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 7 indications[4].[1]

Prezista is one of 215 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

214

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Viral DiseaseActive, not recruiting

HIV InfectionNot yet recruiting

AIDSApproved

COVID-19Approved

PneumocystosisApproved

HIV-1 InfectionApproved

ToxicityActive, not recruiting

Viral DiseaseApproved

Active, not recruiting

HIV InfectionPhase 3

Not yet recruiting

AIDSApproved

Approved

COVID-19Approved

Approved

PneumocystosisApproved

Approved

HIV-1 InfectionApproved

Approved

ToxicityApproved

Active, not recruiting

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Prezista

WWim Janssens

Approved

75 2

Nexavar

Bayer

Preclinical

1 3

Aldactone

Pfizer

Preclinical

1 4

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 5

Statins

Sanofi

Preclinical

1 6

Rayaldee

OOrganon and Co

Preclinical

1 7

SARS-COV-2 VACCINE

Moderna

Preclinical

2 8

Blood Taken

HHospices Civils de Lyon

Preclinical

1 9

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 10

Disease-Modifying Anti-Rheumatic Drugs

Roche

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2029

Phase 3Not yet recruiting

HIV Infection

NCT07792096

Clinical

Trials by Indication[1]

Interaction7 trials

TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01323257·49 enrolled

Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin

Completed·UUniversity of Colorado, Denver·Phase 4·NCT00630734·32 enrolled

A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)

Completed· GSK logo

GSK·Phase 1·NCT02277600·32 enrolled

Show 4 more trials

Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant

Unknown status·MMakerere University·Phase 2·NCT03589040·60 enrolled

Drug Interaction Study Between Inhaled Beclomethasone and Protease Inhibitors in Healthy Volunteers

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00936793·53 enrolled

GSK1349572 Drug Interaction With Etravirine and Either Darunavir/Ritonavir or Lopinavir/Ritonavir

Completed· GSK logo

GSK·Phase 1·NCT00867152·17 enrolled

A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01519336·40 enrolled

Treatment5 trials

Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1

Completed·NNorthwestern University·Phase 2·NCT00993148·25 enrolled

Optimizing Treatment for Treatment-Experienced, HIV-Infected People

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00537394·517 enrolled

A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients

Completed·TTibotec, Inc·Phase 2·NCT01199939·54 enrolled

Show 2 more trials

TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01138605·46 enrolled

Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment

Completed·TTibotec, Inc·Phase 4·NCT00757783·68 enrolled

Tenofovir5 trials

A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02578550·126 enrolled

Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02984852·30 enrolled

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04661397·37 enrolled

Show 2 more trials

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04236453·16 enrolled

Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02475135·72 enrolled

Tics4 trials

Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02159352·49 enrolled

A Phase 4 Study to Evaluate Pharmacokinetics and Safety of Darunavir Along With Ritonavir in Healthy Male Japanese Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01810887·8 enrolled

TMC114-TiDP3-C181: Study to Assess the Pharmacokinetics of Darunavir (DRV) With Different Doses of Ritonavir in Healthy Volunteers.

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT00744887·21 enrolled

Show 1 more trial

Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500

Completed·VViriom·Phase 1·NCT02489487·24 enrolled

Combination Therapy4 trials

A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01448707·274 enrolled

A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01391013·30 enrolled

Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00458302·256 enrolled

Show 1 more trial

A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT01641367·545 enrolled

35 more indications

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

Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)

Completed·RRockefeller University·N/A·NCT00525733·40 enrolled

Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients

Completed·AANRS, Emerging Infectious Diseases·Phase 2·NCT02384967·100 enrolled

Efficacy and Safety3 trials

Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 3·NCT00421551·225 enrolled

Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts

Completed·IInstitut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba·Phase 4·NCT01928407·120 enrolled

Efficacy and Safety Study of Darunavir for the Treatment of HIV/AIDS

Completed·UUniversity of Liverpool·Phase 3·NCT02155101·120 enrolled

Adolescent3 trials

IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults

Completed·IInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group··NCT00977756·168 enrolled

A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 2·NCT00915655·12 enrolled

TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01281813·145 enrolled

Children3 trials

A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 2·NCT00919854·27 enrolled

Population Pharmacokinetics of Antiretroviral in Children

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03194165·65 enrolled

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

ART2 trials

Comparative Study of Three NNRTI-Sparing HAART Regimens

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT00811954·1,814 enrolled

A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04208061·28 enrolled

HIV infection2 trials

Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection

Completed·SSEARCH Research Foundation·Phase 1/2·NCT02475915·15 enrolled

CHAPAS-5: An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa

Not yet recruiting·UUniversity College, London·Phase 3·NCT07792096·800 enrolled

Fed2 trials

TMC114-TiDP3-C176 - A Study in Healthy Volunteers Investigating the Bioequivalence Between Two Commercially Available 400-mg Tablets to One New 800-mg Tablet of Darunavir (DRV) in the Presence of Low-dose Ritonavir Under Fed and Fasted Conditions

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01308658·128 enrolled

A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04718805·22 enrolled

Immunodeficiency2 trials

Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02275780·769 enrolled

GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.

Completed·TTibotec, Inc·Phase 3·NCT00381303·429 enrolled

Pediatric1 trial

TMC114-TiDP29-C169: Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir Tablet

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT00752310·23 enrolled

Viremia1 trial

HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine

Terminated·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT00855413·15 enrolled

HIV-Infected Individuals1 trial

Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals

Terminated·UUniversity Hospital, Basel, Switzerland·Phase 4·NCT02503462·7 enrolled

Impaired Renal Function1 trial

Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT02116660·11 enrolled

CLE1 trial

Nucleosides And Darunavir/Dolutegravir In Africa

Unknown status·MMakerere University·Phase 3·NCT03988452·465 enrolled

Observational Study1 trial

An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT01615601·77 enrolled

Efficacy1 trial

Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors

Completed·CCommunity Research Initiative of New England·Phase 4·NCT00543101·24 enrolled

ESS1 trial

A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01619527·133 enrolled

Female1 trial

Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01374802·14 enrolled

Second-line Treatment1 trial

Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01605084

Age1 trial

Optimization of Darunavir Therapy and Dosage Recommendations

Completed·UUniversité Catholique de Louvain·Phase 4·NCT03101644·127 enrolled

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

HIV1 trial

Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.

Completed·HHospital Clinic of Barcelona··NCT01258374·15 enrolled

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT00855088·13 enrolled

Antiretroviral Treatment1 trial

Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

Withdrawn·JJuan A. Arnaiz·Phase 4·NCT02470650

Platelet Function1 trial

Effects of Steady State Tipranavir/Ritonavir or Darunavir/Ritonavir or Ritonavir on Platelet Function, Coagulation and Fibrinolysis Biomarkers in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02251795·52 enrolled

Adult1 trial

Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

Unknown status·KKirby Institute·Phase 4·NCT03017872·831 enrolled

Effectiveness1 trial

A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 3·NCT00524368·590 enrolled

Statin1 trial

Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz

Completed·NNYU Langone Health·Phase 1·NCT01695954·34 enrolled

Inflammation1 trial

Inflammation and Co-Infections in D²EFT

Withdrawn·KKirby Institute·Phase 4·NCT04183738

Resistance1 trial

Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00517192·40 enrolled

Adult Subject1 trial

A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00783484·37 enrolled

Pregnant Women1 trial

A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00855335·77 enrolled

Toxicity1 trial

NNRTI/PI Toxicity Switch to Darunavir Study

Terminated·SSt Stephens Aids Trust·Phase 4·NCT00765154·12 enrolled

Unspecified4 trials

The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study

Completed·IImperial College London·Phase 1·NCT01348763·13 enrolled

DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)

Completed· GSK logo

GSK·Phase 1·NCT02063360·42 enrolled

Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients

Completed·—·Phase 4·NCT00677300·85 enrolled

Show 1 more trial

Evaluation of Low-dose Darunavir in a Switch Study

Completed·WWillem Daniel Francois Venter·Phase 3·NCT02671383·300 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 20, 2006

PREZISTA

NDA NDA021976

Apr 25, 2007

PREZISTA

NDA NDA021976

Feb 25, 2008

PREZISTA

NDA NDA021976

Mar 7, 2008

PREZISTA

NDA NDA021976

Mar 7, 2008

PREZISTA

NDA NDA021976

Oct 21, 2008

PREZISTA

NDA NDA021976

Oct 21, 2008

PREZISTA

NDA NDA021976

Dec 18, 2008

PREZISTA

NDA NDA021976

Dec 18, 2008

PREZISTA

NDA NDA021976

Jun 15, 2009

PREZISTA

NDA NDA021976

Jun 15, 2009

PREZISTA

NDA NDA021976

Jan 27, 2010

PREZISTA

NDA NDA021976

Jan 27, 2010

PREZISTA

NDA NDA021976

Apr 26, 2010

PREZISTA

NDA NDA021976

Dec 13, 2010

PREZISTA

NDA NDA021976

Oct 19, 2011

PREZISTA

NDA NDA021976

Dec 16, 2011

PREZISTA

NDA NDA021976

Dec 16, 2011

PREZISTA

NDA NDA202895

Feb 13, 2012

PREZISTA

NDA NDA021976

Feb 17, 2012

PREZISTA

NDA NDA021976

Feb 17, 2012

PREZISTA

NDA NDA202895

Jun 1, 2012

PREZISTA

NDA NDA202895

Jun 1, 2012

PREZISTA

NDA NDA021976

Nov 9, 2012

PREZISTA

NDA NDA202895

Nov 9, 2012

PREZISTA

NDA NDA021976

Feb 1, 2013

PREZISTA

NDA NDA202895

Feb 1, 2013

PREZISTA

NDA NDA021976

Feb 1, 2013

PREZISTA

NDA NDA202895

Feb 1, 2013

PREZISTA

NDA NDA021976

Feb 22, 2013

PREZISTA

NDA NDA202895

Feb 22, 2013

PREZISTA

NDA NDA021976

Apr 24, 2013

PREZISTA

NDA NDA202895

Apr 24, 2013

PREZISTA

NDA NDA021976

Jun 14, 2013

PREZISTA

NDA NDA202895

Jun 14, 2013

PREZISTA

NDA NDA021976

Oct 31, 2013

PREZISTA

NDA NDA021976

Nov 7, 2013

PREZISTA

NDA NDA202895

Nov 7, 2013

PREZISTA

NDA NDA021976

Apr 7, 2014

PREZISTA

NDA NDA021976

Apr 7, 2014

PREZISTA

NDA NDA202895

May 8, 2014

PREZISTA

NDA NDA021976

May 8, 2014

PREZISTA

NDA NDA202895

Feb 3, 2015

PREZISTA

NDA NDA021976

Mar 27, 2015

PREZISTA

NDA NDA021976

Mar 27, 2015

PREZISTA

NDA NDA202895

May 27, 2015

PREZISTA

NDA NDA021976

May 27, 2015

PREZISTA

NDA NDA202895

Feb 19, 2016

PREZISTA

NDA NDA021976

Apr 11, 2016

PREZISTA

NDA NDA021976

Jun 17, 2016

PREZISTA

NDA NDA202895

Jun 17, 2016

PREZISTA

NDA NDA021976

Sep 15, 2016

PREZISTA

NDA NDA202895

Sep 15, 2016

PREZISTA

NDA NDA021976

Jun 19, 2017

PREZISTA

NDA NDA202895

Jun 19, 2017

PREZISTA

NDA NDA021976

Jan 25, 2018

PREZISTA

NDA NDA021976

Jan 25, 2018

PREZISTA

NDA NDA202895

Sep 7, 2018

PREZISTA

NDA NDA202895

Sep 7, 2018

PREZISTA

NDA NDA021976

Jan 31, 2019

PREZISTA

NDA NDA202895

Jan 31, 2019

PREZISTA

NDA NDA021976

Mar 21, 2019

PREZISTA

NDA NDA021976

Mar 21, 2019

PREZISTA

NDA NDA202895

May 28, 2019

PREZISTA

NDA NDA202895

May 28, 2019

PREZISTA

NDA NDA021976

Dec 22, 2020

PREZISTA

NDA NDA202895

Dec 22, 2020

PREZISTA

NDA NDA021976

Jul 23, 2021

PREZISTA

NDA NDA021976

Jul 23, 2021

PREZISTA

NDA NDA202895

Aug 17, 2021

PREZISTA

NDA NDA202895

Aug 17, 2021

PREZISTA

NDA NDA021976

Apr 14, 2022

PREZISTA

NDA NDA202895

Apr 14, 2022

PREZISTA

NDA NDA021976

Oct 20, 2022

PREZISTA

NDA NDA021976

Oct 20, 2022

PREZISTA

NDA NDA202895

Mar 31, 2023

PREZISTA

NDA NDA021976

Mar 31, 2023

PREZISTA

NDA NDA202895

Sources

References

[1]
ClinicalTrials.gov — 75 trial records for DARUNAVIR. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Prezista drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — DARUNAVIR compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for DARUNAVIR. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021976). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Prezista. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

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

Patent #Expires

7700645Dec 26, 2026

7700645*PEDJun 26, 2027

Prezista

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2029

Trials by Indication[1]

Interaction7 trials

Treatment5 trials

Tenofovir5 trials

Tics4 trials

Combination Therapy4 trials

HIV-13 trials

Efficacy and Safety3 trials

Adolescent3 trials

Children3 trials

ART2 trials

HIV infection2 trials

Fed2 trials

Immunodeficiency2 trials

Pediatric1 trial

Viremia1 trial

HIV-Infected Individuals1 trial

Impaired Renal Function1 trial

CLE1 trial

Observational Study1 trial

Efficacy1 trial

ESS1 trial

Female1 trial

Second-line Treatment1 trial

Age1 trial

Amyotrophic Lateral Sclerosis1 trial

HIV1 trial

Bone1 trial

Cardiovascular1 trial

ISS1 trial

Antiretroviral Treatment1 trial

Platelet Function1 trial

Adult1 trial

Effectiveness1 trial

Statin1 trial

Inflammation1 trial

Resistance1 trial

Adult Subject1 trial

Pregnant Women1 trial

Toxicity1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News