Details
Stereochemistry | ACHIRAL |
Molecular Formula | C22H23N3O4 |
Molecular Weight | 393.4366 |
Optical Activity | NONE |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
C#Cc1cccc(c1)Nc2c3cc(c(cc3ncn2)OCCOC)OCCOC
InChI
InChIKey=AAKJLRGGTJKAMG-UHFFFAOYSA-N
InChI=1S/C22H23N3O4/c1-4-16-6-5-7-17(12-16)25-22-18-13-20(28-10-8-26-2)21(29-11-9-27-3)14-19(18)23-15-24-22/h1,5-7,12-15H,8-11H2,2-3H3,(H,23,24,25)
Molecular Formula | C22H23N3O4 |
Molecular Weight | 393.4366 |
Charge | 0 |
Count |
|
Stereochemistry | ACHIRAL |
Additional Stereochemistry | No |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Optical Activity | NONE |
DescriptionSources: http://www.drugbank.ca/drugs/DB00530Curator's Comment:: Description was created based on several sources, including
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf
Sources: http://www.drugbank.ca/drugs/DB00530
Curator's Comment:: Description was created based on several sources, including
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf
Erlotinib hydrochloride (trade name Tarceva, Genentech/OSIP, originally coded as OSI-774) is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. Similar to gefitinib, erlotinib specifically targets the epidermal growth factor receptor (EGFR) tyrosine kinase. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor. Erlotinib has recently been shown to be a potent inhibitor of JAK2V617F activity. JAK2V617F is a mutant of tyrosine kinase JAK2, is found in most patients with polycythemia vera (PV) and a substantial proportion of patients with idiopathic myelofibrosis or essential thrombocythemia. The study suggests that erlotinib may be used for treatment of JAK2V617F-positive PV and other myeloproliferative disorders. The mechanism of clinical antitumor action of erlotinib is not fully characterized. Erlotinib inhibits the intracellular phosphorylation of tyrosine kinase associated with the epidermal growth factor receptor (EGFR). Specificity of inhibition with regard to other tyrosine kinase receptors has not been fully characterized. EGFR is expressed on the cell surface of normal cells and cancer cells.
CNS Activity
Originator
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL203 Sources: https://www.ncbi.nlm.nih.gov/pubmed/25882519 |
1.2 nM [IC50] | ||
Target ID: CHEMBL3401 Sources: http://www.drugbank.ca/drugs/DB00530 |
|||
Target ID: CHEMBL5393 Sources: https://www.ncbi.nlm.nih.gov/pubmed/27418107 |
2.23 µM [IC50] | ||
Target ID: CHEMBL614139 Sources: https://www.ncbi.nlm.nih.gov/pubmed/27010345 |
0.02 µM [IC50] | ||
Target ID: CHEMBL5145 Sources: https://www.ncbi.nlm.nih.gov/pubmed/27010345 |
0.08 µM [IC50] | ||
Target ID: CHEMBL2363049 Sources: https://www.ncbi.nlm.nih.gov/pubmed/27010345 |
0.05 µM [IC50] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | TARCEVA Approved UseTARCEVA is a kinase inhibitor indicated for:
Maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. Launch Date1.10064959E12 |
|||
Primary | TARCEVA Approved UseTARCEVA is a kinase inhibitor indicated for:
Maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. Launch Date1.10064959E12 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
1.25 μg/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN |
|
4.07 μg/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, intravenous dose: 100 mg route of administration: Intravenous experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
1969.5 ng/mL Clinical Trial https://clinicaltrials.gov/ct2/show/NCT01032070 |
85 mg/m^2 1 times / day steady, oral dose: 85 mg/m^2 route of administration: oral experiment type: steady co-administered: |
ERLOTINIB plasma | Homo sapiens population: unhealthy age: Children sex: food status: |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
29.9 μg × h/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN |
|
32 μg × h/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, intravenous dose: 100 mg route of administration: Intravenous experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
26716.7 ng*h/mL Clinical Trial https://clinicaltrials.gov/ct2/show/NCT01032070 |
85 mg/m^2 1 times / day steady, oral dose: 85 mg/m^2 route of administration: oral experiment type: steady co-administered: |
ERLOTINIB plasma | Homo sapiens population: unhealthy age: Children sex: food status: |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
14.4 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN |
|
12.4 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, intravenous dose: 100 mg route of administration: Intravenous experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
7% |
ERLOTINIB plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
100 mg 1 times / day single, intravenous Highest studied dose Dose: 100 mg, 1 times / day Route: intravenous Route: single Dose: 100 mg, 1 times / day Sources: |
unhealthy, Median age 54 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 54 years Sex: M+F Population Size: 6 Sources: |
|
150 mg 1 times / day multiple, oral Recommended|MTD Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 7 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 7 Sources: |
Other AEs: Mucositis, Diarrhea... Other AEs: Mucositis (grade 1-2, 28.6%) Sources: Diarrhea (grade 1-2, 85.7%) Hyperbilirubinemia (grade 1-2, 14.3%) Skin toxicity (grade 1-2, 28.6%) |
200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Other AEs: Diarrhea, Hyperbilirubinemia... Other AEs: Diarrhea (grade 1-2, 66.7%) Sources: Hyperbilirubinemia (grade 1-2, 33.3%) Skin toxicity (grade 1-2, 83.3%) Headache (grade 1-2, 33.3%) Diarrhea (grade 4, 33.3%) |
100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Other AEs: Neutropenia... |
100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(35 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Other AEs: Neutropenia, Neutropenia... Other AEs: Neutropenia (grade 3, 33.3%) Sources: Neutropenia (grade 4, 66.7%) Leukopenia (grade 3, 33.3%) Leukopenia (grade 4, 33.3%) |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Disc. AE: Leukopenia... Other AEs: Erysipelas, Leukopenia... AEs leading to discontinuation/dose reduction: Leukopenia (grade 3, 33.3%) Other AEs:Erysipelas (grade 3, 33.3%) Sources: Leukopenia (grade 4, 33.3%) Neutropenia (grade 3, 33.3%) Neutropenia (grade 4, 33.3%) |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Disc. AE: Rash, Diarrhea... Other AEs: Rash, Pruritus... AEs leading to discontinuation/dose reduction: Rash (10%) Other AEs:Diarrhea (4%) Rash (7%) Diarrhea (2%) Rash (grade 3, 8%) Sources: Pruritus (grade 3, <1%) Diarrhea (grade 3, 6%) Nausea (grade 3, 3%) Vomiting (grade 3, 2%) Stomatitis (grade 3, <1%) Constipation (grade 3, 1%) Abdominal pain (grade 3, 2%) Fatigue (grade 3, 14%) Chest pain (grade 3, 4%) Dyspnea (grade 3, 17%) Cough (grade 3, 4%) Hemoptysis (grade 3, 1%) Anorexia (grade 3, 8%) Headache (grade 3, 1%) Neuropathy (grade 3, 3%) Bone pain (grade 3, 3%) Infection (grade 3, 4%) Conjunctivitis (grade 3, <1%) Insomnia (grade 3, <1%) Rash (grade 4, <1%) Diarrhea (grade 4, <1%) Anorexia (grade 4, 1%) Fatigue (grade 4, 4%) Dyspnea (grade 4, 11%) Vomiting (grade 4, <1%) Abdominal pain (grade 4, <1%) |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Disc. AE: Diarrhoea, Rash... AEs leading to discontinuation/dose reduction: Diarrhoea (1%) Sources: Rash (1%) |
2000 mg 1 times / week multiple, oral Highest studied dose Dose: 2000 mg, 1 times / week Route: oral Route: multiple Dose: 2000 mg, 1 times / week Sources: |
unhealthy, Median age 63 years n = 19 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 63 years Sex: M+F Population Size: 19 Sources: |
Other AEs: Fatigue, Dehydration... Other AEs: Fatigue (grade 3, 5.3%) Sources: Dehydration (grade 3, 5.3%) Pneumonitis (grade 3, 5.3%) |
200 mg 2 times / day multiple, oral Highest studied dose Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy, adult n = 6 Health Status: healthy Age Group: adult Sex: M Population Size: 6 Sources: |
Disc. AE: Rash... AEs leading to discontinuation/dose reduction: Rash (grade 3, 100%) Sources: |
1000 mg 1 times / day single, oral Highest studied dose Dose: 1000 mg, 1 times / day Route: oral Route: single Dose: 1000 mg, 1 times / day Sources: |
healthy n = 4 Health Status: healthy Population Size: 4 Sources: |
Other AEs: Erythematous rash... Other AEs: Erythematous rash (grade 1) Sources: |
200 mg 2 times / day multiple, oral Highest studied dose Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy n = 5 Health Status: healthy Population Size: 5 Sources: |
Other AEs: Diarrhea, Transaminases increased... Other AEs: Diarrhea Sources: Transaminases increased |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Hyperbilirubinemia | grade 1-2, 14.3% | 150 mg 1 times / day multiple, oral Recommended|MTD Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 7 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 7 Sources: |
Mucositis | grade 1-2, 28.6% | 150 mg 1 times / day multiple, oral Recommended|MTD Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 7 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 7 Sources: |
Skin toxicity | grade 1-2, 28.6% | 150 mg 1 times / day multiple, oral Recommended|MTD Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 7 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 7 Sources: |
Diarrhea | grade 1-2, 85.7% | 150 mg 1 times / day multiple, oral Recommended|MTD Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 7 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 7 Sources: |
Headache | grade 1-2, 33.3% | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Hyperbilirubinemia | grade 1-2, 33.3% | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Diarrhea | grade 1-2, 66.7% | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Skin toxicity | grade 1-2, 83.3% | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Diarrhea | grade 4, 33.3% | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Neutropenia | grade 3, 33.3% | 100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Leukopenia | grade 3, 33.3% | 100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(35 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Neutropenia | grade 3, 33.3% | 100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(35 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Leukopenia | grade 4, 33.3% | 100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(35 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Neutropenia | grade 4, 66.7% | 100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(35 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Erysipelas | grade 3, 33.3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Neutropenia | grade 3, 33.3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Leukopenia | grade 3, 33.3% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Leukopenia | grade 4, 33.3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Neutropenia | grade 4, 33.3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Rash | 10% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Diarrhea | 2% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Diarrhea | 4% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Rash | 7% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Constipation | grade 3, 1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Headache | grade 3, 1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Hemoptysis | grade 3, 1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Fatigue | grade 3, 14% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Dyspnea | grade 3, 17% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Abdominal pain | grade 3, 2% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Vomiting | grade 3, 2% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Bone pain | grade 3, 3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Nausea | grade 3, 3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Neuropathy | grade 3, 3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Chest pain | grade 3, 4% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Cough | grade 3, 4% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Infection | grade 3, 4% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Diarrhea | grade 3, 6% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Anorexia | grade 3, 8% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Rash | grade 3, 8% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Conjunctivitis | grade 3, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Insomnia | grade 3, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Pruritus | grade 3, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Stomatitis | grade 3, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Anorexia | grade 4, 1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Dyspnea | grade 4, 11% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Fatigue | grade 4, 4% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Abdominal pain | grade 4, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Diarrhea | grade 4, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Rash | grade 4, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Vomiting | grade 4, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Diarrhoea | 1% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Rash | 1% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Dehydration | grade 3, 5.3% | 2000 mg 1 times / week multiple, oral Highest studied dose Dose: 2000 mg, 1 times / week Route: oral Route: multiple Dose: 2000 mg, 1 times / week Sources: |
unhealthy, Median age 63 years n = 19 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 63 years Sex: M+F Population Size: 19 Sources: |
Fatigue | grade 3, 5.3% | 2000 mg 1 times / week multiple, oral Highest studied dose Dose: 2000 mg, 1 times / week Route: oral Route: multiple Dose: 2000 mg, 1 times / week Sources: |
unhealthy, Median age 63 years n = 19 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 63 years Sex: M+F Population Size: 19 Sources: |
Pneumonitis | grade 3, 5.3% | 2000 mg 1 times / week multiple, oral Highest studied dose Dose: 2000 mg, 1 times / week Route: oral Route: multiple Dose: 2000 mg, 1 times / week Sources: |
unhealthy, Median age 63 years n = 19 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 63 years Sex: M+F Population Size: 19 Sources: |
Rash | grade 3, 100% Disc. AE |
200 mg 2 times / day multiple, oral Highest studied dose Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy, adult n = 6 Health Status: healthy Age Group: adult Sex: M Population Size: 6 Sources: |
Erythematous rash | grade 1 | 1000 mg 1 times / day single, oral Highest studied dose Dose: 1000 mg, 1 times / day Route: oral Route: single Dose: 1000 mg, 1 times / day Sources: |
healthy n = 4 Health Status: healthy Population Size: 4 Sources: |
Diarrhea | 200 mg 2 times / day multiple, oral Highest studied dose Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy n = 5 Health Status: healthy Population Size: 5 Sources: |
|
Transaminases increased | 200 mg 2 times / day multiple, oral Highest studied dose Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy n = 5 Health Status: healthy Population Size: 5 Sources: |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
yes [IC50 0.93 uM] | ||||
yes [IC50 31 uM] | ||||
yes [IC50 <0.1 uM] | ||||
yes [Ki 10 uM] | ||||
yes [Ki 14.7 uM] | ||||
yes [Ki 20 uM] | ||||
yes [Ki 35.7 uM] | ||||
yes [Ki 44 uM] |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
major [Km 5.9 uM] | yes (co-administration study) Comment: Coadministration of erlotinib with ketoconazole, a potent inhibitor of CYP3A4, resulted in a significant (67%) increase in erlotinib exposure (Study NP16612). The CYP3A4 inducer rifampicin has been demonstrated to impact the exposure to erlotinib; in Study NP16638 co-administration led to a 64% reduction in erlotinib AUC. Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-743_Tarceva_biopharmr.PDF#page=10 Page: - |
|||
minor | ||||
no | ||||
no | ||||
no | ||||
yes [Km 24 uM] | ||||
yes | ||||
yes | ||||
yes |
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
PubMed
Title | Date | PubMed |
---|---|---|
Small-molecule epidermal growth factor receptor tyrosine kinase inhibitors. | 2003 |
|
Development of the epidermal growth factor receptor inhibitor Tarceva (OSI-774). | 2003 |
|
Erlotinib: CP 358774, NSC 718781, OSI 774, R 1415. | 2003 |
|
Second-line chemotherapy for non-small cell lung cancer. | 2003 Aug |
|
The biological and biochemical effects of CP-654577, a selective erbB2 kinase inhibitor, on human breast cancer cells. | 2003 Aug 1 |
|
Specific method for determination of OSI-774 and its metabolite OSI-420 in human plasma by using liquid chromatography-tandem mass spectrometry. | 2003 Aug 15 |
|
Tolerability of gefitinib in patients receiving treatment in everyday clinical practice. | 2003 Dec |
|
Targeting the epidermal growth factor receptor in non-small cell lung cancer. | 2003 Dec 1 |
|
For investigational targeted drugs, combination trials pose challenges. | 2003 Dec 3 |
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Clinical Trials in Cancer-SMi Conference. 11-12 June 2003, London, UK. | 2003 Jul |
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Inhibitors of epidermal-growth-factor receptors: a review of clinical research with a focus on non-small-cell lung cancer. | 2003 Jul |
|
[Non-small cell lung cancer: 1) Molecular-target therapy]. | 2003 Jul 10 |
|
Challenges and opportunities for Erlotinib (Tarceva): what does the future hold? | 2003 Jun |
|
Erlotinib (Tarceva): an update on the clinical trial program. | 2003 Jun |
|
[Inhibitors of epidermal growth factor receptor and colorectal cancer]. | 2003 Nov |
|
Identifying predictive and surrogate markers of erlotinib antitumor activity other than rash. | 2003 Nov |
|
Can rash associated with HER1/EGFR inhibition be used as a marker of treatment outcome? | 2003 Nov |
|
Erlotinib: preclinical investigations. | 2003 Nov |
|
Targeting the HER1/EGFR receptor to improve outcomes in non-small-cell lung cancer. | 2003 Nov |
|
Epidermal growth factor receptor tyrosine kinase inhibitors in late stage clinical trials. | 2003 Nov |
|
Pharmacology of oral chemotherapy agents. | 2003 Nov-Dec |
|
Gateways to clinical trials. | 2003 Oct |
|
Molecular neuro-oncology and development of targeted therapeutic strategies for brain tumors. Part 1: Growth factor and Ras signaling pathways. | 2003 Oct |
|
Epidermal growth factor receptor inhibitors, gefitinib and erlotinib (Tarceva , OSI-774), in the treatment of bronchioloalveolar carcinoma. | 2003 Sep |
|
Distribution and function of EGFR in human tissue and the effect of EGFR tyrosine kinase inhibition. | 2003 Sep-Oct |
|
Review of epidermal growth factor receptor biology. | 2004 |
|
Potential role for epidermal growth factor receptor inhibitors in combined-modality therapy for non-small-cell lung cancer. | 2004 |
|
HER1/EGFR targeting: refining the strategy. | 2004 |
|
Gateways to clinical trials. | 2004 Apr |
|
Epidermal growth factor receptor inhibitors for the treatment of colorectal cancer: a promise fulfilled? | 2004 Apr |
|
Epidermal growth factor receptor tyrosine kinase inhibitors: evolving role in the treatment of solid tumors. | 2004 Apr |
|
Rationale and clinical validation of epidermal growth factor receptor as a target in the treatment of head and neck cancer. | 2004 Apr |
|
Identification of epidermal growth factor receptor-derived peptides immunogenic for HLA-A2(+) cancer patients. | 2004 Apr 19 |
|
Gefitinib ('Iressa', ZD1839) and new epidermal growth factor receptor inhibitors. | 2004 Feb 9 |
|
Synthesis and SAR of potent EGFR/erbB2 dual inhibitors. | 2004 Jan 5 |
|
Gateways to clinical trials. | 2004 Jan-Feb |
|
Emerging treatments in oncology: focus on tyrosine kinase (erbB) receptor inhibitors. | 2004 Jan-Feb |
|
Benzamides and benzamidines as specific inhibitors of epidermal growth factor receptor and v-Src protein tyrosine kinases. | 2004 Jul 1 |
|
Targeting non-small cell lung cancer with epidermal growth factor tyrosine kinase inhibitors: where do we stand, where do we go. | 2004 Jun |
|
EGFR inhibitors square off at ASCO. | 2004 Jun |
|
Antitumor activity of erlotinib (OSI-774, Tarceva) alone or in combination in human non-small cell lung cancer tumor xenograft models. | 2004 Jun |
|
Epidermal growth factor receptor tyrosine kinase inhibitors. | 2004 Jun 14 |
|
The role of erlotinib (Tarceva, OSI 774) in the treatment of non-small cell lung cancer. | 2004 Jun 15 |
|
The role of EGFR inhibitors in nonsmall cell lung cancer. | 2004 Mar |
|
[Bronchioloalveolar carcinoma (BAC)]. | 2004 Mar |
|
Inverse correlation of epidermal growth factor receptor messenger RNA induction and suppression of anchorage-independent growth by OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in glioblastoma multiforme cell lines. | 2004 Mar |
|
Current data and ongoing trials in patients with recurrent non-small-cell lung cancer. | 2004 May |
|
[Lung cancer: molecular targeting therapy]. | 2004 May |
|
New cytotoxic and molecular-targeted therapies of head and neck tumors. | 2004 May |
|
Combination treatment of glioblastoma multiforme cell lines with the anti-malarial artesunate and the epidermal growth factor receptor tyrosine kinase inhibitor OSI-774. | 2004 May 1 |
Sample Use Guides
The dose for NSCLC is 150 mg/day.
The dose for pancreatic cancer is 100 mg/day.
All doses of TARCEVA should be taken on an empty stomach at least
one hour before or two hours after food
Route of Administration:
Oral
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/26951976
Erlotinib (20 µM) inhibited 33.8% of the growth of T. gondii
Substance Class |
Chemical
Created
by
admin
on
Edited
Sat Jun 26 16:41:09 UTC 2021
by
admin
on
Sat Jun 26 16:41:09 UTC 2021
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Record UNII |
J4T82NDH7E
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Record Status |
Validated (UNII)
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Record Version |
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Classification Tree | Code System | Code | ||
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NCI_THESAURUS |
C2167
Created by
admin on Sat Jun 26 16:41:09 UTC 2021 , Edited by admin on Sat Jun 26 16:41:09 UTC 2021
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NDF-RT |
N0000175605
Created by
admin on Sat Jun 26 16:41:09 UTC 2021 , Edited by admin on Sat Jun 26 16:41:09 UTC 2021
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WHO-VATC |
QL01XE03
Created by
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WHO-ATC |
L01XE03
Created by
admin on Sat Jun 26 16:41:09 UTC 2021 , Edited by admin on Sat Jun 26 16:41:09 UTC 2021
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LIVERTOX |
365
Created by
admin on Sat Jun 26 16:41:09 UTC 2021 , Edited by admin on Sat Jun 26 16:41:09 UTC 2021
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NCI_THESAURUS |
C129825
Created by
admin on Sat Jun 26 16:41:09 UTC 2021 , Edited by admin on Sat Jun 26 16:41:09 UTC 2021
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NDF-RT |
N0000175076
Created by
admin on Sat Jun 26 16:41:09 UTC 2021 , Edited by admin on Sat Jun 26 16:41:09 UTC 2021
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EMA ASSESSMENT REPORTS |
TARCEVA (AUTHORIZED: PANCREATIC NEOPLASMS)
Created by
admin on Sat Jun 26 16:41:09 UTC 2021 , Edited by admin on Sat Jun 26 16:41:09 UTC 2021
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EMA ASSESSMENT REPORTS |
TARCEVA (AUTHORISED: CARCINOMA, NON-SMALL-CELL LUNG)
Created by
admin on Sat Jun 26 16:41:09 UTC 2021 , Edited by admin on Sat Jun 26 16:41:09 UTC 2021
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Code System | Code | Type | Description | ||
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DB00530
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PRIMARY | |||
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183321-74-6
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PRIMARY | |||
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CHEMBL553
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PRIMARY | |||
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4920
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PRIMARY | |||
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C65530
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PRIMARY | |||
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8133
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PRIMARY | |||
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1045
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PRIMARY | |||
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M5000
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PRIMARY | Merck Index | ||
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183321-74-6
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PRIMARY | |||
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8082
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PRIMARY | |||
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C400278
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Erlotinib
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ERLOTINIB
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J4T82NDH7E
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337525
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SUB16423MIG
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176870
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PRIMARY |
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ACTIVE MOIETY |
Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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CSF/PLASMA RATIO | BIOLOGICAL |
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SPECIES BIOLOGICAL |
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