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
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Gemcitabine (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 |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| avgemsi | New Drug Application | 2025-07-20 |
| gemcitabine | ANDA | 2025-07-23 |
| gemcitabine gemcitabine | ANDA | 2019-09-12 |
| gemcitabine hydrochloride | ANDA | 2025-01-09 |
Indications
FDA
EMA
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
3427 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 363 | 616 | 133 | 5 | 88 | 1038 |
| Non-small-cell lung carcinoma | D002289 | — | — | 78 | 242 | 106 | 12 | 21 | 421 |
| Lung neoplasms | D008175 | — | C34.90 | 64 | 230 | 85 | 9 | 19 | 375 |
| Carcinoma | D002277 | — | C80.0 | 66 | 213 | 102 | 2 | 24 | 373 |
| Adenocarcinoma | D000230 | — | — | 119 | 207 | 37 | 2 | 19 | 327 |
| Neoplasms | D009369 | — | C80 | 242 | 114 | 21 | 2 | 8 | 325 |
| Lymphoma | D008223 | — | C85.9 | 77 | 156 | 40 | 7 | 9 | 250 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 46 | 142 | 72 | 1 | 10 | 244 |
| Urinary bladder neoplasms | D001749 | — | C67 | 47 | 139 | 45 | 2 | 18 | 222 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 43 | 129 | 29 | 1 | 15 | 194 |
Show 22 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | — | — | 34 | 52 | 7 | — | 3 | 81 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 24 | 47 | 15 | — | 1 | 74 |
| B-cell lymphoma | D016393 | — | — | 31 | 46 | 15 | — | 1 | 73 |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | 17 | 45 | 16 | — | 5 | 73 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 28 | 37 | 9 | — | 1 | 64 |
| Fallopian tube neoplasms | D005185 | — | — | 19 | 29 | 14 | — | — | 56 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 13 | 28 | 10 | — | 5 | 49 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 10 | 32 | 2 | — | 1 | 42 |
| Ureteral neoplasms | D014516 | EFO_0003844 | C66 | 11 | 27 | 4 | — | 1 | 38 |
| Bile duct neoplasms | D001650 | — | — | 11 | 22 | 7 | — | 1 | 37 |
Show 102 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 34 | 35 | — | — | 5 | 59 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 15 | 8 | — | — | 4 | 23 |
| Esophageal neoplasms | D004938 | — | C15 | 10 | 6 | — | — | 2 | 16 |
| Melanoma | D008545 | — | — | 10 | 7 | — | — | 2 | 15 |
| Leukemia | D007938 | — | C95 | 6 | 8 | — | — | 1 | 14 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 8 | 10 | — | — | — | 14 |
| Multiple myeloma | D009101 | — | C90.0 | 5 | 10 | — | — | — | 12 |
| Ewing sarcoma | D012512 | EFO_0000173 | — | 1 | 9 | — | — | — | 9 |
| Plasma cell neoplasms | D054219 | — | — | 1 | 8 | — | — | — | 8 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 5 | 4 | — | — | — | 7 |
Show 126 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pseudomyxoma peritonei | D011553 | EFO_0007456 | — | 1 | — | — | — | 1 | 2 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | — | — | — | 1 | 2 |
| Diffuse intrinsic pontine glioma | D000080443 | — | — | 2 | — | — | — | — | 2 |
| Connective and soft tissue neoplasms | D018204 | — | — | 1 | — | — | — | — | 1 |
| Pharyngeal neoplasms | D010610 | — | C14.0 | 1 | — | — | — | — | 1 |
| Rhabdoid tumor | D018335 | — | — | 1 | — | — | — | — | 1 |
| Meningioma | D008579 | EFO_0003098 | D32.9 | 1 | — | — | — | — | 1 |
| Ependymoma | D004806 | — | — | 1 | — | — | — | — | 1 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | — | — | — | — | 1 |
| Choroid plexus neoplasms | D016545 | EFO_0007206 | — | 1 | — | — | — | — | 1 |
Show 16 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prognosis | D011379 | — | — | — | — | — | — | 2 | 2 |
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Multiple primary neoplasms | D009378 | — | — | — | — | — | — | 1 | 1 |
| Brain death | D001926 | — | G93.82 | — | — | — | — | 1 | 1 |
| Ascites | D001201 | — | R18 | — | — | — | — | 1 | 1 |
| Appendiceal neoplasms | D001063 | EFO_0003880 | C18.1 | — | — | — | — | 1 | 1 |
| Pleural neoplasms | D010997 | — | — | — | — | — | — | 1 | 1 |
| Maintenance chemotherapy | D060046 | — | — | — | — | — | — | 1 | 1 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | — | — | 1 | 1 |
| Hypoxia | D000860 | — | R09.02 | — | — | — | — | 1 | 1 |
Show 8 more
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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59,360 adverse events reported
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