ARPA-H lays groundwork for first U.S. clinical trials to assess ibogaine as a treatment for serious mental illness 

New investments support key early clinical development steps toward fast-acting therapies for life-threatening psychiatric conditions 

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services, today announced the research teams that will establish the key clinical trial framework required to robustly investigate ibogaine as a novel therapeutic for mental illness. If successful, these investments will deliver the high-quality data and experimental drug products needed to support Investigational New Drug Applications (INDs) to the U.S. Food and Drug Administration (FDA), paving the way for the first clinical trials of therapeutic ibogaine in the United States. 

An estimated 14 million or more Americans have a serious mental illness, including devastating and often life-threatening conditions like post-traumatic stress disorder (PTSD). The burden is especially complex among U.S. Veterans, many of whom experience poor mental health outcomes and unique challenges accessing care. While advances in psychiatric treatment have been transformative for many people, available treatments often take time to take effect, can be difficult to access, and may require multiple attempts before providing relief. For too many, current options still fail to deliver results. 

Anecdotal evidence from international clinics suggests that the botanical compound ibogaine may provide rapid psychiatric symptom relief in some individuals. However, no current IND exists to legally and safely conduct clinical research on ibogaine as a treatment for psychiatric conditions in the United States. In alignment with President Trump's Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness, ARPA-H is working to accelerate clinical trials on therapeutic ibogaine to expand treatment options for people at high risk of negative outcomes from serious mental illness. 

“Our U.S. Veterans and the millions of other Americans suffering from serious mental illness deserve the best possible care,” said Al Bugazia, M.D., Senior Advisor for Special Projects at ARPA-H, who is leading the effort. “Reports of successful ibogaine treatments are too promising to ignore. We owe it to our heroes and every person struggling to ask the bold questions and deliver results in years, not decades. As long as people continue to struggle, doing anything less is not an option.” 

The selected teams are led by: 

• Beond, Inc. This team will deliver high-fidelity clinical data to evaluate the safety, dosing, efficacy, and durability of ibogaine to facilitate further understanding and development. 
• Mark Cuban Cost Plus Drug Company, PBC. This project will establish the regulatory, clinical, chemical, and engineering foundation for a domestically manufactured, single-molecule ibogaine hydrochloride product for potential PTSD treatment. If successful, the resulting evidence may support carefully controlled development in more clinically complex and higher-risk indications. 

The agency’s commitment is up to $4.9 million over five years. Performer awards vary in funding amount per awardee and are contingent upon each team meeting aggressive and accelerated research milestones. 

In addition to the new awards, ARPA-H is currently evaluating proposals for a related effort called Accelerating Safe Clinical Evaluation of Novel Treatments: Ibogaine for Better Outcomes in Opioid Use Disorder (ASCENT-IBO). ASCENT-IBO will build on the results of this initial early clinical development work to accelerate early-stage (Phase 1 and 2) clinical trials of ibogaine that prioritize patient safety and translation into Phase 3 testing. Learn more about ASCENT-IBO.