medcelerator · clinician one-pager
New Oral Medicine for Narcolepsy Type 1 in Adults
Orzeyful (oveporexton) for narcolepsy type 1
FDA Approved · United States, Canada · September 7, 2026
Condition: Narcolepsy Type 1
Who this is for
Orzeyful (oveporexton) is approved in the United States for adults with narcolepsy type 1. It cannot be sold there until the Drug Enforcement Administration schedules it. Health Canada is still reviewing it.
Next clinical step
The FDA has approved this medicine, but it can't be sold in the US until the DEA finishes classifying it as a controlled drug. Ask your doctor about timing. In Canada, authorisation is not confirmed; see Possible routes below if any are listed.
Ways to access this treatment
No treatment-specific route was found in the sources cited.
Possible routes (not confirmed)
United States · Prescription · Applicability unknown
US prescription (FDA-labelled)
FDA-approved, but sales wait on US Drug Enforcement Administration (DEA) scheduling; US availability not confirmed.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220860Orig1s000lbl.pdf
Canada · Health Canada Special Access Programme (SAP) · Applicability unknown
Health Canada Special Access Programme (manufacturer must agree)
SAP here depends on the manufacturer agreeing to supply; no confirmation for this drug.
https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html
General resources for further research
Canadian Clinical Trial Search Portal (Health Canada)
Health Canada's public search of the drug and biologic clinical trials it has authorised in Canada (phase 1 to 3, since April 2013). Search by condition, drug, or trial status and see where trials are running. It replaced the Health Canada Clinical Trials Database in July 2026. A listing is not enrolment, and Health Canada does not recruit patients: ask your clinician and contact the trial sponsor.
https://clinical-trials-search.canada.ca/en/home
ClinicalTrials.gov
US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.
https://clinicaltrials.gov/
AI-produced discussion aid; not prescribing instructions. Approval does not establish coverage. Full article: https://medcelerator.com/articles/orzeyful-oveporexton