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Trial Profile

A Phase 3 trial of midomafetamine

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 16 Aug 2024

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At a glance

Drugs Methylenedioxymetamfetamine (Primary)
Indications Post-traumatic stress disorders
Focus Adverse reactions; Registrational; Therapeutic Use
Sponsors Lykos Therapeutics

Most Recent Events

16 Aug 2024 New trial record
09 Aug 2024 According to a Lykos Therapeutics media release, the FDA has requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of midomafetamine. Lykos plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency's recommendations for a resubmission seeking regulatory approval for midomafetamine capsules.

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