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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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EMA approval date
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Study first post date
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Results 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 HYDROCHLORIDEHospiraN-200795 RX2011-08-04
3 products, RLD, RS
INLEXZOJohnson & JohnsonN-219683 RX2025-09-09
1 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
avgemsiNew Drug Application2026-07-27
gemcitabineNew Drug Application2026-04-27
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
3686 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——7376—149
Breast neoplasmsD001943EFO_0003869C503316—141
Pancreatic neoplasmsD010190EFO_0003860C259183——24
NeoplasmsD009369—C801481——22
Lung neoplasmsD008175—C34.902182—122
Neoplasm metastasisD009362EFO_0009708—6103——16
Ovarian neoplasmsD010051EFO_0003893C56373——12
Urinary bladder neoplasmsD001749—C67—52——7
Peritoneal neoplasmsD010534———33——6
Fallopian tube neoplasmsD005185——133——6
Show 7 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——42———6
SarcomaD012509——43———5
Non-hodgkin lymphomaD008228—C85.924———5
Biliary tract neoplasmsD001661—C24.914———5
LymphomaD008223—C85.934———5
Prostatic neoplasmsD011471—C6132———4
Renal cell carcinomaD002292EFO_0000376—13———4
MelanomaD008545——31———4
RecurrenceD012008——22———4
Colonic neoplasmsD003110—C1831———4
Show 37 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Central nervous system neoplasmsD016543——2————2
MedulloblastomaD008527——1————1
Camurati-engelmann syndromeD003966Orphanet_1328Q78.31————1
Thyroid neoplasmsD013964EFO_0003841—1————1
GlioblastomaD005909EFO_0000515—1————1
GliomaD005910EFO_0000520—1————1
ChondrosarcomaD002813——1————1
Endometrial neoplasmsD016889EFO_0004230—1————1
Rectal neoplasmsD012004——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Maintenance chemotherapyD060046——————11
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 1,906 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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63,274 adverse events reported
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