Elevai Labs Inc. announced on December 9, 2024, the FDA regulatory pathway for EL-22, a pioneering obesity therapy. EL-22 is a first-in-class myostatin asset being developed as a potential combination therapy with GLP-1 receptor agonists.
The therapy aims to address muscle loss, a common side effect of rapid weight loss from GLP-1-based treatments, by preserving muscle mass while reducing fat. This addresses a critical unmet need in the burgeoning obesity treatment market.
The company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in 2025. This clear regulatory path is a crucial step towards advancing EL-22 into clinical trials.
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