Scottsdale Research Institute Announces Submission of Investigational New Drug (IND) Application to FDA for Ibogaine HCl

PHOENIX, AZ, UNITED STATES, July 29, 2026 /EINPresswire.com/ -- Ibogaine HCl is an investigational neuroplastogen designed to promote neuroplasticity and restore neural function disrupted by psychological trauma, traumatic brain injury, and substance use disorders. The active pharmaceutical ingredient (API) will be supplied by Psygen (Canada) utilizing Scottsdale Research Institute’s DEA Schedule I Importer Registration.

PTSD, TBI, and opioid use disorder affect millions of Americans—including military veterans and first responders—for whom existing treatment options remain inadequate.

If authorized by the FDA and Institutional Review Board (IRB), the planned Phase 1 clinical trial is expected to begin in early 2027 and will support advancement into Phase 2 clinical development.

Scottsdale Research Institute/Field to Healed Foundation (SRI/F2H), a nonprofit clinical research organization dedicated to advancing innovative therapies for military veterans, first responders, and others living with post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), and substance use disorders, today announced the submission of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ibogaine Hydrochloride (Ibogaine HCl), an investigational neuroplastogen being developed for the treatment of PTSD, TBI, and opioid use disorder (OUD).

Acceptance of the IND application for review represents an important regulatory milestone in the clinical development of ibogaine as an FDA-regulated investigational medicine. Subject to FDA and IRB authorization, Scottsdale Research Institute anticipates initiating its Phase 1 clinical trial in early 2027 to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effects of Ibogaine HCl in military veterans and civilians living with PTSD and TBI.

“We appreciate the FDA’s acceptance of our IND application for review and the assignment of IND 183727,” said Dr. Sue Sisley, MD, President and Principal Investigator of Scottsdale Research Institute. “This submission represents an important step toward rigorously evaluating ibogaine hydrochloride under the FDA’s regulatory framework. Millions of individuals living with PTSD, traumatic brain injury, opioid use disorder, and related conditions continue to face significant unmet medical needs. We are proud of the scientific and clinical team that made this milestone possible and look forward to working collaboratively with the FDA as we advance this important research program.”

Ibogaine HCl represents a novel therapeutic approach that combines neuroplasticity with a unique polypharmacologic mechanism of action. By interacting with multiple neurotransmitter systems, ibogaine has demonstrated the potential in preclinical and early clinical studies to induce neuroplastic changes that may help restore neural circuits affected by psychological trauma, traumatic brain injury, and chronic substance use.

Unlike currently available therapies that primarily target individual symptoms, Ibogaine HCl is being investigated for its potential to address underlying neurological dysfunction that contributes to PTSD, TBI, opioid use disorder, depression, anxiety, and cognitive impairment.

Scottsdale Research Institute’s Phase 1 clinical trial is designed to generate critical safety, pharmacokinetic, cardiac safety, and dose-ranging data that will inform future Phase 2 studies evaluating the efficacy of Ibogaine HCl. SRI is collaborating with Brian Anderson, M.D., Associate Professor at the University of California, San Francisco (UCSF), to advance the clinical development program.

In addition, SRI is building collaborative relationships with Native American Tribes and tribal partners to support culturally informed and ethically responsible psychedelic research. These relationships form the foundation of an emerging Psychedelic Research Tribal Consortium, led by Michelle Driver, which will help integrate indigenous knowledge and ethical stewardship into the program’s research and development.


About Scottsdale Research Institute

Scottsdale Research Institute (SRI) is a nonprofit clinical research organization dedicated to developing innovative therapies for PTSD, traumatic brain injury, chronic pain, and substance use disorders through FDA-regulated clinical trials. Working in collaboration with leading academic medical centers, tribal partners, and scientific experts, SRI is committed to generating high-quality clinical evidence that expands treatment options for military veterans, first responders, and patients with serious unmet medical needs.

SRI is also advancing HRTT21, an FDA-authorized Investigational New Drug consisting of whole natural psilocybin mushrooms. The Phase 1 clinical trial is expected to conclude in August 2026, with submission of the Phase 2 IND application anticipated shortly thereafter. Upon authorization, HRTT21 is expected to qualify as an Eligible Investigational Drug (EID) under applicable federal Right to Try provisions.

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Dr. Sue Sisley
Scottsdale Research Institute
+1 480-326-6023
SueSisleyMD@srilaboratory.com
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