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The key regulatory milestones: FDA Breakthrough Therapy designation for MASH (September 2024) EMA PRIME designation for MASH (November 2023) China NMPA Breakthrough designation (June 2024) Phase 3 trials (SYNCHRONIZE-1 and SYNCHRONIZE-2) fully enrolled, results expected H1 of this year Estimated FDA filing: Late this year at the earliest Estimated FDA approval: Possibly next year, depending on Phase 3 results If Phase 3 results confirm Phase 2 findings, survodutide could reach the market within the next 12-24 months
We noted that cumulatively applied retatrutide starting at 10 nM (up to 100 nM the highest concentration tested) elevated FOC in HAP in a concentration- and time-dependent manner
And it gets even better: muscle acts like a metabolic powerhouse
When your results depend on molecular precision, you can't afford to gamble on your source material
Your stomach empties slower
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