Last reviewed 2026-05-31 · How we verify

MDMA assisted psychotherapy

Remedy · Phase 2 active Small molecule ✓ Verified May 2026

MDMA assisted psychotherapy is a Small molecule drug developed by Remedy. It is currently in Phase 2 development. Also known as: MDMA-assisted CBCT.

MDMA, a small molecule, has been studied as an intervention in clinical trials for various conditions, including anxiety, post-traumatic stress disorder, and pathological narcissism. Clinical trials have investigated the use of MDMA-assisted therapy for these conditions, with studies ongoing and results pending.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	MDMA assisted psychotherapy
Also known as	MDMA-assisted CBCT
Sponsor	Remedy
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study) (PHASE2)
MDMA-assisted Therapy for Fibromyalgia (EARLY_PHASE1)
MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder (PHASE2, PHASE3)
MDMA-Assisted Therapy for Pathological Narcissism (EARLY_PHASE1)
Social Anxiety MDMA-Assisted Therapy Investigation (PHASE2)
High-Intensity Inpatient MDMA-Assisted Psychotherapy for PTSD (PHASE2)
MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD (PHASE2)
Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

MDMA assisted psychotherapy CI brief — competitive landscape report
MDMA assisted psychotherapy updates RSS · CI watch RSS
Remedy portfolio CI

Frequently asked questions about MDMA assisted psychotherapy

What is MDMA assisted psychotherapy?

MDMA assisted psychotherapy is a Small molecule drug developed by Remedy.

Who makes MDMA assisted psychotherapy?

MDMA assisted psychotherapy is developed by Remedy (see full Remedy pipeline at /company/remedy).

Is MDMA assisted psychotherapy also known as anything else?

MDMA assisted psychotherapy is also known as MDMA-assisted CBCT.

What development phase is MDMA assisted psychotherapy in?

MDMA assisted psychotherapy is in Phase 2.

Manufacturer: Remedy — full pipeline
Also known as: MDMA-assisted CBCT

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing