AUGUST 28, 2025
Biophytis Receives EMA and Belgian Regulatory Approval to Initiate Phase 3 Sarcopenia Clinical Trial Biophytis announced that both Part I (European Medicines Agency scientific review) and Part II (Belgian national ethical assessment) of its Clinical Trial Application (CTA) for a Phase 3 study in sarcopenia have been successfully reviewed and accepted. With these approvals, Biophytis is now authorized to initiate patient enrollment for the Phase 3 sarcopenia trial at selected sites in Belgium. The company will also collaborate with leading clinical centers across additional European Member States under the harmonized European framework. “We are delighted to achieve both EMA and