Varubi, Varuby(rolapitant)
Varubi, Varuby (rolapitant) is a small molecule pharmaceutical. Rolapitant was first approved as Varubi on 2015-09-01. It is used to treat nausea and vomiting in the USA. It has been approved in Europe to treat nausea, neoplasms, and vomiting. It is known to target substance-P receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Varubi (discontinued: Varubi)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rolapitant hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VARUBI | TerSera Therapeutics | N-206500 RX | 2015-09-01 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| varubi | New Drug Application | 2020-08-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| vomiting | HP_0002013 | D014839 | R11.1 |
| nausea | HP_0002018 | D009325 | R11.0 |
Agency Specific
FDA
EMA
No data
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vomiting | D014839 | HP_0002013 | R11.1 | 3 | 4 | 3 | — | — | 10 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | 3 | 3 | — | — | 6 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Germ cell and embryonal neoplasms | D009373 | — | — | — | 1 | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | — | 1 | — | — | — | 1 |
| Cough | D003371 | HP_0012735 | R05 | — | 1 | — | — | — | 1 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rolapitant |
| INN | rolapitant |
| Description | Rolapitant is an azaspiro compound that is 1,7-diazaspiro[4.5]decan-2-one carrying additional phenyl and 1-{[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl substituents at position 8. Used (in the form of the hydrochloride hydrate) for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. It has a role as an antiemetic and a neurokinin-1 receptor antagonist. It is an ether, an azaspiro compound, a member of pyrrolidin-2-ones, a member of piperidines and an organofluorine compound. It is a conjugate base of a rolapitant(1+). |
| Classification | Small molecule |
| Drug class | tachykinin (neurokinin) receptor antagonists: NK1 receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@@H](OC[C@@]1(c2ccccc2)CC[C@]2(CCC(=O)N2)CN1)c1cc(C(F)(F)F)cc(C(F)(F)F)c1 |
Identifiers
| PDB | — |
| CAS-ID | 552292-08-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707331 |
| ChEBI ID | — |
| PubChem CID | 10311306 |
| DrugBank | DB09291 |
| UNII ID | NLE429IZUC (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
TACR1
TACR1
Organism
Homo sapiens
Gene name
TACR1
Gene synonyms
NK1R, TAC1R
NCBI Gene ID
Protein name
substance-P receptor
Protein synonyms
neurokinin receptor 1, NK-1 receptor, NK-1R, Tachykinin receptor 1, tachykinin receptor 1 (substance P receptor; neurokinin-1 receptor)
Uniprot ID
Mouse ortholog
Tacr1 (21336)
substance-P receptor (Q8BYR7)
Variants
No data
Financial
Revenue by drug
$
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£
₣
Varubi – Tesaro
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 280 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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891 adverse events reported
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