The Advanced Research Projects Agency for Health (ARPA‑H) has released Special Notice ARPA‑H‑SN‑26‑158 for ASCENT‑IBO: Accelerating Safe Clinical Evaluation of Novel Treatments – Ibogaine for Better Outcomes in OUD. This effort sits under the Proactive Health Office (PHO) Innovative Solutions Opening (ISO ARPA‑H‑SOL‑24‑106) and is directly tied to Executive Order 14401, which directs federal agencies to accelerate innovative psychedelic drug development for serious mental illness, including ibogaine.
ASCENT‑IBO focuses on one critical piece of that mandate: rigorous, accelerated Phase I/II clinical trials of ibogaine for people with opioid use disorder (OUD) at highest risk of overdose and mortality.
What ARPA‑H Is Asking For Under ASCENT‑IBO
ASCENT‑IBO is not a standalone RFP; it is a targeted area of interest under the PHO ISO that asks teams to submit Solution Summaries for combined Phase I/II ibogaine trials in high‑risk OUD cohorts. ARPA‑H wants Solutions that, at a minimum, address:
Combined Phase I/II clinical trial design that evaluates safety and efficacy in OUD patients at elevated mortality risk, including dosing strategies at therapeutically meaningful, psychoactive exposure levels; set and setting; comparator/placebo strategy; and robust safety monitoring and cardiotoxicity risk mitigation.
Operational plans for trial execution, covering staff training, integration and follow‑up, patient education, and scalable, ethically sound recruitment.
Future development plans for rapid transition into Phase III and the design of a Risk Evaluation and Mitigation Strategy (REMS), with optional use of Expanded Access or Right‑to‑Try pathways to broaden access for eligible patients.
Solutions led by commercial entities that can own IND, trial execution, and eventual market entry are explicitly encouraged, and teams must bring serious regulatory, clinical, and neuroplastogen development expertise.
Key dates in the Special Notice include a Proposers’ Day on September 15, 2026 in the DC metro area and requested Solution Summary submissions by October 15, 2026 at 5 p.m. ET, all routed through the ISO submission process.
Policy Context: EO 14401 And The Opioid Crisis
Executive Order 14401 sets a clear federal policy: remove barriers and accelerate psychedelic and neuroplastogen‑based treatments for serious mental illness, including ibogaine compounds, by aligning FDA, DEA, HHS, VA, and ARPA‑H around faster research, review, and access pathways.
ARPA‑H’s ASCENT‑IBO AOI is a concrete response to that directive in the context of OUD, which affects more than 5 million people in the U.S., with over 75 percent of individuals going completely untreated despite existing medications and psychotherapy. Current MOUD approaches reduce mortality but still show high discontinuation and relapse rates, especially in the critical post‑overdose window. ASCENT‑IBO aims to test whether ibogaine, under gold‑standard safety and regulatory frameworks, can meaningfully improve outcomes for these highest‑risk populations.
For innovators, this is both a scientific and policy inflection point: ARPA‑H is signaling that psychedelic therapies like ibogaine are no longer fringe but part of a high‑risk, high‑impact health innovation portfolio, provided teams can meet demanding expectations on safety, ethics, affordability, and public health impact.
EverGlade is a national advisory firm helping innovators navigate the federal funding ecosystem. We support companies across the funding lifecycle, from early-stage strategy through proposal development, negotiations, and post-award execution, ensuring you win the award and deliver the program.
For additional information on where your capabilities could plug into this emerging program, schedule a conversation with our team.
