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Gemcitabine
Infugem (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 subunit M2 and ribonucleoside-diphosphate reductase large subunit.
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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
Infugem (generic drugs available since 2010-11-15, discontinued: Gemzar)
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
INFUGEMsparcN-208313 RX2018-07-16
10 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
gemcitabineANDA2022-11-29
infugemNew Drug Application2019-12-24
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
29 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial conjunctivitisD003234EFO_1000829H10.0—141—6
Healthy volunteers/patients—1——1—2
Typhoid feverD014435EFO_0006789A01.0———1—1
CataractD002386EFO_0001059H26.9———1—1
Microbial drug resistanceD004352———1—1
InfectionsD007239EFO_0000544———1—1
Eye infectionsD015817EFO_1001888———1—1
InjectionsD007267———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A19111——2
KeratitisD007634H16——1——1
InflammationD007249——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Corneal ulcerD003320H16.0—2———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cataract extractionD0023871————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Periapical diseasesD010483EFO_0010688————11
PterygiumD011625H11.0————11
EndophthalmitisD009877————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)
Structure (InChI/SMILES or Protein Sequence)
Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)C2(F)F)c(=O)n1
Identifiers
PDB4PD5
CAS-ID95058-81-4
RxCUI12574
ChEMBL IDCHEMBL888
ChEBI ID175901
PubChem CID60750
DrugBankDB00441
UNII IDB76N6SBZ8R (ChemIDplus, GSRS)
Target
Agency Approved
RRM2
RRM2
RRM1
RRM1
Organism
Homo sapiens
Gene name
RRM2
Gene synonyms
RR2
NCBI Gene ID
6241
Protein name
ribonucleoside-diphosphate reductase subunit M2
Protein synonyms
ribonucleotide reductase M2 polypeptide, Ribonucleotide reductase small chain, Ribonucleotide reductase small subunit, uncharacterized protein C2orf48
Uniprot ID
Q5WRU7
Mouse ortholog
Rrm2 (20135)
ribonucleoside-diphosphate reductase subunit M2 (Q542E2)
Alternate
No data
Variants
Clinical Variant
Identifier
Target mutation
Effect
Evaluation
Status
VCV000030389ABCG2, 421C>A, Gln141Lysdrug response2021-03-242A
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 72,797 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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1,352 adverse events reported
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