Psyence BioMed partners with Benuvia for ibogaine production

Psyence BioMed partners with Benuvia for ibogaine production

Psyence Biomedical Ltd. has announced a strategic partnership with Benuvia Operations, LLC to manufacture pharmaceutical-grade ibogaine at a Texas facility. This collaboration aims to produce ibogaine under current Good Manufacturing Practice (cGMP) standards, according to a company press release.

Manufacturing agreement details

The agreement involves Psyence's Texas subsidiary, Texas Ibogaine Research Corporation (TIRC), working with Benuvia to produce the active pharmaceutical ingredient (API) for ibogaine. Benuvia's facility in Round Rock, Texas, is DEA-registered and spans 83,000 square feet, making it well-suited for controlled-substance manufacturing. The company currently holds about half of the U.S. aggregate production quota for ibogaine.

Regulatory steps and timeline

Benuvia is advancing applications for the necessary import permits and procurement quotas with the Drug Enforcement Administration (DEA). The partnership builds on a prior agreement between TIRC and Psyence Labs Ltd., which includes an exclusive U.S. license for ibogaine supply and distribution. A definitive agreement is expected by November 30, 2026.

Why it matters

The collaboration could significantly impact the availability of pharmaceutical-grade ibogaine in the U.S., a substance under scrutiny for its potential in treating opioid use disorder and other conditions. However, ibogaine remains a controlled substance, and the FDA has not approved it for therapeutic use. The timing and scale of production will depend on DEA quotas and regulatory approvals.

Psyence BioMed's partnership with Benuvia marks a significant step in the potential commercialization of ibogaine in the United States.