Rozlytrek(entrectinib)
Rozlytrek (entrectinib) is a small molecule pharmaceutical. Entrectinib was first approved as Rozlytrek on 2019-08-15. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat neoplasms and non-small-cell lung carcinoma.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
Rozlytrek
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rozlytrek | New Drug Application | 2024-11-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ENTRECTINIB, ROZLYTREK, GENENTECH INC | |||
| 2030-10-20 | ODE-448 | ||
| 2026-10-20 | NP, NPP | ||
| 2026-08-15 | ODE-265, ODE-313 | ||
| 2024-08-15 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Entrectinib, Rozlytrek, Genentech Inc | |||
| 10398693 | 2038-07-18 | DP | |
| 11253515 | 2038-07-18 | DP | |
| 10738037 | 2037-05-18 | DS, DP | U-2946 |
| 11091469 | 2037-05-18 | U-2617, U-2618 | |
| 10561651 | 2035-02-19 | U-2745 | |
| 10231965 | 2035-02-17 | U-2617, U-2618 | |
| 9085565 | 2033-05-22 | DS, DP | |
| 9649306 | 2033-05-22 | U-2617, U-2618 | |
| 8299057 | 2029-03-01 | DS, DP | |
| 8673893 | 2028-07-08 | U-2617, U-2618 | |
| 9029356 | 2028-07-08 | DS, DP | |
| 9085558 | 2028-07-08 | DP | |
| 9255087 | 2028-07-08 | U-2617, U-2618 | |
| 9616059 | 2028-07-08 | U-2618 | |
HCPCS
No data
Clinical
Clinical Trials
41 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 | 1 | 3 | — | — | — | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Melanoma | D008545 | — | — | 1 | 1 | — | — | — | 1 |
| Uveal neoplasms | D014604 | EFO_1001230 | — | 1 | 1 | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Entrectinib |
| INN | entrectinib |
| Description | Entrectinib is a member of the class of indazoles that is 1H-indazole substituted by [4-(4-methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzoyl]amino and 3,5-difluorobenzyl groups at positions 3 and 5, respectively. It is a potent inhibitor of TRKA, TRKB, TRKC, ROS1, and ALK (IC50 values of 0.1 to 1.7 nM), and used for the treatment of NTRK, ROS1 and ALK gene fusion-positive solid tumours. It has a role as an antineoplastic agent, an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor, an antibacterial agent and an apoptosis inducer. It is a difluorobenzene, a member of indazoles, a member of benzamides, a N-methylpiperazine, a member of oxanes, a secondary amino compound and a secondary carboxamide. |
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors: tropomyosin receptor kinase (TRK) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1CCN(c2ccc(C(=O)Nc3n[nH]c4ccc(Cc5cc(F)cc(F)c5)cc34)c(NC3CCOCC3)c2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 1108743-60-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1983268 |
| ChEBI ID | — |
| PubChem CID | 25141092 |
| DrugBank | DB11986 |
| UNII ID | L5ORF0AN1I (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Rozlytrek – Roche
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 2,889 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,002 adverse events reported
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