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Drug ReportsPitavastatin
Pitavastatin
Livalo, Nikita, Pitavastatin, Zypitamag (pitavastatin) is a small molecule pharmaceutical. Pitavastatin was first approved as Livalo on 2009-08-03. It is used to treat hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA. It is known to target 3-hydroxy-3-methylglutaryl-Coenzyme A reductase.
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Financial
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Events Timeline
5D
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3M
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Livalo, Pitavastatin, Zypitamag (discontinued: Nikita, Zypitamag)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pitavastatin sodium
Tradename
Company
Number
Date
Products
NIKITALupin ResearchN-209875 DISCN2017-08-04
3 products, RLD
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Pitavastatin calcium
Tradename
Company
Number
Date
Products
LIVALOKowaN-022363 RX2009-08-03
3 products, RLD, RS
Pitavastatin magnesium
Tradename
Company
Number
Date
Products
ZYPITAMAGMedicureN-208379 RX2017-07-14
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
livaloNew Drug Application2024-09-03
nikitaNew Drug Application2023-06-30
pitavastatinANDA2025-02-04
pitavastatin calciumANDA2024-12-03
zypitamagNew Drug Application2025-01-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypercholesterolemia—D006937—
hypertriglyceridemiaEFO_0004211D015228—
hyperlipoproteinemias—D006951—
Agency Specific
FDA
EMA
Expiration
Code
PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM, AUROBINDO PHARMA
2024-02-19PC
Patent Expiration
Patent
Expires
Flag
FDA Information
Pitavastatin Magnesium, Zypitamag, Medicure
88291862031-01-19DS, DP
Pitavastatin Calcium, Livalo, Kowa Co
70227132024-02-19U-998
85579932024-02-02DP
ATC Codes
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AA: Hmg coa reductase inhibitors, plain lipid modifying drugs
— C10AA08: Pitavastatin
HCPCS
No data
Clinical
Clinical Trials
107 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937————2——2
DyslipidemiasD050171————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePitavastatin
INNpitavastatin
Description
Pitavastatin is a dihydroxy monocarboxylic acid that is (6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]hept-6-enoic acid in which the two hydroxy groups are located at positions 3 and 5 (the 3R,5S-stereoisomer). Used as its calcium salt for treatment of hypercholesterolemia (elevated levels of cholesterol in the blood) on patients unable to sufficiently lower their cholesterol levels by diet and exercise. It has a role as an antioxidant. It is a member of quinolines, a dihydroxy monocarboxylic acid, a member of cyclopropanes, a statin (synthetic) and a member of monofluorobenzenes. It is a conjugate acid of a pitavastatin(1-).
Classification
Small molecule
Drug classenzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors)
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Structure (InChI/SMILES or Protein Sequence)
O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Identifiers
PDB—
CAS-ID147511-69-1
RxCUI—
ChEMBL IDCHEMBL1201753
ChEBI ID32020
PubChem CID5282452
DrugBank—
UNII IDM5681Q5F9P (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
HMGCR
HMGCR
Organism
Homo sapiens
Gene name
HMGCR
Gene synonyms
NCBI Gene ID
Protein name
3-hydroxy-3-methylglutaryl-Coenzyme A reductase
Protein synonyms
3-hydroxy-3-methylglutaryl CoA reductase (NADPH), HMG-CoA reductase, hydroxymethylglutaryl-CoA reductase
Uniprot ID
Mouse ortholog
Hmgcr (15357)
3-hydroxy-3-methylglutaryl-coenzyme A reductase (Q5U4I2)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Pitavastatin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,845 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,442 adverse events reported
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