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 |
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
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 infections | D015658 | EFO_0000764 | B20 | 22 | 42 | 58 | 40 | 31 | 182 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 7 | 14 | 20 | 9 | 13 | 58 |
| Hiv | D006678 | — | O98.7 | 11 | 7 | 14 | 18 | 6 | 55 |
| Infections | D007239 | EFO_0000544 | — | 6 | 9 | 9 | 10 | 3 | 35 |
| Hiv-1 | D015497 | — | — | 4 | 8 | 9 | 4 | 1 | 25 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | 1 | 8 | 13 | 1 | 4 | 24 |
| Healthy volunteers/patients | — | — | — | 18 | — | — | 3 | — | 21 |
| Communicable diseases | D003141 | — | — | 1 | 5 | 6 | 5 | — | 15 |
| Hepatitis c | D006526 | — | B19.2 | 4 | 3 | 1 | 1 | 1 | 8 |
| Covid-19 | D000086382 | — | U07.1 | — | 3 | 3 | 1 | 2 | 8 |
Show 35 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv-2 | D015498 | — | — | 1 | 1 | 1 | — | 3 | 6 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 1 | — | 2 | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 1 | — | — | 2 |
| Fibrosis | D005355 | — | — | — | 2 | 1 | — | — | 2 |
| Virus diseases | D014777 | — | B34 | — | 2 | 1 | — | — | 2 |
| Coronavirus | D017934 | — | — | — | — | 1 | — | 1 | 2 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 1 | 1 | — | — | 1 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | 1 | — | — | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | — | 1 |
| Pneumocystis pneumonia | D011020 | EFO_0007448 | B59 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 2 | — | — | — | 1 | 3 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | — | 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 |
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
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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