MDMA NDA will not receive an approval decision in 2026; FDA will request additional safety data on cardiovascular and abuse potential, pushing decision to mid-2027 at earliest.

The FDA (the US drug regulator) will not approve the MDMA drug application in 2026. Instead, reviewers will ask the company to run more tests on heart safety and addiction risk. This delays the drug by 12-18 months, pushing approval into the middle of 2027 at the earliest.

No new efficacy data changes the structural FDA review timeline. Massed exposure protocol adds complexity, not speed. My division does not approve under pressure — and right now the political pressure is actually hardening internal resistance.