Prezista
(DARUNAVIR)ApprovedSmall molecule
Darunavir is used to treat HIV infection by helping to reduce the amount of HIV in the blood, usually taken together with other HIV medications to help people with HIV live longer and healthier lives.[2] Prezista is currently approved and in use across 9 indications[4].[1]
Prezista is one of 268 small molecule programs targeting AIDS. It is currently in Approved.
9
Indications
74
Total Trials
0
Active Trials
267
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
1931 competitors in COVID-19
#DrugCompanyPhaseTrials
1Prezista
WWim Janssens
Approved
Spikevax
ModernaPreclinical
Bnt162b2
BioNTechPreclinical
COVID-19 Vaccine
ModernaPreclinical
Biaxin
AbbViePreclinical
Stivarga
BayerPreclinical
Aimovig
AmgenPreclinical
Aldactone
PfizerPreclinical
Nexavar
BayerPreclinical
Singulair
AstraZenecaPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Clinical
Trials by Indication[1]
Interaction7 trials
Show 4 more trials
Tenofovir5 trials
Show 2 more trials
Treatment5 trials
Optimizing Treatment for Treatment-Experienced, HIV-Infected People
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00537394·517 enrolled
Tics4 trials
Combination Therapy4 trials
Show 1 more trial
35 more indications
Children3 trials
Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00260078·75 enrolled
Adolescent3 trials
HIV-13 trials
Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.
Completed·CCentre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida·Phase 3·NCT00849160·100 enrolled
Immunodeficiency2 trials
Fed2 trials
ART2 trials
Platelet Function1 trial
Resistance1 trial
Effectiveness1 trial
Efficacy1 trial
Observational Study1 trial
Second-line Treatment1 trial
HIV infection1 trial
HIV-Infected Individuals1 trial
Antiretroviral Treatment1 trial
Adult Subject1 trial
Pregnant Women1 trial
Pediatric1 trial
Viremia1 trial
Impaired Renal Function1 trial
Amyotrophic Lateral Sclerosis1 trial
HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT02437110·122 enrolled
ESS1 trial
Female1 trial
Bone1 trial
Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen
Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT01400412·262 enrolled
Cardiovascular1 trial
ISS1 trial
Unspecified4 trials
Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients
Completed·—·Phase 4·NCT00677300·85 enrolled
Show 1 more trial
Regulatory
FDA Approval Timeline[5]
Dec 18, 2008
PREZISTA
NDA NDA021976
Dec 16, 2011
PREZISTA
NDA NDA202895
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Prezista drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for DARUNAVIR. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Human Immunodeficiency Virus Type 1 Protease Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- WWim Janssens
Patent Landscape[6]
Patent Cliff
Dec 26, 2026
Earliest patent expiration — generic entry possible after this date