Developer · TAK · Japan

Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited is a global, research-and-development-driven biopharmaceutical company headquartered in Osaka, Japan. Its neuroscience portfolio includes an orexin franchise targeting sleep-wake disorders, with oveporexton (TAK-861) as the lead OX2R-selective agonist asset.

takeda.com ↗

2compounds
2programs
1indication
Approvedlead asset

Phase distribution

  • Approved1
  • Phase 21

Modality

  • Small molecule 2

Mechanism focus

Pipeline (2)

Catalysts · 2 upcoming · 4 reported

  • 2H 2026Anticipated

    TAK-360forNarcolepsyTopline data

    Phase 2 idiopathic hypersomnia dose-finding topline — estimated primary completion 16 Jul 2026

    NCT06812078source ↗

  • FY2026 (by Mar 2027)Delayed

    TAK-360forNarcolepsyTopline data

    Phase 2b NT2 dose-finding topline (TAK-360-2001, NCT06952699) — Takeda guides FY2026; CT.gov primary completion moved to 30 Nov 2026

    NCT06952699source ↗

Recently reported

  • 2026-06-15met

    OveporextonforNarcolepsyFull results

    SLEEP 2026: FirstLight/RadiantLight secondary and exploratory endpoints (function via FINI, cognition, nighttime sleep/REM)

    source ↗

  • 2026-02-10

    OveporextonforNarcolepsyRegulatory

    FDA accepted the oveporexton NDA for narcolepsy type 1 and granted Priority Review, with a PDUFA target action date in Q3 2026.

    source ↗

  • 2025-07-14met

    OveporextonforNarcolepsyTopline data

    Phase 3 FirstLight and RadiantLight pivotal studies met all primary and key secondary endpoints (p<0.001) at week 12.

    source ↗

  • 2025-05-14met

    OveporextonforNarcolepsyFull results

    Phase 2b (TAK-861-2001) met primary MWT endpoint and key secondary endpoints (ESS, weekly cataplexy rate); results published in the New England Journal of Medicine.

    source ↗

Recent activity

  • Aug 5, 2026Phase changeOveporexton·NarcolepsyApprovedFDA approved ORZEYFUL (oveporexton) tablets for narcolepsy type 1 in adults, on the basis of two randomized, double-blind, placebo-controlled 12-week studies in 273 adults. Approval was granted to Takeda Pharmaceuticals America, Inc. Marketing is lawful only after the DEA issues its Controlled Substances Act scheduling decision.source ↗
  • Jun 15, 2026ReadoutOveporexton·NarcolepsymetSLEEP 2026: FirstLight/RadiantLight secondary and exploratory endpoints (function via FINI, cognition, nighttime sleep/REM)source ↗
  • Feb 10, 2026ReadoutOveporexton·NarcolepsyFDA accepted the oveporexton NDA for narcolepsy type 1 and granted Priority Review, with a PDUFA target action date in Q3 2026.source ↗
  • Jul 14, 2025ReadoutOveporexton·NarcolepsymetPhase 3 FirstLight and RadiantLight pivotal studies met all primary and key secondary endpoints (p<0.001) at week 12.source ↗
  • May 14, 2025ReadoutOveporexton·NarcolepsymetPhase 2b (TAK-861-2001) met primary MWT endpoint and key secondary endpoints (ESS, weekly cataplexy rate); results published in the New England Journal of Medicine.source ↗
  • May 6, 2025Phase changeTAK-360·NarcolepsyPhase 2Phase 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.source ↗
  • Feb 7, 2025Phase changeTAK-360·NarcolepsyPhase 2Phase 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).source ↗

Trials recruiting · 3 recruiting of 83 sponsored

  • Phase 3Vortioxetine tablets, Placebo tabletsn=18030 sites · Japan

    A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder

    Major Depressive DisorderNCT07204314 ↗

Showing 1 of 3 recruiting trials.

Competitive landscape

Other companies developing against Takeda Pharmaceutical Company Limited's targets or indications.

Leadership & advisors (5)