Education Library

The FDA publicly released its rejection letter in September 2025 for transparency, and the sponsor has since rebranded as Resilient Pharmaceuticals as it looks for a path forward. As of mid-2026, MDMA-assisted therapy is not an approved prescription treatment anywhere in the U.S. — it remains accessible only through clinical trials, and MDMA itself stays classified as a Schedule I controlled substance.

Oregon and Colorado run the country's only fully operational legal psilocybin programs for adults, and New Mexico's legislature passed a Medical Psilocybin Act in 2025, aiming to see its first patients by the end of 2026. Federally psilocybin remains Schedule I, though the FDA granted COMPASS Pathways a priority review voucher in April 2026 following a presidential executive order on psychedelic research.

The program, called IMPACT (Ibogaine Medicine for PTSD, Addiction, and Cognitive Trauma), is led by UTHealth Houston and UTMB Health with a consortium that includes UT Austin, Texas Tech University, and Baylor College of Medicine; Mississippi and West Virginia have since said they'll join. Ibogaine carries more serious cardiac safety considerations than other compounds on this page, remains Schedule I federally, and is not FDA-approved.

About a quarter of patients achieve fuller symptom remission, and pairing infusions with psychotherapy or repeating doses can extend the benefit. Generic ketamine is not FDA-approved for depression — it's approved only as an anesthetic — so its use for mood disorders is off-label, offered at specialized ketamine clinics under a clinician's supervision.

Trial data supporting the 2025 monotherapy approval showed meaningfully higher remission rates than placebo within four weeks. Spravato is administered only in certified healthcare settings under a Risk Evaluation and Mitigation Strategy (REMS) due to sedation and dissociation risks, with patients monitored on-site after each dose.

In controlled trials, roughly 4 in 10 patients respond and about a third reach full remission — well above sham-device rates — and most who respond keep the benefit for 3 to 12 months. Side effects are usually mild, most often scalp discomfort or headache, and serious risks such as seizure are rare.

By early 2026, roughly a dozen prescription digital therapeutics had reached FDA clearance or authorization. Access is expanding on the payer side too: CMS approved new reimbursement codes for this category in late 2024, and some major insurers began covering FDA-cleared digital therapeutics in 2025.

Within a week, the FDA issued priority review vouchers to three psychedelic-therapy programs, and the order directs a Right to Try pathway for eligible patients to access certain investigational psychedelics, including ibogaine, outside a clinical trial. Even so, MDMA, psilocybin, and ibogaine all remain Schedule I federally as of mid-2026 — none has full FDA approval as a prescription drug. Priority review and Right to Try speed up and widen access; they are not the same as approval.

Oregon's model is a supported-adult-use framework, not a clinical one — facilitators aren't required to be licensed therapists, and over 100 service centers were operating statewide by 2026. Colorado decriminalized personal use and possession for adults 21+ under a 2022 ballot measure and is phasing in a licensed healing-center model. Texas hasn't legalized psilocybin for public use, but has taken a research-first approach, directing state funding toward ibogaine trials instead. Roughly two dozen additional states were considering psychedelic-related legislation as of 2026.