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Prezista(darunavir)
Prezcobix, Prezista, Rezolsta, Symtuza (darunavir) is a small molecule pharmaceutical. Darunavir was first approved as Prezista on 2006-06-23. 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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Prezista (generic drugs available since 2017-11-21)
Combinations
Prezcobix, Symtuza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cobicistat
+
Darunavir
Tradename
Company
Number
Date
Products
PREZCOBIXJohnson & JohnsonN-205395 RX2015-01-29
1 products, RLD, RS
Cobicistat
+
Darunavir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
SYMTUZAJohnson & JohnsonN-210455 RX2018-07-17
1 products, RLD, RS
Darunavir
Tradename
Company
Number
Date
Products
PREZISTAJohnson & JohnsonN-021976 RX2008-02-25
4 products, RLD
PREZISTAJohnson & JohnsonN-202895 RX2011-12-16
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
darunavirANDA2023-06-05
prezcobixNew Drug Application2023-04-10
prezistaNew Drug Application2022-10-28
symtuzaNew Drug Application2021-08-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acquired immunodeficiency syndromeEFO_0000765D000163B20
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Cobicistat / Darunavir / Emtricitabine / Tenofovir Alafenamide Fumarate, Symtuza, Janssen Prods
107865182038-07-19U-2978
87540652032-08-15DS, DPU-2352, U-2765
92967692032-08-15DS, DPU-2352, U-2765
73907912025-04-17DS, DP
Cobicistat / Darunavir, Prezcobix, Janssen Prods
100397182032-10-06DP
81483742029-09-03DS, DPU-1279, U-2353, U-2364, U-2365, U-2766, U-2767, U-2768, U-2939
77006452026-12-26DS, DP
85189872024-02-16DS, DP
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AE: Protease inhibitors, direct acting antivirals
— J05AE10: Darunavir
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR14: Darunavir and cobicistat
— J05AR22: Emtricitabine, tenofovir alafenamide, darunavir and cobicistat
— J05AR26: Darunavir and ritonavir
HCPCS
No data
Clinical
Clinical Trials
171 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_0000764B20131818211482
HivD006678O98.71031010—33
Healthy volunteers/patients—16——3—19
Hiv-1D0154972342—11
InfectionsD007239EFO_00005443—21—6
Acquired immunodeficiency syndromeD000163EFO_0000765B201——113
HyperlipidemiasD006949EFO_0003774E78.51——1—2
Cardiovascular diseasesD002318EFO_0000319I98———112
PapillomaviridaeD027383———1—1
Cytomegalovirus infectionsD003586EFO_0001062B25———1—1
Show 4 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv-2D015498—11—24
CoronavirusD017934——1—12
PregnancyD011247EFO_0002950Z33.1——1——1
Pneumocystis pneumoniaD011020EFO_0007448B59——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD003267—2———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis cD006526B19.22————2
Opioid-related disordersD009293EFO_0005611F111————1
Insulin resistanceD007333EFO_00026141————1
Amyotrophic lateral sclerosisD000690EFO_0000253G12.211————1
HepacivirusD0161741————1
AsthmaD001249EFO_0000270J451————1
PharmacokineticsD0105991————1
Latent tuberculosisD055985Z22.71————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A19————11
Covid-19D000086382U07.1————11
PneumoniaD011014EFO_0003106J18————11
Therapeutic equivalencyD013810————11
Drug interactionsD004347————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDARUNAVIR
INNdarunavir
Description
Darunavir is an N,N-disubstituted benzenesulfonamide bearing an unsubstituted amino group at the 4-position, used for the treatment of HIV infection. A second-generation HIV protease inhibitor, darunavir was designed to form robust interactions with the protease enzyme from many strains of HIV, including those from treatment-experienced patients with multiple resistance mutations to other protease inhibitors. It has a role as a HIV protease inhibitor and an antiviral drug. It is a furofuran, a carbamate ester and a sulfonamide.
Classification
Small molecule
Drug classantivirals: HIV protease inhibitors (saquinavir type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)CN(C[C@@H](O)[C@H](Cc1ccccc1)NC(=O)O[C@H]1CO[C@H]2OCC[C@@H]12)S(=O)(=O)c1ccc(N)cc1
Identifiers
PDB—
CAS-ID206361-99-1
RxCUI460132
ChEMBL IDCHEMBL1323
ChEBI ID367163
PubChem CID213039
DrugBankDB01264
UNII IDYO603Y8113 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,972 documents
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Safety
Black-box Warning
Black-box warning for: Symtuza
Adverse Events
Top Adverse Reactions
Mock data
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2,613 adverse events reported
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