The Advanced Research Projects Agency for Health (ARPA‑H) has released Special Notice ARPA‑H‑SN‑26‑156 under its Proactive Health Office (PHO), focusing on early clinical development of ibogaine for opioid use disorder (OUD).
This Special Notice sits under ARPA‑H’s Proactive Health Office Innovative Solutions Opening (ISO PHO‑SOL‑24‑106), which is an open solicitation for “revolutionary solutions” that do not yet fit inside a defined program. ARPA‑H is using that ISO to respond directly to Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” which calls for faster development and appropriate drug approvals for psychoplastogen therapeutics such as ibogaine.
Solution Summaries responding to this Special Notice are requested by August 9, 2026.
The Area of Interest: Ibogaine for Opioid Use Disorder
The Special Notice frames ibogaine squarely within the national response to serious mental illness and substance use disorders. ARPA‑H cites data showing that:
- Substance use disorders affect roughly 49 million Americans and 2.8 million veterans
- More than 5 million people in the U.S. are estimated to have opioid use disorder
- Over 75% of individuals with opioid use disorder receive no treatment at all
Current standards of care, such as medications for OUD such as naltrexone or buprenorphine plus psychotherapy, reduce overdose risk but leave high relapse and discontinuation rates, especially around critical periods such as treatment dropout or non‑fatal overdose.
Against that backdrop, ARPA‑H notes emerging evidence that psychoplastogens like ibogaine may have potential in serious mental illness and OUD, but there are currently no active trials with an open Investigational New Drug (IND) application to study ibogaine’s safety and efficacy in OUD. The agency positions this as a clear gap and states its intent to “support the early clinical development of ibogaine for OUD.”
What ARPA-H Is Asking For
ARPA‑H is not standing up a full program yet; instead, it is using the ISO to gather Solution Summaries around a foundational piece of a larger ibogaine initiative. Specifically, ARPA‑H invites Solutions that can:
- Develop and submit an IND application for ibogaine to treat individuals with treatment‑resistant OUD or OUD with high mortality risk after a recent non‑fatal overdose, including a regulatory strategy with FDA and a cardiotoxicity risk‑mitigation plan
- Design a Phase 1 clinical protocol based on “gold standard science”
- Plan for procurement of GMP‑grade ibogaine and associated Chemistry, Manufacturing, and Control (CMC) activities, including compliance with federal requirements for importing, handling, and administering a Schedule I substance
ARPA‑H flags several attributes of particularly “advantageous” Solutions:
- A commercial entity leading the work and holding responsibility for the commercial IND, to improve the path to market
- Inclusion of a regulatory consultant with experience in psychoplastogen drug development
- Clear description of any state‑level funding or partnerships already in place for ibogaine or related therapeutics
- Rough plans to maintain affordability and price transparency after advanced clinical development
The agency reiterates that this Special Notice is informational and supplementary to the ISO. It is not a standalone solicitation, and responding is not required to participate in future ARPA‑H opportunities.
Connections to HHS/FDA and VA’s MOU
This Special Notice does not stand alone. In parallel, HHS, FDA, and VA have executed MOU 225‑26‑007, a five‑year agreement to coordinate on treatments for substance use disorder and mental health conditions in veterans, including psychedelic drug products. That MOU focuses on clinical data sharing, real‑world evidence, and operational readiness inside VA.
ARPA‑H’s ibogaine Special Notice can be read as the upstream research counterpart to that coordination framework. While the HHS/FDA–VA MOU centers on how high‑risk psychiatric treatments (including psychedelics) would be evaluated, regulated, and deployed within the VA system, ARPA‑H is being asked under Executive Order 14401 to:
- Develop a larger program in at least one serious mental illness area, such as OUD
- Allocate funds and partner with states already moving to advance psychoplastogen therapeutics
- De‑risk early clinical development and regulatory pathways for ibogaine
For more context on how the MOU frames veterans’ mental health and psychedelic therapies, see our related piece on the HHS–VA agreement and rapid‑acting psychiatric treatments for veterans.
Why This Matters
For companies and teams working in OUD and serious mental illness, this Special Notice makes ARPA‑H’s expectations pretty clear: it wants translational plans that move ibogaine into an IND, early human trials, and compliant manufacturing for a Schedule I substance, not basic mechanism work; it expects regulatory and manufacturing readiness, including cardiotoxicity risk management and solid CMC; and it is aiming for integration with state and federal efforts, tying into state psychoplastogen programs and the HHS/FDA–VA framework for how data and evidence will move as these therapies get closer to care.
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