Tarceva(erlotinib)
Erlotinib, Tarceva (erlotinib) is a small molecule pharmaceutical. Erlotinib was first approved as Tarceva on 2004-11-18. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma and pancreatic neoplasms. The pharmaceutical is active against epidermal growth factor receptor. In addition, it is known to target solute carrier organic anion transporter family member 2B1.
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Therapeutic Areas
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Drug Products
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New Drug Application (NDA)
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Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Erlotinib hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TARCEVA | OSI Pharmaceuticals | N-021743 DISCN | 2004-11-18 | 3 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| erlotinib | ANDA | 2023-10-05 |
| erlotinib hydrochloride | ANDA | 2023-01-30 |
| tarceva | New Drug Application | 2016-10-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
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Clinical
Clinical Trials
861 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 86 | 208 | 66 | 12 | 44 | 378 |
| Neoplasms | D009369 | — | C80 | 64 | 31 | 4 | 1 | 9 | 101 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 22 | 60 | 6 | 1 | 13 | 90 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 29 | 51 | 7 | 1 | 3 | 85 |
| Adenocarcinoma of lung | D000077192 | — | — | 4 | 11 | — | 1 | 1 | 14 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 4 | 9 | — | 1 | 1 | 12 |
| Adenocarcinoma | D000230 | — | — | 3 | 6 | — | 1 | — | 9 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 4 | 1 | 1 | 1 | 8 |
| Exanthema | D005076 | HP_0000988 | — | — | 2 | — | 1 | 1 | 4 |
| Carcinoma | D002277 | — | C80.0 | — | 2 | — | 1 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Head and neck neoplasms | D006258 | — | — | 13 | 14 | 2 | — | 1 | 26 |
| Squamous cell carcinoma | D002294 | — | — | 12 | 13 | 1 | — | 2 | 22 |
| Colorectal neoplasms | D015179 | — | — | 5 | 13 | 3 | — | 1 | 20 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 9 | 14 | 1 | — | 1 | 20 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 9 | 11 | 1 | — | — | 17 |
| Squamous cell neoplasms | D018307 | — | — | 3 | 8 | 3 | — | 2 | 14 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 4 | 10 | 1 | — | — | 12 |
| Esophageal neoplasms | D004938 | — | C15 | 4 | 7 | 1 | — | — | 12 |
| Small cell lung carcinoma | D055752 | — | — | 2 | 6 | 1 | — | — | 8 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 5 | 1 | — | — | 6 |
Show 9 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 8 | 17 | — | — | 1 | 24 |
| Glioblastoma | D005909 | EFO_0000515 | — | 8 | 12 | — | — | — | 15 |
| Gliosarcoma | D018316 | — | — | 6 | 9 | — | — | — | 12 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 3 | 8 | — | — | — | 10 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 6 | 4 | — | — | — | 8 |
| Central nervous system neoplasms | D016543 | — | — | 4 | 5 | — | — | — | 8 |
| Rectal neoplasms | D012004 | — | — | 6 | 4 | — | — | — | 8 |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | 3 | 5 | — | — | — | 8 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 6 | — | — | — | 7 |
| Prostatic neoplasms | D011471 | — | C61 | 3 | 5 | — | — | — | 7 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | 1 | 2 |
| Anus neoplasms | D001005 | EFO_0003835 | C21 | 2 | — | — | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | 2 | — | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | — | 1 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | — | 1 |
| Anemia | D000740 | HP_0001903 | D64.9 | 1 | — | — | — | — | 1 |
| Hodgkin disease | D006689 | — | C81 | 1 | — | — | — | — | 1 |
| Leukemia myeloid chronic atypical bcr-abl negative | D054438 | — | C92.2 | 1 | — | — | — | — | 1 |
Show 14 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Second primary neoplasms | D016609 | — | — | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Germ-line mutation | D018095 | — | — | — | — | — | — | 1 | 1 |
| Multiple primary neoplasms | D009378 | — | — | — | — | — | — | 1 | 1 |
| Eye abnormalities | D005124 | HP_0000478 | Q15.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Erlotinib |
| INN | erlotinib |
| Description | Erlotinib is a quinazoline compound having a (3-ethynylphenyl)amino group at the 4-position and two 2-methoxyethoxy groups at the 6- and 7-positions. It has a role as an antineoplastic agent, a protein kinase inhibitor and an epidermal growth factor receptor antagonist. It is a member of quinazolines, a terminal acetylenic compound, an aromatic ether and a secondary amino compound. |
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1 |
Identifiers
| PDB | — |
| CAS-ID | 183321-74-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL553 |
| ChEBI ID | 114785 |
| PubChem CID | 176870 |
| DrugBank | DB00530 |
| UNII ID | J4T82NDH7E (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
SLCO2B1
SLCO2B1
Organism
Homo sapiens
Gene name
SLCO2B1
Gene synonyms
KIAA0880, OATP2B1, OATPB, SLC21A9
NCBI Gene ID
Protein name
solute carrier organic anion transporter family member 2B1
Protein synonyms
OATP-B, OATP-RP2, OATP2B1, OATPRP2, Organic anion transporter B, Organic anion transporter polypeptide-related protein 2, Organic anion transporting polypeptide 2B1, solute carrier family 21 (organic anion transporter), member 9, Solute carrier family 21 member 9
Uniprot ID
Mouse ortholog
Slco2b1 (101488)
solute carrier organic anion transporter family member 2B1 (Q8BXB6)
Variants
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Financial
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Tarceva – Roche
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Trends
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Safety
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47,567 adverse events reported
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