Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TAK-925
Danavorexton · 3 trials · 4 indications
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Clinical laboratory evaluations include hematology, blood chemistry, and urinalysis.
Vital signs include heart rate, respiratory rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP).
A standard 12-lead ECG will be performed.
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3. |
| Danavorexton LD | EXPERIMENTAL | Danavorexton LD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3. |
| Danavorexton HD | EXPERIMENTAL | Danavorexton HD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3. |
| TAK-925 Dose A | EXPERIMENTAL | TAK-925 dose A intravenous (IV) infusion in each treatment sequence (crossover design). |
| TAK-925 Dose B | EXPERIMENTAL | TAK-925 dose B IV infusion in each treatment sequence (cross over design). |
| Cohort A1; TAK-925 (Dose Level A1) | EXPERIMENTAL | TAK-925, Dose Level A, once daily for up to 7 days in healthy participants. |
| Cohort A2; TAK-925 (Dose Level A2) | EXPERIMENTAL | TAK-925, Dose Level A2, once daily for up to 7 days in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A3; TAK-925 (Dose Level A3) | EXPERIMENTAL | TAK-925, Dose Level A3, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A4; TAK-925 (Dose Level A4) | EXPERIMENTAL | TAK-925, Dose Level A4, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A5; TAK-925 (Dose Level A5) | EXPERIMENTAL | TAK-925, Dose Level A5, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A6; TAK-925 (Dose Level A6) | EXPERIMENTAL | TAK-925, Dose Level A6, once daily for up to 7 days in healthy elderly participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Part A (Cohorts A1-A6); TAK-925 Placebo | PLACEBO_COMPARATOR | TAK-925 Placebo, once daily for up to 7 days in healthy participants. |
| Cohort B1; TAK-925 (Dose Level B1) | EXPERIMENTAL | TAK-925, Dose Level B1, once daily for up to 7 days in participants with narcolepsy. |
| Cohort B2; TAK-925 (Dose Level B2) | EXPERIMENTAL | TAK-925, Dose Level B2, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort B3; TAK-925 (Dose Level B3) | EXPERIMENTAL | TAK-925, Dose Level B3, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort B4; TAK-925 (Dose Level B4) | EXPERIMENTAL | TAK-925, Dose Level B4, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Part B (Cohorts B1-B4); TAK-925 Placebo | PLACEBO_COMPARATOR | TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy. |
| Cohort C1; TAK-925 (Dose Level C1) | EXPERIMENTAL | TAK-925, Dose Level C1, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort C2; TAK-925 (Dose Level C2) | EXPERIMENTAL | TAK-925, Dose Level C2, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Part C (Cohorts C1-C2); TAK-925 Placebo | PLACEBO_COMPARATOR | TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy. |
| Cohort A'1; TAK-925 (Dose Level A'1) | EXPERIMENTAL | TAK-925, Dose Level A'1, single dose in healthy participants. |
| Cohort A'2; TAK-925 (Dose Level A'2) | EXPERIMENTAL | TAK-925, Dose Level A'2, single dose in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Name | Type | Description |
|---|---|---|
| Danavorexton | DRUG | Danavorexton intravenous infusion. |
| Placebo | DRUG | Placebo intravenous infusion. |
| TAK-925 | DRUG | TAK-925 IV infusion |
Inclusion Criteria: 1. Has OSA diagnosed according to the International Classification of Sleep Disorders-3 (ICSD-3) criteria and an AHI of 12-50 events/hour sleep (documented by an in-clinic PSG or at-home sleep test within the last 12 months). Participants who do not have PSG results from within ...
Danavorexton is an investigational small molecule being studied for the treatment of sleep apnea, specifically obstructive sleep apnea. It is being developed by Takeda Pharmaceutical Company Limited. The drug has been tested in a Phase 1 clinical trial in adults with obstructive sleep apnea, but it is not yet approved for any indication.
Danavorexton is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is responsible for the clinical development of the drug, including the completed Phase 1 trial in adults with obstructive sleep apnea.
Danavorexton is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency for any indication.
Danavorexton has been evaluated in one completed Phase 1 clinical trial: NCT05180890, titled "A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep Apnea." The trial enrolled 13 participants in Australia and was randomized, double-blind, and placebo-controlled.
Yes, Danavorexton is also known as TAK-925. TAK-925 is the code name used by Takeda Pharmaceutical Company Limited during early development. Both names refer to the same investigational small molecule being studied for obstructive sleep apnea.