HHS awards $4.9 million to prepare first ibogaine PTSD studies

The money will not fund patient research directly but will support manufacturing, dosing and study design, with data from Beond's Mexico clinics.

By Theo Adeyemi, Regulation and biotech correspondent
. 2-minute read.
Illustration: HHS awards $4.9 million to prepare first ibogaine PTSD studies
Illustration: Clinical Observer

Health Secretary Robert F. Kennedy Jr. said Thursday that his department will award up to $4.9 million to lay groundwork for the first U.S. studies of ibogaine as a treatment for post-traumatic stress disorder, according to Medical Xpress and STAT.

The funding, Kennedy said, will not go directly to patient research, but will support manufacturing, dosing and design of studies for ibogaine, Medical Xpress reported.

Ibogaine comes from a West African shrub. Its side effects can include intense hallucinations, nausea, vomiting, tremors and sometimes fatal irregular heart rhythms. The drug is illegal, in the most restrictive class along with LSD, ecstasy and most other psychedelics, according to Medical Xpress.

Veterans groups and psychedelic advocates argue that ibogaine could help with hard-to-treat conditions such as PTSD, severe depression and opioid addiction. Because of its restricted status, U.S. research on the drug has largely stalled for decades, Medical Xpress reported.

According to PBS News, Kennedy said the government will get data and treatment guidance from Beond Inc., a Texas company that has treated over 3,000 patients with ibogaine in Mexico, where the drug is not heavily regulated. "That is going to allow us to dramatically accelerate the clinical trial process," Kennedy said. "We're going to have, I think, a record drug approval process."

Kennedy added that further awards may examine ibogaine for addiction, Medical Xpress reported. Doug Collins, secretary of veterans affairs, said the collaboration would prioritize safety and "best-in-class research." "For veterans living with PTSD, we owe them both urgency and the best science we can produce," Collins said.

The announcement follows an executive order President Donald Trump signed in April that told federal agencies to accelerate review and research of psychedelics that might help with mental health, according to Medical Xpress. The Food and Drug Administration is now reviewing three psychedelic applications, including potential medicines based on psilocybin and MDMA. Decisions on those drugs could come within weeks or months. Ibogaine research has progressed more slowly because of its safety risks, according to Medical Xpress.

Most available ibogaine data come from patients treated in Mexico or other countries with less stringent regulation of the drug, according to Medical Xpress. A single course of treatment at an ibogaine clinic costs $10,000 to $20,000, and typically includes heart monitoring with emergency medical workers on standby. Trump's executive order followed podcaster Joe Rogan's claim that he texted Trump about ibogaine. According to Rogan, the president replied, "Sounds great. Do you want FDA approval? Let's do it."

Sources: Medical Xpress, STAT, PBS News

Theo AdeyemiRegulation and biotech correspondent

Theo Adeyemi covers drug regulation and the biotech industry for Clinical Observer. He writes from regulators' notices, company filings and published reporting.

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