Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA
Jay B. Nair, Linda B Hakes, Berra Yazar-Klosinski, Kathryn Paisner
ACS Omega December 20, 2021 DOI: 10.1021/acsomega.1c05520 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Methodology or process development Peer reviewed |
|---|---|
| Topics | MDMA |
| Keywords | Yield engineering Clinical trial Pharmacology |
| Citations | 12 |
| Key points | The first fully validated cGMP synthesis of MDMA achieved up to 5 kg with 41-53% yield and >99.9% purity. |
Abstract
MDMA is increasingly used in clinical research, but no cGMP process has yet been reported. We describe here the first fully validated cGMP synthesis of up to 5 kg (≈30 000 patient doses) of MDMA in a four-step process beginning with a noncontrolled starting material. The overall yield was acceptable (41-53%, over four steps), and the chemical purity of the final product was excellent, exceeding 99.9% of the peak area by HPLC in each of the four validation trials. The availability of cGMP-compliant MDMA will facilitate ongoing clinical trials and provide for future therapeutic use, if encouraging results lead to FDA approval.
Citations in the library
Cited by 5
- Expert recommendations for Germany’s integration of psychedelic-assisted therapy BMC Medical Education October 24, 2024
- New frontiers in the biosynthesis of psychoactive specialized metabolites Current Opinion in Plant Biology September 16, 2024
- Bioproduction of 3,4-methylenedioxymethamphetamine and derivatives. Biodesign research June 1, 2025
- “You can only take your clients as far as you’ve been yourself”: examining the intersections between psychedelic-assisted therapy, lived-living experience, and clinical practice Drugs Education Prevention and Policy March 22, 2026
- Swim in the Chiral Pool: MDMA and MDA Enantiomers from Alanine-Derived Precursors. ACS Omega June 6, 2023
Cites 14
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- Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology November 1, 2018
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- A Review of 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy Frontiers in Psychiatry March 20, 2019
and 9 more in the library