Levoleucovorin calcium
Fusilev, Khapzory (levoleucovorin calcium) is a small molecule pharmaceutical. Levoleucovorin calcium was first approved as Fusilev on 2008-03-07.
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Therapeutic Areas
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Trade Name
FDA
EMA
Fusilev, Khapzory (generic drugs available since 2015-03-09)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fusilev | New Drug Application | 2020-11-24 |
| khapzory | New Drug Application | 2023-06-02 |
| levoleucovorin calcium | ANDA | 2023-05-31 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Levoleucovorin, Khapzory, Acrotech Biopharma | |||
| 11541012 | 2039-03-25 | DP | |
HCPCS
No data
Clinical
Clinical Trials
605 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 | 27 | 115 | 79 | 1 | 8 | 220 | ||
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 14 | 27 | 7 | 1 | 2 | 47 |
| Adenocarcinoma | D000230 | 7 | 20 | 10 | 1 | 1 | 34 | ||
| Toxoplasmosis | D014123 | EFO_0007517 | B58 | 1 | — | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 28 | 23 | 10 | — | — | 58 | |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 20 | 29 | 8 | — | 1 | 49 |
| Rectal neoplasms | D012004 | 13 | 19 | 9 | — | 1 | 40 | ||
| Lymphoma | D008223 | C85.9 | 5 | 20 | 10 | — | 3 | 37 | |
| Colonic neoplasms | D003110 | C18 | 10 | 14 | 13 | — | 1 | 35 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 5 | 16 | 15 | — | 2 | 34 | |
| Leukemia | D007938 | C95 | 2 | 20 | 10 | — | 2 | 34 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 5 | 2 | 8 | — | 8 | 23 |
| Esophageal neoplasms | D004938 | C15 | 8 | 15 | 2 | — | 1 | 23 | |
| Pneumocystis pneumonia | D011020 | EFO_0007448 | B59 | 2 | — | 6 | — | 5 | 13 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | 3 | 5 | — | — | — | 8 | ||
| Cerebral toxoplasmosis | D016781 | EFO_0007200 | B58.2 | 2 | 2 | — | — | 1 | 5 |
| Renal cell carcinoma | D002292 | 3 | 3 | — | — | — | 5 | ||
| Central nervous system neoplasms | D016543 | 1 | 3 | — | — | 1 | 5 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 2 | — | — | — | 4 |
| Acinar cell carcinoma | D018267 | 2 | 2 | — | — | — | 4 | ||
| Osteosarcoma | D012516 | 1 | 3 | — | — | 1 | 4 | ||
| Myelodysplastic syndromes | D009190 | D46 | 2 | 2 | — | — | — | 4 | |
| Bile duct neoplasms | D001650 | 1 | 2 | — | — | — | 3 | ||
| Biphenotypic leukemia acute | D015456 | C95.0 | 1 | 3 | — | — | — | 3 |
Show 39 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 | 3 | — | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | 3 | — | — | — | — | 3 | ||
| Lung neoplasms | D008175 | C34.90 | 3 | — | — | — | — | 3 | |
| Triple negative breast neoplasms | D064726 | 2 | — | — | — | — | 2 | ||
| Fallopian tube neoplasms | D005185 | 2 | — | — | — | — | 2 | ||
| Hepatitis c | D006526 | B19.2 | 2 | — | — | — | — | 2 | |
| Glioblastoma | D005909 | EFO_0000515 | 2 | — | — | — | — | 2 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
| Squamous cell carcinoma of head and neck | D000077195 | 1 | — | — | — | — | 1 | ||
| Peritoneal neoplasms | D010534 | 1 | — | — | — | — | 1 |
Show 12 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Juvenile arthritis | D001171 | EFO_0002609 | M08 | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Appetitive behavior | D001070 | — | — | — | — | 1 | 1 | ||
| Healthy diet | D000072001 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LEVOLEUCOVORIN CALCIUM |
| INN | calcium levofolinate |
| 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)NC[C@H](CNc1ccc(C(=O)N[C@@H](CCC(=O)[O-])C(=O)[O-])cc1)N2C=O.[Ca+2] |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1908361 |
| ChEBI ID | — |
| PubChem CID | 6006 |
| DrugBank | DB00650 |
| UNII ID | 778XL6VBS8 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
Fusilev - Spectrum Pharmaceuticals
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 142 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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2,883 adverse events reported
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