Clinical-stage biotechnology company Biophytis SA (Euronext Growth Paris:ALBPS) (OTC:BPTSY) announced on Thursday that it has received regulatory clearance to initiate its Phase 3 clinical trial in sarcopenia.

Both the European Medicines Agency (EMA) and Belgian authorities have approved the company's Clinical Trial Application.

The EMA's Part I assessment confirmed that the study meets scientific and methodological standards, including protocol design, benefit-risk evaluation, product quality, and safety. Belgium's Part II review approved all national and ethical aspects of the study, covering informed consent, data protection, investigator qualifications, and participant safeguards.

With these approvals, Biophytis can begin patient enrolment in Belgium and expand the trial across additional European Member States under the harmonised regulatory framework. The company said that the authorisation marks a critical step toward advancing treatment options for sarcopenia.