Reyataz

(ATAZANAVIR)

ApprovedSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Atazanavir is used to treat HIV infection by helping to reduce the amount of virus in the blood, allowing the immune system to work better and stay healthier longer.[2] Reyataz is currently approved and in use across 11 indications[4].[1]

Reyataz is one of 349 small molecule programs targeting AIDS. It is currently in Approved.

Indications

Total Trials

Active Trials

348

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AIDSApproved

Metabolic SyndromeActive, not recruiting

HIV InfectionActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Viral DiseaseActive, not recruiting

HyperlipidemiaActive, not recruiting

HIV-1 InfectionApproved

HyperbilirubinemiaActive, not recruiting

ImmunodeficiencyActive, not recruiting

COVID-19Active, not recruiting

AIDSApproved

Approved

Metabolic SyndromeApproved

Active, not recruiting

HIV InfectionApproved

Active, not recruiting

Cardiovascular DiseasePreclinical

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

HyperlipidemiaPhase 3

Active, not recruiting

HIV-1 InfectionApproved

Approved

HyperbilirubinemiaPreclinical

Active, not recruiting

ImmunodeficiencyPhase 2

Active, not recruiting

COVID-19Phase 2

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Reyataz

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

1 2

Spikevax

Moderna

Preclinical

21 3

Bnt162b2

BioNTech

Preclinical

29 4

COVID-19 Vaccine

Moderna

Preclinical

27 5

Biaxin

AbbVie

Preclinical

2 6

Aimovig

Amgen

Preclinical

1 7

Aldactone

Pfizer

Preclinical

1 8

Nexavar

Bayer

Preclinical

1 9

Stivarga

Bayer

Preclinical

1 10

Singulair

AstraZeneca

Preclinical

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

Clinical

Trials by Indication[1]

Treatment5 trials

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

Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults

Terminated· GSK logo

GSK·Phase 2·NCT02386098·86 enrolled

TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00896051·50 enrolled

Show 2 more trials

Atazanavir and Lamivudine for Treatment Simplification

Completed·—·Phase 4·NCT00885482·40 enrolled

A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00028067·500 enrolled

Interaction5 trials

Drug Interaction Study With Proton Pump Inhibitor

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00357240·56 enrolled

A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat

Completed·RRadboud University Medical Center·Phase 1·NCT02565888·16 enrolled

A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01591850·51 enrolled

Show 2 more trials

GSK1349572 Drug Interaction Study With Atazanavir/Ritonavir and Atazanavir

Completed· GSK logo

GSK·Phase 1·NCT00883935·24 enrolled

Pharmacokinetic Study in Healthy Adult Volunteers to Assess the Interactions Between Steady-State Tipranavir and Atazanavir in the Presence of Ritonavir

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02253836·21 enrolled

HIV-14 trials

Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients

Completed·TThe HIV Netherlands Australia Thailand Research Collaboration·Phase 1/2·NCT00411957·22 enrolled

Genetics and HIV-1 Protease Inhibitors

Completed·UUniversity of Colorado, Denver·Phase 4·NCT01388543·31 enrolled

Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01332227·132 enrolled

Show 1 more trial

Pharmacokinetic and Safety Study of Raltegravir and Atazanavir in a Once Daily Dose Regimen in HIV-1 Infected Patients

Completed·RRadboud University Medical Center·Phase 2·NCT00943540·20 enrolled

HIV infection4 trials

Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00013520·1,125 enrolled

Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01232127·25 enrolled

Study to Evaluate a HIV Drug for the Treatment of HIV Infection

Completed· GSK logo

GSK·Phase 2·NCT01803074·107 enrolled

Show 1 more trial

Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01691794·108 enrolled

Immunodeficiency4 trials

Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00389207·576 enrolled

A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

Completed· GSK logo

GSK·Phase 3·NCT01910402·499 enrolled

HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

Completed· GSK logo

GSK·Phase 2·NCT01384734·254 enrolled

Show 1 more trial

Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00552240·154 enrolled

39 more indications

Efficacy and Safety3 trials

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 of Tenofovir DF/Atazanavir Enhanced With Low Dose of Ritonavir in HIV-Infected Patients

Terminated·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00122577·50 enrolled

Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01620944·3 enrolled

Drug3 trials

Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV

Completed·GGermans Trias i Pujol Hospital·Phase 1·NCT00307502·675 enrolled

Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00002240

Preventing Sexual Transmission of HIV With Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00074581·3,526 enrolled

ART3 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

SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

Unknown status·CClinical Alliance for Research & Education - Infectious Diseases, LLC.·Phase 4·NCT00426296

Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

Completed·NNorthwestern University·Phase 3·NCT00225017·50 enrolled

HIV3 trials

Study to Evaluate the Influence of Nevirapine to Atazanavir in Steady State Equilibrium in HIV Patients

Completed·GGermans Trias i Pujol Hospital·Phase 4·NCT00355719·14 enrolled

Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

Terminated·UUniversity of Oklahoma·Phase 4·NCT00420355·19 enrolled

Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00528060·35 enrolled

Children2 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

Population Pharmacokinetics of Antiretroviral in Children

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

Tenofovir2 trials

Switch to Unboosted Atazanavir With Tenofovir Study

Completed·UUniversity of British Columbia·Phase 4·NCT01351740·50 enrolled

Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population

Completed·UUniversity of North Carolina, Chapel Hill··NCT01180075·85 enrolled

Effectiveness2 trials

Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00004584

Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00007202·55 enrolled

Tics2 trials

Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen

Terminated·RRadboud University Medical Center·Phase 2·NCT02566707·9 enrolled

Effect of Different Boosting Agents on Pharmacokinetics of BILR 355 BS Dissolved in Polyethylene Glycol 400 (PEG 400) in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02257008·44 enrolled

Adult2 trials

Safety, Tolerability, and Blood Levels of Ritonavir-Boosted Atazanavir and Rifampin When Taken Together in HIV Uninfected Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00096850·18 enrolled

A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05236738·42 enrolled

Endothelial Function2 trials

Effect of Atazanavir on Endothelial Function in HIV-Infected Patients

Completed·FFoundation for Cardiovascular Research, Zurich·Phase 4·NCT00447070·50 enrolled

Atazanavir and Endothelial Function in Older HIV Patients

Completed·—·Phase 2/3·NCT03019783·60 enrolled

Tenofovir Disoproxil Fumarate2 trials

Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT00118898·1,864 enrolled

A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir

Completed· Roche logo

Roche·Phase 1·NCT01592305·40 enrolled

Phase II2 trials

A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00067782

Phase IIB Pilot of Atazanavir + Raltegravir

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00768989·167 enrolled

ESS2 trials

Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01404572·12 enrolled

Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01003990·710 enrolled

Trial1 trial

Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials

Completed·AAcrotech Biopharma Inc.·Phase 1·NCT04184869·8 enrolled

TED1 trial

Boosted Atazanavir and Truvada Given Once-Daily - BATON Study

Completed· Gilead logo

Gilead·Phase 4·NCT00224445·100 enrolled

Prospective1 trial

Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT00084136·1,571 enrolled

Metabolism1 trial

ATAGLU: Study of Glucose Metabolism in HIV Positive Patients That Switch From Another Protease Inhibitor to Atazanavir

Unknown status·UUniversity of Roma La Sapienza·N/A·NCT02102048·300 enrolled

Type 1 Diabetes Mellitus1 trial

A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus

Completed·—·Phase 1·NCT01421355·15 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

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

Pilot Study1 trial

Pilot Study of a Raltegravir Based NRTI Sparing Regimen

Completed·YYale University·N/A·NCT00814879·60 enrolled

Clinical Trial1 trial

Two Clinical Trials to Evaluate Pharmacokinetics of Unboosted and Boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers

Unknown status·—·Phase 1·NCT01368783·32 enrolled

MPA1 trial

Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01837719·64 enrolled

AIN1 trial

Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00028301

Maintenance Therapy1 trial

Atazanavir/Ritonavir Maintenance Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00084019·36 enrolled

Cardiovascular Disease1 trial

Effect of the HIV Protease Inhibitors Atazanavir and Lopinavir/Ritonavir on Cardiovascular Disease Risk Factors

Completed·IIndiana University·N/A·NCT00720590·30 enrolled

Menstrual Cycle1 trial

Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT00869960·24 enrolled

LAM1 trial

A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00013897

Completed· GSK logo

GSK·Phase 4·NCT00082394

Metabolic Syndrome1 trial

A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00312754·70 enrolled

Hyperlipidemia1 trial

Atazanavir or Boosted Atazanavir Substitution for Ritonavir Boosted PI in Patients With Hyperlipidemia

Completed·SStanford University·Phase 3·NCT00160329·60 enrolled

COVID-191 trial

Antiviral Agents Against COVID-19 Infection

Completed·HHospital do Coracao·Phase 2/3·NCT04468087·256 enrolled

Drug Interactions1 trial

Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00833482·185 enrolled

Cardiovascular1 trial

Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections··NCT00851799·334 enrolled

Hyperbilirubinemia1 trial

The Effects of Atazanavir-induced Hyperbilirubinemia During Human Endotoxemia

Completed·RRadboud University Medical Center·N/A·NCT00916448·30 enrolled

ALS1 trial

Atazanavir for HIV Infected Individuals: An Early Access Program

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT00046345

Unspecified3 trials

DDI HV (ATV - Merck)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00518297·22 enrolled

Taste Properties of Atazanavir and Cobicistat

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02307656·6 enrolled

PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01099579·82 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 20, 2003

REYATAZ

NDA NDA021567

Jun 2, 2014

REYATAZ

NDA NDA206352

Sources

References

[1]
ClinicalTrials.gov — 80 trial records for ATAZANAVIR. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Reyataz drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — ATAZANAVIR compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for ATAZANAVIR. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206352). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company 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: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Reyataz

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Treatment5 trials

Interaction5 trials

HIV-14 trials

HIV infection4 trials

Immunodeficiency4 trials

Efficacy and Safety3 trials

Drug3 trials

ART3 trials

HIV3 trials

Children2 trials

Tenofovir2 trials

Effectiveness2 trials

Tics2 trials

Adult2 trials

Endothelial Function2 trials

Tenofovir Disoproxil Fumarate2 trials

Phase II2 trials

ESS2 trials

Trial1 trial

TED1 trial

Prospective1 trial

Metabolism1 trial

Type 1 Diabetes Mellitus1 trial

Second-line Treatment1 trial

Impaired Renal Function1 trial

Pilot Study1 trial

Clinical Trial1 trial

MPA1 trial

AIN1 trial

Maintenance Therapy1 trial

Cardiovascular Disease1 trial

Menstrual Cycle1 trial

LAM1 trial

Adolescent1 trial

Antiretroviral Treatment1 trial

Efficacy1 trial

Metabolic Syndrome1 trial

Hyperlipidemia1 trial

COVID-191 trial

Drug Interactions1 trial

Cardiovascular1 trial

Hyperbilirubinemia1 trial

ALS1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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