Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Danavorexton · 2 trials · 2 indications
| 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. |
| Cohort A1: Danavorexton Low Dose | EXPERIMENTAL | Danavorexton low dose or danavorexton placebo-matching infusion, once, intravenously on Day 1 in healthy adult participants with intravenous propofol as induction anesthetic and inhaled sevoflurane as the primary maintenance anesthetic. |
| Cohort A2: Danavorexton Middle Dose | EXPERIMENTAL | Danavorexton middle dose or danavorexton placebo-matching infusion, once, intravenously on Day 1 in healthy adult participants with intravenous propofol as induction anesthetic and inhaled sevoflurane as the primary maintenance anesthetic. |
| Cohort A3: Danavorexton High Dose | EXPERIMENTAL | Danavorexton high dose or danavorexton placebo-matching infusion, single, intravenously on Day 1 in healthy adult participants with intravenous propofol as induction anesthetic and inhaled sevoflurane as the primary maintenance anesthetic. |
| Cohort P: Danavorexton TBD | EXPERIMENTAL | Danavorexton dose to be decided (TBD) or danavorexton placebo-matching infusion, once, intravenously on Day 1 in healthy adult participants with intravenous propofol as induction and primary maintenance anesthetic. Dose of danavorexton will be based on the review of observed safety and tolerability data and pharmacokinetic (PK) data of previous cohorts. |
| Name | Type | Description |
|---|---|---|
| Danavorexton | DRUG | Danavorexton intravenous infusion. |
| Placebo | DRUG | Placebo intravenous infusion. |
| Danavorexton Placebo | DRUG | Danavorexton placebo-matching intravenous infusion. |
| Propofol | DRUG | Propofol intravenous bolus. |
| Sevoflurane | DRUG | Sevoflurane inhalation. |
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 use in sleep apnea and in healthy volunteers. It is being developed by Takeda Pharmaceutical Company Limited. The drug is currently in Phase 1 clinical development and is not approved by the FDA.
The molecular target of Danavorexton has not been disclosed in available information. The drug is a small molecule being investigated for its effects in sleep apnea and in healthy volunteers, but its specific mechanism of action is not publicly detailed.
Danavorexton is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 1 clinical trials for sleep apnea and in healthy volunteers.
Danavorexton is in Phase 1 clinical development. It has completed two Phase 1 trials, one in healthy volunteers and one in adults with obstructive sleep apnea. The drug is investigational and has not received FDA approval.
Danavorexton has completed two Phase 1 trials. NCT05025397 studied the drug in anesthetized healthy adults in the United States with 28 participants. NCT05180890 studied Danavorexton (TAK-925) in adults with obstructive sleep apnea in Australia with 13 participants.
Yes, Danavorexton is also known as TAK-925. The clinical trial NCT05180890, which studied the drug in adults with obstructive sleep apnea, refers to Danavorexton as TAK-925 in its title.