FDA issues no new psychedelic-specific guidance document before Q4 2026; existing 2023 draft remains the operative framework for any Lykos resubmission.

The FDA (the US drug regulator) published a draft guidance document in 2023 explaining how companies should design clinical trials for psychedelic drugs. As of now, the FDA has not replaced or updated that document, and it almost certainly won't release a new one before the final quarter of 2026. That 2023 draft remains the rulebook any company — including Lykos Therapeutics, which is trying to resubmit its MDMA-assisted therapy application after the FDA rejected it — must follow when designing their studies.

Guidance revision requires interagency review cycles that outlast this quarter. Sponsors will lean on functional-unblinding critiques already documented.