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TAK-360

Phase 2

Narcolepsy Type 2 | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: May 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment88
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06952699A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)PHASE2 RECRUITING 88May 6, 2025Aug 20, 2026May 27, 202652 United States, China +5
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Study Endpoints
Primary Endpoints
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Up to 15 Weeks

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

Secondary Endpoints
Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score
Baseline, Week 4
Change from Baseline at Week 4 in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)
Baseline, Week 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAK-360EXPERIMENTALParticipants will receive TAK-360 tablets, orally, for 4 weeks.
PlaceboPLACEBO_COMPARATORParticipants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks.
Interventions
NameTypeDescription
TAK-360DRUGTAK-360 tablet.
PlaceboOTHERTAK-360 matching placebo tablet.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites52

Key Inclusion Criteria: 1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\]. 2. The participant has a documented, current diagnosis of NT2. Key Exclusion Criteria: 1. The parti...

Countries:United StatesChinaFranceItalyJapanSouth KoreaSpain
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Recent Changes (Last 90 Days)
LOWMay 28, 2026NCT06952699lastUpdatePostDate: changed
LOWMay 28, 2026NCT06952699lastUpdatePostDate: changed
LOWMay 26, 2026NCT06952699primaryCompletionDate: changed
LOWMay 24, 2026NCT06952699studyFirstPostDate: changed