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 diseases | D006425 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| enbrace hr | unapproved drug other | 2025-01-02 |
| enlyte | unapproved drug other | 2022-07-01 |
| leucovorin | ANDA | 2014-09-26 |
| leucovorin calcium | ANDA | 2025-09-29 |
| paxlyte | unapproved drug other | 2024-12-19 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J0640 | Injection, leucovorin calcium, per 50 mg |
Clinical
Clinical Trials
2661 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 neoplasms | D015179 | — | — | 115 | 342 | 173 | 9 | 23 | 602 |
| Neoplasms | D009369 | — | C80 | 119 | 92 | 33 | 2 | 9 | 230 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 73 | 134 | 38 | 1 | 10 | 223 |
| Rectal neoplasms | D012004 | — | — | 46 | 114 | 51 | 1 | 10 | 207 |
| Colonic neoplasms | D003110 | — | C18 | 44 | 86 | 60 | 1 | 12 | 183 |
| Adenocarcinoma | D000230 | — | — | 34 | 104 | 30 | 1 | 6 | 157 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 28 | 102 | 28 | 2 | 7 | 151 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 31 | 66 | 25 | 1 | 4 | 119 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 2 | 4 | 10 | 8 | 56 | 79 |
| Lymphoma | D008223 | — | C85.9 | 16 | 43 | 17 | 1 | 7 | 75 |
Show 112 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 16 | 39 | 26 | — | 5 | 78 |
| Leukemia | D007938 | — | C95 | 8 | 36 | 21 | — | 4 | 64 |
| Carcinoma | D002277 | — | C80.0 | 13 | 38 | 17 | — | 5 | 64 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 35 | 30 | 6 | — | 4 | 64 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 7 | 30 | 18 | — | 5 | 54 |
| Pancreatic ductal carcinoma | D021441 | — | — | 20 | 24 | 6 | — | 1 | 46 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 8 | 29 | 4 | — | 1 | 33 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 13 | 18 | 2 | — | 2 | 31 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 16 | 17 | 6 | — | 2 | 31 |
| Fallopian tube neoplasms | D005185 | — | — | 16 | 15 | 7 | — | — | 31 |
Show 199 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | 2 | — | — | 15 | 26 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 12 | 11 | — | — | — | 16 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 13 | 4 | — | — | — | 15 |
| Osteosarcoma | D012516 | — | — | 7 | 6 | — | — | 3 | 15 |
| Cognitive dysfunction | D060825 | — | G31.84 | 1 | 3 | — | — | 10 | 14 |
| Triple negative breast neoplasms | D064726 | — | — | 10 | 7 | — | — | — | 13 |
| Sarcoma | D012509 | — | — | 5 | 7 | — | — | 1 | 13 |
| Myelodysplastic syndromes | D009190 | — | D46 | 8 | 4 | — | — | — | 11 |
| Aging | D000375 | GO_0007568 | R41.81 | — | 2 | — | — | 9 | 11 |
| Hodgkin disease | D006689 | — | C81 | 7 | 5 | — | — | — | 10 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 5 | — | — | — | 1 | 6 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 5 | — | — | — | — | 5 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 3 | — | — | — | 2 | 5 |
| Sezary syndrome | D012751 | — | C84.1 | 3 | — | — | — | 1 | 4 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | — | — | — | 1 | 3 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | — | — | — | 1 | 2 |
| Pseudomyxoma peritonei | D011553 | EFO_0007456 | — | 1 | — | — | — | 1 | 2 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Photosensitivity disorders | D010787 | — | L57.1 | 1 | — | — | — | 1 | 2 |
Show 53 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gyrate atrophy | D015799 | — | — | — | — | — | — | 12 | 12 |
| Breast feeding | D001942 | — | — | — | — | — | — | 8 | 8 |
| Avitaminosis | D001361 | EFO_0005878 | E56.9 | — | — | — | — | 7 | 7 |
| Alopecia | D000505 | — | L64 | — | — | — | — | 5 | 5 |
| Healthy diet | D000072001 | — | — | — | — | — | — | 5 | 5 |
| Feeding behavior | D005247 | — | — | — | — | — | — | 5 | 5 |
| Diet therapy | D004035 | — | — | — | — | — | — | 4 | 4 |
| Child development | D002657 | — | — | — | — | — | — | 4 | 4 |
| Nutritional status | D009752 | — | — | — | — | — | — | 4 | 4 |
| Postoperative cognitive complications | D000079690 | — | — | — | — | — | — | 4 | 4 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Leucovorin calcium |
| INN | calcium 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 | — |
| Image (chem structure or protein) |  |
| 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-ID | 1492-18-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201138 |
| ChEBI ID | — |
| PubChem CID | 6006 |
| DrugBank | DB00650 |
| UNII ID | RPR1R4C0P4 (ChemIDplus, GSRS) |
Target
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Trends
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Safety
Black-box Warning
Black-box warning for: Enlyte
Adverse Events
Top Adverse Reactions
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29,135 adverse events reported
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