Gemcitabine
Infugem (gemcitabine) is a small molecule pharmaceutical. Gemcitabine was first approved as Gemzar on 1996-05-15. It is used to treat breast neoplasms, non-small-cell lung carcinoma, ovarian neoplasms, and pancreatic ductal carcinoma in the USA. The pharmaceutical is active against ribonucleoside-diphosphate reductase subunit M2 and ribonucleoside-diphosphate reductase large subunit.
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Commercial
Trade Name
FDA
EMA
Infugem (generic drugs available since 2010-11-15, discontinued: Gemzar)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
gemcitabine | ANDA | 2022-11-29 |
infugem | New Drug Application | 2019-12-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
breast neoplasms | EFO_0003869 | D001943 | C50 |
non-small-cell lung carcinoma | — | D002289 | — |
ovarian neoplasms | EFO_0003893 | D010051 | C56 |
pancreatic ductal carcinoma | — | D021441 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Gemcitabine Hydrochloride, Infugem, Sun Pharm | |||
9241948 | 2033-07-01 | DP |
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | — | 1 | 4 | 1 | — | 6 |
Healthy volunteers/patients | — | 1 | — | — | 1 | — | 2 | ||
Typhoid fever | D014435 | EFO_0006789 | A01.0 | — | — | — | 1 | — | 1 |
Cataract | D002386 | EFO_0001059 | H26.9 | — | — | — | 1 | — | 1 |
Microbial drug resistance | D004352 | — | — | — | 1 | — | 1 | ||
Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | 1 | |
Eye infections | D015817 | EFO_1001888 | — | — | — | 1 | — | 1 | |
Injections | D007267 | — | — | — | 1 | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cataract extraction | D002387 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Periapical diseases | D010483 | EFO_0010688 | — | — | — | — | 1 | 1 | |
Pterygium | D011625 | H11.0 | — | — | — | — | 1 | 1 | |
Endophthalmitis | D009877 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | GEMCITABINE |
INN | gemcitabine |
Description | Gemcitabine is a 2'-deoxycytidine having geminal fluoro substituents in the 2'-position. An inhibitor of ribonucleotide reductase, gemcitabine is used in the treatment of various carcinomas, particularly non-small cell lung cancer, pancreatic cancer, bladder cancer and breast cancer. It has a role as a photosensitizing agent, a DNA synthesis inhibitor, a prodrug, an EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor, an environmental contaminant, a xenobiotic, a radiosensitizing agent, an antineoplastic agent, an antimetabolite, an antiviral drug and an immunosuppressive agent. It is an organofluorine compound and a pyrimidine 2'-deoxyribonucleoside. |
Classification | Small molecule |
Drug class | nucleoside antiviral or antineoplastic agents, cytarabine or azarabine derivatives |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)C2(F)F)c(=O)n1 |
Target
Agency Approved
RRM2
RRM2
RRM1
RRM1
Organism
Homo sapiens
Gene name
RRM2
Gene synonyms
RR2
NCBI Gene ID
Protein name
ribonucleoside-diphosphate reductase subunit M2
Protein synonyms
ribonucleotide reductase M2 polypeptide, Ribonucleotide reductase small chain, Ribonucleotide reductase small subunit, uncharacterized protein C2orf48
Uniprot ID
Mouse ortholog
Rrm2 (20135)
ribonucleoside-diphosphate reductase subunit M2 (Q542E2)
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
---|---|---|---|---|
VCV000030389 | ABCG2, 421C>A, Gln141Lys | drug response | 2021-03-24 | 2A |
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:

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Additional graphs summarizing 72,797 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions

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1,352 adverse events reported
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