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
Trade Name
FDA
EMA
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 |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| varubi | New Drug Application | 2020-08-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| nausea | HP_0002018 | D009325 | R11.0 |
| vomiting | HP_0002013 | D014839 | R11.1 |
Agency Specific
FDA
EMA
No data
Clinical
Clinical Trials
223 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuromuscular blockade | D019148 | — | 5 | 2 | 17 | 21 | 45 | ||
| Anesthesia | D000758 | — | 1 | 7 | 8 | 11 | 27 | ||
| General anesthesia | D000768 | — | 3 | 7 | 2 | 7 | 19 | ||
| Muscle relaxation | D009126 | — | 2 | 3 | 5 | 1 | 10 | ||
| Postoperative pain | D010149 | G89.18 | — | — | 1 | 3 | 3 | 7 | |
| Laparoscopy | D010535 | — | — | — | 4 | 2 | 6 | ||
| Muscle weakness | D018908 | HP_0001324 | — | — | 1 | 2 | 1 | 4 | |
| Delayed emergence from anesthesia | D055191 | — | — | — | 3 | 1 | 4 | ||
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | 2 | 2 | 4 | |
| Rapid sequence induction and intubation | D000079603 | — | — | 2 | 1 | 1 | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart arrest | D006323 | EFO_0009492 | I46 | — | 1 | 1 | — | 1 | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | 1 | — | — | 1 |
| Lung neoplasms | D008175 | C34.90 | — | 1 | 1 | — | — | 1 | |
| Nerve block | D009407 | — | — | 1 | — | — | 1 | ||
| Back pain | D001416 | HP_0003418 | M54 | — | — | 1 | — | — | 1 |
| Local anesthesia | D000772 | — | — | 1 | — | — | 1 | ||
| Spinal fusion | D013123 | — | — | 1 | — | — | 1 | ||
| Organophosphate poisoning | D062025 | — | 1 | 1 | — | — | 1 | ||
| Muscle fatigue | D018763 | — | — | 1 | — | — | 1 | ||
| Hypothermia | D007035 | HP_0002045 | T68 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | — | 1 |
| Out-of-hospital cardiac arrest | D058687 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Delirium | D003693 | R41.0 | 1 | — | — | — | 2 | 3 | |
| High-frequency jet ventilation | D006611 | 1 | — | — | — | — | 1 | ||
| Spinal fractures | D016103 | EFO_0003902 | S12 | 1 | — | — | — | — | 1 |
| Spinal stenosis | D013130 | EFO_0007490 | M48.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharyngitis | D010612 | R07.0 | — | — | — | — | 3 | 3 | |
| Critical illness | D016638 | — | — | — | — | 2 | 2 | ||
| Patient satisfaction | D017060 | — | — | — | — | 2 | 2 | ||
| Neuromuscular monitoring | D061886 | — | — | — | — | 2 | 2 | ||
| Strabismus | D013285 | HP_0000486 | H50.2 | — | — | — | — | 1 | 1 |
| Melanoma | D008545 | — | — | — | — | 1 | 1 | ||
| Colorectal neoplasms | D015179 | — | — | — | — | 1 | 1 | ||
| Fasciculation | D005207 | R25.3 | — | — | — | — | 1 | 1 | |
| Pneumothorax | D011030 | J93.11 | — | — | — | — | 1 | 1 | |
| Bronchoscopy | D001999 | — | — | — | — | 1 | 1 |
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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 | 1665496 |
| 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
Clinical Variant
No data
Financial
Varubi - Tesaro
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 231 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,365 adverse events reported
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