Scottsdale Research Institute files FDA IND for ibogaine trial

Scottsdale Research Institute says it submitted an Investigational New Drug application to the FDA for Ibogaine HCl, a potential treatment for PTSD, traumatic brain injury and opioid use disorder. If regulators and an IRB clear the study, a Phase 1 trial could start in early 2027.

Why it matters: - Scottsdale Research Institute is trying to move ibogaine hydrochloride into FDA-regulated human testing for conditions with limited treatment options. - The planned study targets PTSD, traumatic brain injury and opioid use disorder, which affect millions of Americans, including veterans and first responders. - If the program advances, Phase 1 data could support later-stage development of a new neuroplastogen-based therapy.

What happened: - Scottsdale Research Institute/Field to Healed Foundation said it submitted an Investigational New Drug application to the U.S. Food and Drug Administration for Ibogaine HCl. - The application covers an investigational neuroplastogen being developed for PTSD, TBI and opioid use disorder. - The organization said the FDA accepted the IND for review and assigned it IND 183727. - If the FDA and an Institutional Review Board authorize the study, the first Phase 1 trial is expected to begin in early 2027.

The details: - The Phase 1 trial is designed to evaluate safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects. - The study is expected to enroll military veterans and civilians living with PTSD and TBI. - Scottsdale Research Institute said the trial will also generate cardiac safety and dose-ranging data for future Phase 2 studies. - Psygen of Canada will supply the active pharmaceutical ingredient using Scottsdale Research Institute’s DEA Schedule I Importer Registration. - Dr. Sue Sisley, president and principal investigator of Scottsdale Research Institute, said the submission is a step toward rigorously evaluating ibogaine hydrochloride under the FDA’s regulatory framework. - Sisley said the research team is looking forward to working with the FDA as the program advances. - Scottsdale Research Institute is collaborating with Brian Anderson, M.D., an associate professor at the University of California, San Francisco.

Between the lines: - The filing signals a push to test a compound that researchers believe may work differently from symptom-targeting therapies by addressing underlying neurological dysfunction. - Preclinical and early clinical studies have suggested ibogaine may promote neuroplastic changes through a polypharmacologic mechanism that interacts with multiple neurotransmitter systems. - The project also reflects a broader effort to build psychedelic research with tribal partners and Native American Tribes. - Michelle Driver is leading an emerging Psychedelic Research Tribal Consortium intended to incorporate indigenous knowledge and ethical stewardship into the work.

What's next: - The FDA and an IRB still need to authorize the trial before enrollment can begin. - Scottsdale Research Institute expects the Phase 1 study to start in early 2027 if approvals come through. - Results from that trial would inform later Phase 2 efficacy studies. - The organization is also advancing HRTT21, an FDA-authorized Investigational New Drug consisting of whole natural psilocybin mushrooms. - SRI expects the HRTT21 Phase 1 trial to conclude in August 2026 and plans to submit a Phase 2 IND shortly after. - SRI said HRTT21 is expected to qualify as an Eligible Investigational Drug under federal Right to Try provisions once authorized.