Drugs / Rolapitant
Rolapitant
also known as
SCH 619734 · Rolapitant hcl h20 · Rolapitant Hydrochloride · Rolapitant hydrochloride monohydrate · Varubi · Varuby
Small molecule targets TACR1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Varuby | — | 2017-04-19 | europa.eu ↗ |
| Approved | US (FDA) | VARUBI | — | 2015-09-01 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02434861 | May → Jul 2015 | chemotherapy-induced toxicity | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02382666 | Jan → Aug 2015 | chemotherapy-induced toxicity | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT03960151 | May 2018 → May 2021 | germ cell tumor | Costantine Albany | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02732015 | Oct 2016 → Jul 2020 | sarcoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00539721 | Oct 2007 → Jul 2008 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00506545 | Jan → Oct 2007 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00394966 | Sep 2006 → Mar 2008 | — | Schering-Plough | Completed | No outcome recorded |
| Phase 33 trials · 3 met primary | ||||||
| Phase 3 | NCT01499849 | Feb 2012 → May 2014 | chemotherapy-induced toxicity | Tesaro, Inc. | Completed | Met primary |
| Phase 3 | NCT01500226 | Feb 2012 → Feb 2014 | chemotherapy-induced toxicity | Tesaro, Inc. | Completed | Met primary |
| Phase 3 | NCT01500213 | Feb 2012 → Mar 2014 | chemotherapy-induced toxicity | Tesaro, Inc. | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT07442890 | Apr 2026 → Apr 2028 expected | lung cancer | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT02991456 Comparator | Oct 2017 → May 2022 | chemotherapy-induced toxicity | Duke University | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-06-28 | TerSera Therapeutics LLC | TESARO Enters Asset Purchase Agreement with TerSera® Therapeutics LLC for VARUBI® in the U.S. and Canada tersera.com ↗ |
| 2017-10-26 | OPKO Health, Inc. | OPKO Health Licensee TESARO Announces FDA Approval of VARUBI® IV for Delayed Nausea and Vomiting Associated with Chemotherapy opko.com ↗ |
| 2015-11-16 | OPKO Health, Inc. | OPKO Licensee TESARO Announces the Launch of VARUBI(TM) (Rolapitant) in the United States opko.com ↗ |
| 2015-09-02 | OPKO Health, Inc. | OPKO Licensee TESARO Receives FDA Approval for VARUBI™ (rolapitant) opko.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rolapitant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01500213 ↗ |
| Known as | Rolapitant hcl h20 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707331 ↗ |
| Known as | Rolapitant Hydrochloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02732015 ↗ |
| Known as | Rolapitant hydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707331 ↗ |
| Known as | SCH 619734 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00506545 ↗ |
| Known as | Varubi | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707331 ↗ |
| Known as | Varuby | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707331 ↗ |
| Action | Inhibit | “rolapitant, an NK-1 receptor antagonist” PMID 26272769 ↗ Aug 20151“Neurokinin 1 receptor antagonist” CHEMBL3707331 ↗ |
| Modality | Small molecule | — CHEMBL3707331 ↗ |
| Route | Oral | “x 1 orally” NCT00394966 ↗ |
| Target | TACR1 | “Neurokinin 1 receptor antagonist” CHEMBL3707331 ↗ |