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Verified 4 Aug 2026

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TAK-360

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.

Enrolling

At a glance

Known asTAK-360
SponsorTakeda
MechanismOral orexin receptor agonist
StagePhase 2
IndicationsNT1 · NT2 · IH
Registered trials4 · 4 recruiting
Last verified4 Aug 2026
Phase 2
NT1 · NT2 · IH

Where it stands

TAK-360 is Takeda's second orexin programme, running behind oveporexton. Where oveporexton is aimed squarely at narcolepsy type 1, TAK-360 is being tested across all three of the sleep disorders this class is chasing, in three parallel Phase 2 studies that are recruiting now.

One point is worth flagging because it is easy to misread. The pooled long-term extension study NCT07646678 carries a Phase 2/3 label on the registry. That label reflects the mix of participants rolling in from earlier studies, not a pivotal efficacy trial. TAK-360 is a Phase 2 programme.

Registered trials

All 4 studies on ClinicalTrials.gov that name TAK-360 or its development code, pulled from the registry on 4 Aug 2026.

Registry IDStudyPhaseStatusPrimary completion
NCT07646678 A Study of TAK-360 in People With Narcolepsy or Idiopathic HypersomniaPooled long-term extension safety study across all three conditions. The registry label is Phase 2/3, but this is not a pivotal efficacy trial.500 participants Phase 2/Phase 3 Recruiting 15 Jun 2031
NCT07633301 A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)Narcolepsy type 1. Recruiting.92 participants Phase 2 Recruiting 28 Nov 2027
NCT06952699 A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)Narcolepsy type 2. Recruiting.88 participants Phase 2 Recruiting 30 Nov 2026
NCT06812078 A Study of TAK-360 in Adults With Idiopathic HypersomniaIdiopathic hypersomnia. Recruiting.96 participants Phase 2 Recruiting 30 Nov 2026

Trial records are maintained by the sponsor and change without notice. Follow each link for current recruitment status and eligibility.

TAK-360 — common questions

Is TAK-360 in Phase 3?

No. TAK-360 is a Phase 2 programme. Its pooled long-term extension safety study, NCT07646678, carries a Phase 2/3 label on ClinicalTrials.gov, but that is an extension study and not a pivotal efficacy trial.

What conditions is TAK-360 being tested in?

Three, in parallel Phase 2 studies that are recruiting: narcolepsy type 1 (NCT07633301), narcolepsy type 2 (NCT06952699) and idiopathic hypersomnia (NCT06812078).

How is TAK-360 different from oveporexton?

Both are Takeda orexin programmes, but oveporexton is approved in China and under review in the US and Japan for narcolepsy type 1, while TAK-360 is still in Phase 2 and is being tested across NT1, NT2 and idiopathic hypersomnia.

Source

This entry was last checked against its primary source on 4 Aug 2026: https://clinicaltrials.gov/study/NCT07646678

Found something out of date? Send a correction with a primary source and it will be fixed.