Approved but not yet on shelves: the psychiatry decisions still pending this fall
Two summer approvals are waiting on DEA scheduling. A psilocybin application is racing a priority voucher, and the FDA has held its first public hearing on psychedelics. Here is where each stands.
Key points
- Centanafadine (Simtriyo, ADHD) and oveporexton (Orzeyful, narcolepsy type 1) were approved this summer. Neither can be sold until the DEA publishes a scheduling rule, and as of late October we found no such notice for either drug.
- Compass Pathways expects to complete its rolling NDA for COMP360 psilocybin in the fourth quarter of 2026. It holds a Commissioner's National Priority Voucher, which aims at a review of one to two months.
- On September 14 the FDA held a public hearing on psychedelic drugs. The hearing did not address any specific application or scheduling decision, and no psychedelic is approved.
An FDA approval letter usually means a drug can be prescribed within weeks. This fall, two of the year's most closely watched psychiatric and sleep-medicine approvals have shown the exception. For a drug with abuse potential, a second agency has to act before anything reaches a pharmacy shelf. Here is a status check as of early November.
Centanafadine: approved July 24, still waiting
The FDA approved Otsuka's Simtriyo (centanafadine), a once-daily extended-release capsule, on July 24, 2026. It is indicated for ADHD in adults and in children 6 and older who weigh at least 20 kg. It is the first approved norepinephrine–dopamine–serotonin reuptake inhibitor. The label carries boxed warnings for suicidal thoughts and behaviors in pediatric patients and for abuse, misuse and addiction.
The approval letter has an unusual clause. It says CSA scheduling of the product was not complete when the letter was issued, and that Simtriyo may be marketed only after the DEA publishes a Federal Register notice announcing interim final scheduling of centanafadine. Otsuka has said it expects to launch later in 2026, after scheduling. As of the latest coverage we could find, from mid-October, the drug was not commercially available, the DEA had not announced a schedule and we found no Federal Register notice.
Oveporexton: approved August 5, same bottleneck
Takeda's Orzeyful (oveporexton) was approved on August 5, 2026, for adults with narcolepsy type 1. It is an oral orexin-2 receptor agonist taken twice daily. The approval was based on two 12-week placebo-controlled trials that together enrolled 273 adults. At approval Takeda said it expected a DEA controlled-substance classification within about 90 days, and the US launch is tied to that step. We found no Federal Register notice for oveporexton either.
Why 90 days?
The Improving Regulatory Transparency for New Medical Therapies Act added a provision at 21 U.S.C. 811(j). When HHS recommends that a newly approved drug be controlled in schedules II through V, the DEA must issue an interim final rule within 90 days. The process is already working this year. On August 27, 2026, the DEA used it to place a different new drug, the anesthetic cipepofol, in schedule IV. Clinicians waiting for either drug should watch the Federal Register, not the FDA's announcements.
COMP360 psilocybin: a voucher and a deadline
Compass Pathways told investors in August that the FDA had granted a rolling submission for COMP360 in treatment-resistant depression in April. Some NDA modules had been filed, and the company was on track to complete the submission in the fourth quarter of 2026. COMP360 also received a Commissioner's National Priority Voucher, a program that aims for a review of one to two months after a complete filing. Compass has guided to a potential launch in the first half of 2027. That depends on FDA approval and, because psilocybin is in Schedule I, on DEA rescheduling.
DT120 picks up a second Breakthrough designation
On September 8, 2026, the FDA granted Breakthrough Therapy designation to DT120 (lysergide orally disintegrating tablet) for major depressive disorder. The sponsor is Definium Therapeutics, formerly MindMed. Coverage cited the phase 3 Emerge trial, in which a single 100 µg dose produced an 8.1-point placebo-adjusted improvement on the MADRS at week 6 in 149 patients. The drug's earlier Breakthrough designation, for generalized anxiety disorder, dates to March 2024. Breakthrough status is not an approval.
The September 14 psychedelics hearing
The FDA, together with the VA, SAMHSA, ARPA-H and NIDA, held a Part 15 public hearing titled "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs." The hearing followed Executive Order 14401 of April 18, 2026, which directs agencies to speed research and review of psychedelics for serious mental illness. More than 18,000 people registered, and about 80 speakers presented. Debate centered on how much supervision dosing sessions need, from mandatory psychiatrist oversight to nurse-led models, and on rural access. By design, the hearing excluded individual applications, scheduling and legalization. The written comment period closed October 5.
| Product | Indication | FDA status | What's next |
|---|---|---|---|
| Simtriyo (centanafadine) | ADHD, age 6+ | Approved July 24, 2026 | DEA interim final rule; then launch |
| Orzeyful (oveporexton) | Narcolepsy type 1, adults | Approved August 5, 2026 | DEA scheduling; then US launch |
| COMP360 (psilocybin) | Treatment-resistant depression | Rolling NDA; priority voucher | Full filing targeted Q4 2026 |
| DT120 (lysergide ODT) | GAD; MDD | Breakthrough for both | Phase 3 program continuing |
Sources
- NDA 218145 approval letter (Simtriyo, centanafadine) — U.S. Food and Drug Administration
- Schedules of Controlled Substances: Placement of cipepofol in Schedule IV (interim final rule) — Federal Register
- FDA approves Orzeyful for type 1 narcolepsy in adults — Healio
- Compass Pathways second quarter and first half 2026 financial results and business highlights (Form 8-K) — U.S. Securities and Exchange Commission
- Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing (09/14/2026) — U.S. Food and Drug Administration
- DT120 ODT receives FDA Breakthrough Therapy designation for MDD — HCPLive