Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-951 · 1 trial · 1 indication
Percentage of participants with complete response, defined as no emesis (vomiting or retching) and no need for rescue therapy (indicated if vomiting/retching and/or nausea score ≥4 or upon participant's request) were reported. The severity of nausea was scored using a self-reported, 11-point numerical Verbal Rating Scale (VRS), where 0 represents no nausea and 10 represents the worst nausea possible. Significant nausea was defined as a VRS score ≥4. Percentages are rounded off to whole number at the nearest single decimal.
| Arm | Type | Description |
|---|---|---|
| Ondansetron 4 mg IV | EXPERIMENTAL | Participants received prophylaxis with ondansetron 4 mg, intravenously (IV) immediately before induction and TAK-951 placebo subcutaneously (SC) approximately 30 to 45 minutes before the end of surgery (wound closure). |
| TAK-951 4 mg SC | EXPERIMENTAL | Participants received prophylaxis with ondansetron placebo IV immediately before induction and TAK 951 4 mg, SC, approximately 30 to 45 minutes before the end of surgery (wound closure). |
| Name | Type | Description |
|---|---|---|
| TAK-951 | DRUG | TAK-951 SC injection |
| Ondansetron | DRUG | Ondansetron IV injection |
| Ondansetron Placebo | DRUG | Ondansetron placebo-matching IV injection |
| TAK-951 Placebo | DRUG | TAK-951 placebo-matching SC injection |
Inclusion Criteria: 1. Participants undergoing elective surgery under general anesthesia, expected to last for at least 1 hour from induction of anesthesia to wound closure. 2. Participants are expected to require or have agreed to stay, at least 1 overnight in the hospital. 3. Participants America...
TAK-951 is being developed for the prevention of postoperative nausea and vomiting (PONV) in adults undergoing planned surgery. It is an investigational small molecule from Takeda Pharmaceutical Company Limited and has been studied in a Phase 2 clinical trial in the United States.
TAK-951 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating the drug for postoperative nausea and vomiting.
TAK-951 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 trial for postoperative nausea and vomiting has been completed.
TAK-951 has been evaluated in one completed Phase 2 trial, NCT04557189, titled "A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery." The trial enrolled 89 adults aged 18 and older in the United States and was randomized, double-blind, and controlled.
No, TAK-951 is not FDA approved. It is an investigational small molecule in Phase 2 clinical development for postoperative nausea and vomiting. The only listed trial, NCT04557189, has been completed, but no regulatory approval has been granted.