GLP-1 Pipeline Update: May 2026
Quarterly view of the GLP-1 pipeline and anticipated indications
Editorial team
Maryam Tabatabai, PharmD
Editor-In-Chief
Associate Vice President, Clinical Information
Carole Kerzic, RPh
Executive Editor
Drug Information Pharmacist Principal
Nicole Kjesbo, PharmD, BCPS
Executive Editor
Clinical Program Development Director Senior, Pipeline
DISCLAIMER
The drug pipeline is fluid; the dates and information within this publication are subject to change. Nothing herein is or shall be construed as a promise or representation regarding past or future events and Prime Therapeutics expressly disclaims any and all liability relating to the use of or reliance on the information contained in this presentation. The information contained in this publication is intended for educational purposes only and should not be considered clinical, financial, or legal advice. By receipt of this publication, each recipient agrees that the information contained herein will be kept confidential and that the information will not be photocopied, reproduced, distributed to, or disclosed to others at any time without the prior written consent of Prime Therapeutics.
All brand names are property of their respective owners.
Introduction
The first glucagon-like peptide-1 receptor agonist (GLP-1) for type 2 diabetes mellitus (T2DM) was FDA-approved 25 years ago. Over a decade ago, the first injectable GLP-1 received FDA approval for chronic weight management. Since then, several GLP-1s for obesity have been approved for new indications such as secondary cardiovascular risk reduction (Wegovy), sleep apnea (Zepbound) and metabolic dysfunction-associated steatohepatitis or MASH (Wegovy). Notably, oral semaglutide (Wegovy) became the first oral GLP-1 approved for weight loss and weight loss plus secondary CV risk reduction. Researchers are still learning about GLP-1’s other potential uses, and more market growth is expected.
There are three GLP-1 FDA decisions expected in early-mid 2026
- Eli Lilly’s Mounjaro with a new indication to reduce the risk of major adverse cardiovascular events (MACE) in patients with T2DM
- Eli Lilly’s oral once-daily orforglipron for weight loss
- Novo Nordisk’s higher dose (7.2 mg) injectable once-weekly Wegovy for weight loss
Given the considerable continued growth expected in the GLP-1 pipeline, Prime Therapeutics’ talented team of clinical experts actively monitors this emerging landscape. The risk to benefit profile of these agents and outcomes data are key as we evaluate the evidence. Moreover, holistic care of patients remains a cornerstone of care.
Our GLP-1 Pipeline Update offers a credible clinical snapshot of what is on the horizon. The below tables display the earliest potential approval dates of the agents listed. Dates are based on manufacturer published announcements or communications or are estimated based on study completion dates and may change as more information becomes available.
Keep reading to learn more, explore the FAQ below and visit the Quarterly Drug Pipeline for deeper insights into anticipated therapies in development.
Access the complete GLP-1 Pipeline Update table for February 2026.
GLP-1s by year and indication
GLP-1s by indication and year
GLP-1 pipeline FAQs
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On March 19, 2026, the FDA approved a new, high-dose semaglutide (Wegovy HD) injection (7.2 mg) for once-weekly, subcutaneous (SC) administration for weight reduction and long-term maintenance. In the STEP UP clinical trial, the 7.2-mg dose demonstrated a mean weight loss of 20.7% at 72 weeks, compared with a reduction of 17.5% with the previously approved semaglutide (Wegovy) injection (2.4 mg) and 2.4% with placebo. Wegovy HD was approved using the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program that expedites FDA review.
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On April 1, 2026, the FDA approved orforglipron (Foundayo) by Eli Lilly — for adults with obesity or overweight who also have weight-related medical problems — to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Also approved under the CNPV pilot, Foundayo is a once-daily, oral nonpeptide GLP-1 that requires dose titration to mitigate gastrointestinal side effects. Unlike oral semaglutide, a peptide GLP-1, Foundayo can be taken at any time of the day without restrictions on food and water intake. Foundayo is available in 0.8-mg, 2.5-mg, 5.5-mg, 9-mg, 14.5-mg and 17.2-mg tablets of orforglipron. In the double-blind, placebo-controlled ATTAIN-1 trial, continuous use of the highest dose of Foundayo led to an average weight loss of 12.4% (27.3 pounds) after 72 weeks, compared with 0.9% (2.2 pounds) with placebo.
- Novo Nordisk is awaiting an FDA decision for their fixed-dose combination of the amylin receptor agonist, cagrilintide, and the GLP-1, semaglutide. It is expected to be packaged in a dual-chamber device for once-weekly SC injection. If approved, cagrilintide/semaglutide would be the first amylin/GLP-1 combination for weight management. In the REDEFINE 1 clinical trial, patients treated with the combination achieved a mean weight loss of 22.7% at 68 weeks, and more than 40% of participants achieved at least a 25% reduction in body weight.
- Eli Lilly is awaiting an FDA decision for a new indication for Mounjaro to reduce the risk of a major adverse cardiovascular event (MACE) in patients with type 2 diabetes mellitus (T2DM). The submission is supported by the SURPASS CVOT trial, which showed that Mounjaro reduced the risk of MACE — including cardiovascular (CV) death, heart attack, or stroke — by 8% compared with dulaglutide (Trulicity; p=0.086), demonstrating noninferiority to Trulicity regarding CV risk. The FDA decision is expected in mid-2026.
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Novo Nordisk filed a supplemental drug application for Ozempic 25-mg oral tablets for T2DM in adults. The company expects an FDA decision by the end of 2026.
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Eli Lilly is planning to submit orforglipron (Foundayo) for the treatment of T2DM in the second quarter of 2026 under the CNPV, making it possible for the drug to receive FDA approval in late 2026.
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Eli Lilly reports that tirzepatide is in clinical trials for autoimmune conditions in patients with obesity or overweight. These trials, which are estimated to complete in 2027, include its use as monotherapy in adults with type 1 diabetes mellitus (T1DM). In addition, combination therapy with ixekizumab (Taltz) is in Phase 3 trials for adults with plaque psoriasis (PSO) or psoriatic arthritis (PsA). The trials are expected to complete in the first half of 2026. Tirzepatide combined with mirikizumab (Omvoh) is being evaluated in Phase 3 trials for adults with ulcerative colitis (UC) or Crohn’s disease (CD). Completion of these studies is expected in 2028.
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Novo Nordisk’s injectable semaglutide is also in Phase 3 development for T1DM with and without comorbidities. Most studies are small and include semaglutide used as monotherapy or combination therapy (with an insulin ± sodium-glucose cotransporter 2 inhibitor [SGLT2i]). Completion dates range from 2024 through 2029.
A Phase 2 clinical study (SEMALCO) conducted in Denmark evaluated whether weekly semaglutide injections could help reduce drinking in adults with moderate-to-severe AUD who also had obesity. The study of 108 adults compared semaglutide with placebo, in addition to cognitive behavioral therapy. After 26 weeks, participants treated with semaglutide had a greater reduction in heavy drinking days (41.1%) compared with those who received placebo (26.4%).
A Phase 3 study (CRAVE) of injectable semaglutide use in U.S. veterans with AUD has been announced, with primary completion estimated for April 2028. Tirzepatide and investigational GLP-1 agents pemvidutide (by Altimmune), brenipatide and maxdutide (both by Eli Lilly) are also in Phase 2 trials for AUD.
Yes. In February 2026, the FDA approved Ozempic as the new proprietary name for the 1.5-mg, 4-mg and 9-mg oral semaglutide formulations for adults with T2DM. Ozempic tablets provide improved bioavailability, enabling them to deliver a therapeutic effect comparable to the original 3-mg, 7-mg and 14-mg oral semaglutide doses marketed as Rybelsus. This name change is intended to clarify that both the oral and injectable formulations of Ozempic are approved to treat T2DM. The new Ozempic tablets became available in the United States on May 4, 2026. This is the only oral GLP-1 that is FDA approved for primary and secondary MACE reduction in adults with T2DM at high risk for these events, including patients with existing heart disease.
| GLP-1 | GIP | Amylin | Glucagon | Insulin | |
|---|---|---|---|---|---|
| dulaglutide (Trulicity) | X | ||||
| exenatide (Bydureon BCise) | X | ||||
| liraglutide (Victoza, Saxenda) | X | ||||
| liraglutide/insulin degludec (Xultophy) | X | X | |||
| lixisenatide/insulin glargine (Soliqua) | X | X | |||
| semaglutide (Ozempic, Wegovy, Rybelsus) | X | ||||
| orforglipron (Foundayo) | X | ||||
| tirzepatide (Mounjaro, Zepbound) | X | X | |||
| cagrilintide/semaglutide | X | X | |||
| retatrutide | X | X | X | ||
| survodutide | X | X | |||
| VK2735 | X | X |
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Multiple generics of liraglutide (Victoza) are available for the treatment of T2DM.
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In August 2025, Teva launched the first generic of liraglutide (Saxenda) for weight loss in adults and adolescents. Additional generics for Saxenda may enter the market on or after Feb. 24, 2026.
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One generic version of exenatide injection (Byetta) is available in the United States for adults with T2DM. Marketing of brand Byetta has been discontinued in the United States.
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A generic for dulaglutide (Trulicity) could be available at the end of 2027.
Glossary
CD Chron's disease
CLBP chronic low back pain
CNPV Commissioner's National Priority Voucher
CV cardiovascular
CVD cardiovascular disease
GLP glucose-dependent insulinotropic polypeptide
MACE major adverse cardiovascular events
PSO psoriatic arthritis
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