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Drug ReportsDarunavir ethanolate
Darunavir ethanolate
Darunavir, Prezcobix, Prezista, Rezolsta, Symtuza (darunavir ethanolate) is a small molecule pharmaceutical. Darunavir ethanolate was first approved as Prezista on 2007-02-11. 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
Combinations
Prezcobix
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cobicistat
+
Darunavir ethanolate
Tradename
Company
Number
Date
Products
PREZCOBIXJohnson & JohnsonN-205395 RX2015-01-29
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
prezcobixNew Drug Application2025-04-02
prezistaNew Drug Application2024-07-23
symtuzaNew Drug Application2024-07-23
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Cobicistat / Darunavir Ethanolate, Prezcobix, Janssen Prods
100397182032-10-06DP
81483742029-09-03DS, DPU-1279, U-2939
77006452026-12-26DS, 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
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_0000764B202242584031182
Acquired immunodeficiency syndromeD000163EFO_0000765B207142091358
HivD006678—O98.71171418655
InfectionsD007239EFO_0000544—69910335
Hiv-1D015497——4894125
Immunologic deficiency syndromesD007153—D84.918131424
Healthy volunteers/patients———18——3—21
Communicable diseasesD003141——1565—15
Hepatitis cD006526—B19.2431118
Covid-19D000086382—U07.1—33128
Show 35 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv-2D015498——111—36
PneumoniaD011014EFO_0003106J18——1—23
Liver cirrhosisD008103EFO_0001422K74.0—21——2
FibrosisD005355———21——2
Virus diseasesD014777—B34—21——2
CoronavirusD017934————1—12
Chronic hepatitisD006521—K73.9—11——1
Treatment-resistant depressive disorderD061218————1——1
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
Coronavirus infectionsD018352EFO_0007224B34.2—2———2
Sars-cov-2D000086402———2———2
ContraceptionD003267———2———2
Renal insufficiencyD051437—N19—1———1
Viral pneumoniaD011024EFO_0007541J12.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A192———13
MalnutritionD044342EFO_0008572E40-E463————3
Opioid-related disordersD009293EFO_0005611F111————1
HyperlipoproteinemiasD006951——1————1
Crush injuriesD000071576—T14.81————1
Insulin resistanceD007333EFO_0002614E88.8191————1
Amyotrophic lateral sclerosisD000690EFO_0000253G12.211————1
Motor neuron diseaseD016472EFO_0003782G12.21————1
SclerosisD012598——1————1
HepacivirusD016174——1————1
Show 3 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitis bD019694EFO_0004239B18.1————11
Respiratory insufficiencyD012131—J96.9————11
DiarrheaD003967—R19.7————11
MorbidityD009017——————11
Therapeutic equivalencyD013810——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDarunavir ethanolate
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.CCO
Identifiers
PDB—
CAS-ID1133378-37-6
RxCUI—
ChEMBL IDCHEMBL1201127
ChEBI ID—
PubChem CID213039
DrugBankDB01264
UNII IDYO603Y8113 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
Black-box warning for: Symtuza
Adverse Events
Top Adverse Reactions
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10,172 adverse events reported
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