What the FDA Requires in the NDA Efficacy Data: TRIUMPH-4: 28.7% weight loss Complete TRIUMPH-1: 28.3% weight loss Complete TRIUMPH-2, 3 Pending Safety Data: Side effect profile across all populations Short-term and medium-term adverse events Drug interactions, especially with diabetes medications Manufacturing Data: Scale-up capability for millions of doses per month Quality control and stability data Cold chain distribution logistics Realistic NDA Submission Scenarios Scenario 1: Everything Goes Right (Late 2027) All TRIUMPH trials complete by July 2026 Data analysis: AugustSeptember 2026 NDA submission: December 2026 FDA filing decision: February 2027 PDUFA date: December 2027 Approval: December 2027 | Launch: Q1 2028 Scenario 2: The Realistic Path (Mid-2028) TRIUMPH trials complete Q2Q3 2026 Data analysis: 34 months NDA submission: FebruaryMarch 2027 FDA filing decision: AprilMay 2027 PDUFA date: FebruaryMarch 2028 Approval: Q1 2028 | Launch: Q2Q3 2028 Scenario 3: If Something Goes Wrong (2029+) Potential delays: unexpected safety signal, manufacturing issues, FDA Complete Response Letter requesting additional data, or significant trial delays
These can include B vitamins, with B-12 shots of methylcobalamin being the most common, and weight loss injections such as MIC injections
doi: 10.1016/j.freeradbiomed.2024.08.039 198 ZhuL.YuT.WangW.XuT.GengW.LiN.et al
Who Should Not Use These Medications People with a personal or family history of medullary thyroid cancer should avoid both medications
Overall, 112 female participants received either the HCP ( n = 57) at 10 g per day or placebo ( n = 55) for 8 weeks
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