Nearly all of the participants were from comparable backgrounds and resided in the same region of the world
A plausible scenario, then, looks like this: Phase 3 primary completion in late 2025, NDA submission in the second half of 2025, FDA filing acceptance and review initiation in early 2026, and a PDUFA (Prescription Drug User Fee Act) action date likely in mid to late 2026
They're hopping on the bandwagon, but we have been driving that bandwagon since we launched
By delivering comparable weight loss results to injectable semaglutide in clinical trials, without the need for injections, it provides GLP-1 therapy as an option for patients who prefer oral medications or who have avoided injectables
Data are represented as median and IQR
The weight loss peptide market includes well-known options such as semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound)