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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Darunavir, Prezista (discontinued: Darunavir, Prezista)
CombinationsSymtuza
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 |
|---|---|---|---|---|
| PREZISTA | Johnson & Johnson | N-021976 RX | 2008-02-25 | 4 products, RLD |
| PREZISTA | Johnson & Johnson | N-202895 RX | 2011-12-16 | 1 products, RLD, RS |
Show 1 discontinued
Cobicistat
+
Darunavir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYMTUZA | Johnson & Johnson | N-210455 RX | 2018-07-17 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| darunavir | ANDA | 2026-09-15 |
| darunavir 600 and 800 mg | ANDA | 2025-06-05 |
| prezcobix | New Drug Application | 2025-04-08 |
| prezcobix prezcobix ped | New Drug Application | 2026-02-01 |
| prezista | New Drug Application | 2025-08-29 |
| symtuza | New Drug Application | 2026-04-17 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cobicistat / Darunavir / Emtricitabine / Tenofovir Alafenamide Fumarate, Symtuza, Janssen Prods | |||
| 10786518 | 2038-07-19 | U-2978 | |
| 8754065 | 2032-08-15 | DS, DP | U-2352, U-2765 |
| 9296769 | 2032-08-15 | DS, DP | U-2352, U-2765 |
| 7390791 | 2025-04-17 | DS, DP | |
| Cobicistat / Darunavir, Prezcobix, Janssen Prods | |||
| 10039718 | 2032-10-06 | DP | |
| 8148374 | 2029-09-03 | DS, DP | U-1279, U-2353, U-2364, U-2365, U-2766, U-2767, U-2768, U-2939 |
| 7700645 | 2026-12-26 | DS, DP | |
| 8518987 | 2024-02-16 | DS, 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
287 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 | 39 | 55 | 40 | 27 | 172 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 12 | 16 | 26 | 10 | 13 | 72 |
| Hiv | D006678 | — | O98.7 | 11 | 7 | 14 | 18 | 7 | 56 |
| Hiv-1 | D015497 | — | — | 4 | 8 | 9 | 4 | 1 | 25 |
| Healthy volunteers/patients | — | — | — | 18 | — | — | 3 | — | 21 |
| Infections | D007239 | EFO_0000544 | — | 6 | 6 | 5 | 3 | 2 | 21 |
| Hepatitis c | D006526 | — | B19.2 | 4 | 4 | 1 | 1 | 1 | 9 |
| Covid-19 | D000086382 | — | U07.1 | — | 3 | 3 | 1 | 2 | 8 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | 1 | 2 | 2 | 1 | 1 | 6 |
| Communicable diseases | D003141 | — | — | 1 | 2 | 2 | 2 | — | 6 |
Show 40 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 |
| Virus diseases | D014777 | — | B34 | 1 | 1 | 1 | — | — | 3 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 1 | — | 2 | 3 |
| Viremia | D014766 | — | B34.9 | — | 1 | 1 | — | — | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 1 | — | — | 2 |
| Coronavirus | D017934 | — | — | — | — | 1 | — | 1 | 2 |
| Occupational injuries | D060051 | — | — | — | — | 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 |
| Fibrosis | D005355 | — | — | — | 1 | — | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 1 | — | — | — | 1 |
| Dyslipidemias | D050171 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | — | — | — | — | 1 |
| Thrombosis | D013927 | — | — | 1 | — | — | — | — | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | — | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 1 | — | — | — | — | 1 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | — | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Latent tuberculosis | D055985 | — | Z22.7 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | — | 1 | 1 |
| 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 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 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 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Darunavir |
| 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 |
Identifiers
| PDB | — |
| CAS-ID | 206361-99-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1323 |
| ChEBI ID | 367163 |
| 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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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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Trends
PubMed Central
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Symtuza
Adverse Events
Top Adverse Reactions
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16,558 adverse events reported
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