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# Pfizer Nixes Oral Weight Loss Drug Development
- URL: https://www.fdaweb.com/pfizer-nixes-oral-weight-loss-drug-development/
- Published: 2025-04-14T12:00:00.000Z
- Updated: 2026-09-14T14:57:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159000

Pfizer says it is discontinuing development of danuglipron, an experimental oral GLP-1 receptor agonist being evaluated for chronic weight management. Despite promising results from recent dose-optimization studies, including successful achievement of key pharmacokinetic goals and a formulation with potential Phase 3 viability, the company opted to stop further development after reviewing comprehensive safety data and receiving input from FDA and other regulatory authorities, according to the company.

Pfizer notes that its decision follows an isolated case of a potential drug-induced liver injury in one asymptomatic participant from a study, which resolved after discontinuation of the drug. While the overall incidence of liver enzyme elevations in the danuglipron clinical program was consistent with other approved GLP-1 treatments, Pfizer states that the totality of safety data — combined with recent regulatory feedback — prompted the move.

The action is a blow to the drug maker as it had hopes of entering the GLP-1 weight-loss market while also offering an oral alternative to current, high-profile injectable therapies semaglutide and tirzepatide. The company emphasizes that it will continue investing in treatments for metabolic and cardiovascular diseases, including the development of its oral GIPR antagonist candidate and other early-stage obesity therapies.