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TAK-360 · 4 trials · 3 indications
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.
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. 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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| TAK-360 Long Term Extension (LTE) Phase | EXPERIMENTAL | Participants will receive one of the available TAK-360 doses for up to approximately 5 years in this trial. Participants will enter the LTE on the dose they were in the parent trial or for participants with discontinued dosing regimen in the parent trial to the next closest available dose/dosing regimen for their indication in this trial. Participants rolling over to this trial from a placebo arm in the parent trial, will receive one of the available TAK-360 doses. Placebo will be only administered as needed to maintain dose blinding between TAK-360 doses and regimens. |
| Part A: TAK-360 | EXPERIMENTAL | Participants will receive TAK-360 tablets, orally. |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants will receive TAK-360 matching placebo tablets, orally. |
| Part B: TAK-360 | EXPERIMENTAL | Participants will receive TAK-360 tablets, orally. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants will receive TAK-360 matching placebo tablets, orally. |
| Part C | EXPERIMENTAL | Participants will receive TAK-360 tablets, orally. |
| TAK-360 | EXPERIMENTAL | Participants will receive TAK-360 tablets, orally, for 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| TAK-360 | DRUG | TAK-360 tablets |
| Placebo | DRUG | TAK-360-matching placebo tablets |
Key Inclusion Criteria: 1. Participant is willing and able to understand and fully comply with trial procedures and requirements. 2. Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial. 3. Participant has provided informe...
TAK-360 is an investigational small molecule being studied for idiopathic hypersomnia, narcolepsy type 1, and narcolepsy type 2. It is in Phase 2 clinical development and is not yet approved for any indication. All four listed studies are currently recruiting adults aged 18 and older.
TAK-360 targets OX2R, the orexin 2 receptor, a receptor class protein. By acting on OX2R, the drug is designed to engage the orexin signaling pathway, which is relevant to sleep-wake regulation in narcolepsy and idiopathic hypersomnia. TAK-360 is a small molecule administered as an investigational therapy.
TAK-360 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is running the Phase 2 program across multiple countries, including the United States, Japan, China, Australia, South Korea, France, Italy, Spain, and Hong Kong.
TAK-360 is in Phase 2 clinical development. It has not been approved by the FDA or any other regulatory agency, and it remains an investigational drug. The Phase 2 program includes four recruiting studies across narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.
TAK-360 is being studied in four Phase 2 trials: NCT07646678 in narcolepsy and idiopathic hypersomnia, NCT07633301 in narcolepsy type 1 with cataplexy, NCT06952699 in narcolepsy type 2 without cataplexy, and NCT06812078 in idiopathic hypersomnia. All are randomized, double-blind, placebo-controlled, and currently recruiting adults.
The TAK-360 Phase 2 program has a combined planned enrollment of 596 participants across its studies. NCT07646678 plans to enroll 500 participants, NCT07633301 plans 92, NCT06812078 plans 96, and NCT06952699 plans 88. All four studies enroll adults aged 18 and older and are currently recruiting.