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 | 2025-08-04 |
| 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
3473 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 | 375 | 625 | 139 | 5 | 90 | 1062 |
| Non-small-cell lung carcinoma | D002289 | — | — | 90 | 255 | 108 | 12 | 21 | 447 |
| Neoplasms | D009369 | — | C80 | 255 | 153 | 26 | 2 | 8 | 373 |
| Lung neoplasms | D008175 | — | C34.90 | 46 | 151 | 40 | 4 | 15 | 232 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 46 | 129 | 57 | 1 | 10 | 218 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 41 | 136 | 35 | 1 | 14 | 203 |
| Urinary bladder neoplasms | D001749 | — | C67 | 43 | 126 | 40 | 1 | 16 | 201 |
| Adenocarcinoma | D000230 | — | — | 72 | 118 | 19 | 2 | 13 | 186 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 43 | 126 | 24 | 1 | 10 | 174 |
| Carcinoma | D002277 | — | C80.0 | 24 | 99 | 41 | 1 | 16 | 170 |
Show 24 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nasopharyngeal carcinoma | D000077274 | — | — | 13 | 70 | 53 | — | 14 | 141 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 27 | 56 | 16 | — | 1 | 84 |
| Sarcoma | D012509 | — | — | 35 | 50 | 7 | — | 2 | 79 |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | 17 | 48 | 20 | — | 5 | 79 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 28 | 34 | 8 | — | 1 | 61 |
| Fallopian tube neoplasms | D005185 | — | — | 19 | 30 | 15 | — | — | 58 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 11 | 30 | 10 | — | 5 | 49 |
| B-cell lymphoma | D016393 | — | — | 19 | 28 | 6 | — | — | 40 |
| Non-muscle invasive bladder neoplasms | D000093284 | — | — | 7 | 21 | 8 | — | 4 | 34 |
| Uterine cervical neoplasms | D002583 | — | — | 6 | 12 | 13 | — | 1 | 30 |
Show 101 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 35 | 36 | — | — | 6 | 62 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 18 | 11 | — | — | 5 | 28 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 6 | 18 | — | — | 1 | 24 |
| Esophageal neoplasms | D004938 | — | C15 | 12 | 7 | — | — | 3 | 20 |
| Mesothelioma | D008654 | — | C45 | 2 | 15 | — | — | 1 | 17 |
| Melanoma | D008545 | — | — | 12 | 6 | — | — | 2 | 16 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 9 | 11 | — | — | — | 16 |
| Rectal neoplasms | D012004 | — | — | 12 | 7 | — | — | — | 14 |
| Multiple myeloma | D009101 | — | C90.0 | 5 | 10 | — | — | — | 12 |
| Leukemia | D007938 | — | C95 | 5 | 6 | — | — | 1 | 11 |
Show 135 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 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 2 | — | — | — | — | 2 |
| Diffuse intrinsic pontine glioma | D000080443 | — | — | 2 | — | — | — | — | 2 |
| Connective and soft tissue neoplasms | D018204 | — | — | 1 | — | — | — | — | 1 |
| Pharyngeal neoplasms | D010610 | — | C14.0 | 1 | — | — | — | — | 1 |
| Kaposi sarcoma | D012514 | — | C46 | 1 | — | — | — | — | 1 |
| Islet cell carcinoma | D018273 | — | C25.4 | 1 | — | — | — | — | 1 |
| Islet cell adenoma | D007516 | EFO_0007331 | D13.7 | 1 | — | — | — | — | 1 |
| Rhabdoid tumor | D018335 | — | — | 1 | — | — | — | — | 1 |
| Meningioma | D008579 | EFO_0003098 | D32.9 | 1 | — | — | — | — | 1 |
Show 21 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypoxia | D000860 | — | R09.02 | — | — | — | — | 2 | 2 |
| Prognosis | D011379 | — | — | — | — | — | — | 2 | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 2 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 2 | 2 |
| Residual neoplasm | D018365 | — | — | — | — | — | — | 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 |
Show 15 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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Safety
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60,621 adverse events reported
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