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AboutPricing
Drug ReportsGemcitabine
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
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
respiratory tract diseasesD012140
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
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 HYDROCHLORIDEACCORD HLTHCAREN-209604 RX2017-08-03
4 products, RLD, RS
GEMCITABINE HYDROCHLORIDEHospiraN-200795 RX2011-08-04
3 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
gemcitabineNew Drug Application2023-09-11
gemcitabine gemcitabineANDA2019-09-12
gemcitabine hydrochlorideANDA2020-09-14
gemcitabine hydrochloride gemcitabine hydrochlorideANDA2022-11-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
non-small-cell lung carcinoma—D002289—
ovarian neoplasmsEFO_0003893D010051C56
pancreatic ductal carcinoma—D021441—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Gemcitabine Hydrochloride, Infugem, Sun Pharm
92419482033-07-01DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BC: Pyrimidine analogues, antineoplastic antimetabolites
— L01BC05: Gemcitabine
HCPCS
Code
Description
J9198
Injection, gemcitabine hydrochloride, (infugem), 100 mg
J9201
Injection, gemcitabine hydrochloride, not otherwise specified, 200 mg
Clinical
Clinical Trials
3098 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 neoplasmsD010190EFO_0003860C25323527108459879
Non-small-cell lung carcinomaD002289——50178821214312
NeoplasmsD009369—C80192721214238
Ovarian neoplasmsD010051EFO_0003893C5635652811114
Pancreatic ductal carcinomaD021441——3952111490
Urologic neoplasmsD014571—C64-C68123051—40
AdenocarcinomaD000230——102121—28
Renal cell carcinomaD002292EFO_0000376—61411122
T-cell lymphoma peripheralD016411——61313—19
T-cell lymphomaD016399——222117
Show 3 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C503610840—7175
Urinary bladder neoplasmsD001749—C67339527—11149
Lung neoplasmsD008175HP_0100526C34.90269129—3134
CholangiocarcinomaD018281—C22.1288120—7121
Biliary tract neoplasmsD001661—C24.9248315—3107
Nasopharyngeal neoplasmsD009303——94536—790
Nasopharyngeal carcinomaD000077274——83936—886
SarcomaD012509——29394—161
Gallbladder neoplasmsD005706EFO_0004606C23153312—456
Fallopian tube neoplasmsD005185——192710——52
Show 76 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——2326——444
Stomach neoplasmsD013274EFO_0003897C16126——419
Kidney neoplasmsD007680EFO_0003865C64211——114
Esophageal neoplasmsD004938—C1574——213
Endometrial neoplasmsD016889EFO_0004230—79———13
MelanomaD008545——84——111
B-cell lymphomaD016393——85———10
Multiple myelomaD009101—C90.047———8
Ewing sarcomaD012512EFO_0000173—17———7
Mantle-cell lymphomaD020522—C83.144———7
Show 89 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470—C92.03———14
T-cell lymphoma cutaneousD016410—C84.A1———12
Pseudomyxoma peritoneiD011553EFO_0007456—1———12
Diffuse intrinsic pontine gliomaD000080443——2————2
Connective and soft tissue neoplasmsD018204——1————1
Rhabdoid tumorD018335——1————1
EpendymomaD004806——1————1
AstrocytomaD001254EFO_0000271—1————1
Choroid plexus neoplasmsD016545EFO_0007206—1————1
OligodendrogliomaD009837EFO_0000631—1————1
Show 13 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PrognosisD011379——————22
Circulating neoplastic cellsD009360——————11
Multiple primary neoplasmsD009378——————11
Brain deathD001926—G93.82————11
PancreatectomyD010180EFO_0002581—————11
Pleural effusionD010996HP_0002202J90————11
AscitesD001201HP_0001541R18————11
Appendiceal neoplasmsD001063EFO_0003880C18.1————11
Pleural neoplasmsD010997——————11
Maintenance chemotherapyD060046——————11
Show 5 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGemcitabine
INNgemcitabine
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 classnucleoside antiviral or antineoplastic agents, cytarabine or azarabine derivatives
Image (chem structure or protein)Loading
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-ID95058-81-4
RxCUI—
ChEMBL IDCHEMBL888
ChEBI ID175901
PubChem CID60750
DrugBankDB00441
UNII IDB76N6SBZ8R (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 83,297 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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43,050 adverse events reported
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