remy Research hub.

CagriSema REDEFINE-4 (Feb 23, 2026): Head-to-head vs tirzepatide failed non-inferiority — 20.2% vs 23.6% at 84 weeks. NDA already on file (Dec 18, 2025); Novo's current guidance points to a Q4 2026 U.S. decision window. REIMAGINE 5 and REDEFINE 9 (Sep 21, 2026): in type 2 diabetes, CagriSema 1.0/1.0 mg reached 12.4% weight loss vs 9.1% for tirzepatide 5 mg at week 60 (HbA1c −1.71 vs −1.67 points, non-inferior); REDEFINE 9 showed 21.0% vs 2.0% placebo at week 68.

Foundayo (orforglipron) FDA approved Apr 1, 2026 — first oral non-peptide GLP-1. ATTAIN-MAINTAIN and SURMOUNT-MAINTAIN (May 12, 2026): after a switch from maximum-tolerated Wegovy or Zepbound, Foundayo alone kept all but 0.9 kg and 5.0 kg of prior weight loss over a year; in a separate trial, stepping Zepbound down to 5 mg kept all but 5.6 kg.

Survodutide SYNCHRONIZE-1 (topline April 28, 2026): up to 16.6% at 76 weeks (efficacy estimand; up to 17.8 kg). SYNCHRONIZE-2 (Oct 1, 2026): up to 13.1% vs 3.1% placebo at 76 weeks in obesity with T2D (efficacy estimand). No regulatory filing has been announced. Amycretin AMAZE 12 (April 21, 2026): Novo Nordisk started a Phase 3 trial for post-diet weight maintenance; in May it also announced a UAE logistics hub.

Regulatory: Oral Wegovy FDA approved Dec 22, 2025 (16.6% if all adhered; 13.6% in the primary analysis). Wegovy HD (semaglutide 7.2 mg injection) FDA approved Mar 19, 2026. The European Commission approved the 7.2 mg Wegovy maintenance dose on Feb 17, 2026, and the Wegovy pill with a single-dose 7.2 mg pen on Jul 15, 2026. In the UAE, the Emirates Drug Establishment approved Foundayo on Apr 3, 2026 and the Wegovy pill on Jun 1, 2026. Foundayo was authorised by the UK MHRA on Aug 10, 2026 for weight management and type 2 diabetes.

September–October 2026: Zealand announced the start of the Phase 3 ZUPREME program for petrelintide (Sep 22) and ZUPREME-2 read out on Oct 7 (up to 9.2% vs 2.0% at week 28 in T2D); Viking reported the VK2735 maintenance-study Part 1 topline (Sep 22) and its oral Phase 3 SUNRISE trials were first posted on ClinicalTrials.gov (Oct 9); Lilly reported EloraTZP Phase 2b results (Sep 30).

Complete Obesity Drug Tracker — October 2026
Drug Sponsor Mechanism Stage Weight Loss
Liraglutide (Saxenda) Novo Nordisk GLP-1 agonist (daily injectable) Approved Dec 23, 2014 8.4 kg vs 2.8 kg at 56 wks (SCALE); generic liraglutide 3 mg approved Aug 2025
Semaglutide (Wegovy) Novo Nordisk GLP-1 agonist (injectable) Approved ~15% (STEP 1)
Semaglutide (Wegovy pill) Novo Nordisk GLP-1 agonist (oral) Approved Dec 22, 2025 16.6% if adherent; 13.6% primary (OASIS 4); EC approved Jul 15, 2026; UAE approved Jun 1, 2026
Wegovy 7.2 mg pen Novo Nordisk GLP-1 agonist (injectable, high-dose) FDA approved Mar 19, 2026 (Wegovy HD) Up to 20.7%; EC approved the 7.2 mg dose Feb 17, 2026 and the single-dose pen Jul 15, 2026
Tirzepatide (Zepbound) Eli Lilly Dual GLP-1/GIP agonist Approved ~22.5% (SURMOUNT-1, efficacy estimand); SURMOUNT-MAINTAIN 5 mg step-down data (May 12, 2026)
Orforglipron (Foundayo) Eli Lilly Oral non-peptide GLP-1 Approved Apr 1, 2026 12.4% at 72 wks (ATTAIN-1, efficacy estimand); ATTAIN-MAINTAIN maintenance data; UAE approved Apr 3, 2026
CagriSema Novo Nordisk Cagrilintide + semaglutide NDA Filed Dec 18, 2025 22.7% (REDEFINE 1); REDEFINE-4 failed non-inferiority vs tirz (20.2% vs 23.6%, Feb 23, 2026); current guidance points to Q4 2026
Retatrutide Eli Lilly Triple agonist (GLP-1/GIP/GCGR) Phase 3 (TRIUMPH-1, -2, -3 toplines reported; US filing planned by Q1 2027) 28.3% at 80wk (efficacy estimand); up to 30.3% at 104wk BMI ≥35 ext; not approved
Survodutide Boehringer Ingelheim / Zealand Dual GLP-1/glucagon Phase 3 (SYNCHRONIZE-1 Apr 2026; SYNCHRONIZE-2 Oct 2026) Up to 16.6% at 76wk (efficacy estimand; up to 17.8 kg); up to 13.1% in T2D (SYNCHRONIZE-2)
VK2735 (subcutaneous) Viking Therapeutics Dual GLP-1/GIP Phase 3 (VANQUISH-1 & -2 fully enrolled; readouts 2027) About 16–19% at 21 wks of weekly dosing (maintenance study Part 1, Sep 22, 2026); up to 14.7% at 13 wks (Phase 2)
Amycretin (zenagamtide) Novo Nordisk Unimolecular GLP-1/amylin Phase 3 — AMAZE program since Feb 2026; oral AMAZE 9 since Aug 2026 ~22% (Phase 1b/2); UAE logistics hub announced May 2026
Mazdutide (IBI362) Innovent / Lilly China Dual GLP-1/glucagon Approved in China (NMPA, Jun 2025); not FDA/EMA ~15% (Phase 3 China)
Petrelintide Roche / Zealand Amylin analog (monotherapy) Phase 3 (ZUPREME-3/-4/-5, announced Sep 22, 2026) 10.7% at 42 wks (ZUPREME-1); up to 9.2% vs 2.0% at 28 wks in T2D (ZUPREME-2, Oct 7, 2026)
Oral VK2735 Viking Therapeutics Dual GLP-1/GIP (oral) Phase 2 complete; Phase 3 SUNRISE registered Oct 9, 2026 Up to 12.2% at 13 wks
MariTide (maridebart cafraglutide) Amgen GLP-1 agonist + GIP receptor antagonist (monthly injection) Phase 3 (MARITIME, since Mar 2025) No Phase 3 readout yet (MARITIME-1 and -2 primary completion est. Jan 2027)
Eloralintide Eli Lilly Amylin receptor agonist Phase 3 (ENLIGHTEN, since Dec 2025) With tirzepatide (EloraTZP): up to 23.3% vs 14.8% on tirzepatide 15 mg, 48 wks, T2D (Phase 2b efficacy estimand, Sep 30, 2026)
Cagrilintide (alone) Novo Nordisk Amylin analog (monotherapy) Phase 3 (RENEW, since Nov 2025) No Phase 3 readout yet
Elecoglipron (AZD5004) AstraZeneca Oral non-peptide GLP-1 Phase 3 (Embold, since Jun 2026) 11.8% at 36 wks at 75 mg (Phase 2b VISTA)

Which Obesity Drugs Are FDA Approved?

As of October 2026, five incretin-based medicines are FDA approved for chronic weight management: Saxenda, Wegovy (injection), the Wegovy pill, Zepbound and Foundayo. Saxenda (daily liraglutide 3 mg, approved December 2014; its label now also covers children aged 12 and older) was the first GLP-1 approved for weight management, and a generic liraglutide 3 mg has been approved since August 2025. Older non-incretin drugs (phentermine/topiramate, naltrexone/bupropion and orlistat) and setmelanotide (for rare genetic obesity) are also FDA approved but sit outside this tracker. Wegovy (injectable semaglutide 2.4 mg, approved June 2021) was the first weekly injectable GLP-1 specifically approved for obesity, demonstrating approximately 15% mean weight loss in the STEP 1 trial. Its approval marked the beginning of the modern GLP-1 obesity drug era. A higher 7.2 mg dose, Wegovy HD, was FDA approved on March 19, 2026.

Zepbound (tirzepatide, approved November 2023) raised the efficacy ceiling significantly. As a dual GLP-1/GIP agonist, it showed approximately 22.5% weight loss in the SURMOUNT-1 trial — the highest figure for any approved obesity drug at the time. Tirzepatide demonstrated that multi-receptor agonism could deliver meaningfully greater weight reduction than single-target GLP-1 drugs. For a deeper look at the differences between dual and single agonists, see the GLP-1, GIP and glucagon mechanism guide.

The Wegovy pill (oral semaglutide 25 mg, approved December 2025) became the first oral GLP-1 drug approved for obesity, evolving from the Rybelsus oral semaglutide formulation used for diabetes. The OASIS 4 trial reported 16.6% weight loss with the adherence estimand (13.6% versus 2.2% on placebo in the primary treatment-policy analysis). Its approval expanded the treatment paradigm beyond injections, though the pill requires fasting conditions and water restrictions at dosing.

Foundayo (orforglipron, approved April 1, 2026) is the newest FDA-approved obesity drug and the first oral GLP-1 that can be taken at any time of day without food or water restrictions. In the ATTAIN-1 Phase 3 trial, Foundayo delivered 12.4% weight loss at 72 weeks. Its approval was historic: the FDA cleared it just 50 days after filing under the National Priority Voucher Program, making it the fastest new molecular entity approval since 2002. As a non-peptide small molecule, Foundayo is meaningfully cheaper to manufacture than injectable biologics. For the direct status answer, use the orforglipron status page; for the pricing, label, and launch-impact analysis, use the Foundayo deep dive.

Which Drugs Have Filed for FDA Approval?

CagriSema is the only obesity drug with a pending NDA at the FDA as of October 2026. Novo Nordisk filed the application in December 2025 based on results from the REDEFINE 1 trial, which showed 22.7% average weight loss. CagriSema combines cagrilintide (an amylin analog) with semaglutide (a GLP-1 agonist) in a single weekly injection.

Novo Nordisk's current guidance points to a Q4 2026 U.S. decision window. If approved, CagriSema would be the first combination therapy and the first amylin-based drug approved for obesity. The REDEFINE clinical program includes additional trials evaluating CagriSema in populations with type 2 diabetes and cardiovascular disease. For a head-to-head comparison of CagriSema’s mechanism against tirzepatide, see our CagriSema vs tirzepatide analysis.

CagriSema’s filing is strategically important for Novo Nordisk as the company seeks to defend its position against Eli Lilly’s growing portfolio: Lilly now has both Zepbound (injectable) and Foundayo (oral) on the market, plus retatrutide in Phase 3 (see retatrutide approval status). The amylin component in CagriSema represents a mechanistically distinct approach that targets satiety through a pathway not addressed by GLP-1 or GIP agonism alone. For a direct comparison between the amylin-based approaches, see our zenagamtide vs CagriSema analysis.

Which Drugs Are in Phase 3 Trials?

At least ten obesity programs are in Phase 3 as of October 2026 (ClinicalTrials.gov, checked October 12, 2026), spanning multiple mechanisms and delivery formats. Retatrutide (Eli Lilly) is the most closely watched: this triple agonist targeting GLP-1, GIP, and glucagon receptors showed approximately 24% weight loss in Phase 2. In the Phase 3 TRIUMPH program, TRIUMPH-1 reported 28.3% at 80 weeks (efficacy estimand), and TRIUMPH-2 and TRIUMPH-3 reported positive results on July 23, 2026. Lilly says it will file for US approval no later than Q1 2027; the head-to-head TRIUMPH-5 trial vs tirzepatide is still running. For details on how retatrutide compares to tirzepatide and CagriSema, see our three-way comparison.

Survodutide (Boehringer Ingelheim), a dual GLP-1/glucagon agonist, showed approximately 18.7% weight loss in Phase 2, then up to 16.6% at 76 weeks in Phase 3 SYNCHRONIZE-1 and up to 13.1% in SYNCHRONIZE-2 (obesity with T2D). It is being evaluated in both obesity and metabolic dysfunction-associated steatohepatitis (MASH). Its glucagon component differentiates it from GLP-1/GIP dual agonists by targeting hepatic lipid metabolism. For a head-to-head breakdown, see our survodutide vs retatrutide analysis.

Zenagamtide (amycretin) advanced to Phase 3 in Q1 2026 after showing approximately 22% weight loss in Phase 1b/2 data. Novo Nordisk’s AMAZE program evaluates this unimolecular GLP-1/amylin agonist in obesity, while the AMBITION program (AMBITION 7 started in August 2026) targets type 2 diabetes. The oral tablet trial AMAZE 9 started on August 31, 2026. Unlike CagriSema, which co-injects two separate drugs, zenagamtide combines both receptor activities in a single molecule.

Viking Therapeutics’ VK2735 (subcutaneous) entered Phase 3 (VANQUISH) after demonstrating up to 14.7% weight loss in just 13 weeks of Phase 2 treatment — a rapid onset that drew significant attention. In the Part 1 topline of a maintenance study (September 22, 2026), 21 weeks of weekly dosing gave about 16–19% weight loss versus about 0% on placebo, and participants moved to monthly or every-other-week injections kept up to 90% or 97% of that loss versus 61% on placebo (exploratory endpoints). Both pivotal trials are now fully enrolled (VANQUISH-2 enrollment completed March 26, 2026; VANQUISH-1 fully enrolled per the April 29, 2026 Q1 report), with readouts expected in 2027. Mazdutide (Innovent/Lilly China), a dual GLP-1/glucagon agonist, was approved in China in June 2025. Its Phase 3 trials are run by Innovent in China, where the 9 mg adult-obesity dose has been under NMPA review since November 2025; Lilly’s trials outside China are Phase 1 and 2. Chinese Phase 3 data showed approximately 15% weight loss.

Petrelintide (Roche/Zealand Pharma), the first amylin analog tested as a standalone obesity monotherapy, moved into Phase 3: Zealand announced the start of the ZUPREME-3, -4 and -5 trials (about 7,000 participants, run with Roche) on September 22, 2026, and ClinicalTrials.gov lists ZUPREME-3 as started on September 30, 2026. It reported 10.7% weight loss at 42 weeks in ZUPREME-1 and, on October 7, 2026, up to 9.2% versus 2.0% on placebo at week 28 in people with type 2 diabetes (ZUPREME-2).

Other programs now in Phase 3 include Amgen’s monthly MariTide (maridebart cafraglutide, a GLP-1 receptor agonist and GIP receptor antagonist; MARITIME trials since March 2025), Lilly’s amylin agonist eloralintide (ENLIGHTEN trials since December 2025), Novo Nordisk’s cagrilintide on its own (RENEW trials since November 2025) and AstraZeneca’s oral elecoglipron (Embold, since June 2026). Lilly also reported Phase 2b results for EloraTZP, a combination of eloralintide and tirzepatide, on September 30, 2026: up to 23.3% weight loss versus 14.8% with tirzepatide 15 mg at 48 weeks (efficacy estimand) in 367 adults with obesity or overweight and type 2 diabetes. Lilly plans Phase 3 by the end of 2026.

Which Drugs Are in Phase 2?

With petrelintide now in Phase 3 (see above), the most watched Phase 2 program on this tracker is oral VK2735, which is about to start Phase 3.

Oral VK2735 (Viking Therapeutics) is one of the most watched oral programs after subcutaneous VK2735’s strong Phase 2 results. The oral formulation showed up to 12.2% weight loss at 13 weeks in the VENTURE-Oral trial, positioning it as a potential competitor to both Foundayo and the Wegovy pill if the oral dual-agonist approach continues to deliver in longer trials. For a broader comparison of all oral candidates, see our oral obesity drugs 2026 analysis. Viking’s oral Phase 3 trials SUNRISE-1 (NCT07868835) and SUNRISE-2 (NCT07868939) were first posted on ClinicalTrials.gov on October 9, 2026; both were not yet recruiting on October 12, so this tracker will move oral VK2735 to Phase 3 once Viking confirms the start.

What Should Researchers Watch Next?

Four developments will shape the obesity drug landscape through the rest of 2026 and into 2027. First, the CagriSema FDA decision (current guidance: Q4 2026, no public PDUFA date) will determine whether amylin-based combinations enter the US market. Second, the retatrutide US filing, which Lilly says will come no later than Q1 2027 after positive TRIUMPH-1, -2 and -3 readouts, and the TRIUMPH-5 head-to-head result vs tirzepatide.

Third, watch zenagamtide’s AMAZE Phase 3 data — if its ~22% early signal holds, it could position the unimolecular GLP-1/amylin format as Novo Nordisk’s long-term successor to semaglutide. Fourth, the oral obesity drug race is entering a new phase now that Foundayo is approved alongside the Wegovy pill: Viking’s oral VK2735 will need to demonstrate that a dual-agonist oral can close the efficacy gap with injectables to compete. For the full pipeline timeline, see our obesity drug pipeline timeline.

The broader question for researchers tracking this space is whether oral multi-agonists can match or approach the efficacy of injectable multi-agonists — a gap that current data suggests still exists but is narrowing with each new trial readout. For concerns about discontinuation effects, see our analysis of GLP-1 discontinuation and weight regain data.

May 2026 Research Update — Two Tracker Additions

Elecoglipron (AZD5004, AstraZeneca) — an oral non-peptide GLP-1 receptor agonist — reported Phase 2b VISTA and SOLSTICE results at ADA on June 8, 2026 and moved into Phase 3. In VISTA, the 75 mg group lost 11.8% at 36 weeks versus 0.3% with placebo. In SOLSTICE, HbA1c fell 1.9 percentage points and body weight 7.7% at 26 weeks versus 0.2 points and 1.7% with placebo. AstraZeneca plans obesity, diabetes, cardiovascular, and kidney outcome trials. AstraZeneca primary source.

Separately, the 2025 CVOT Summit consensus report in Cardiovascular Diabetology (Schnell et al, May 6, 2026) synthesised 12 months of cardio-kidney-metabolic outcomes data for the GLP-1, SGLT2, and incretin classes — a multi-society consensus document that provides authoritative context for the integrated-care pathway behind the 2026 approval slate.

Frequently Asked Questions
As of October 12, 2026, the FDA-approved incretin medicines for chronic weight management are Saxenda (daily liraglutide 3 mg, December 2014; generic liraglutide 3 mg since August 2025), Wegovy injection (semaglutide 2.4 mg, June 2021; 7.2 mg Wegovy HD dose March 19, 2026), the Wegovy pill (oral semaglutide 25 mg, December 22, 2025), Zepbound (tirzepatide, November 2023) and Foundayo (orforglipron, April 1, 2026). Older non-incretin drugs (phentermine/topiramate, naltrexone/bupropion, orlistat) and setmelanotide (Imcivree, for rare genetic obesity) are also FDA approved but sit outside this tracker. For the direct yes-or-no answer on each drug, use the linked status pages from this hub.
Not yet. Novo Nordisk filed a New Drug Application (NDA) with the FDA on December 18, 2025 based on the REDEFINE 1 trial showing 22.7% weight loss. The head-to-head REDEFINE-4 trial (Feb 23, 2026) failed non-inferiority vs tirzepatide (20.2% vs 23.6% at 84 weeks). Novo's current guidance points to a Q4 2026 U.S. decision window, with no public PDUFA date posted. In September 2026 REIMAGINE 5 showed 12.4% vs 9.1% weight loss against tirzepatide 5 mg in type 2 diabetes. If approved, CagriSema would be the first combination amylin/GLP-1 therapy for obesity.
Retatrutide (Eli Lilly) showed 28.3% mean weight loss (efficacy estimand) at 80 weeks on 12 mg in the pivotal Phase 3 TRIUMPH-1 trial (May 21, 2026 topline), with up to 30.3% at 104 weeks in a BMI ≥35 extension — the highest figure reported for any obesity drug in a Phase 3 trial. 45.3% of participants achieved ≥30% weight loss. It is a triple agonist targeting GLP-1, GIP, and glucagon receptors. TRIUMPH-2 (T2D) and TRIUMPH-3 (obesity with established CVD) reported positive results on July 23, 2026. TRIUMPH-2 was published in full in The Lancet on September 29, 2026. Lilly says it will file for US approval no later than Q1 2027; retatrutide is not approved anywhere.
Both are FDA-approved oral GLP-1 drugs for obesity. The Wegovy pill (oral semaglutide 25 mg) showed 16.6% weight loss in OASIS 4 if all participants adhered (13.6% in the primary analysis) but must be taken on an empty stomach with limited water. Foundayo (orforglipron) showed 12.4% weight loss in ATTAIN-1 on the comparable efficacy estimand (11.2% in the primary analysis) but can be taken at any time of day without food or water restrictions. For a full comparison, see our oral obesity drugs 2026 guide.
Several programs target the amylin pathway: CagriSema (Novo Nordisk, cagrilintide + semaglutide, NDA filed), petrelintide (Roche/Zealand, amylin analog monotherapy, Phase 3 since September 2026), zenagamtide/amycretin (Novo Nordisk, unimolecular GLP-1/amylin agonist, Phase 3 in injectable and oral forms), eloralintide (Lilly, amylin agonist, Phase 3; its combination with tirzepatide, EloraTZP, reported Phase 2b results on September 30, 2026) and cagrilintide on its own (Novo Nordisk, Phase 3). The amylin pathway is emerging as a key area of obesity drug investment.
Foundayo (orforglipron) set a record: FDA approved just 50 days after filing under the National Priority Voucher Program, the fastest NME approval since 2002. CagriSema has the next-shortest current path, with a Q4 2026 U.S. decision window but no public PDUFA date posted. Lilly says it will file for US approval no later than Q1 2027; Boehringer Ingelheim has not announced a survodutide filing date.

Our Research Standards

This article cites peer-reviewed studies, FDA filings, and ClinicalTrials.gov data. All claims are cross-referenced against primary sources. We update articles when new trial data or regulatory decisions are published. Read our editorial policy →

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Editorial Review

Editorial Board, Remy Research

The Remy Research Editorial Board reviews research articles covering GLP-1 receptor agonists, triple agonists, and the obesity drug pipeline. Its review spans peptide analytical chemistry, HPLC purity validation, and clinical trial data interpretation.

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References & Citations
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  2. Novo Nordisk. CagriSema NDA filing. December 2025. prnewswire.com
  3. Jastreboff AM, et al. Retatrutide Phase 2 trial. N Engl J Med. 2023. doi:10.1056/NEJMoa2301972
  4. Eli Lilly. FDA approves Foundayo (orforglipron). April 2026. investor.lilly.com
  5. Eli Lilly. Orforglipron ATTAIN-1 Phase 3 results. August 2025. investor.lilly.com
  6. Roche. Petrelintide ZUPREME-1 Phase 2 results. March 2026. roche.com
  7. Novo Nordisk. Zenagamtide (amycretin) Phase 3 advancement. Q1 2026. novonordisk.com
  8. Viking Therapeutics. VK2735 pipeline. vikingtherapeutics.com
  9. Viking Therapeutics. VANQUISH-2 enrollment completed; Viking expects to complete both VANQUISH studies in 2027 (March 26, 2026). ir.vikingtherapeutics.com
  10. Viking Therapeutics. Viking Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update: VANQUISH-1 and VANQUISH-2 fully enrolled. April 29, 2026. ir.vikingtherapeutics.com
  11. Eli Lilly. Retatrutide TRIUMPH-2 and TRIUMPH-3 topline results; BLA planned Q1 2027. July 23, 2026. investor.lilly.com
  12. FDA. FDA approves higher dose semaglutide (Wegovy HD 7.2 mg). March 19, 2026. fda.gov
  13. Novo Nordisk. CagriSema REIMAGINE 5 and REDEFINE 9 results. September 21, 2026. globenewswire.com
  14. MHRA. UK first in Europe to authorise orforglipron for weight management and type 2 diabetes. August 10, 2026. gov.uk
  15. Boehringer Ingelheim. Positive data from two Phase III SYNCHRONIZE obesity trials. boehringer-ingelheim.com
  16. ADA Meeting News. Primary results for SOLSTICE and VISTA (elecoglipron / AZD5004) to be shared at ADA 2026 Scientific Sessions, June 5–8. April 27, 2026. adameetingnews.org
  17. Schnell O, et al. CVOT Summit Report 2025 — cardiovascular-kidney-metabolic disease consensus across GLP-1, SGLT2, and incretin classes. Cardiovasc Diabetol. 2026 May 6;25(1):142. PMID 42092956. pubmed.ncbi.nlm.nih.gov
  18. Bellido V, et al. Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial. Lancet. 2026;408(10563):1455–1472. Published September 29, 2026. doi:10.1016/S0140-6736(26)01861-1. pubmed.ncbi.nlm.nih.gov
  19. U.S. Food and Drug Administration. Drugs@FDA: Saxenda (liraglutide) injection, NDA 206321, original approval December 23, 2014. accessdata.fda.gov
  20. Pi-Sunyer X, et al. A randomized, controlled trial of 3.0 mg of liraglutide in weight management (SCALE Obesity and Prediabetes). N Engl J Med. 2015;373(1):11–22. doi:10.1056/NEJMoa1411892. pubmed.ncbi.nlm.nih.gov
  21. U.S. Food and Drug Administration. Drugs@FDA: liraglutide injection (Teva), ANDA 214568, generic of Saxenda, approved August 27, 2025. accessdata.fda.gov
  22. U.S. Food and Drug Administration. Drugs@FDA records: Qsymia (NDA 022580, 2012), Contrave (NDA 200063, 2014), Xenical (NDA 020766, 1999) and Imcivree (NDA 213793, 2020). Checked October 12, 2026. accessdata.fda.gov
  23. Novo Nordisk. The European Commission approves the 7.2 mg maintenance dose of injectable Wegovy for adults with obesity. February 17, 2026. biospace.com
  24. Emirates Drug Establishment. Emirates Drug Establishment approves oral obesity treatment (Foundayo), marking shift away from injections. April 3, 2026. ede.gov.ae
  25. Emirates Drug Establishment. Emirates Drug Establishment approves oral Wegovy (semaglutide) for weight management and cardiovascular risk reduction. June 1, 2026. ede.gov.ae
  26. Zealand Pharma. Zealand Pharma announces initiation of the registrational Phase 3 ZUPREME program of petrelintide in people with overweight or obesity. September 22, 2026. globenewswire.com
  27. Zealand Pharma. Zealand Pharma announces positive Phase 2 ZUPREME-2 topline results for amylin analog petrelintide in people with overweight or obesity and type 2 diabetes. October 7, 2026. globenewswire.com
  28. ClinicalTrials.gov. ZUPREME-3: A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity (NCT07843498). Recruiting; started September 30, 2026. Checked October 12, 2026. clinicaltrials.gov
  29. Viking Therapeutics. Positive topline results from maintenance study of GLP-1/GIP agonist VK2735 (Part 1). September 22, 2026. prnewswire.com
  30. ClinicalTrials.gov. Oral VK2735 for Weight Management Phase 3 (SUNRISE 1) (NCT07868835). First posted October 9, 2026; not yet recruiting. Checked October 12, 2026. clinicaltrials.gov
  31. ClinicalTrials.gov. Oral VK2735 for Weight Management in Adults With Type 2 Diabetes Mellitus Phase 3 (SUNRISE 2) (NCT07868939). First posted October 9, 2026; not yet recruiting. Checked October 12, 2026. clinicaltrials.gov
  32. Eli Lilly. EloraTZP (eloralintide and tirzepatide) delivered greater weight loss and A1C reduction vs. tirzepatide 15 mg in adults with obesity and type 2 diabetes. September 30, 2026. investor.lilly.com
  33. ClinicalTrials.gov. MARITIME-1: Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (NCT06858839). Active, not recruiting; primary completion estimated January 2027. Checked October 12, 2026. clinicaltrials.gov
  34. ClinicalTrials.gov. ENLIGHTEN-1: A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes (NCT07321886). Recruiting. Checked October 12, 2026. clinicaltrials.gov
  35. ClinicalTrials.gov. RENEW 1: Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide (NCT07220642). Active, not recruiting. Checked October 12, 2026. clinicaltrials.gov
  36. ClinicalTrials.gov. Embold: Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight (NCT07667803). Recruiting; started June 29, 2026. Checked October 12, 2026. clinicaltrials.gov
  37. ClinicalTrials.gov. AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight (NCT07339423). Recruiting; started February 24, 2026. Checked October 12, 2026. clinicaltrials.gov
  38. ClinicalTrials.gov. AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss (NCT07503210). Started April 21, 2026. Checked October 12, 2026. clinicaltrials.gov
  39. ClinicalTrials.gov. AMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight (NCT07720271). Recruiting; started August 31, 2026. Checked October 12, 2026. clinicaltrials.gov
  40. Innovent Biologics. The Phase 3 GLORY-2 study of mazdutide 9 mg in Chinese adults with moderate to severe obesity was simultaneously published in JAMA and presented at the ADA Scientific Sessions (9 mg NDA submitted November 2025 and accepted by the NMPA). June 8, 2026. innoventbio.com
  41. U.S. Food and Drug Administration. Novel Drug Approvals for 2026 (Foundayo, April 1, 2026; no CagriSema or retatrutide entry as of October 12, 2026). fda.gov

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