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 |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
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 |
|---|---|---|---|---|
| PREZCOBIX | Johnson & Johnson | N-205395 RX | 2015-01-29 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| darunavir | ANDA | 2025-03-19 |
| darunavir 600 and 800 mg | ANDA | 2024-01-18 |
| prezcobix | New Drug Application | 2025-04-02 |
| prezista | New Drug Application | 2024-07-23 |
| symtuza | New Drug Application | 2024-07-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv infections | EFO_0000764 | D015658 | B20 |
| acquired immunodeficiency syndrome | EFO_0000765 | D000163 | B20 |
Agency Specific
FDA
EMA
No data
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 infections | D015658 | EFO_0000764 | B20 | 1 | 2 | 9 | 5 | 1 | 17 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 1 | 6 | 2 | — | 9 |
| Hiv-1 | D015497 | — | — | 2 | — | 2 | 1 | — | 5 |
| Hiv | D006678 | — | O98.7 | 1 | — | 3 | 1 | — | 5 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | 2 | — | 2 |
| Weight gain | D015430 | — | — | — | — | — | 1 | — | 1 |
| Hiv seropositivity | D006679 | — | — | — | — | — | 1 | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | 1 | — | 1 |
| Viremia | D014766 | — | B34.9 | — | — | — | 1 | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunologic deficiency syndromes | D007153 | — | D84.9 | 1 | — | 4 | — | — | 5 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 2 | — | — | — | 2 |
| Sars-cov-2 | D000086402 | — | — | — | 2 | — | — | — | 2 |
| Contraception | D003267 | — | — | — | 2 | — | — | — | 2 |
| Renal insufficiency | D051437 | — | N19 | — | 1 | — | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | 1 | 4 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 2 | — | — | — | 1 | 3 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Hyperlipoproteinemias | D006951 | — | — | 1 | — | — | — | — | 1 |
| Crush injuries | D000071576 | — | T14.8 | 1 | — | — | — | — | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | — | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 1 | — | — | — | — | 1 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 1 | — | — | — | — | 1 |
| Sclerosis | D012598 | — | — | 1 | — | — | — | — | 1 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | — | — | — | 1 | 1 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | — | — | — | 1 | 1 |
| Diarrhea | D003967 | — | R19.7 | — | — | — | — | 1 | 1 |
| Morbidity | D009017 | — | — | — | — | — | — | 1 | 1 |
| Therapeutic equivalency | D013810 | — | — | — | — | — | — | 1 | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | — | — | 1 | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 1 | 1 |
| Radius fractures | D011885 | EFO_0003957 | S52.37 | — | — | — | — | 1 | 1 |
| Wrist fractures | D000092503 | — | S52.54 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Darunavir ethanolate |
| INN | darunavir |
| 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 class | antivirals: 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.CCO |
Identifiers
| PDB | — |
| CAS-ID | 1133378-37-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201127 |
| ChEBI ID | — |
| PubChem CID | 213039 |
| DrugBank | DB01264 |
| UNII ID | YO603Y8113 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 12,009 documents
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Safety
Black-box Warning
Black-box warning for: Darunavir, Symtuza
Adverse Events
Top Adverse Reactions
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15,945 adverse events reported
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