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 via OpenAlex
Summary
AI-generated from the abstractA fully validated cGMP synthesis of up to 5 kg (≈30,000 patient doses) of MDMA has been achieved for the first time, using a four-step process starting from a noncontrolled material. The overall yield was 41–53% over four steps, and chemical purity exceeded 99.9% by HPLC in all validation trials. This cGMP-compliant MDMA will support ongoing clinical trials and potential future therapeutic use if FDA approval is obtained.
Study at a glance
| Characteristics | Methodology or process development Peer reviewed |
|---|---|
| Topics | MDMA |
| Keywords | Yield engineering Clinical trial Pharmacology Internal medicine |
| Citations | 12 |
| Key finding | 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.