Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed for narcolepsy Type 1, narcolepsy Type 2, and idiopathic hypersomnia. It is currently in Phase 2 clinical trials for these sleep disorders.
TAK-360 targets the OX2R receptor, which is the orexin 2 receptor. By acting on this receptor, it is being studied for its potential effects on sleep-wake regulation in narcolepsy and idiopathic hypersomnia.
TAK-360 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting Phase 2 clinical trials for this investigational drug.
TAK-360 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 2 trials are currently recruiting participants.
TAK-360 is being studied in four Phase 2 trials: NCT06812078 for idiopathic hypersomnia, NCT06952699 for narcolepsy Type 2, NCT07633301 for narcolepsy Type 1, and NCT07646678 for narcolepsy or idiopathic hypersomnia. All trials are recruiting adults aged 18 and older.
TAK-360 is the primary name for this investigational drug. No alternative names have been reported for this compound in clinical development.