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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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YTD
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EMA approval date
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Study first post date
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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
Gemcitabine, Inlexzo (discontinued: Gemcitabine, Gemzar, Infugem)
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 HealthcareN-209604 RX2017-08-03
4 products, RLD, RS
GEMCITABINE HYDROCHLORIDEHospiraN-200795 RX2011-08-04
3 products, RLD, RS
INLEXZOJohnson & JohnsonN-219683 RX2025-09-09
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
avgemsiNew Drug Application2026-07-27
gemcitabineANDA2026-08-20
gemcitabine gemcitabineANDA2019-09-12
gemcitabine hydrochlorideANDA2025-01-09
inlexzoNew Drug Application2025-09-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
ovarian neoplasmsEFO_0003893D010051C56
pancreatic ductal carcinoma—D021441—
non-small-cell lung carcinoma—D002289—
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
3737 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_0003860C253996611516951122
Non-small-cell lung carcinomaD002289——1022691091124468
NeoplasmsD009369—C8027217132310405
Lung neoplasmsD008175—C34.905015341314233
Urinary bladder neoplasmsD001749—C674613445119219
CholangiocarcinomaD018281—C22.14414338117216
Biliary tract neoplasmsD001661—C24.94414127313197
Pancreatic ductal carcinomaD021441——841032327174
AdenocarcinomaD000230——629616212156
Neoplasm metastasisD009362EFO_0009708—58883125155
Show 25 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C504713260—10223
Nasopharyngeal carcinomaD000077274——127860—15156
Large b-cell lymphoma diffuseD016403—C83.3296319—295
Gallbladder neoplasmsD005706EFO_0004606C23175021—582
SarcomaD012509——35516—279
Non-hodgkin lymphomaD008228—C85.932388—167
Fallopian tube neoplasmsD005185——213117——63
Liver neoplasmsD008113EFO_1001513C22.0113211—551
Non-muscle invasive bladder neoplasmsD000093284——82313—643
B-cell lymphomaD016393——17254——35
Show 109 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——4543——673
Kidney neoplasmsD007680EFO_0003865C64618——124
Esophageal neoplasmsD004938—C15128——321
MelanomaD008545——139——118
Endometrial neoplasmsD016889EFO_0004230—1011———17
Rectal neoplasmsD012004——127———14
Multiple myelomaD009101—C90.0611———13
LeukemiaD007938—C9567——112
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.066——111
T-cell lymphoma cutaneousD016410—C84.A83——111
Show 142 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pseudomyxoma peritoneiD011553EFO_0007456—1———12
Hematologic diseasesD006402EFO_0005803D75.92————2
Diffuse intrinsic pontine gliomaD000080443——2————2
Connective and soft tissue neoplasmsD018204——1————1
Pharyngeal neoplasmsD010610—C14.01————1
Kaposi sarcomaD012514—C461————1
Islet cell carcinomaD018273—C25.41————1
Islet cell adenomaD007516EFO_0007331D13.71————1
MeningiomaD008579EFO_0003098D32.91————1
EpendymomaD004806——1————1
Show 19 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypoxiaD000860—R09.02————22
PrognosisD011379——————22
InflammationD007249MP_0001845—————22
MalnutritionD044342EFO_0008572E40-E46————22
Residual neoplasmD018365——————22
Acute diseaseD000208——————11
Multiple primary neoplasmsD009378——————11
Brain deathD001926—G93.82————11
AscitesD001201—R18————11
Appendiceal neoplasmsD001063EFO_0003880C18.1————11
Show 18 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
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,906 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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64,731 adverse events reported
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