The U.S. Department of Veterans Affairs is making ibogaine its next major focus in psychedelic medicine, signaling a significant shift in how federal agencies approach treatment for veterans with PTSD and substance use disorders. During an August 7 visit to Seattle's VA Medical Center, Veterans Affairs Secretary Doug Collins revealed that the agency is collaborating with the FDA to develop safety protocols for ibogaine, a psychoactive compound derived from the Tabernanthe iboga shrub native to equatorial Central and West Africa.

What Is Ibogaine and Why Is the VA Interested?

Ibogaine is a naturally occurring alkaloid that researchers have also synthesized in laboratory settings. The VA sees potential in using it to treat conditions like PTSD and addiction in veterans, though the compound carries cardiac risks that require careful management. Collins acknowledged that federal sourcing for ibogaine remains a work in progress, noting that the agency is exploring cooperation with international partners to secure supplies.

The VA's push reflects a broader federal commitment to psychedelic research. In July, the VA, FDA, and U.S. Department of Health and Human Services signed a Memorandum of Understanding to collaborate on advancing President Trump's April Executive Order on psychedelics. Additionally, the U.S. House of Representatives passed legislation containing psychedelics amendments that would require the VA to submit progress reports and designate an official to oversee work on emerging therapeutic interventions.

How Is the FDA Updating Its Approach to Psychedelic Trials?

The FDA released final guidance in July 2026 on clinical investigations of psychedelics, building on a draft version from 2023. The updated guidance provides clearer recommendations for researchers designing psychedelic studies and includes several notable changes that could shape how these medications are tested and eventually delivered to patients.

Key updates to the FDA's guidance include:

• Broader Scope: The guidance now explicitly accounts for atypical psychedelics like ibogaine, not just classical compounds like psilocybin and LSD.
• Simplified Monitor Requirements: Trial monitors can now be any health care provider with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently.
• Expanded Assistant Monitor Eligibility: Individuals with a nursing degree plus one year of clinical experience in a licensed mental health care setting can now serve as assistant monitors.
• Treatment Paradigm Clarity: Sponsors must describe whether psychological support or psychotherapy is featured in trials, and this information may appear in product labeling.
• Long-Term Follow-Up Standards: The most informative trial design would include a blinded 12-month follow-up with prespecified criteria for retreatment, a stricter standard than the draft guidance suggested.
• MAOI Interaction Warnings: The guidance strengthens warnings about potential interactions between monoamine oxidase inhibitors and psychedelics.

The FDA is requesting public input on the final guidance through October 5, 2026. A public hearing is scheduled for September 14 at the FDA's White Oak campus in Maryland, with virtual attendance available. Federal leaders specifically want feedback on provider training and credentialing, patient safety promotion, access considerations, and best practices for data collection and standardization.

"It's going to be safe when we do it with our veterans. That's our key," said Doug Collins, U.S. Department of Veterans Affairs Secretary, regarding ibogaine safety protocols.

Doug Collins, U.S. Department of Veterans Affairs Secretary

What's Happening With MDMA-Assisted Therapy for PTSD?

Resilient Pharmaceuticals, the company formerly known as Lykos Therapeutics, has resubmitted a new drug application to the FDA for MDMA-assisted therapy for PTSD. Notably, this resubmission does not include a new Phase 3 clinical trial, despite the FDA's 2024 rejection of the initial application.

The Multidisciplinary Association for Psychedelic Studies (MAPS), the nonprofit organization that grew into Lykos and later became Resilient, believes the updated FDA guidance supports their approach. MAPS founder Rick Doblin stated that the new guidance aligns with what the organization has already been doing, suggesting that the FDA's clarifications may help advance the MDMA application without requiring additional large-scale studies.

This development reflects a potential shift in how the FDA evaluates psychedelic therapies. Rather than requiring entirely new Phase 3 trials, the agency may be willing to work with companies using existing data if it aligns with the updated guidance framework.

How Are Pharmaceutical Companies Investing in Psychedelics?

Beyond government initiatives, major pharmaceutical companies are making significant financial commitments to psychedelic medicine. Eli Lilly, the world's largest pharmaceutical company by prescription drug sales, acquired AtaiBeckley Inc. for $2.8 billion upfront in July 2026, with potential additional payments of up to $1 billion based on clinical milestones, bringing the total deal value to $3.8 billion.

Through this acquisition, Eli Lilly gains access to two fast-acting psychedelic candidates for treatment-resistant depression. BPL-003 is a synthetic nasal form of 5-MeO-DMT with FDA Breakthrough Therapy Designation, positioned to enter Phase 3 trials. VLS-01 is a form of DMT that dissolves in the cheek. Both compounds produce psychedelic effects within a roughly two-hour clinic session, making them potentially practical for medical settings.

This acquisition follows other major pharmaceutical moves in the psychedelic space. Japanese pharmaceutical company Otsuka acquired Transcend Therapeutics in March 2026, and AbbVie acquired Gilgamesh Pharmaceuticals' bretisilocin in 2025. These deals signal that major pharmaceutical companies view psychedelic medicine as a significant growth opportunity in psychiatry.

Steps to Prepare for Psychedelic Therapy Rollout

As psychedelic medications move closer to potential FDA approval, healthcare systems and practitioners are preparing for clinical delivery. The VA's ongoing efforts include several key preparedness measures:

• Provider Training Programs: The VA is developing therapist training programs, with Dr. Rachel Yehuda playing a central role in scaling training approaches for VA practitioners who will deliver psychedelic-assisted therapies.
• Multi-Site Clinical Trials: The VA is conducting a multi-site trial testing psilocybin for treatment-resistant depression using Compass Pathways' COMP360 formulation at five VA locations across the country, with recruitment expected to begin soon.
• Safety Protocol Development: Federal agencies are collaborating to develop Risk Evaluation and Mitigation Strategies to address cardiac and other safety concerns specific to compounds like ibogaine.
• Regulatory Alignment: The VA, FDA, and HHS are working together through a Memorandum of Understanding to ensure consistent standards and information sharing as psychedelic therapies advance through clinical development.

The convergence of federal initiatives, updated regulatory guidance, and pharmaceutical investment suggests that psychedelic-assisted therapies could become available through medical channels within the next few years. For veterans and patients with treatment-resistant conditions, these developments represent a potential new treatment pathway. For healthcare providers, the updated FDA guidance and upcoming public hearing offer opportunities to shape how these therapies will be trained, delivered, and monitored once approved.