Small Molecule · TAK-360

TAK-360

Phase 2Takeda Pharmaceutical Company Limited (4502.T)
  • Fast Track

TAK-360 is an investigational oral, brain-penetrant, orexin receptor 2 (OX2R)-selective small-molecule agonist developed by Takeda. It is the second OX2R agonist in Takeda's orexin franchise after oveporexton (TAK-861), and is being developed for the orexin-non-deficient central disorders of hypersomnolence — narcolepsy type 2 (narcolepsy without cataplexy) and idiopathic hypersomnia — where it is intended to promote wakefulness by directly stimulating OX2R signalling. As of June 2026 TAK-360 is in Phase 2 dose-finding studies in NT2 (NCT06952699) and IH (NCT06812078), with a Phase 2/3 long-term safety extension (NCT07646678) planned across NT1/NT2/IH. No chemical structure or quantitative receptor affinity has been publicly disclosed.

Also known as: TAK-360

Data current as of

Modality
Small molecule
Mechanism
OX2 receptor agonist
Highest phase
Phase 2
Lead indication
Narcolepsy
Developer
Takeda Pharmaceutical Company Limited (4502.T)
Designations
Fast Track
Trials
3 tracked · 2 recruiting
Next catalyst
2H 2026 — Topline data (Narcolepsy)

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.

TargetActionAffinity
OX2 receptorprimaryHCRTR2Agonist—ⓘ

Formulations

FormulationRouteRegimenPharmacokinetics
TAK-360 oral tablet
Tablets administered orally in a Phase 2 dose-finding study (dose amounts and frequency not disclosed).
Oral——

Development timeline

Phase 2Feb 2025 – Aug 2026
  1. UpcomingPhase 2 NT2 dose-finding topline (TAK-360-2001) — estimated primary completion 20 Aug 2026
  2. UpcomingPhase 2 idiopathic hypersomnia dose-finding topline — estimated primary completion 16 Jul 2026
  3. 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.
  4. 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).

TAK-360 for Narcolepsy

Phase 2RecruitingNarcolepsy indication →

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.

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

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

Started Jun 2026· Primary completion Jun 2031

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)

Started May 2025· Primary completion Aug 2026

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)

Started Feb 2025· Primary completion Jul 2026

Related compounds

Other OX2 receptor compounds

More from Takeda Pharmaceutical Company Limited

Identifiers

    Sources

    1. A Study of TAK-360 in Adults With Idiopathic Hypersomnia — ClinicalTrials.gov
    2. A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2) — ClinicalTrials.gov
    3. A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia (long-term extension) — ClinicalTrials.gov
    4. OX2 receptor (orexin receptor type 2 / HCRTR2), target 322 — IUPHAR/BPS Guide to Pharmacology