GLP-1 Pipeline Update: August 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
Over a decade ago, the first injectable glucagon-like peptide-1 receptor agonist (GLP-1) for type 2 diabetes mellitus (T2DM) was approved by the Food and Drug Administration (FDA) for chronic weight management. Since then, several GLP-1s for obesity have been approved for new indications, such as cardiovascular risk reduction (Wegovy), obstructive sleep apnea (Zepbound) and metabolic dysfunction-associated steatohepatitis (MASH; Wegovy). Notably, two oral GLP-1s (Wegovy and Foundayo) and an injectable high-dose formulation of Wegovy are now approved for weight management. As researchers investigate new therapeutic applications for this class, robust market growth is expected.
There are four GLP-1 FDA decisions to watch in 2026
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Eli Lilly’s injectable Mounjaro, with a new indication to reduce the risk of major adverse cardiovascular events in patients with T2DM, is expected in the third quarter of 2026.
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Eli Lilly’s oral Foundayo for T2DM is expected in the fourth quarter of 2026.
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Novo Nordisk’s oral Ozempic 25 mg tablet, with a new use for T2DM, is expected in the fourth quarter of 2026.
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Novo Nordisk’s injectable, fixed-dose combination of semaglutide and cagrilintide, an amylin receptor agonist, for weight loss is expected in December 2026.
Given the considerable continued expansion and innovation across the GLP-1 pipeline, Prime Therapeutics’ team of clinical experts actively monitors emerging evidence and developments. While evaluating the balance between benefits, risks and real-world outcomes is central to this work, delivering holistic, patient-centered care remains the cornerstone of our practice.
Our GLP-1 Pipeline Update offers a timely clinical snapshot of innovation on the horizon. Read on to learn more, explore the FAQs below and visit the Quarterly Drug Pipeline for deeper insights into anticipated therapies currently in development.
Access the complete GLP-1 Pipeline Update table for August 2026.
GLP-1s by year and indication
GLP-1s by indication and year
GLP-1 receptor agonist pipeline update FAQs
Eli Lilly is awaiting an FDA decision for a new indication for tirzepatide (Mounjaro) to reduce the risk of major adverse cardiovascular events (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 and stroke — by 8% compared with dulaglutide (Trulicity; P=0.086), demonstrating noninferiority to Trulicity regarding CV risk. The FDA decision is expected in the third quarter of 2026.
Novo Nordisk is awaiting an FDA decision on its fixed-dose combination of cagrilintide, an amylin receptor agonist, and semaglutide, a GLP-1. The therapy is designed for once-weekly subcutaneous administration using a dual-chamber injection device. If approved, it would be the first GLP-1/amylin agonist 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 lost at least 25% of their body weight. An FDA decision is anticipated in December 2026.
Novo Nordisk filed a supplemental New Drug Application (sNDA) for semaglutide (Ozempic) 25 mg oral tablets for adults with T2DM. The company expected an FDA decision during the second quarter of 2026. Currently, the oral formulation of Ozempic is available as 1.5 mg, 4 mg and 9 mg tablet strengths to treat adults with T2DM.
In the second quarter of 2026, Novo Nordisk submitted semaglutide (Wegovy) 25 mg tablets to the FDA for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). No timeline for the FDA decision has been announced, but Prime Therapeutics estimates that it could occur sometime in 2026 or early 2027.
Eli Lilly submitted orforglipron (Foundayo) for the treatment of T2DM during the second quarter of 2026 under the Commissioner's National Priority Review Voucher (CNPV) pilot program, making its approval possible in the fourth quarter of 2026.
GLP-1s promote weight loss, with reductions in fat mass generally exceeding losses in lean mass. Lean mass comprises all nonfat tissues in the body, including skeletal muscle, organs, bone, connective tissue and water. Available evidence suggests that the proportion of weight loss attributable to lean mass with GLP-1 therapies appears broadly comparable to that observed with lifestyle interventions alone. However, because GLP-1s typically produce greater overall weight loss, the absolute amount of lean mass lost may be higher. Across clinical trials for GLP-1s, lean mass loss has accounted for approximately 25%–40% of total weight loss. Directed head-to-head trial comparisons of lean mass changes among individual GLP-1s are lacking.
Pivotal clinical trials for oral orforglipron (Foundayo), injectable tirzepatide (Zepbound) and injectable semaglutide (Wegovy) each contained subsets of patients who underwent dual-energy X-ray absorptiometry (DXA) to assess body composition. The table below displays DXA results in patients with obesity or overweight and without T2DM.
| Trial | Total body fat mass change | Total lean body mass change | Fat mass contribution | Lean mass contribution |
|---|---|---|---|---|
| ATTAIN-1 orforglipron (pooled doses) n=171 Week 72 |
-13.8% | -4.5% | 73.1% | 26.9% |
| SURMOUNT-1 tirzepatide (pooled doses) n=160 Week 72 |
-33.9% | -10.9% | ~75% | ~25% |
| STEP-1 semaglutide 2.4 mg n=95 Week 68 |
-19.3% | -9.7% | Not directly reported | Not directly reported |
While GLP-1s have been shown to reduce lean body mass and improve the lean mass-to-fat mass ratio, questions remain regarding their effects on skeletal muscle mass, muscle strength, physical function and long-term metabolic outcomes that have not been evaluated in clinical trials. Potential skeletal muscle mass loss is of particular concern in older adults and individuals who experience substantial weight loss, as these populations may be at greater risk for losses in muscle strength and physical function. Importantly, incorporating adequate dietary protein intake and personalized resistance training in any weight loss program may help preserve muscle mass and overall functional health.
Eli Lilly reports that tirzepatide is in clinical trials for autoimmune conditions in patients with obesity or overweight. These trials, which are estimated to be completed in 2027, include its use as monotherapy in adults with type 1 diabetes mellitus (T1DM). In addition, topline results are expected in 2026 for combination therapy of tirzepatide with ixekizumab (Taltz) for adults with obesity or overweight with plaque psoriasis (PSO) or psoriatic arthritis (PsA). Tirzepatide combined with mirikizumab (Omvoh) is also being evaluated in Phase 3 trials for adults with ulcerative colitis (UC) or Crohn’s disease (CD) with obesity or overweight, with study completion anticipated in 2028.
Novo Nordisk’s injectable semaglutide is 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 co-transporter 2 inhibitor [SGLT2i]), with completion dates ranging from 2024 through 2029.
GLP-1 hormone receptors are expressed widely throughout the body, including key reward-processing regions of the brain. Although the central mechanisms by which GLP-1s influence alcohol consumption are not fully defined, evidence suggests that GLP-1 hormone signaling may help modulate reward responses, reduce motivation to consume alcohol and prevent relapse by lowering alcohol-induced reward, supporting the use of GLP-1s as a potential target for AUD treatment.
The Phase 2 SEMALCO study 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%).
The Phase 3 CRAVE study of injectable semaglutide use in U. S. veterans with AUD has been announced, with primary completion estimated in April 2028. Tirzepatide and the investigational GLP-1s 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 Novo Nordisk’s oral semaglutide tablets for adults with T2DM. The renamed tablets, available in 1.5 mg, 4 mg and 9 mg strengths, are designed to provide improved bioavailability, with therapeutic effects comparable to the original 3 mg, 7 mg and 14 mg oral semaglutide doses marketed as Rybelsus.
The name change was intended to clarify that both the oral and injectable formulations of Ozempic are approved for T2DM. The new Ozempic tablets became available in the United States on May 4, 2026, and have replaced Rybelsus tablets. Patients taking Rybelsus will require a new prescription with the new dose and Ozempic National Drug Code (NDC) number.
Ozempic is the only oral GLP-1 approved by the FDA for primary and secondary CV risk reduction — including heart attack, stroke and death — in adults with T2DM who are at high risk for these events or have established 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 |
Multiple generics are available for liraglutide (Victoza) for the treatment of T2DM.
In August 2025, Teva launched the first generic of liraglutide (Saxenda) for weight loss in adults and adolescents. Additional generics for Saxenda became available in February 2026, and Teva discontinued marketing its generic in May 2026.
One generic version of exenatide injection (Byetta) is available in the United States for adults with T2DM. Marketing of the brand-name Byetta has been discontinued in the United States.
A generic for dulaglutide (Trulicity) could be available at the end of 2027.
Glossary
CV cardiovascular
CVD cardiovascular disease
DXA dual-energy X-ray absorptiometry
FDA Food and Drug Administration
GIP glucose-dependent insulinotropic polypeptide
GLP-1 glucagon-like peptide-1
GLP-1s glucagon-like peptide-1 receptor agonists
HTN hypertension
MACE major adverse cardiovascular event
MASH metabolic dysfunction-associated steatohepatitis
NDC National Drug Code
OA osteoarthritis
OSA obstructive sleep apnea
PsA psoriatic arthritis
PSO plaque psoriasis
SC subcutaneous
SGLT2i sodium-glucose co-transporter 2 inhibitor
T1DM type 1 diabetes mellitus
T2DM type 2 diabetes mellitus
UC ulcerative colitis
U.S. United States
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