ARPA-H ASCENT-IBO: Ibogaine Clinical Trials for Opioid Use Disorder (Funding Opportunity Overview)
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Quick Answer
ASCENT-IBO (Accelerating Safe Clinical Evaluation of Novel Treatments: Ibogaine for Better Outcomes in Opioid Use Disorder) is a funding opportunity from the Advanced Research Projects Agency for Health (ARPA-H). It is issued as Special Notice ARPA-H-SN-26-158 under the Proactive Health Office Innovative Solutions Opening (ISO) ARPA-H-SOL-24-106. ARPA-H is seeking teams to design and run accelerated, combined Phase I and Phase II clinical trials that evaluate the safety and efficacy of ibogaine in high-risk patients with opioid use disorder (OUD). Interested organizations submit a Solution Summary of no more than six pages by October 15, 2026 at 5:00 p.m. ET. Commercial, industry-led teams with an active or imminent Investigational New Drug (IND) application are explicitly favored. This effort implements Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness.
What Is ASCENT-IBO and Who Issued It?
ASCENT-IBO is a Special Notice published by ARPA-H, the research funding agency within the U.S. Department of Health and Human Services that pursues high-risk, high-reward health breakthroughs. The full title is Accelerating Safe Clinical Evaluation of Novel Treatments: Ibogaine for Better Outcomes in Opioid Use Disorder.
The Special Notice carries identifier ARPA-H-SN-26-158. It builds on an earlier notice, ARPA-H-SN-26-156, which established a Proactive Health Office (PHO) area of interest tied to Executive Order 14401. ASCENT-IBO is supplementary to the underlying solicitation and does not change it. All submissions are made to, and must comply with, the PHO Innovative Solutions Opening ISO ARPA-H-SOL-24-106.
In plain terms, ARPA-H wants to close a specific gap: despite anecdotal reports of ibogaine reducing opioid cravings and withdrawal, there is currently no active U.S. clinical trial with an open IND studying ibogaine for OUD. ASCENT-IBO is the agency's push to change that quickly and safely.
Why Is ARPA-H Funding Ibogaine Research Now?
Opioid use disorder affects more than five million people in the United States, and more than 75 percent of individuals with OUD receive no treatment at all. Existing medications for OUD such as buprenorphine, methadone, and naltrexone, usually paired with psychotherapy, reduce overdose deaths and improve outcomes, but dropout and relapse rates remain high, and the period following treatment discontinuation or a nonfatal overdose is a well-documented window of elevated mortality risk.
Ibogaine belongs to a class of compounds ARPA-H refers to as neuroplastogens, rapid-acting interventions that may drive lasting, beneficial changes in brain function. Early and largely anecdotal evidence from unregulated clinics abroad suggests it may meaningfully reduce opioid cravings and withdrawal, but that evidence has never been tested in a rigorous, federally authorized U.S. trial.
The policy driver is Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness, signed April 18, 2026. The order directs the federal government to accelerate research models and drug approvals for psychedelic and neuroplastogen-based treatments, specifically naming ibogaine, and to partner with state governments advancing this work. Texas launched an ibogaine research consortium in 2025, which is one example of the state-level activity the order references.
What Is ARPA-H Actually Looking For?
ARPA-H is asking for a Solution Summary of no more than six pages that describes, at a high level, a plan to design and execute accelerated clinical trials of ibogaine for OUD. A competitive Solution must address all three of the following tasks. Partial responses that cover only one or two tasks are unlikely to advance.
Task 1: Combined Phase I/II Clinical Trial Design
The centerpiece of the ask is a study design that evaluates safety and efficacy at the same time, in patient cohorts with OUD who are at increased risk of mortality. ARPA-H wants the design described at a high level across four specific dimensions:
Dosing strategy. Ibogaine dosing approaches that reach clinically relevant, psychoactive exposure levels associated with therapeutic effect.
Set and setting. The therapeutic environment and psychological support framework used during and after ibogaine administration to maximize therapeutic potential.
Placebo strategy. An appropriate placebo or active comparator that minimizes patient bias and preserves blinding as much as ibogaine's strong psychoactive profile allows, including a plan to measure patient unblinding so its effect on outcomes can be interpreted.
Safety assessments and risk mitigation. Rigorous monitoring aligned with gold-standard scientific and regulatory principles. Solutions are expected to name known and anticipated risks in ibogaine and OUD populations, in particular drug-related cardiotoxicity, drug-drug interactions, and detoxification and opioid withdrawal management, and to describe active safety controls such as dose de-escalation or step-back actions that prioritize patient safety.
Task 2: Operational Plans for Trial Execution
Beyond the design, ARPA-H wants a high-level operational plan for actually running the trial. This includes staff training, integration planning, patient education, and a patient recruitment strategy that is scalable and ethically sound.
Task 3: Future Development Plans
Solutions should show a path forward, including high-level plans to prepare for accelerated entry into Phase III and plans to develop a Risk Evaluation and Mitigation Strategy (REMS).
There is also an encouraged but optional element. Solutions that consider using the FDA's Expanded Access program or the Right-to-Try Act to broaden access for eligible patients are described by ARPA-H as highly encouraged, though not required.
What Makes a Solution Competitive?
ARPA-H is unusually direct about what will rise to the top. A startup or company preparing a Solution Summary should weigh the following signals:
Commercial, industry-led teams are favored. ARPA-H states that Solutions led by a commercial entity responsible for all clinical trial execution activities may be most advantageous for rapid advancement and eventual market entry.
An IND is close to the center of the evaluation. Solutions with an IND application already submitted, or with imminent plans to submit to the FDA, will be prioritized.
Combined Phase I and II design plus well-defined safety strategies are prioritization criteria in their own right.
Full coverage of the statement of work is expected. Teams are responsible for every element of the SOW and are expected to have adequate personnel, including regulatory consultants with neuroplastogen drug development expertise.
Existing relationships and state-level support should be spelled out. If a team has partnerships or state-level backing for ibogaine or neuroplastogen clinical development, ARPA-H wants those commitments described clearly.
Affordability and public health thinking help. Because ARPA-H aims to increase patient access, the most competitive Solutions will include initial concepts for affordability, price transparency, and public health benefit models for the period after advanced clinical development.
What Is Out of Scope?
Some approaches are explicitly disqualified. ASCENT-IBO does not want Solutions that propose ibogaine-derived derivatives or analogues, other neuroplastogen compounds including but not limited to psilocybin and ketamine, or neuromodulation-based treatments. This notice is specifically about ibogaine itself for OUD.
How Much Funding Is Available?
The Special Notice does not publish a dollar figure, a ceiling, or a fixed number of awards for ASCENT-IBO. This is normal for this type of vehicle. ASCENT-IBO runs through the Proactive Health Office Innovative Solutions Opening (ISO ARPA-H-SOL-24-106), and ARPA-H funds ISO projects on an individual basis using its range of flexible mechanisms, which for this kind of translational work typically means Other Transaction agreements rather than standard grants. Award size is negotiated based on the scope of the proposed trial rather than set by a published cap.
Two practical points follow from this. First, ARPA-H will not reimburse any costs incurred in responding to this Special Notice, attending Proposers' Day, or preparing submissions to the ISO. Second, the ISO uses a two-step gate: proposers submit a Solution Summary first, ARPA-H provides written feedback on viability and interest, and a full proposal should only be submitted after that feedback is received. A full proposal submitted without ARPA-H's written response can be rejected.
What Are the Key Dates and Deadlines?
Proposers' Day registration opened: August 5, 2026
Proposers' Day registration deadline: September 7, 2026 at 5:00 p.m. ET
Proposers' Day (Washington, D.C. metro area): September 15, 2026, 8:00 a.m. to 5:00 p.m. ET
Solution Summary requested by: October 15, 2026 at 5:00 p.m. ET
All dates are subject to change, and the Special Notice on SAM.gov is the authoritative source. The underlying ISO itself remains open on a rolling basis, but ASCENT-IBO's Solution Summary target date is October 15, 2026.
What Is Proposers' Day and Should You Attend?
Proposers' Day is an optional event held in the Washington, D.C. metro area for organizations considering a Solution. It is not intended for patients, patient advocates, or general-interest audiences. The agenda includes an overview of the area of interest by government personnel, lightning talks where organizations can present one slide in three minutes on a first-come first-served basis, and a panel of federal agencies covering regulatory considerations, clinical guidance, and anticipated challenges.
Registration is required in advance through the ARPA-H Solutions events page, there is no fee, and there is no same-day registration. In-person attendees must present valid government-issued photo identification. Virtual attendance is available once registration is verified. If a team wants to give a lightning talk, it must flag that intent during registration, with no more than one submission per organization.
How Do You Apply?
Interested organizations submit a Solution Summary of no more than six pages, following Appendix A of the PHO ISO ARPA-H-SOL-24-106, through the ARPA-H Solutions site. The Solution Summary must be responsive to all three tasks described above. After review, ARPA-H contacts proposers with further guidance, and only teams that receive a positive written response should proceed to a full proposal.
ARPA-H expects that strong Solutions will require combining expertise, facilities, and capabilities across organizations, and it maintains a teaming page where prospective performers can post profiles and find collaborators. This is worth using early, since assembling clinical, regulatory, and commercial expertise before the deadline is one of the harder parts of a competitive submission.
Frequently Asked Questions
What does ASCENT-IBO stand for?
ASCENT-IBO stands for Accelerating Safe Clinical Evaluation of Novel Treatments: Ibogaine for Better Outcomes in Opioid Use Disorder. It is an ARPA-H funding opportunity focused on accelerated Phase I and Phase II clinical trials of ibogaine for opioid use disorder.
What is the Notice ID for ASCENT-IBO?
The Special Notice is ARPA-H-SN-26-158. Submissions are made through the Proactive Health Office Innovative Solutions Opening, ISO ARPA-H-SOL-24-106.
When is the ASCENT-IBO Solution Summary due?
The Solution Summary is requested by October 15, 2026 at 5:00 p.m. ET. Dates can change, so confirm against the Special Notice on SAM.gov before finalizing a submission.
How long is the Solution Summary?
No more than six pages, following Appendix A of the ISO ARPA-H-SOL-24-106.
Does a company need an IND to apply?
An IND is not an absolute requirement to submit a Solution Summary, but ARPA-H will prioritize Solutions that already have an IND application submitted or have imminent plans to submit one to the FDA. Teams without a clear IND path are at a competitive disadvantage.
Can academic institutions apply, or is this only for companies?
Academic and other organizations can participate, and teaming is encouraged. However, ARPA-H states that commercial, industry-led Solutions where a single commercial entity is responsible for all clinical trial execution may be most advantageous for rapid advancement and market entry. Many competitive teams will pair a commercial lead with academic and clinical partners.
Are psilocybin, ketamine, or ibogaine analogues eligible?
No. Solutions proposing ibogaine-derived derivatives or analogues, other neuroplastogens such as psilocybin and ketamine, or neuromodulation-based treatments do not align with this notice. ASCENT-IBO is specifically about ibogaine for OUD.
How much money can an awardee receive?
The Special Notice does not publish a specific dollar amount or ceiling. Funding runs through the PHO ISO, which uses ARPA-H's flexible mechanisms, commonly Other Transaction agreements, with award size scoped to the proposed trial. ARPA-H does not reimburse costs of responding to the notice.
Do you have to attend Proposers' Day to submit?
No. Proposers' Day is optional. It is a useful way to hear directly from federal agencies on regulatory and clinical considerations and to find teaming partners, but attendance is not a condition of submitting a Solution Summary.
What safety risks does ARPA-H specifically want addressed?
ARPA-H calls out drug-related cardiotoxicity, drug-drug interactions, and detoxification and opioid withdrawal management as known and anticipated risks, and it expects active mitigation strategies such as dose de-escalation or step-back actions to protect patient safety.
What executive order is this connected to?
ASCENT-IBO implements Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness, signed April 18, 2026, which directs the federal government to accelerate access to psychedelic and neuroplastogen treatments, including ibogaine, for serious mental illness.
How BW&CO Can Help
BW&CO Consulting helps deep-tech, biotech, medtech, and health-focused startups win non-dilutive federal funding. For an opportunity like ASCENT-IBO, that means positioning a combined Phase I/II design against ARPA-H's stated priorities, tightening the IND and regulatory narrative, structuring a commercial-led team with the right clinical and neuroplastogen expertise, and preparing a Solution Summary that clears ARPA-H's written-feedback gate on the first pass. If you are considering a submission, reach out before the October 15, 2026 target date so there is time to build the team and the trial narrative.
