Area of Interest under PHO ISO: ASCENT-IBO

The National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H) announced ARPA-H-SN-26-158, a special notice soliciting clinical trial solutions for ibogaine as a treatment for opioid use disorder, with responses due by October 15, 2026 at 5 PM ET. Submissions are made through the open Innovative Solutions Opening vehicle ARPA-H-SOL-24-106 and must take the form of Solution Summaries not exceeding six pages.

ARPA-H prioritizes solutions from commercial entities with regulatory expertise in neuroplastogen drug development, existing state-level partnerships, combined Phase I/II trial designs with defined safety strategies, and submitted or imminent FDA Investigational New Drug applications. Proposed solutions must address three primary tasks: combined Phase I/II clinical trial design with dosing strategy, therapeutic environment specifications, and comprehensive safety assessments mitigating risks such as cardiotoxicity and drug-drug interactions; operational execution plans covering staff training, patient recruitment, and education; and future Phase III development and Risk Evaluation and Mitigation Strategy pathways. Solutions may not include ibogaine derivatives, other neuroplastogen compounds, or neuromodulation treatments.

ARPA-H will conduct a Proposers' Day on September 15, 2026 in the DC Metro Area; registration opens August 5, 2026 and closes September 7, 2026. The notice implements Executive Order 14401 on accelerating medical treatments for serious mental illness. ARPA-H will not reimburse response or event participation costs.