Leucovorin calcium
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1952
- First approval year
- 1952
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Leucovorin calcium
- Molecular weight
- 511.51
- Structure (SMILES)
- Nc1nc(=O)c2c([nH]1)NCC(CNc1ccc(C(=O)N[C@@H](CCC(=O)[O-])C(=O)[O-])cc1)N2C=O.[Ca+2]
- leucovorin calcium
- Leucovorin calcium
- leucovorin calcium component of folfox
- Leucovorin calcium component of folfox
- leucovorin calcium preservative free
- Leucovorin calcium preservative free
- wellcovorin
- Wellcovorin
- 5 fluorouracil leucovorin calcium
- anhydrous calcium folinate
- Anhydrous calcium folinate
- calcium folinate
- Calcium folinate
- CALCIUM FOLINATE [EP MONOGRAPH]
- calcium folinate [INN]
- CALCIUM FOLINATE [JAN]
- CALCIUM FOLINATE [MART.]
- CALCIUM FOLINATE [VANDF]
- Calcium folinate [WHO-DD]
- calcium folinate ep monograph
- calcium folinate inn
- calcium folinate jan
- calcium folinate mart
- calcium folinate pentahydrate
- Calcium folinate pentahydrate
- calcium folinate vandf
- calcium folinate who dd
- calcium n p 6rs 2 amino 5 formyl 5 6 7 8 tetrahydro 4 hydroxy 6 pteridinyl methyl amino benzoyl l glutamate 1 1
- CALCIUM N-(P-((((6RS)-2-AMINO-5-FORMYL-5,6,7,8-TETRAHYDRO-4-HYDROXY-6-PTERIDINYL)METHYL)AMINO)BENZOYL)-L-GLUTAMATE (1:1)
- folfox component leucovorin calcium
- Folfox component leucovorin calcium
- folic acid related compound a
- Folic acid related compound a
And 29 more, listed on the interactive page.
- ATC classification codes
- V03AF03
Sources for recorded values
- CAS registry numbers
- 1492-18-8
- ChEMBL ID
- CHEMBL1201138
- InChIKey
- KVUAALJSMIVURS-ZEDZUCNESA-L
- RxNorm IDs (RxCUI)
- 225852
- FDA ingredient codes (UNII)
- RPR1R4C0P4
- 78759347
- 135403647
- 135883785
- Applicant
- AVYXA HOLDINGS
- Approval date
- 3 Feb 2026
- Application number
- NDA220406
- Patents
- 1
- Designations
- 2
- Earliest recorded loss of exclusivity
- 23 Dec 2044
- 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
Administration routes
- Oral
- Parenteral
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000094
- Subject identifier
- D015456
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000178
- Subject identifier
- D013274
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 1
- 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
- 2
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Neoplasms, Plasma Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000200
- Subject identifier
- D054219
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000209
- Subject identifier
- D015456
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000211
- Subject identifier
- D016411
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 3
- 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
- 3
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Burkitt Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000309
- Subject identifier
- D002051
- Condition
- Carcinoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Leukemia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Osteosarcoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000637
- Subject identifier
- D012516
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000707
- Subject identifier
- D002294
- Condition
- Melanoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
And 89 more, listed on the interactive page.
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000220
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000228
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000365
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000565
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000637
- Condition identifier
- EFO_0001064
- Highest recorded phase
- 3
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 3
- Condition identifier
- EFO_0002916
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003100
- Condition identifier
- EFO_0003833
- Condition identifier
- EFO_0003860
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003891
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003897
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004142
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004288
- Condition identifier
- EFO_0005221
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006859
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007517
- Highest recorded phase
- 1
- Condition identifier
- EFO_0009708
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000318
- Highest recorded phase
- 2
And 123 more, listed on the interactive page.
- Event
- abdominal pain
- Reports
- 270
- Reporting signal score
- 99.8297
- Event
- bone marrow failure
- Reports
- 108
- Reporting signal score
- 126.956
- Event
- dehydration
- Reports
- 252
- Reporting signal score
- 177.397
- Event
- diarrhoea
- Reports
- 734
- Reporting signal score
- 342.031
- Event
- drug toxicity
- Reports
- 67
- Reporting signal score
- 100.173
- Event
- febrile neutropenia
- Reports
- 357
- Reporting signal score
- 510.055
- Event
- haematotoxicity
- Reports
- 64
- Reporting signal score
- 99.7886
- Event
- injection site pain
- Reports
- 2
- Reporting signal score
- 82.2819
- Event
- leukopenia
- Reports
- 143
- Reporting signal score
- 107.823
- Event
- mucosal inflammation
- Reports
- 143
- Reporting signal score
- 187.716
- Event
- nausea
- Reports
- 510
- Reporting signal score
- 82.1883
- Event
- neuropathy peripheral
- Reports
- 260
- Reporting signal score
- 242.03
- Event
- neurotoxicity
- Reports
- 111
- Reporting signal score
- 161.418
- Event
- neutropenia
- Reports
- 635
- Reporting signal score
- 806.836
- Event
- palmar-plantar erythrodysaesthesia syndrome
- Reports
- 95
- Reporting signal score
- 106.078
- Event
- pulmonary embolism
- Reports
- 146
- Reporting signal score
- 80.2798
- Event
- pyrexia
- Reports
- 382
- Reporting signal score
- 120.148
- Event
- skin toxicity
- Reports
- 52
- Reporting signal score
- 94.825
- Event
- small intestinal obstruction
- Reports
- 60
- Reporting signal score
- 85.0207
- Event
- stomatitis
- Reports
- 138
- Reporting signal score
- 124.09
- Event
- thrombocytopenia
- Reports
- 295
- Reporting signal score
- 207.248
- Event
- vomiting
- Reports
- 494
- Reporting signal score
- 171.032
- NCT00000658
- NCT03169790
- NCT00000714
- NCT00000724
- NCT00000730
- NCT00001013
- NCT00001014
- NCT00001016
- NCT00000794
- NCT00000966
- NCT00001449
- NCT00003331
- NCT00003925
- NCT00004913
- NCT00005068
- NCT00007878
- NCT00009815
- NCT00009828
- NCT00020488
- NCT00021073
- NCT00042861
- NCT00042874
- NCT00043121
- NCT00044785
- NCT00080990
And 873 more, listed on the interactive page.
- Dose
- 1-2 mg/kg/day (for patients less than 40kg) or 1-2 mg/kg/day (for patients 40kg or more)
- Route
- Oral
- How often
- Once daily or in divided doses up to 6 times per day
- Administer with or without food
- Do not crush
- Hydrogen bond acceptors
- 9
- Hydrogen bond donors
- 7
- Polar surface area
- 219.84
- Calculated partition coefficient (ALogP)
- -0.73
- Prodrug
- No
- Chirality
- Racemic
- Inorganic
- No
- Rule-of-five violations
- 1
- Rotatable bonds
- 10
- Heavy atoms
- 35
- Molecular formula
- C20H21CaN7O7
- Monoisotopic mass
- 511.1128369
- Natural product
- Yes
- 0054-4496
- 0054-4497
- 0054-4498
- 0054-4499
- 0054-8496
- 0069-5886
- 0143-9368
- 0143-9552
- 0143-9553
- 0143-9554
- 0143-9555
- 0555-0484
- 0555-0485
- 0904-7584
- 25021-813
- 25021-814
- 25021-815
- 25021-816
- 25021-828
- 42806-133
- 42806-134
- 42806-358
- 42806-359
- 50742-181
- 50742-182
And 36 more, listed on the interactive page.
- Recorded assays
- 1
- Active assays
- 0
Related records
Trials (423)
- 05-001: Treatment of Acute Lymphoblastic Leukemia in Children
- 5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab
- A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia
- A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.
- A Multicenter, Clinical Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With mCRC
- A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
- A Phase I, Pharmacological, and Biological Study of OSI-774 in Combination With FOLFOX 4 (5-FU, Leucovorin, and Oxaliplatin) and Bevacizumab (Avastin) in Patients With Advanced Colorectal Cancer
- A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors
- A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma
- A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
- A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome
- A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
- A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
- A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS
- A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
- A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer
- A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
- A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
- A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP
- A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia
Approved for (1)
In development for (111)
- Acute lymphoblastic leukemia Phase 3
- Acute myeloid leukemia Phase 1
- Adenocarcinoma Phase 3
- Adult glioblastoma Phase 1
- Anaplastic astrocytoma Phase 1
- Anaplastic large cell lymphoma Phase 2
- Anaplastic oligodendroglioma Phase 1
- Appendix cancer Phase 2
- Autism Phase 2
- Autism spectrum disorder 1 Phase 2
- B-cell acute lymphoblastic leukemia Phase 3
- Bile duct cancer Phase 2
- Bile duct carcinoma Phase 2
- Biliary tract cancer Phase 3
- Biliary tract neoplasm Phase 3
- Brain cancer Phase 3
- Brain neoplasm Phase 3
- Breast cancer Phase 2
- Burkitt lymphoma Phase 2
- Cancer Phase 3