Verified 4 Aug 2026
Narcolepsy type 1 destroys the neurons that make orexin. A new class of drugs puts the signal back. This page tracks every one of them — who owns it, how far it has come, and what happens next.
FDA decision window · Q3 2026
57days until the Q3 2026 window closes
oveporexton · Takeda · narcolepsy type 1
NDA accepted with Priority Review on 10 Feb 2026. The FDA set a PDUFA target in the third quarter of 2026 without naming a day. As of Takeda's Q1 FY2026 earnings release on 30 Jul 2026, the US application remained under review, with launch preparations underway for the second half of 2026.
Takeda
Approved in China on 22 Jul 2026 for adults and adolescents 16 and over — the first oral OX2R-selective agonist approved anywhere. Under Priority Review in the US and under review in Japan.
Phase 3 FirstLight and RadiantLight both met all primary and secondary endpoints.
Alkermes
Phase 3 Brilliance program opened 1 Apr 2026: Study 302 and Study 304 in NT1, Study 303 in NT2. Vibrance-3 continues in idiopathic hypersomnia at Phase 2.
First oral OX2R agonist to show efficacy in a large Phase 2 study in NT2, where patients are not orexin-deficient.
Centessa Pharmaceuticals — a wholly owned subsidiary of Eli Lilly since 24 Jun 2026
A registrational Phase 2/3 study (NCT07598708) opened 29 May 2026: 222 participants with NT1 or NT2, randomized against placebo. The earlier Phase 2 program continues as a long-term extension (NCT07096674) covering NT1, NT2 and IH. Eli Lilly completed its acquisition of Centessa on 24 Jun 2026, making it a wholly owned subsidiary.
Phase 2a data on 55 participants was the first showing of an oral OX2R agonist working across NT1, NT2 and IH.
Takeda
Three parallel Phase 2 studies are recruiting: NT1 (NCT07633301), NT2 (NCT06952699) and idiopathic hypersomnia (NCT06812078). A pooled long-term extension safety study across all three conditions (NCT07646678) carries a Phase 2/3 label but is not a pivotal efficacy trial.
Eisai
Advanced to Phase 2 (NCT07493265, recruiting), evaluating efficacy and safety in adults with narcolepsy, after completed Phase 1 studies including a placebo- and active-comparator-controlled study in NT1.
Centessa Pharmaceuticals — a wholly owned subsidiary of Eli Lilly since 24 Jun 2026
Phase 1 study (NCT07082829) recruiting healthy adults and older adults, including a sleep-deprivation proof-of-concept arm. Centessa describes ORX142 as targeting select neurological and neurodegenerative disorders.
Centessa Pharmaceuticals — a wholly owned subsidiary of Eli Lilly since 24 Jun 2026
Now in a Phase 1 study (NCT07413666) in healthy adults, past the IND-enabling stage it was in previously. Centessa's most potent OX2R agonist to date, being developed for neuropsychiatric disorders.
Alkermes
Phase 1, in development for fatigue associated with multiple sclerosis and Parkinson's disease, per Alkermes' own pipeline page. Not yet listed on ClinicalTrials.gov under this compound name.
Alkermes
Phase 1, in development for attention-deficit hyperactivity disorder, per Alkermes' own pipeline page. Not yet listed on ClinicalTrials.gov under this compound name.
TAK-994
Takeda — Stopped in Phase 2 after liver safety signals emerged. Oveporexton is the successor compound.
danavorexton
Takeda — TAK-925, an intravenous OX2R agonist used to establish the mechanism in humans. Superseded by oral compounds.
JZP441
Jazz Pharmaceuticals — Oral OX2R agonist licensed from Sumitomo Pharma (as DSP-0187). The Phase 1b efficacy study in narcolepsy type 1 (NCT06961266) was terminated in early 2026 for business reasons, not a safety signal. The compound no longer appears on Jazz's pipeline page.
What is an orexin agonist?
The drug class, in plain language
Narcolepsy type 1
What is lost, and what that costs
Narcolepsy type 2 and idiopathic hypersomnia
The harder half of the pipeline
Orexin agonists vs orexin antagonists
Same receptor, opposite direction
Orexin agonists vs current narcolepsy treatments
Replacement versus compensation
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