Compass Pathways, Transcend Therapeutics, and the Usona Institute have been named the first recipients of FDA National Priority Vouchers following last week’s landmark executive order, for programs developing psilocybin and methylone, an MDMA analog.

“These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions,” said FDA Commissioner Marty Makary, M.D., M.P.H.

Issued by President Trump on April 18, the “Accelerating Medical Treatments for Serious Mental Illness” order directed the FDA to provide these high-value regulatory tools to designated breakthrough therapies. By securing these vouchers, the three organizations are now positioned to shave months off the typical regulatory review timeline, significantly shortening the path to commercialization for their lead candidates.

The vouchers, known as Priority Review Vouchers (PRVs), are powerful regulatory assets that grant the holder a fast-track review from the FDA by reducing the target review time from ten months to six. Originally designed to incentivize development in rare pediatric or tropical diseases, their application to psychedelics marks a strategic shift in federal policy. 

Compass Pathways appears to be the closest to utilizing this advantage. Recent Phase 3 data for its lead compound, COMP360 (synthetic psilocybin), demonstrated a “highly statistically significant” antidepressant effect in patients with treatment-resistant depression (TRD). 

The company was the first to confirm being a recipient of one of the three vouchers, via a press release published Friday.  

According to CEO Kabir Nath, the company is potentially the first to bring a classic psychedelic to market, with a rolling NDA submission already underway. Compass expects to complete its filing by the second half of 2026.

The remaining two organisations to receive the vouchers were not identified by the FDA on its release, but can be deducted from the information provided by the agency, as the only two working in late stage trials with the compounds targeted by the measure.

Transcend Therapeutics’ voucher comes at a pivotal moment in its corporate evolution. The New York-based firm was recently acquired by Japanese pharmaceutical giant Otsuka in a deal worth up to $1.2 billion, and is developing a pipeline for methylone, a non-hallucinogenic analog of MDMA. By focusing on neuroplasticity without the intense cognitive alterations associated with classic MDMA, Transcend is targeting a unique regulatory niche for PTSD. 

Finally, the Usona Institute—a non-profit medical research organization—continues its push for psilocybin as a treatment for Major Depressive Disorder (MDD). Unlike its commercial counterparts, Usona’s receipt of the voucher underscores the administration’s intent to support diverse research models, including non-profit institutes. Usona is currently conducting its “uAspire” Phase 3 trial, which evaluates a single 25mg dose of psilocybin. The voucher ensures that once Usona completes its trial work, the resulting data will receive the highest level of federal priority, ensuring that patient access is not delayed by administrative bottlenecks.

Interestingly, ibogaine was not targeted for the fast-track measure in spite of being a central protagonist of the executive order’s announcement last week by the White House.

President Donald J. Trump signed an executive order on Saturday aimed at speeding up the development and approval of psychedelic-based treatments for serious mental illness in the United States.

The directive targets a range of conditions, including major depressive disorder and substance use disorders, specifically for patients who have not responded to traditional therapies.

The order signals a significant shift in federal drug policy by prioritizing the evaluation of substances like psilocybin and ibogaine, which are currently classified as Schedule I controlled substances. While advocates have hailed the move as a breakthrough for mental health innovation, medical experts have raised questions regarding the safety profile of some compounds and the practicalities of their implementation.

“Today’s Executive Order reflects growing recognition that modern mental health challenges demand new approaches,” said Betty Aldworth, Co-Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS).

Key Provisions

The primary objective of the order is to streamline the regulatory pathway for “Breakthrough Therapy” drugs. Specifically, the directive instructs the Food and Drug Administration (FDA) to issue Commissioner’s National Priority Vouchers for psychedelic drugs that have already received breakthrough designations. These vouchers are designed to accelerate the review process, potentially reducing wait times for federal approval from months to weeks.

Furthermore, the order expands the “Right to Try” framework to include investigational psychedelic compounds. This provision is intended to allow patients with life-threatening or severely debilitating conditions to access experimental treatments—including ibogaine—provided they have met basic safety requirements and are currently under FDA review.

To bolster research at the local level, the Secretary of Health and Human Services (HHS) has been directed to allocate $50 million through the Advanced Research Projects Agency for Health (ARPA-H). This funding is earmarked to match state-level investments in psychedelic research programs. The move appears to follow the lead of states like Texas, which recently authorized state-funded research into ibogaine for veterans.

Federal Coordination and Scheduling

The executive order also mandates increased inter-agency cooperation. The HHS, FDA, and Department of Veterans Affairs (VA) are required to sign data-sharing agreements to pool clinical trial results. The goal is to provide the FDA with a more robust evidence base to facilitate timely evaluations.

Addressing the legal status of these substances, the order directs the Attorney General to initiate a review of relevant products immediately following the successful completion of Phase 3 clinical trials. This is intended to ensure that if a drug is approved by the FDA, the process of rescheduling it under the Controlled Substances Act can occur as quickly as possible.

What the Order Doesn’t Do

Despite the sweeping language of the directive, several legal and medical hurdles remain. The order does not immediately legalize or “deschedule” psychedelics. Substances such as MDMA, LSD, and psilocybin remain in the most restrictive federal category for illegal drugs. Any rescheduling remains contingent on the completion of rigorous Phase 3 clinical trials and subsequent FDA approval.

Importantly, the order does not mandate insurance coverage for these experimental therapies. Industry analysts noted that because these treatments remain largely unapproved, they are unlikely to be covered by private or public insurance in the near term, potentially limiting access to those who can afford out-of-pocket costs at private clinics.

“Today, people desperate for healing are traveling abroad or self-medicating with impure substances and little support. Efforts like today’s Executive Order must be paired with regulated psychedelics, provider training, and robust insurance coverage,” said Aldworth.

Finally, the order does not bypass existing safety protocols. While it seeks to “accelerate” the process, drugs must still demonstrate safety and efficacy through the standard clinical trial pipeline.

Medical and Scientific Context

The administration’s focus on ibogaine has drawn particular attention. Derived from a West African shrub, ibogaine has been studied for its potential to interrupt opioid addiction and treat post-traumatic stress disorder (PTSD). However, it is also known for potential cardiac toxicity. Some researchers expressed concern that emphasizing ibogaine over other psychedelics with more established safety profiles could be premature.

“As federal agencies move to reduce longstanding barriers to research, it is essential that progress across this broader class of compounds remains grounded in rigorous science, careful evaluation, and a commitment to patient safety,” said Ismail L. Ali, J.D., Co-Executive Director of MAPS. 

The advocate has called for “alignment with global public health principles” when working with ibogaine and the Iboga plant from which it’s extracted.

“Ibogaine has the potential to address the devastating crisis of opioid use disorder. However, because iboga is a limited resource, mass production of ibogaine can harm the people, traditions, and land where iboga is grow,” he said.

The order represents a rare area of emerging bipartisan interest, as lawmakers from both parties have expressed support for expanding research into how psychedelics might assist veterans and those struggling with treatment-resistant depression. However, the success of the initiative will ultimately depend on the results of ongoing clinical trials and the ability of federal agencies to navigate the complex safety and regulatory requirements involved in bringing Schedule I substances to the medical market.

Market Impact

The news provided a boost for companies in the psychedelics sector that are publicly traded, reflecting growing investor confidence in the field. Shares from Compass Pathways, a company with a Phase 3 program in psilocybin, were up 43% on Monday. AtaiBeckley was up 24% and GH Research 16%.

Picture: courtesy of the White House.

Elephant Gate, a new accelerator launched by Pink Elephant, has opened applications for its inaugural cohort, aiming to support early-stage companies building foundational infrastructure for the growing psychedelics sector. The program will deploy $150,000 into up to ten pre-seed and seed-stage startups annually, with submissions open through May 15, 2026.

The new accelerator initiative fits into a growing trend of interest from investors and funds, following a long capital drought that affected the space from 2022 to 2024. While investment and consolidation picked up during 2025, it was mainly focused on drug discovery and development, leaving small startups and companies focused on developing the infrastructure for the implementation of psychedelic therapies out of the radar and fighting to survive.

Elephant Gate describes the psychedelics infrastructure subsector as “a critical gap in the ecosystem.”

As clinical trials expand, regulatory pathways evolve, and new compounds move closer to approval, the need for scalable systems supporting delivery, training, and patient access has become increasingly apparent, they have said in a press release.

The accelerator will run from 2026 through 2028, backing a total of 30 companies across three cohorts. While headquartered in San Francisco, Elephant Gate operates as a fully remote program with a global scope, explicitly inviting founders from Europe, Asia, and beyond to apply.

The initiative has secured partnerships with Psychedelics Today and JLS Fund, reflecting a blend of media reach, education, and venture capital expertise. Psychedelics Today reports an annual audience of over 2.2 million learners, while JLS Fund focuses on investments across neuroscience, mental health, and enabling technologies within psychedelic medicine.

Elephant Gate’s investment thesis centers on infrastructure layers rather than drug development itself. Areas of focus include education and training platforms, clinical support software, AI-assisted integration therapy, clinical delivery systems, and patient acquisition tools. However, the program maintains flexibility, encouraging applications from founders working outside these categories if they align with the broader ecosystem vision.

In addition to capital, selected companies will receive access to a network of practitioners and operators, along with go-to-market support and introductions to institutional co-investors. The program also emphasizes community building among founders navigating similar regulatory and operational challenges.

“The psychedelic ecosystem is emerging from the ground up,” said Natalia Fedulova, Partner at Elephant Gate. “We are here to back the entrepreneurs who are building the infrastructure that will define how millions of people access these therapeutic modalities over the next decades.”

Applications for the first cohort close on May 15, 2026, with the program open globally to pre-seed and seed-stage companies. Interested founders can apply directly or contact the team via email at hello@elephantgate.co