Vitrakvi(larotrectinib)
Vitrakvi (larotrectinib) is a small molecule pharmaceutical. Larotrectinib was first approved as Vitrakvi on 2018-11-26. It is used to treat neoplasm drug resistance and neoplasm metastasis in the USA. It has been approved in Europe to treat abdominal neoplasms. It is known to target high affinity nerve growth factor receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Vitrakvi
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| vitrakvi | New Drug Application | 2025-04-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| neoplasm metastasis | EFO_0009708 | D009362 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LAROTRECTINIB SULFATE, VITRAKVI, BAYER HEALTHCARE | |||
| 2025-11-26 | ODE-215, ODE-220, ODE-221 | ||
LAROTRECTINIB SULFATE, VITRAKVI, BAYER HLTHCARE | |||
| 2025-11-26 | ODE-215, ODE-220, ODE-221 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Larotrectinib Sulfate, Vitrakvi, Bayer Healthcare | |||
| 10045991 | 2037-04-04 | U-2473 | |
| 10137127 | 2037-04-04 | DP | |
| 10668072 | 2037-04-04 | DP | |
| 11191766 | 2037-04-04 | U-2471 | |
| 11484535 | 2037-04-04 | U-2470 | |
| 10799505 | 2036-08-15 | DS, DP | |
| 9782414 | 2035-11-16 | U-2471, U-2475 | |
| 10172861 | 2035-11-16 | DS, DP | |
| 8513263 | 2029-12-23 | DS, DP | |
| 8865698 | 2029-10-21 | U-2469 | |
| 9127013 | 2029-10-21 | DS, DP | |
| 9447104 | 2029-10-21 | U-2470 | |
| 9676783 | 2029-10-21 | U-2469 | |
| 10005783 | 2029-10-21 | U-2472 | |
| 10047097 | 2029-10-21 | U-2474 | |
| 10774085 | 2029-10-21 | U-2470 | |
| Larotrectinib Sulfate, Vitrakvi, Bayer Hlthcare | |||
| 10285993 | 2035-11-16 | U-2470 | |
| 10813936 | 2035-11-16 | U-2987 | |
HCPCS
No data
Clinical
Clinical Trials
25 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 2 | 3 | — | — | 5 | 9 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 2 | — | — | — | 2 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Melanoma | D008545 | — | — | — | 1 | — | — | — | 1 |
| Biliary tract neoplasms | D001661 | — | C24.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Larotrectinib |
| INN | larotrectinib |
| Description | Larotrectinib, sold under the brand name Vitrakvi, is a medication for the treatment of cancer. It is an inhibitor of tropomyosin kinase receptors TrkA, TrkB, and TrkC. It was discovered by Array BioPharma and licensed to Loxo Oncology in 2013.
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors: tropomyosin receptor kinase (TRK) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(Nc1cnn2ccc(N3CCC[C@@H]3c3cc(F)ccc3F)nc12)N1CC[C@H](O)C1 |
Identifiers
| PDB | — |
| CAS-ID | 1223403-58-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3889654 |
| ChEBI ID | — |
| PubChem CID | 46188928 |
| DrugBank | DB14723 |
| UNII ID | PF9462I9HX (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
NTRK1
NTRK1
Organism
Homo sapiens
Gene name
NTRK1
Gene synonyms
MTC, TRK, TRKA
NCBI Gene ID
Protein name
high affinity nerve growth factor receptor
Protein synonyms
gp140trk, Neurotrophic tyrosine kinase receptor type 1, neurotrophic tyrosine kinase, receptor, type 1, Oncogene TRK, p140-TrkA, Trk-A, TRK1-transforming tyrosine kinase protein, tropomyosin receptor kinase A, Tropomyosin-related kinase A, Tyrosine kinase receptor, Tyrosine kinase receptor A
Uniprot ID
Mouse ortholog
Ntrk1 (18211)
high affinity nerve growth factor receptor (Q3UFB7)
Variants
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Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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777 adverse events reported
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