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Rolapitant - Oral
Rolapitant - Oral is a Small molecule drug developed by Tesaro, Inc.. It is currently in Phase 1 development. Also known as: Rolapitant.
Rolapitant is an oral medication used to treat chemotherapy-induced nausea and vomiting, as well as nausea and vomiting caused by other conditions. It is also being studied as an antiemetic in patients receiving radiotherapy and temozolomide for malignant glioma.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Rolapitant - Oral |
|---|---|
| Also known as | Rolapitant |
| Sponsor | Tesaro, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Rolapitant and Palonosetron (NA)
- Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide (PHASE2)
- Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy (PHASE3)
- Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy (PHASE3)
- Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy (PHASE3)
- An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant (PHASE1)
- Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888) (PHASE2)
- A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rolapitant - Oral CI brief — competitive landscape report
- Rolapitant - Oral updates RSS · CI watch RSS
- Tesaro, Inc. portfolio CI
Frequently asked questions about Rolapitant - Oral
What is Rolapitant - Oral?
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Is Rolapitant - Oral also known as anything else?
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Related
- Manufacturer: Tesaro, Inc. — full pipeline
- Also known as: Rolapitant
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing