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Kaletra(lopinavir)
Kaletra (lopinavir) is a small molecule pharmaceutical. Lopinavir was first approved as Kaletra on 2000-09-15. It is used to treat acquired immunodeficiency syndrome in the USA. It has been approved in Europe to treat HIV infections.
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COVID-19
Case Study: COVID-19
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Combinations
Kaletra (generic drugs available since 2016-12-27)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lopinavir
+
Ritonavir
Tradename
Company
Number
Date
Products
KALETRAAbbVieN-021251 RX2000-09-15
1 products, RLD, RS
KALETRAAbbVieN-021906 RX2005-10-28
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
kaletraNew Drug Application2020-10-01
lopinavir and ritonavirANDA2023-03-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acquired immunodeficiency syndromeEFO_0000765D000163B20
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR10: Lopinavir and ritonavir
HCPCS
No data
Clinical
Clinical Trials
281 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B201442444430166
HivD006678O98.766812635
Covid-19D000086382U07.1—1295426
Acquired immunodeficiency syndromeD000163EFO_0000765B201—37213
TuberculosisD014376EFO_0000774A15-A1924—4111
Healthy volunteers/patients—4——217
InfectionsD007239EFO_00005442211—6
PregnancyD011247EFO_0002950Z33.11231—6
Sars-cov-2D000086402—32115
PneumoniaD011014EFO_0003106J18—11125
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalariaD008288EFO_0001068B543—2——5
Respiratory distress syndromeD012128EFO_1000637J80121—13
Hiv-2D015498——1——1
Breast feedingD001942——1——1
Virus diseasesD014777B34——1——1
Middle east respiratory syndrome coronavirusD065207—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis cD006526B19.221——25
DiseaseD004194EFO_0000408R69—1———1
ParasitemiaD01851211———1
Hepatitis bD006509—1———1
Brain neoplasmsD001932EFO_0003833C71—1———1
GlioblastomaD005909EFO_0000515—1———1
GliomaD005910EFO_0000520—1———1
GliosarcomaD018316—1———1
EpendymomaD004806—1———1
AstrocytomaD001254EFO_0000271—1———1
Show 1 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD0105991————1
Insulin resistanceD007333EFO_00026141————1
Therapeutic equivalencyD0138101————1
Drug interactionsD0043471————1
HypertriglyceridemiaD015228EFO_00042111————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Viral pneumoniaD011024EFO_0007541J12.9————22
Wasting syndromeD019282R64————11
Cytokine release syndromeD000080424D89.83————11
Drug-related side effects and adverse reactionsD064420T88.7————11
Neurobehavioral manifestationsD019954EFO_0004364————11
Medication adherenceD055118EFO_0006344————11
Child behaviorD002652————11
Biliary liver cirrhosisD008105K74.3————11
CoronavirusD017934————11
Hodgkin diseaseD006689C81————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLOPINAVIR
INNlopinavir
Description
Lopinavir is a dicarboxylic acid diamide that is amphetamine is substituted on nitrogen by a (2,6-dimethylphenoxy)acetyl group and on the carbon alpha- to nitrogen by a (1S,3S)-1-hydroxy-3-{[(2S)-3-methyl-2-(2-oxotetrahydropyrimidin-1-yl)butanoyl]amino}-4-phenylbutyl group. An antiretroviral of the protease inhibitor class, it is used against HIV infections as a fixed-dose combination with another protease inhibitor, ritonavir. It has a role as an antiviral drug, a HIV protease inhibitor and an anticoronaviral agent. It is a member of amphetamines and a dicarboxylic acid diamide.
Classification
Small molecule
Drug classantivirals: HIV protease inhibitors (saquinavir type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1cccc(C)c1OCC(=O)N[C@@H](Cc1ccccc1)[C@@H](O)C[C@H](Cc1ccccc1)NC(=O)[C@H](C(C)C)N1CCCNC1=O
Identifiers
PDB—
CAS-ID192725-17-0
RxCUI195088
ChEMBL IDCHEMBL729
ChEBI ID31781
PubChem CID92727
DrugBankDB01601
UNII ID2494G1JF75 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Kaletra - AbbVie
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,646 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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69 adverse events reported
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