Schedules of Controlled Substances: Placement of Oveporexton in Schedule IV

What it does

On August 5, 2026, the United States Food and Drug Administration (FDA) approved a new drug application for Orzeyful (oveporexton) for the treatment of narcolepsy type 1 in adults. The Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place oveporexton, chemically known as N-[(2S,3R)-2-[[3-(3,5- difluorophenyl)-2-fluorophenyl]methyl]-4,4-difluoro-1-(2-hydroxy-2- methylpropanoyl)pyrrolidin-3-yl]ethanesulfonamide, in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing oveporexton, including its salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.

The Drug Enforcement Administration's summary, as published in the Federal Register.

What changed in the regulation

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 1308

Wording on eCFR: the day before it took effect and from the day it took effect (first part listed).

Compared with

The Drug Enforcement Administration has published 27 final rules in 2026 so far, compared with 17 in all of 2025.

Counted by the Tribune from Federal Register records since Jan. 1, 2025.

What happens next and when

This rule is effective November 12, 2026. Comments must be submitted electronically or postmarked on or before December 14, 2026. The electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register