Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rolapitant Dose 1 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Rolapitant Dose 1 | EXPERIMENTAL | - |
| Rolapitant Dose 2 | EXPERIMENTAL | - |
| Rolapitant Dose 3 | EXPERIMENTAL | - |
| Rolapitant Dose 4 | EXPERIMENTAL | - |
| Ondansetron | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Rolapitant Dose 1 | DRUG | Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
| Rolapitant Dose 2 | DRUG | Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
| Rolapitant Dose 3 | DRUG | Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
| Rolapitant Dose 4 | DRUG | 200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
| Ondansetron | DRUG | Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1 |
| Placebo | DRUG | Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
Inclusion Criteria: * Women aged 18 years or older of any race with an American Society of Anesthesiologists (ASA) physical status of I to III who are scheduled to undergo elective open abdominal surgery under general anesthesia. * Women whose postoperative hospitalization is expected to last at le...
Rolapitant Dose 1 was studied for the prevention of postoperative nausea and vomiting. It was evaluated in a Phase 2 clinical trial in adult female patients undergoing surgery. The program was investigated by Merck & Company, Inc. as a potential treatment in this surgical supportive care setting.
Rolapitant Dose 1 is a small molecule antagonist of TACR1, also known as the neurokinin 1 receptor. By blocking this receptor, the compound is designed to interfere with substance P signaling, a pathway involved in triggering nausea and vomiting. This mechanism underlies its investigation for postoperative nausea and vomiting.
Rolapitant Dose 1 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 2 clinical study of this asset for postoperative nausea and vomiting. The program is part of the company's broader research in supportive care for surgical patients.
Rolapitant Dose 1 is in Phase 2 development. It has completed one Phase 2 clinical trial for postoperative nausea and vomiting. The drug is investigational and has not been approved by the FDA for any indication. No active trials are currently listed for this asset.
Rolapitant Dose 1 has been evaluated in one completed clinical trial, NCT00539721, titled A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1). The trial was Phase 2, randomized, double-blind, placebo-controlled, and enrolled 619 adult female participants.