Psyence BioMed to Make Pharmaceutical-Grade Ibogaine in Texas

Psyence Biomedical Ltd., a Nasdaq-listed company developing psychedelic-derived medicines, said Monday that its Texas subsidiary has signed a manufacturing agreement to produce pharmaceutical-grade ibogaine in the United States, a step the company frames as groundwork for regulated research into the drug as a treatment for opioid use disorder.

The subsidiary, Texas Ibogaine Research Corporation, will work with Benuvia Operations LLC, which runs an approximately 83,000-square-foot, DEA-registered controlled-substance plant in Round Rock, Texas. The goal is to manufacture ibogaine active pharmaceutical ingredient to current Good Manufacturing Practice standards.

Why manufacturing is the bottleneck

Ibogaine is a Schedule I controlled substance derived from an African shrub, and it has circulated for years mainly through unregulated clinics abroad. Companies hoping to study it in the United States have struggled to obtain material that regulators will accept in a clinical filing, where the source of a drug and the consistency of each batch matter as much as the molecule itself.

"While ibogaine has been discussed for decades, pharmaceutical-grade manufacturing capacity in the United States has remained extremely limited," Benuvia chief executive Terry Novak said in the announcement. "Through our partnership with TIRC and Psyence BioMed, we believe we have an opportunity to change that."

Benuvia says it already holds roughly half of the U.S. aggregate production quota for ibogaine, the allotment the Drug Enforcement Administration sets for how much of a controlled substance may be made each year. The company said it is advancing applications for the import permit and procurement quota the planned production would require.

A supply chain, not yet a treatment

The agreement builds on a binding term sheet between TIRC and Psyence Labs Ltd. covering an exclusive U.S. license, supply and wholesale distribution arrangement for PsyLabs' ibogaine. The parties have said they intend to replace the term sheet with a definitive agreement by Nov. 30, 2026.

Psyence was explicit that the partnership is a manufacturing and regulatory milestone, not clinical evidence. No trial has begun, and the U.S. Food and Drug Administration has not approved ibogaine for any use. "Establishing a U.S.-based manufacturing pathway is intended to strengthen chain-of-custody controls, batch consistency and the chemistry, manufacturing and controls work required to support future regulatory submissions," said Dr. John Thorne, project lead at TIRC.

The company says the effort is aimed at patients with unmet needs, including opioid use disorder, other substance use disorders and mental health conditions affecting veterans.

Where ibogaine research stands

Ibogaine has drawn interest because of anecdotal reports and small studies suggesting it can interrupt opioid withdrawal and craving, but the evidence base remains thin and the drug carries known cardiac risks, including dangerous heart-rhythm changes. Much of the recent momentum in the United States has come from state-level veterans programs rather than federal approvals. Missouri enacted a law in 2026 to study ibogaine for veterans, and Mississippi has joined a multistate research consortium, while California has directed money toward psychedelic research for veterans.

Psyence is not the only company positioning for ibogaine. Other developers have pursued the compound alongside psilocybin and related "neuroplastogen" candidates, betting that a regulated supply and a clean regulatory pathway will be prerequisites for any future approval.

What would have to happen next

Even with domestic manufacturing in place, the timing and scale of any U.S. ibogaine production would be governed by DEA quotas, controlled-substance import rules and other authorizations, Psyence said. A definitive supply agreement still has to be concluded, and any human study would require FDA authorization.

For now the announcement amounts to an infrastructure bet: that the hardest part of studying ibogaine in America is not the science but producing a drug the government will let researchers use. People seeking help for opioid addiction currently rely on approved options such as buprenorphine and methadone, which remain the standard of care while ibogaine research proceeds.