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Drug ReportsDarunavir
Prezista(darunavir)
Darunavir, 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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Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Darunavir, Prezista (discontinued: Darunavir, Prezista)
Combinations
Symtuza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
Cobicistat
+
Darunavir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
SYMTUZAJohnson & JohnsonN-210455 RX2018-07-17
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
darunavirANDA2025-03-19
darunavir 600 and 800 mgANDA2025-06-05
prezcobixNew Drug Application2025-04-08
prezistaNew Drug Application2025-08-29
symtuzaNew Drug Application2024-07-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acquired immunodeficiency syndromeEFO_0000765D000163B20
hiv infectionsEFO_0000764D015658B20
chronic hepatitis bEFO_0004239D019694B18.1
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
285 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_0000764B201285116
Acquired immunodeficiency syndromeD000163EFO_0000765B203172—12
Hiv-1D015497——2—21—5
HivD006678—O98.71—31—5
Weight gainD015430—————1—1
Viral sexually transmitted diseasesD015229—————1—1
Hiv seropositivityD006679—————1—1
ObesityD009765EFO_0001073E66.9———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544———1——1
Virus diseasesD014777—B34——1——1
PregnancyD011247EFO_0002950Z33.1——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———8————8
Hiv-2D015498——1————1
Immunologic deficiency syndromesD007153—D84.91————1
Indications Without Phase
No data
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)Loading
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
RxCUI—
ChEMBL IDCHEMBL1323
ChEBI ID367163
PubChem CID213039
DrugBankDB01264
UNII IDYO603Y8113 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Darunavir
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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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,400 documents
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Safety
Black-box Warning
Black-box warning for: Darunavir, Symtuza
Adverse Events
Top Adverse Reactions
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16,308 adverse events reported
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