FDA Approval Timeline: From NDA to Market Launch NDA Submission: Q4 2026 Eli Lilly will compile efficacy data primarily from TRIUMPH-1, supportive data from TRIUMPH-4, the safety database across all trials, and manufacturing/labeling documentation
As of February 2025, China already had 60-70 late-stage (Phase 2 or later) pipeline assets, directly competing with semaglutide, tirzepatide and other candidates in diabetes and weight loss
Clinical Epidemiology
Oral testosterone Oral testosterone undecanoate is more convenient than topical or injectable forms of testosterone, and its been shown to perform somewhere in between the two for efficacy.12 Its a more novel treatment, and the jury is still out regarding fertility effects
Results Patients lose an average of 10-15% of body weight over 68 weeks in registration trials for FDA-approved formulations
Among those who completed a 6-month check-in, 97% of customers on plans with compounded GLP-1s reported an improvement in their overall health
