Area of Interest under PHO ISO: ASCENT-IBO

The ASCENT-IBO initiative, managed by the ARPA-H Proactive Health Office under solicitation ARPA-H-SN-26-158, seeks revolutionary solutions to accelerate the clinical evaluation of ibogaine for treating high-risk populations with opioid use disorder. Aligned with Executive Order 14401, the program focuses on implementing accelerated combined Phase I and II clinical trials to evaluate safety and efficacy. Proposers must provide comprehensive safety strategies to mitigate risks such as cardiotoxicity and drug-drug interactions, detailed operational plans for trial execution, and strategic roadmaps for Phase III entry and the development of a Risk Evaluation and Mitigation Strategy. Priority will be given to solutions that have already submitted or have imminent plans to submit an Investigational New Drug application to the FDA. The government views commercial-led solutions as particularly advantageous for rapid market entry and encourages the inclusion of models for affordability, price transparency, and public health benefits. This notice explicitly excludes the use of ibogaine derivatives, analogues, neuromodulation treatments, or other neuroplastogens such as ketamine and psilocybin. All Solution Summaries must be submitted by October 15, 2026, in accordance with the formal solicitation ISO ARPA-H-SOL-24-106.