GLP-1 Pipeline Update: February 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
-
On Dec. 22, 2025, the FDA approved Novo Nordisk’s oral Wegovy 25 mg as the first oral GLP-1 therapy for weight loss. It is approved for: (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. FDA approval was supported by the OASIS-4 trial that showed that once-daily oral Wegovy 25 mg as an adjunct to lifestyle led to a mean weight change in body weight from baseline to week 64 of -13.6% compared to -2.2% with placebo (p<0.0001) in adults with obesity or overweight (without diabetes).
-
On Dec. 19, 2025, the indication for Eli Lilly’s Mounjaro to improve glycemic control was expanded to include pediatric patients as young as 10 years of age who have T2DM. The SURPASS-PEDS trial demonstrated safety and efficacy in this younger population. Adverse reactions reported in pediatric patients treated with Mounjaro were similar to those reported in adults; however, the incidence of vomiting, abdominal pain and hypoglycemia were higher in the pediatric population.
-
Eli Lilly is awaiting an FDA decision for a new indication for Mounjaro to reduce the risk of MACE in patients with T2DM. The submission is supported by the SURPASS-CVOT trial, which showed that Mounjaro reduced the risk of MACE—including CV death, heart attack, or stroke—by 8% compared with Trulicity (p=0.086), demonstrating noninferiority to Trulicity regarding CV risk.
-
Novo Nordisk is awaiting an FDA decision for a higher dose of injectable Wegovy of 7.2 mg once weekly for chronic weight management in adults with obesity. In the STEP-UP trial, significantly greater body weight loss at 72 weeks was achieved with Wegovy 7.2 mg (18.7%) compared to Wegovy 2.4 mg (15.6%) and placebo (3.9%) (both p<0.001). The higher dose may allow Wegovy to compete with Zepbound more closely, which achieved weight loss of 19.5% and 20.9% with its higher doses of 10 mg and 15 mg, respectively, at 72 weeks.
-
Orforglipron is a once-daily oral GLP-1 by Eli Lilly awaiting an FDA decision for the treatment of adults with obesity or overweight by 2Q 2026. The ATTAIN-1 trial reported a mean change in body weight at 72 weeks of -11.2% with the highest dose of orforglipron 36 mg compared to -2.1% with placebo in adults with obesity or overweight and at least one weight-related comorbidity. If approved, orforglipron will be the second oral GLP-1 agent for weight loss and is expected to compete with oral Wegovy.
-
Novo Nordisk filed a supplemental drug application for Ozempic 25 mg tablets for T2DM in adults. The company expects an FDA decision by the end of 2026.
-
Eli Lilly reports that tirzepatide is in clinical trials for autoimmune conditions in patients with obesity or overweight. These trials include its use as “monotherapy” in adults with T1DM, which are estimated to complete in 2027. In addition, “combination therapy” with ixekizumab (Taltz) is in Phase 3 trials for adults with plaque psoriasis (PSO) or psoriatic arthritis (PsA)─trials are expected to complete in 1H 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 are expected in 2028.
-
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 ± SGLT2i) with completion dates ranging from 2024 through 2029.
-
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 may enter the market on or after Feb. 24, 2026.
-
One generic version of exenatide injection (Byetta) is available in the U.S. for adults with T2DM. Marketing of brand Byetta has been discontinued in the U.S.
-
A generic for dulaglutide (Trulicity) could be available at the end of 2027.
Semaglutide’s patent protection in Canada expired in January 2026. Several generic manufacturers have already submitted applications to Health Canada and are preparing to launch their products later in 2026. As a result, Canada could be the first country to offer lower-cost generic versions of injectable Ozempic for diabetes and Wegovy for weight loss. Novo Nordisk also plans to introduce two new, lower-priced brand-name products in Canada: Plosbrio and Poviztra as chemically identical alternatives to Ozempic and Wegovy, respectively.
In the United States, semaglutide generics are not expected until after patent expiration around 2031-2033 or later. The FDA may allow personal importation only in limited cases, such as, for serious conditions without adequate FDA‑approved treatments, for up to a 90‑day supply, and with written confirmation that the drug is for personal use.
Yes, in February 2026, the FDA approved Ozempic as the new proprietary name for the “oral” semaglutide tablet formulations of 1.5 mg, 4 mg, and 9 mg 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 tablets of 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 will be available in 2Q 2026.
Novo Nordisk is advising patients prescribed Rybelsus to continue taking their medication as prescribed. The company plans to share information with patients, caregivers, and health care professionals to explain what to expect at the pharmacy in 2Q 2026.
Glossary
CKD chronic kidney disease
CNS central nervous system
CV cardiovascular
CVD cardiovascular disease
HTN hypertension
MACE major adverse cardiovascular events
Login Portals
Compliance / Legal
Company
