Drugs / oveporexton
last change 30 days ago re-read 2 minutes ago

oveporexton

also known as TAK-861

Small molecule

Developed for
narcolepsy 1 · narcolepsy without cataplexy
Investigated by
Takeda

Trials 6 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT05687903 Jan → Dec 2023 narcolepsy 1 Takeda Completed No outcome recorded
Phase 2 NCT05687916 Jan → Dec 2023 narcolepsy without cataplexy Takeda Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05816382 Apr 2023 → Feb 2028 expected narcolepsy 1 Takeda Recruiting No outcome recorded
Phase 33 trials
Phase 3 NCT07363720 Jan → Oct 2026 expected narcolepsy 1 Takeda Recruiting No outcome recorded
Phase 3 NCT06505031 Oct 2024 → Jun 2025 narcolepsy 1 Takeda Completed No outcome recorded
Phase 3 NCT06470828 Jul 2024 → Jun 2025 narcolepsy 1 Takeda Completed No outcome recorded

Press releases naming this drug 9 releases

DateIssuerRelease
2026-08-05 Takeda U.S. FDA Approves Takeda’s ORZEYFUL™ (oveporexton), the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 1 takeda.com
2026-07-22 Takeda Takeda’s ORZEYFUL (oveporexton) Approved in China as First Orexin Agonist and Only Medicine to Treat Narcolepsy Type 1 takeda.com
2026-06-15 Takeda New Pivotal Study Data Show Takeda’s Oveporexton Improved Daily Function, Cognition and Nighttime Sleep for People with Narcolepsy Type 1 takeda.com
2025-09-08 Takeda Takeda Presents Orexin Data from Landmark Oveporexton (TAK-861) Phase 3 Program in Narcolepsy Type 1 at World Sleep 2025 takeda.com
2025-07-14 Takeda Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1 takeda.com
2025-05-14 Takeda The New England Journal of Medicine Publishes Data from Phase 2b Trial of Oral Orexin Receptor 2 Agonist Oveporexton (TAK-861) in People with Narcolepsy Type 1 takeda.com
2024-09-19 Takeda Takeda to Present Additional Clinical Trial Study Data Highlighting the Impact of Orexin Agonist TAK-861 on the Burden of Narcolepsy at Sleep Europe 2024 takeda.com
2024-06-03 Takeda Takeda’s TAK-861 Phase 2b Late-Breaking Data Presentations at SLEEP 2024 Demonstrate Clinically Meaningful Impact of Oral Orexin Agonist in Narcolepsy Type 1 Compared to Placebo takeda.com
2024-02-08 Takeda Takeda Intends to Rapidly Initiate the First Global Phase 3 Trials of TAK-861, an Oral Orexin Agonist, in Narcolepsy Type 1 in First Half of Fiscal Year 2024 takeda.com

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as oveporexton “participants with narcolepsy type 1 received once- or twice-daily oveporexton (TAK-861), an oral orexin receptor 2-selective agonist, or placebo.” PMID 40367374 May 2025
Known as TAK-861 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05687903
5

NCT06505031

NCT07363720

NCT06470828

NCT05816382

NCT05687916

Action Activate “an oral orexin receptor 2-selective agonist” PMID 40367374 May 2025
Modality Small molecule CHEMBL6068065
Route Oral “Participants were randomized 1:1:1:1:1 to twice-daily oral oveporexton or matching placebo” PMID 41359331 Feb 2026