Gemcitabine
Gemcitabine (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 large subunit and ribonucleoside-diphosphate reductase subunit M2.
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Commercial
Trade Name
FDA
EMA
Gemcitabine, Inlexzo (discontinued: Gemcitabine, Gemzar, Infugem)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gemcitabine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | Accord Healthcare | N-209604 RX | 2017-08-03 | 4 products, RLD, RS |
| GEMCITABINE HYDROCHLORIDE | Hospira | N-200795 RX | 2011-08-04 | 3 products, RLD, RS |
| INLEXZO | Johnson & Johnson | N-219683 RX | 2025-09-09 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| avgemsi | New Drug Application | 2025-08-04 |
| gemcitabine | ANDA | 2025-07-23 |
| gemcitabine gemcitabine | ANDA | 2019-09-12 |
| gemcitabine hydrochloride | ANDA | 2025-01-09 |
| inlexzo | New Drug Application | 2025-09-11 |
Indications
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EMA
Agency Specific
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EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Gemcitabine Hydrochloride, Infugem, Sun Pharm | |||
| 9241948 | 2033-07-01 | DP | |
Clinical
Clinical Trials
3478 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 2 | 1 | — | — | 4 |
| Non-muscle invasive bladder neoplasms | D000093284 | — | — | — | 1 | 3 | — | — | 4 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Transitional cell carcinoma | D002295 | — | — | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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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 |
Identifiers
| PDB | — |
| CAS-ID | 95058-81-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL888 |
| ChEBI ID | 175901 |
| PubChem CID | 60750 |
| DrugBank | DB00441 |
| UNII ID | B76N6SBZ8R (ChemIDplus, GSRS) |
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Safety
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60,621 adverse events reported
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