Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA

Jay B Nair; Linda Hakes; Berra Yazar-Klosinski; Kathryn Paisner

doi:10.1021/acsomega.1c05520

Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA

ACS Omega. 2021 Dec 20;7(1):900-907. doi: 10.1021/acsomega.1c05520. eCollection 2022 Jan 11.

Authors

Jay B Nair¹, Linda Hakes², Berra Yazar-Klosinski³, Kathryn Paisner⁴

Affiliations

¹ MAPS Public Benefit Corporation (MAPS PBC), 3141 Stevens Creek Blvd #40547, San Jose, California 95117, United States.
² Independent Consultant for MAPS Public Benefit Corporation, 3141 Stevens Creek Blvd #40547, San Jose, California 95117, United States.
³ Multidisciplinary Association for Psychedelic Studies (MAPS), 3141 Stevens Creek Blvd #40563, San Jose, California 95117, United States.
⁴ KP2 LLC, 2510 14th Ave., Oakland, California 94606, United States.

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.