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Darunavir (DRV)
Darunavir (DRV) is a HIV protease inhibitor Small molecule drug developed by Tibotec Pharmaceuticals, Ireland. It is currently in Phase 3 development for HIV-1 infection in treatment-naïve and treatment-experienced patients (in combination with other antiretroviral agents). Also known as: TMC114, Prezista.
Darunavir is a protease inhibitor that blocks HIV protease, preventing the cleavage of viral polyproteins and maturation of infectious HIV particles.
Darunavir is a protease inhibitor that blocks HIV protease, preventing the cleavage of viral polyproteins and maturation of infectious HIV particles. Used for HIV-1 infection in treatment-naïve and treatment-experienced patients (in combination with other antiretroviral agents).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Darunavir (DRV) |
|---|---|
| Also known as | TMC114, Prezista |
| Sponsor | Tibotec Pharmaceuticals, Ireland |
| Drug class | HIV protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Darunavir binds to the active site of HIV protease with high affinity, inhibiting the enzyme's ability to process viral precursor proteins into functional structural and enzymatic proteins. This prevents the formation of mature, infectious viral particles, thereby reducing viral replication and slowing disease progression in HIV-infected patients. It is typically used in combination with other antiretroviral agents and a ritonavir booster to achieve therapeutic plasma concentrations.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced patients (in combination with other antiretroviral agents)
Common side effects
- Diarrhea
- Nausea
- Headache
- Rash
- Abdominal pain
- Vomiting
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV (PHASE1, PHASE2)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
- Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
- Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy (PHASE2)
- Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Darunavir (DRV) CI brief — competitive landscape report
- Darunavir (DRV) updates RSS · CI watch RSS
- Tibotec Pharmaceuticals, Ireland portfolio CI
Frequently asked questions about Darunavir (DRV)
What is Darunavir (DRV)?
How does Darunavir (DRV) work?
What is Darunavir (DRV) used for?
Who makes Darunavir (DRV)?
Is Darunavir (DRV) also known as anything else?
What drug class is Darunavir (DRV) in?
What development phase is Darunavir (DRV) in?
What are the side effects of Darunavir (DRV)?
What does Darunavir (DRV) target?
Related
- Drug class: All HIV protease inhibitor drugs
- Target: All drugs targeting HIV protease
- Manufacturer: Tibotec Pharmaceuticals, Ireland — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for HIV-1 infection in treatment-naïve and treatment-experienced patients (in combination with other antiretroviral agents)
- Also known as: TMC114, Prezista
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing