TAK-360 · program
TAK-360 for Narcolepsy
- Fast Track
Phase 2 dose-finding program of the oral OX2R-selective agonist TAK-360 in narcolepsy type 2 (narcolepsy without cataplexy). The lead controlled study, NCT06952699 (TAK-360-2001), is a randomized, double-blind, placebo-controlled, dose-finding adaptive trial evaluating safety, tolerability and efficacy over a 4-week treatment period (est. n=88; started 6 May 2025; recruiting; estimated primary completion 20 Aug 2026). A parallel Phase 2 study in idiopathic hypersomnia (NCT06812078) is running as a separate indication, and a Phase 2/3 long-term safety extension across NT1/NT2/IH (NCT07646678) is planned. Takeda is reported to have received FDA Fast Track designation for TAK-360 (reviewer to verify the primary source/scope). No efficacy results have been reported. TAK-360 is the follow-on to oveporexton (TAK-861), Takeda's lead OX2R agonist for narcolepsy type 1.
Development timeline
- UpcomingPhase 2 NT2 dose-finding topline (TAK-360-2001) — estimated primary completion 20 Aug 2026
- UpcomingPhase 2 idiopathic hypersomnia dose-finding topline — estimated primary completion 16 Jul 2026
- Phase 2 dose-finding adaptive RCT of TAK-360 in narcolepsy type 2 (NCT06952699, est n=88) began; first posted/started on ClinicalTrials.gov. Lead controlled efficacy/safety study for the NT2 indication.
- Phase 2 dose-finding adaptive RCT of TAK-360 in idiopathic hypersomnia (NCT06812078, est n=96) began — the first registered TAK-360 efficacy study, establishing the Phase 2 program across the orexin-non-deficient hypersomnias (IH is a separate indication from this NT2 program).
Readouts
- 2H 2026AnticipatedTopline dataNCT06952699
Phase 2 NT2 dose-finding topline (TAK-360-2001) — estimated primary completion 20 Aug 2026
- 2H 2026AnticipatedTopline dataNCT06812078
Phase 2 idiopathic hypersomnia dose-finding topline — estimated primary completion 16 Jul 2026
Clinical trials in Narcolepsy
NCT07646678Phase 2/3Unknownn=500
A Long-term Extension Trial to Evaluate the Safety and Tolerability of TAK-360 in Participants With Selected Central Hypersomnia Conditions
NCT06952699TAK-360-2001Phase 2Recruitingn=88
A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)
NCT06812078Phase 2Recruitingn=96
A Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Idiopathic Hypersomnia (IH)
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| TAK-360 oral tablet Tablets administered orally in a Phase 2 dose-finding study (dose amounts and frequency not disclosed). | Oral | — | — |
Mechanism of action
TAK-360 is a selective agonist of the orexin (hypocretin) receptor 2 (OX2R; gene HCRTR2), a class A Gq-coupled GPCR. By directly activating OX2R it mimics the wake-promoting action of endogenous orexin-A/orexin-B neuropeptides. The therapeutic rationale targets central disorders of hypersomnolence in which orexin neurotransmission is intact or only partially reduced (narcolepsy type 2 and idiopathic hypersomnia), distinct from narcolepsy type 1, where orexin neurons are largely destroyed. No quantitative human OX2R potency (Ki/EC50) for TAK-360 has been publicly disclosed.
| Target | Action | Affinity |
|---|---|---|
| OX2 receptorprimaryHCRTR2 | Agonist | —ⓘ |
← Full TAK-360 compound page (identity, identifiers, all indications)
Sources
- A Study of TAK-360 in Adults With Idiopathic Hypersomnia — ClinicalTrials.gov
- A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2) — ClinicalTrials.gov
- A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia (long-term extension) — ClinicalTrials.gov
- OX2 receptor (orexin receptor type 2 / HCRTR2), target 322 — IUPHAR/BPS Guide to Pharmacology