Gemcitabine
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1996
- First approval year
- 1996
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Gemcitabine
- Molecular weight
- 263.2
- Structure (SMILES)
- Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)C2(F)F)c(=O)n1
- gemzar
- Gemzar
- gemcitabina
- Gemcitabina
- gemcitabina cisplatino
- gemcitabine
- Gemcitabine
- GEMCITABINE [HSDB]
- gemcitabine [INN]
- GEMCITABINE [MI]
- GEMCITABINE [USAN]
- GEMCITABINE [VANDF]
- Gemcitabine [WHO-DD]
- gemcitabine hsdb
- gemcitabine inn
- gemcitabine mi
- gemcitabine usan
- gemcitabine vandf
- gemcitabine who dd
- ly 188011
- LY-188011
- ly188011
- LY188011
- nsc 613327
- NSC-613327
- ATC classification codes
- L01BC05
Sources for recorded values
- CAS registry numbers
- 95058-81-4
- ChEMBL ID
- CHEMBL888
- InChIKey
- SDUQYLNIPVEERB-QPPQHZFASA-N
- PubChem compound IDs
- 60750
- RxNorm IDs (RxCUI)
- 12574
- FDA ingredient codes (UNII)
- B76N6SBZ8R
- Applicant
- JANSSEN BIOTECH
- Approval date
- 9 Sept 2025
- Application number
- NDA219683
- Patents
- 0
- Designations
- 2
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- gemcitabine
- Type
- Synthetic organic
- Drug name stem
- -citabine
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- ribonucleotide reductase catalytic subunit M1
- Gene symbol
- RRM1
- Protein identifier
- P23921
- Primary target
- Yes
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- ribonucleotide reductase regulatory subunit M2
- Gene symbol
- RRM2
- Protein identifier
- P31350
- Primary target
- Yes
- Mechanism
- DNA polymerase (alpha/delta/epsilon) inhibitor
- Action type
- Inhibitor
- Target
- DNA polymerase (alpha/delta/epsilon)
- Mechanism
- Ribonucleoside-diphosphate reductase RR1 inhibitor
- Action type
- Inhibitor
- Target
- Ribonucleoside-diphosphate reductase RR1
- Action type
- Inhibitor
- Gene symbol
- POLA1|POLD1|POLE
- Protein identifier
- P09884|P28340|Q07864
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- RRM1
- Protein identifier
- P23921
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- RRM2
- Protein identifier
- P31350
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Sarcoma, Ewing
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000174
- Subject identifier
- D012512
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Hodgkin Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000211
- Subject identifier
- D016411
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Adenocarcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Immunoblastic Lymphadenopathy
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000255
- Subject identifier
- D007119
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000294
- Subject identifier
- D001749
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Carcinoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Glioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000326
- Subject identifier
- D005910
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Neoplasms, Germ Cell and Embryonal
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000514
- Subject identifier
- D009373
- Condition
- Leiomyosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000564
- Subject identifier
- D007890
- Condition
- Leukemia
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Adenocarcinoma of Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000571
- Subject identifier
- D000077192
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Mesothelioma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000588
- Subject identifier
- D008654
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Osteosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000637
- Subject identifier
- D012516
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
And 89 more, listed on the interactive page.
- Condition identifier
- EFO_0000096
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000183
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000211
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000228
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000255
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000294
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000305
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000313
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000365
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000403
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000514
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000564
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000588
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000637
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000707
- Condition identifier
- EFO_0000708
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000770
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001061
- Highest recorded phase
- 3
And 232 more, listed on the interactive page.
- Event
- anaemia
- Reports
- 1,378
- Reporting signal score
- 995.552
- Event
- capillary leak syndrome
- Reports
- 108
- Reporting signal score
- 265.898
- Event
- cholangitis
- Reports
- 257
- Reporting signal score
- 587.333
- Event
- diffuse large b-cell lymphoma recurrent
- Reports
- 99
- Reporting signal score
- 251.687
- Event
- disease progression
- Reports
- 1,223
- Reporting signal score
- 1,610.46
- Event
- febrile neutropenia
- Reports
- 718
- Reporting signal score
- 750.311
- Event
- general physical health deterioration
- Reports
- 466
- Reporting signal score
- 328.067
- Event
- haematotoxicity
- Reports
- 270
- Reporting signal score
- 499.836
- Event
- haemolytic uraemic syndrome
- Reports
- 226
- Reporting signal score
- 628.339
- Event
- leukopenia
- Reports
- 580
- Reporting signal score
- 567.891
- Event
- malignant neoplasm progression
- Reports
- 938
- Reporting signal score
- 1,327.86
- Event
- metastases to liver
- Reports
- 257
- Reporting signal score
- 429.374
- Event
- mucosal inflammation
- Reports
- 293
- Reporting signal score
- 280.264
- Event
- neoplasm progression
- Reports
- 302
- Reporting signal score
- 362.948
- Event
- neuropathy peripheral
- Reports
- 479
- Reporting signal score
- 252.416
- Event
- neutropenia
- Reports
- 1,385
- Reporting signal score
- 1,329.85
- Event
- neutrophil count decreased
- Reports
- 337
- Reporting signal score
- 279.436
- Event
- pancytopenia
- Reports
- 494
- Reporting signal score
- 434.702
- Event
- platelet count decreased
- Reports
- 556
- Reporting signal score
- 297.265
- Event
- pleural effusion
- Reports
- 440
- Reporting signal score
- 345.473
- Event
- pneumonitis
- Reports
- 269
- Reporting signal score
- 281.168
- Event
- pyrexia
- Reports
- 1,298
- Reporting signal score
- 488.17
- Event
- recall phenomenon
- Reports
- 128
- Reporting signal score
- 393.316
- Event
- thrombocytopenia
- Reports
- 1,661
- Reporting signal score
- 2,020.9
- Event
- thrombotic microangiopathy
- Reports
- 492
- Reporting signal score
- 1,242.12
- NCT00001431
- NCT00005648
- NCT00005926
- NCT00035035
- NCT00102752
- NCT00191568
- NCT00219557
- NCT00220649
- NCT00242190
- NCT00267020
- NCT00336648
- NCT00515866
- NCT00558207
- NCT00574275
- NCT00637247
- NCT00711191
- NCT00732082
- NCT00833859
- NCT00839332
- NCT01019382
- NCT01045941
- NCT01049880
- NCT01086332
- NCT01251640
- NCT01294358
And 1,406 more, listed on the interactive page.
- Dose
- 1000 mg/m2 or 1250 mg/m2
- Route
- Intravenous
- How often
- On Days 1 and 8 of each 21-day cycle, weekly for the first 7 weeks then weekly for 3 weeks of each 28-day cycle, or as specified per cancer type
- Dilute with 0.9% Sodium Chloride to at least 0.1 mg/mL before administration
- Diluted solution can be stored up to 24 hours at 20-25°C
- Discard if particulate matter or discoloration is observed
- Hydrogen bond acceptors
- 7
- Hydrogen bond donors
- 3
- Polar surface area
- 110.6
- Calculated partition coefficient (ALogP)
- -1.29
- Calculated partition coefficient (XLogP)
- -1.5
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 2
- Heavy atoms
- 18
- Molecular formula
- C9H11F2N3O4
- Monoisotopic mass
- 263.07176216
- Natural product
- No
- 57894-225
- Recorded assays
- 2,810
- Active assays
- 1,080
- Confirmatory
- Other
- Screening
- Antimetabolites, Antineoplastic
Oral bioavailability
- Median
- 3.2
- Mean
- 3.2
- Minimum
- 3.2
- Maximum
- 3.2
- Unit
- %
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- F
Related records
Trials (2,173)
- (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
- (PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer
- 1911GCCC: Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma
- 1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy
- 24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC
- 2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen
- 9-ING-41 in Patients With Advanced Cancers
- 9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma
- 9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
- A 2-part Phase 1/2 Open-label Trial on ODM-212
- A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma
- A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease.
- A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients
- A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer
- A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
- A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]
- A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.
- A Clinical Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin
- A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients
- A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment
Approved for (2)
- Cancer
- Neoplasm
In development for (112)
- Acute lymphoblastic leukemia Phase 2
- Acute myeloid leukemia Phase 1
- Adenocarcinoma Phase 2
- Adult T-cell leukemia/lymphoma Phase 2
- Anaplastic large cell lymphoma Phase 2
- Angioimmunoblastic T-cell lymphoma Phase 3
- Anxiety Phase 2
- Bile duct cancer Phase 2
- Bile duct carcinoma Phase 2
- Biliary tract cancer Phase 3
- Biliary tract disorder Phase 2
- Biliary tract neoplasm Phase 3
- Bone cancer Phase 2
- Bone neoplasm Phase 2
- Bone sarcoma Phase 2
- Brain cancer Phase 1
- Breast cancer Phase 3
- Breast carcinoma Phase 3
- Breast neoplasm Phase 3
- Carcinoma Phase 3
Targets (14)
- POLA1 DNA polymerase (alpha/delta/epsilon) inhibitor
- POLA2 DNA polymerase (alpha/delta/epsilon) inhibitor
- POLD1 DNA polymerase (alpha/delta/epsilon) inhibitor
- POLD2 DNA polymerase (alpha/delta/epsilon) inhibitor
- POLD3 DNA polymerase (alpha/delta/epsilon) inhibitor
- POLD4 DNA polymerase (alpha/delta/epsilon) inhibitor
- POLE DNA polymerase (alpha/delta/epsilon) inhibitor
- POLE2 DNA polymerase (alpha/delta/epsilon) inhibitor
- POLE3 DNA polymerase (alpha/delta/epsilon) inhibitor
- PRIM1 DNA polymerase (alpha/delta/epsilon) inhibitor
- PRIM2 DNA polymerase (alpha/delta/epsilon) inhibitor
- RRM1 Ribonucleoside-diphosphate reductase RR1 inhibitor
- RRM2 Ribonucleoside-diphosphate reductase RR1 inhibitor
- RRM2B Ribonucleoside-diphosphate reductase RR1 inhibitor