Protecting Innovation for Psychedelic Therapies Fast-Tracked Under New Executive Order

On April 18, 2026, President Trump signed an Executive Order to accelerate FDA approval of certain psychedelic therapies for mental illness. Keep reading to find out what the Order entails, and how an accelerated approval process for psychedelics might impact your intellectual property (IP) strategy.

The Order provides a series of directions designed to accelerate FDA approval of and patient access to psychedelic therapies.

1. Faster FDA Review for Certain Psychedelic “Breakthrough” Therapies

The Order directs the FDA Commissioner to issue Commissioner’s National Priority Vouchers to “appropriate psychedelic drugs” that (i) have received Breakthrough Therapy designation for treating serious mental illness and (ii) that meet the voucher program’s criteria.

The FDA Commissioner’s National Priority Voucher (CNPV) program aims to reduce review times for drug and biological product applications and manufacturing or efficacy supplements by using a board-style review process to accelerate review and approval of products that align with U.S. national health priorities.

2. Pre‑Approval Access Pathways

The Order directs FDA and DEA to establish a pathway for eligible patients to access certain investigational psychedelic drugs (such as ibogaine) that are under FDA review and have met basic safety requirements.

3. Federal Funding to Match State Psychedelic Research Programs

The Order requires the Secretary of Health and Human Services (HHS) to allocate $50 million through Advanced Research Projects for Health (ARPA‑H) to match state government investments supporting psychedelic research programs for serious mental illness populations.

4. Expanded Clinical Trial Participation and Evidence Generation

The Order calls for HHS and FDA to collaborate with the Department of Veterans Affairs and the private sector to increase clinical trial participation and evidence generation for experimental psychedelic therapies.

5. Earlier Rescheduling Review Triggered by Phase 3 Success

The Order directs the Attorney General to initiate reviews of relevant products upon successful completion of Phase 3 trials so they can be rescheduled as soon as possible upon FDA approval, where appropriate.

While the Order provides directions to certain government agencies (FDA, DEA, HHS, VA, DOJ), the extent of its impact will depend on how these agencies implement those directions. Nevertheless, we can glean from the Order several pertinent takeaways for innovators and IP owners developing psychedelic therapies.

Practical Takeaways for Innovators and IP owners

Coordinate with your regulatory and IP teams: Many early FDA approvals in this space may qualify as first approvals for a given compound, triggering five years of New Chemical Entity (NCE) exclusivity. Such regulatory protections administered by the FDA are typically layered with patent protections to maximize market protection. Where expedited FDA pathways are in play, align patent strategy early with the most likely labeled indication(s). This ensures your patents will cover the approved use.

Reassess patent application filing timelines: Accelerated regulatory review timelines for psychedelics with Breakthrough Therapy designations compresses the time available to build a defensible patent portfolio before launch. File patent applications on core formulations and key methods of use before clinical trial details become public and well before product approval. Within each application family, consider staggered claim scope (broad-to-narrow) to create fallback positions for litigation and post-grant challenges.

Identify your strongest drug patent(s) early: Mandatory clinical trials and FDA regulatory review can consume much of a drug patent’s 20-year term. Under 35 U.S.C. § 156, up to five years of term lost from the FDA regulatory process can be restored via Patent Term Extension (PTE). Importantly, although one may file multiple PTE applications, only one patent covering the approved product will receive PTE. Identify the strongest PTE candidate patent application(s) early and pursue issuance on a timeline that preserves maximum restoration.

Treat clinical trials as IP-generators: Ongoing clinical studies often reveal patentable, patient-centric innovations—dose and regimen refinement, patient stratification, administration protocols, safety warnings, pharmacokinetics (e.g., Cmax, Tmax, AUC), and combination therapies. Capture these insights promptly and file follow-on applications before any public disclosure.

Expect new players and new prior art: The Order’s pro‑development posture and funding support may attract additional entrants in the field. More entrants can mean more patents and publications that influence patentability. Accelerated clinical trials and approval timeline can increase not only the volume of prior art publications, but also the speed of disclosure. Plan early for freedom-to-operate analyses and for offensive/defensive IP challenges (e.g., ex parte reexamination, post-grant review, or inter partes review).

Map non-patent exclusivities and protect know-how: In parallel with patents, evaluate other barriers to entry such as orphan drug exclusivity (where applicable), three-year exclusivity for certain clinical investigations supporting labeling changes, and pediatric incentives. Also identify protectable trade secrets—particularly CMC/manufacturing details, analytical methods, patient databases, and quality controls—best kept out of patents and align documentation and confidentiality practices to protect this innovation too.