GLP-1 Pipeline Update: November 2025 - Prime Therapeutics
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GLP-1 Pipeline Update: November 2025
Quarterly view of the GLP-1 pipeline and anticipated indications
November 20, 2025
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). Researchers are still learning about their other potential uses, and more market growth is expected.
There are three GLP-1 FDA decisions expected in 2025, all for Novo Nordisk’s semaglutide:
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Ozempic for T2DM and peripheral artery disease (PAD)
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Wegovy SC for heart failure with preserved ejection fraction (HFpEF) and obesity
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The first oral GLP-1 (oral formulation of Wegovy 25 mg) for weight loss and weight loss plus secondary CV risk reduction
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. Explore the FAQ below and visit the October 2025 Quarterly Drug Pipeline for deeper insights.
Access the complete GLP-1 Pipeline Update table for November 2025.
GLP-1s by year and indication
GLP-1s by indication and year
GLP-1 pipeline FAQs
In October 2025, Novo Nordisk received FDA approval for their supplemental new drug application (sNDA) for semaglutide (Rybelsus) 7 mg and 14 mg tablets to reduce the risk of major adverse cardiac events (MACE) in adults with T2DM and who are at high risk for these events, including cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. FDA approval was based on the SOUL cardiovascular outcomes trial (CVOT) that demonstrated a 14% relative reduction in risk of MACE in patients treated with Rybelsus 14 mg orally once daily for approximately 5 years compared to those who received placebo. Moreover, risk reductions were seen across all components of MACE, namely cardiovascular death, non-fatal heart attack and non-fatal stroke.
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Novo Nordisk is awaiting new indications for their injectable semaglutide products.
- Novo Nordisk resubmitted Wegovy SC for the treatment of patients with heart failure with preserved ejection fraction (HFpEF) and obesity. A prespecified analysis of pooled data from the STEP-HFpEF and STEP-HFpEF DM trials demonstrated that significantly more patients treated with Wegovy 2.4 mg SC once weekly had an improvement of at least one New York Heart Association (NYHA) functional class compared to those who received placebo (32.6% versus 21.5%, respectively; p<0.001) from baseline to 52 weeks. In addition, fewer semaglutide-treated patients experienced deterioration in NYHA functional class (2.09% versus 5.24%, respectively; p=0.003).
- Ozempic was submitted to the FDA for the treatment of patients with T2DM and peripheral artery disease (PAD). T2DM is a leading risk factor for PAD, which limits physical functions. Published data from the Phase 3b STRIDE trial reported that Ozempic 1 mg SC once weekly improved maximum walking distance by 13% compared to placebo after 52 weeks (p=0.0004).
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Novo Nordisk is awaiting new approvals for their oral semaglutide products.
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Novo Nordisk announced FDA acceptance of their New Drug Application (NDA) for a 25 mg oral version of Wegovy for two new indications: (1) chronic weight management in adults living with obesity or who are overweight with at least one comorbid condition, and (2) to reduce the risk of MACE in adults with overweight or obesity and established CVD. If approved, Wegovy will become the first oral GLP-1 indicated for chronic weight management. The NDA was based on results from the OASIS-4 trial in adults with obesity or overweight. Patients with diabetes were excluded. Enrolled patients were randomized to once-daily oral Wegovy 25 mg or placebo, as an adjunct to lifestyle intervention for 64 weeks. Mean weight change was -13.6% in the Wegovy group versus -2.2% in the placebo group (p<0.0001). In addition, 79% of patients who received Wegovy compared to 31% who received placebo achieved at least 5% of their body weight (p<0.0001).
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- As of Dec. 21, 2024, three generic versions of liraglutide (Victoza) for the treatment of T2DM are commercially available in the U.S. An authorized generic (AG) version launched in the U.S. in June 2024. Additional generics for Victoza may become available in 2025.
- The FDA approved Amneal’s generic version of AstraZenaca’s exenatide injection (Byetta). This is the first generic for the GLP-1 receptor agonist. Byetta is indicated as an adjunct to diet and exercise in adults with T2DM and is dosed twice daily via SC injection. Amneal launched its generic in late November 2024. In addition, in October 2024, AstraZeneca announced that it will discontinue marketing brand Byetta.
- On August 27, 2025, the FDA approved the first generic version of liraglutide (Saxenda) for weight loss in adults and adolescents with obesity and adults with overweight and at least one weight-related comorbid condition. Teva immediately launched the generic on August 28, 2025. Additional generics for Saxenda may be approved on or after Feb. 24, 2026.
- A generic for dulaglutide (Trulicity) could be available in 2027.
Yes, for a large part, the GLP1 shortage has been resolved.
- In February 2025, the FDA announced that the shortage of semaglutide injectable products (Ozempic, Wegovy) was resolved.
- The dulaglutide (Trulicity) shortage was resolved in June 2025.
- As of July 2025, generic versions of liraglutide (Victoza) and brand Saxenda are available; however, in early November 2025, the FDA indicated that supply of brand Victoza is limited due to delayed shipping.
Other companies with phase 3 trials include:
- Zealand and Boehringer Ingelheim have survodutide in Phase 3 trials and is included in the GLP-1 Pipeline Update. Survodutide targets the GLP-1 receptor and glucagon receptor. Zealand reports that they are studying survodutide for treatment of obesity. An FDA decision could be as early as 2027 based on estimated trial completion dates. Survodutide is also being studied in Phase 3 trials for the treatment of MASH.
- Amgen’s investigational maridebart caftaglutide (Maritide) targets the GLP-1 receptor and glucose-dependent insulinotropic polypeptide receptor (GIPR). Phase 3 trials for obesity and weight-related conditions are enrolling patients. FDA approval is expected in 2028 or beyond.
- Viking’s dual GLP-1/GIP receptor agonists VK2735 is being investigated in oral and SC formulations. The Phase 3 trial for obesity and related conditions initiated in 2025. FDA approval could occur in 2028 or beyond.
Yes, in November 2025, Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s investigational orforglipron received CNPVs for obesity and related health conditions. National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need. Key benefits of the pilot program include faster review times of one to two months, rather than 10 to 12 months, while maintaining FDA’s rigorous safety and efficacy standards. The basis of the accelerated timeline is a one-day “tumor board style” meeting which convenes a multidisciplinary group of physicians and scientists for a team-based review. Injectable Wegovy is currently under review by the FDA for the treatment of patients with heart failure with preserved ejection fraction (HFpEF) and obesity and a new 25 mg oral version of Wegovy under review is being reviewed for two indications: (1) chronic weight management in adults living with obesity or who are overweight with at least one comorbid condition, and (2) to reduce the risk of MACE in adults with overweight or obesity and established CVD.
On Nov. 6, 2025, Novo Nordisk and Eli Lilly entered into a series of agreements with the U.S. government to expand access and lower cost of GLP-1 agents for Medicare recipients beginning in 2026. Currently, medications for obesity alone are not covered under Medicare. The new agreement will allow Medicare Part D coverage for anti-obesity medicines for certain populations. State Medicaid programs will also have access to these prices if they opt into them. Both companies will receive three years of tariff relief.
Select highlights of the agreement are:
Select highlights of the agreement are:
- Medicare prices for the injectable anti-obesity agents semaglutide (Wegovy) and tirzepatide (Zepbound), as well as their corresponding agents for T2DM Ozempic and Mounjaro, will be $245 per month. Medicare beneficiaries will pay a $50 copay per month. State Medicaid programs will also have access to these medications at these prices.
- Self-pay patients may purchase injectable Wegovy and Ozempic at $350 per month and Zepbound and oral orforglipron (if FDA approved), at an average price of $346 per month through TrumpRx. The initial dose of investigational oral Wegovy or certain similar oral GLP-1s in each company’s pipeline, if approved, will be available for $150 per month through TrumpRx.
- TrumpRx is a federal initiative to connect patients directly with discounted prices. Per the TrumpRx site, it is expected to launch in January 2026.
Glossary
CKD chronic kidney disease
CNS central nervous system
CVD cardiovascular disease
FDA Food and Drug Administration
GLP-1 glucagon-like peptide-1
GLP-1s glucagon-like peptide-1 receptor agonists
HF heart failure
MASH metabolic dysfunction-associated steatohepatitis
OA osteoarthritis
OSA obstructive sleep apnea
PAD peripheral arterial disease
SC subcutaneous
T2DM type 2 diabetes mellitus
U.S. United States
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