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In April, the FDA announced National Priority Vouchers, clinical trial authorizations, a Breakthrough Device designation, and other updates on therapeutics, diagnostics, and device-based treatments for psychiatric illness. This roundup highlights some of these actions. For information on approvals in other specialties during the first quarter of 2026, see the Medscape Medical News FDA Drug Approvals page.

Psychedelics Receive FDA Fast Track

The Trump administration released an executive order on April 18 directing federal agencies to accelerate research on Schedule I psychedelics, including lysergic acid diethylamide, psilocybin, methylenedioxymethamphetamine (MDMA), and ibogaine. The acceleration includes Breakthrough Therapy designation, National Priority Vouchers, and at least $50 million in funding from existing US Department of Health and Human Services funds. Moreover, the order directs the agency to partner with states that are developing programs to advance psychedelic drugs for serious mental illnesses. The FDA said these actions are intended to shorten review timelines and expand access pathways, including potential use under Right to Try provisions for eligible patients.

Oral Noribogaine Trial for Alcohol Use Disorder (AUD) Moves Forward

The FDA accepted an investigational new drug application (NDA) for oral noribogaine (DMX-1001) on April 23, manufacturer DemeRx reported. Noribogaine is a novel therapy for the treatment of AUD that combines neuroplasticity and polypharmacology mechanisms of action. Compared with ibogaine, noribogaine remains in the body longer, which may contribute to long-term neuroplastic changes and potential repair of neural circuits damaged by chronic substance abuse.

This is the first time the FDA has authorized a US-based clinical trial of an ibogaine-related compound, with phase 2 clinical trials of DMX-1001 for AUD expected in 2027. As reported by Medscape Medical News, there are no published randomized, placebo-controlled trials of ibogaine, and its mechanism of action remains poorly understood. Moreover, there are documented safety concerns such as cardiac risk that caused fatal arrhythmias outside monitored settings.

Department of Justice (DOJ) Eases Marijuana Restrictions

On April 23, the DOJ eased restrictions on some marijuana products and reclassified the drug from Schedule I to Schedule III for medicinal and research uses. State-regulated medical marijuana products would move from being classified alongside highly addictive drugs, such as heroin, to a category of drugs that have low-to-moderate potential for abuse, such as common painkillers, ketamine, and testosterone. FDA-approved marijuana products would also be in that category. The recreational use of marijuana remains an illegal Schedule I controlled substance, but the DOJ plans to start proceedings on June 29 for a broader reclassification of the drug.

Priority Vouchers for Psychedelic Compounds

Following the executive order on psychedelics issues earlier in the month, the FDA awarded National Priority Vouchers on April 24 to three companies developing psychedelic therapies. Of the compounds under development, Compass Pathways’ COMP360 (a synthetic psilocybin) for treatment-resistant depression (TRD) is furthest along. Both the nonprofit Usona Institute’s psilocybin for major depressive disorder (MDD) and Transcend Therapeutics’s TSND-201 (methylone, a synthetic drug similar to MDMA) for posttraumatic stress disorder are also on a fast track. FDA Commissioner Marty Makary, MD, said, he expected the agency to issue a decision by the late summer or fall, and that the therapies would be administered in a supervised clinical setting.

Brain Implant Trial for Depression Gets the Green Light

On April 27, the FDA approved a clinical trial of a therapeutic brain-computer interface for the treatment of TRD under an Investigational Device Exemption, manufacturer Motif Neurotech reported. The RESONATE Early Feasibility Study will assess the safety of the XCS System, an implant about the size of a blueberry that is wirelessly powered. The device is placed in the skull above the dura without touching the brain in a 20-minute outpatient procedure. In addition to collecting safety data, the 12-month study will also measure meaningful reductions in depressive symptoms, quality of life, anxiety, and cognitive function.

FDA Clears Lumateperone for Schizophrenia Relapse

The supplemental NDA for lumateperone (Caplyta; Johnson & Johnson) for the prevention of relapse in adults with schizophrenia was cleared by the FDA on April 27. Lumateperone was first approved in the US in 2019 as an adjunctive treatment with antidepressants in adults with MDD, schizophrenia, and bipolar I or II depression, as well as for use as monotherapy or with lithium or valproate. The new expanded indication was based on phase 3 data that showed treatment with the oral, once daily atypical antipsychotic showed long-term efficacy and tolerability in adults with schizophrenia, extending time to relapse during a 26-week double-blind treatment period, as previously reported by Medscape Medical News.

mRNA Biomarker for Schizophrenia, Bipolar Gets Breakthrough Tag

On April 28, the FDA granted a Breakthrough Device designation to the mRNA Gene Biomarker blood-based assay, manufacturer Laguna Diagnostics announced. The test is designed to help distinguish between schizophrenia and bipolar disorder I in symptomatic patients. Its use is intended to be in conjunction with clinical assessment and other patient information. The designation was based on findings of a 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy.