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AboutPricing
Drug ReportsLeucovorin calcium
Leucovorin calcium
Leucovorin (leucovorin calcium) is a small molecule pharmaceutical. Leucovorin calcium was first approved as Leucovorin calcium on 1982-01-01. It is used to treat folic acid deficiency and megaloblastic anemia in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
enbrace hrunapproved drug other2026-02-10
enlyteunapproved drug other2022-07-01
lederle leucovorinunapproved drug for use in drug shortage2025-12-18
leucovorinANDA2014-09-26
leucovorin calciumANDA2026-03-31
paxlyteunapproved drug other2025-12-08
vykouraNew Drug Application2026-03-12
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AF: Detoxifying agents for antineoplastic treatment
— V03AF03: Calcium folinate
HCPCS
Code
Description
J0640
Injection, leucovorin calcium, per 50 mg
Clinical
Clinical Trials
2764 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——126351176925622
NeoplasmsD009369—C801259932210239
Pancreatic neoplasmsD010190EFO_0003860C257713940112232
Rectal neoplasmsD012004——4611651110209
Colonic neoplasmsD003110—C18468660113186
Stomach neoplasmsD013274EFO_0003897C16311022828154
AdenocarcinomaD000230——301023016154
Neoplasm metastasisD009362EFO_0009708—31682614122
AnemiaD000740EFO_0004272D64.9241095680
LymphomaD008223—C85.91643141772
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.0164125—579
Esophageal neoplasmsD004938—C1516497—467
LeukemiaD007938—C9583518—460
Hepatocellular carcinomaD006528—C22.0103418—559
CarcinomaD002277—C80.0133216—558
Pancreatic ductal carcinomaD021441——25287—152
Biliary tract neoplasmsD001661—C24.99298—137
RecurrenceD012008——17183—234
Fallopian tube neoplasmsD005185——17169——34
Gastrointestinal neoplasmsD005770—C26.916176—332
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———92——1627
Endometrial neoplasmsD016889EFO_0004230—1410———17
Triple negative breast neoplasmsD064726——138———16
Myeloid leukemia acuteD015470—C92.0134———15
OsteosarcomaD012516——76——315
Cognitive dysfunctionD060825—G31.8413——1115
SarcomaD012509——67——114
Myelodysplastic syndromesD009190—D4684———11
AgingD000375GO_0007568R41.81—2——911
Hodgkin diseaseD006689—C8175———10
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599——5———16
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A5————5
T-cell lymphoma cutaneousD016410—C84.A3———25
Sezary syndromeD012751—C84.13———14
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.92———13
Skin neoplasmsD012878EFO_0004198C441———12
Pseudomyxoma peritoneiD011553EFO_0007456—1———12
Drug interactionsD004347——2————2
Therapeutic equivalencyD013810——2————2
Photosensitivity disordersD010787—L57.11———12
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gyrate atrophyD015799——————1212
Breast feedingD001942——————88
AvitaminosisD001361EFO_0005878E56.9————77
Nutritional statusD009752——————55
AlopeciaD000505—L64————55
Healthy dietD000072001——————55
Feeding behaviorD005247——————55
Diet therapyD004035——————44
Child developmentD002657——————44
Postoperative cognitive complicationsD000079690——————44
Show 210 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLeucovorin calcium
INNcalcium folinate
Description
Folinic acid, also known as leucovorin, is a medication used to decrease the toxic effects of methotrexate and pyrimethamine. It is also used in combination with 5-fluorouracil to treat colorectal cancer and pancreatic cancer, may be used to treat folate deficiency that results in anemia, and methanol poisoning. It is taken by mouth, injection into a muscle, or injection into a vein.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
Nc1nc(=O)c2c([nH]1)NCC(CNc1ccc(C(=O)N[C@@H](CCC(=O)[O-])C(=O)[O-])cc1)N2C=O.[Ca+2]
Identifiers
PDB—
CAS-ID1492-18-8
RxCUI—
ChEMBL IDCHEMBL1201138
ChEBI ID—
PubChem CID6006
DrugBankDB00650
UNII IDRPR1R4C0P4 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Enlyte
Adverse Events
Top Adverse Reactions
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29,660 adverse events reported
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