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Drug ReportsLevoleucovorin
Levoleucovorin
Khapzory, Levoleucovorin (levoleucovorin) is a small molecule pharmaceutical. Levoleucovorin was first approved as Fusilev on 2008-03-07.
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Events Timeline
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Khapzory, Levoleucovorin (discontinued: Fusilev, Khapzory, Levoleucovorin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Levoleucovorin
Tradename
Company
Number
Date
Products
KHAPZORYAcrotech BiopharmaN-211226 RX2018-10-19
1 products, RLD, RS
Show 1 discontinued
Levoleucovorin calcium
Tradename
Company
Number
Date
Products
FUSILEVAcrotech BiopharmaN-020140 DISCN2008-03-07
3 products, RLD
LEVOLEUCOVORIN CALCIUMAllerganN-208723 DISCN2016-09-29
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
khapzoryNew Drug Application2024-12-12
levoleucovorinANDA2023-08-01
levoleucovorin calciumANDA2023-08-29
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Levoleucovorin, Khapzory, Acrotech Biopharma
115410122039-03-25DP
ATC Codes
No data
HCPCS
Code
Description
J0641
Injection, levoleucovorin, not otherwise specified, 0.5 mg
J0642
Injection, levoleucovorin (khapzory), 0.5 mg
Clinical
Clinical Trials
1488 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 neoplasmsD01517981268146619478
AdenocarcinomaD000230451084018183
Pancreatic neoplasmsD010190EFO_0003860C2552963118165
LeukemiaD007938C9530844736154
NeoplasmsD009369C8076702423154
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.021684546131
Lymphoid leukemiaD007945C9121634044119
Stomach neoplasmsD013274EFO_0003897C1624661917106
LymphomaD008223C85.917662118103
Neoplasm metastasisD009362EFO_00097081241201470
Show 28 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277C80.02551297101
Rectal neoplasmsD012004215425599
Colonic neoplasmsD003110C18173438786
RecurrenceD01200818337154
Non-hodgkin lymphomaD008228C85.972310341
Hepatocellular carcinomaD006528C22.03209433
Pancreatic ductal carcinomaD02144114175133
Gastrointestinal neoplasmsD005770C26.917131326
Hiv infectionsD015658EFO_0000764B20528924
SyndromeD013577965220
Show 106 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovarian neoplasmsD010051EFO_0003893C566813
Multiple myelomaD009101C90.06711
Myeloproliferative disordersD009196D47.13810
Mantle-cell lymphomaD020522C83.11010
Burkitt lymphomaD002051C83.711010
Breast neoplasmsD001943EFO_0003869C50459
SarcomaD012509369
MelanomaD008545758
Digestive system neoplasmsD004067648
Hodgkin diseaseD006689C81267
Show 135 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A33
Leukemia myeloid chronic atypical bcr-abl negativeD054438C92.211
ThrombocytosisD013922D75.8311
OsteomyelitisD010019EFO_0003102M8611
Skin neoplasmsD012878EFO_0004198C4411
MalariaD008288EFO_0001068B5411
Plasma cell leukemiaD007952C90.111
Pharyngeal neoplasmsD010610C14.011
Wasting syndromeD01928211
Weight lossD01543111
Show 21 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pre-eclampsiaD011225EFO_0000668O1433
Diet therapyD00403522
Acquired immunodeficiency syndromeD000163EFO_0000765B2022
Memory disordersD00856922
EclampsiaD004461O1522
Healthy dietD00007200122
HypercholesterolemiaD00693722
OverweightD050177E66.322
AggressionD000374EFO_000301511
AtaxiaD001259R27.011
Show 41 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLevoleucovorin
INNcalcium 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
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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
Identifiers
PDB
CAS-ID68538-85-2
RxCUI
ChEMBL IDCHEMBL1908841
ChEBI ID63606
PubChem CID6006
DrugBankDB00650
UNII ID778XL6VBS8 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Khapzory Spectrum Pharmaceuticals
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Fusilev Spectrum Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 537 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,912 adverse events reported
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