Scottsdale Research Institute submits IND for ibogaine

Scottsdale Research Institute's IND submission

The Scottsdale Research Institute (SRI), a nonprofit clinical research organization, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ibogaine hydrochloride (HCl), according to EIN Presswire. This investigational neuroplastogen is being developed to address post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), and opioid use disorder (OUD).

What the study aims to achieve

The IND application, now under FDA review with the assignment of IND 183727, marks a significant regulatory milestone for SRI. If approved, the Phase 1 clinical trial is expected to commence in early 2027. The trial will focus on assessing the safety, tolerability, pharmacokinetics, and initial pharmacodynamic effects of ibogaine HCl in military veterans and civilians affected by PTSD and TBI.

The potential of ibogaine HCl

Ibogaine HCl is noted for its unique polypharmacologic mechanism, which interacts with various neurotransmitter systems. This interaction has shown potential in preclinical and early clinical studies to induce neuroplastic changes that could restore neural circuits disrupted by psychological trauma, TBI, and chronic substance use. Unlike existing therapies that target specific symptoms, ibogaine HCl aims to address the underlying neurological dysfunction contributing to these conditions.

Collaboration and future plans

SRI is collaborating with Brian Anderson, M.D., an Associate Professor at the University of California, San Francisco, to advance the clinical development of ibogaine HCl. The institute is also working with Native American Tribes and tribal partners to ensure culturally informed and ethically responsible psychedelic research. These collaborations are part of the emerging Psychedelic Research Tribal Consortium, led by Michelle Driver.

Why it matters

Millions of Americans, including military veterans and first responders, suffer from PTSD, TBI, and OUD, with current treatment options often proving inadequate. The development of ibogaine HCl could provide a novel therapeutic approach, potentially expanding treatment options for these conditions.

SRI is also advancing other investigational therapies, such as HRTT21, an FDA-authorized Investigational New Drug consisting of whole natural psilocybin mushrooms, highlighting the institute's commitment to exploring innovative treatment avenues.