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)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| enbrace hr | unapproved drug other | 2023-12-15 |
| enlyte | unapproved drug other | 2022-07-01 |
| leucovorin | ANDA | 2014-09-26 |
| leucovorin calcium | ANDA | 2024-10-14 |
| paxlyte | unapproved drug other | 2024-08-01 |
| pyrimethamine leucovorin | unapproved drug other | 2015-11-30 |
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
5567 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 | — | — | 141 | 446 | 203 | 17 | 34 | 761 |
| Non-small-cell lung carcinoma | D002289 | — | — | 148 | 411 | 200 | 15 | 31 | 729 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 108 | 340 | 155 | 9 | 24 | 580 |
| Leukemia | D007938 | — | C95 | 88 | 237 | 98 | 16 | 26 | 415 |
| Neoplasms | D009369 | — | C80 | 219 | 168 | 54 | 4 | 11 | 397 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | 32 | 83 | 125 | 86 | 33 | 348 |
| Adenocarcinoma | D000230 | — | — | 83 | 211 | 59 | 4 | 18 | 334 |
| Lymphoma | D008223 | — | C85.9 | 75 | 200 | 50 | 9 | 20 | 315 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 30 | 80 | 110 | 80 | 26 | 315 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 52 | 151 | 77 | 19 | 17 | 288 |
Show 269 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rectal neoplasms | D012004 | — | — | 29 | 116 | 41 | — | 8 | 181 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 30 | 61 | 31 | — | 9 | 121 |
| Myelodysplastic syndromes | D009190 | — | D46 | 28 | 65 | 17 | — | 7 | 105 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 6 | 59 | 29 | — | 17 | 105 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 43 | 43 | 10 | — | 3 | 86 |
| Preleukemia | D011289 | — | — | 25 | 52 | 13 | — | 6 | 85 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 26 | 42 | 18 | — | 1 | 82 |
| Myeloid leukemia | D007951 | — | C92 | 22 | 46 | 14 | — | 1 | 78 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 13 | 41 | 4 | — | 5 | 55 |
| Pancreatic ductal carcinoma | D021441 | — | — | 22 | 31 | 5 | — | 2 | 52 |
Show 253 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 18 | 16 | — | — | 3 | 32 |
| Plasmacytoma | D010954 | — | C90.3 | 7 | 19 | — | — | 5 | 27 |
| Mantle-cell lymphoma | D020522 | — | — | 4 | 18 | — | — | — | 20 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 12 | 13 | — | — | — | 19 |
| Melanoma | D008545 | — | — | 16 | 9 | — | — | 1 | 18 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 1 | 3 | — | — | 12 | 16 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 2 | 14 | — | — | — | 15 |
| Urologic neoplasms | D014571 | — | C64-C68 | 9 | 12 | — | — | — | 15 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 5 | 8 | — | — | 3 | 15 |
| Blast crisis | D001752 | — | — | 2 | 13 | — | — | — | 14 |
Show 209 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 5 | — | — | — | — | 5 |
| Drug interactions | D004347 | — | — | 4 | — | — | — | — | 4 |
| Therapeutic equivalency | D013810 | — | — | 3 | — | — | — | — | 3 |
| Oxidative stress | D018384 | EFO_1001905 | — | 1 | — | — | — | 2 | 3 |
| Atrophy | D001284 | — | — | 2 | — | — | — | 1 | 3 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | 2 | — | — | — | — | 2 |
| Weight loss | D015431 | HP_0001824 | — | 1 | — | — | — | 1 | 2 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | — | — | — | 1 | 2 |
| Methemoglobinemia | D008708 | — | D74 | 1 | — | — | — | 1 | 2 |
| Autoimmune lymphoproliferative syndrome | D056735 | — | D89.82 | 2 | — | — | — | — | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Growth disorders | D006130 | — | — | — | — | — | — | 11 | 11 |
| Gyrate atrophy | D015799 | — | — | — | — | — | — | 11 | 11 |
| Eclampsia | D004461 | HP_0100601 | O15 | — | — | — | — | 6 | 6 |
| Feeding behavior | D005247 | — | — | — | — | — | — | 5 | 5 |
| Diet therapy | D004035 | — | — | — | — | — | — | 4 | 4 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 4 | 4 |
| Avitaminosis | D001361 | EFO_0005878 | E56.9 | — | — | — | — | 4 | 4 |
| Memory disorders | D008569 | — | — | — | — | — | — | 4 | 4 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 4 | 4 |
| Healthy diet | D000072001 | — | — | — | — | — | — | 4 | 4 |
Show 218 more
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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Financial
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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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40,024 adverse events reported
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