Area of Interest under ARPA-H-SOL-24-106

The Advanced Research Projects Agency for Health (ARPA-H) issued a Special Notice on July 15, 2026, announcing an area of interest under the Innovative Solutions Opening (ISO) solicitation ARPA-H-SOL-24-106 for early clinical development of ibogaine to treat opioid use disorder, with solution summaries due by August 9, 2026. The notice implements Executive Order 14401 on accelerating psychoplastogen therapeutics for serious mental illness and targets treatment-resistant OUD and patients at elevated mortality risk from recent nonfatal overdose.

ARPA-H seeks solutions addressing three task areas: development and FDA submission of an Investigational New Drug application for ibogaine, including regulatory engagement strategy and cardiotoxicity risk mitigation; development of a safe Phase 1 clinical trial protocol aligned with gold-standard science; and procurement and development of good manufacturing practice-grade clinical material with Chemistry, Manufacturing, and Control processes and Schedule 1 substance handling compliance.

ARPA-H encourages solutions led by commercial entities responsible for FDA interactions to expedite commercialization and market entry. Proposers should include regulatory consultants with psychoplastogen drug development expertise and identify existing state-level funding relationships. Solutions must detail rough plans for maintaining affordability and price transparency post-clinical development. The notice is informational only; ARPA-H provides no reimbursement for response costs and assumes no obligation to acknowledge receipt or pursue further action.