Viread

(Tenofovir disoproxil)

ApprovedSmall molecule

Tenofovir disoproxil is used to treat HIV infection and chronic hepatitis B by helping to slow or stop the virus from multiplying in the body. It is often used as part of combination therapy with other antiviral medications.[2] Viread is currently approved and in use across 11 indications[4].[1]

Viread is one of 260 small molecule programs targeting Chronic Hepatitis. It is currently in Approved.

Indications

Total Trials

Active Trials

259

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Chronic HepatitisCompleted

Hepatitis B Virus InfectionActive, not recruiting

HIV InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

Primary Biliary CirrhosisApproved

HepatitisApproved

COVID-19Approved

Hepatocellular CarcinomaActive, not recruiting

Hepatitis BActive, not recruiting

Chronic Hepatitis BNot yet recruiting

Chronic HepatitisApproved

Completed

Hepatitis B Virus InfectionApproved

Active, not recruiting

HIV InfectionApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

Primary Biliary CirrhosisApproved

Approved

HepatitisApproved

Approved

COVID-19Approved

Approved

Hepatocellular CarcinomaPreclinical

Active, not recruiting

Hepatitis BPhase 3

Active, not recruiting

Chronic Hepatitis BPhase 3

Not yet recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Viread

Gilead

Approved

32 2

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 3

Nitrostat

VViatris Specialty LLC

Preclinical

1 4

Low-Molecular-Weight Heparin

Daiichi Sankyo

Preclinical

3 5

Statins

Sanofi

Preclinical

1 6

Singulair

AstraZeneca

Preclinical

1 7

Rayaldee

OOrganon and Co

Preclinical

1 8

SARS-COV-2 VACCINE

Moderna

Preclinical

2 9

Biological Data

UUniversity Hospital, Bordeaux

Preclinical

3 10

Blood Taken

HHospices Civils de Lyon

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Active, not recruiting

Hepatitis B

NCT02344498

Phase 3Active, not recruiting

Hepatitis B

NCT04704024

Q4 2029

Phase 3Not yet recruiting

Chronic Hepatitis B

NCT07797231

Q1 2030

Phase 2Recruiting

Weight Gain

NCT05652478

Clinical

Trials by Indication[1]

Chronic Hepatitis8 trials

Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)

Terminated· Arrowhead Pharmaceuticals logo

Arrowhead Pharmaceuticals·Phase 2·NCT02577029·79 enrolled

A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04439539·54 enrolled

An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05275023·37 enrolled

Show 5 more trials

Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 4·NCT03485534·189 enrolled

Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B

Unknown status·SSeng Gee Lim·Phase 4·NCT02774837·146 enrolled

Tenofovir in Asian Chronic Hepatitis B Patients

Completed·TThe University of Hong Kong·N/A·NCT01728935·141 enrolled

A phase4 Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B

Completed·SSamjin Pharmaceutical Co., Ltd.·Phase 4·NCT05282407·118 enrolled

Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B

Completed·SSamjin Pharmaceutical Co., Ltd.·Phase 4·NCT05286346·113 enrolled

Chronic Hepatitis B Virus Infection4 trials

A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04667104·48 enrolled

A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04585789·24 enrolled

A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05005507·1 enrolled

Show 1 more trial

A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05123599·24 enrolled

Hepatitis B3 trials

Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa

Active, not recruiting·OOslo University Hospital··NCT02344498·7,350 enrolled

PROLIFICA - West African Treatment Cohort for Hepatitis B

Completed·IImperial College London··NCT02129829·1,079 enrolled

A Phase III, Randomized, 2x2 Factorial Trial to Assess the Efficacy of Antiviral Therapy in Women and Infants in Reducing Vertical Transmission of Hepatitis B in Africa

Active, not recruiting·UUniversity of Alabama at Birmingham·Phase 3·NCT04704024·334 enrolled

ART1 trial

Artery Elasticity After Switch From Epzicom to Truvada

Terminated·HHennepin Healthcare Research Institute·Phase 4·NCT00998582·27 enrolled

HIV Prevention1 trial

PK and PD Study of Oral F/TAF for HIV Prevention

Completed·CCONRAD·Phase 1·NCT02904369·73 enrolled

15 more indications

Prevention1 trial

Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss

Terminated·UUniversity College Dublin·Phase 4·NCT02322099·53 enrolled

Prognosis1 trial

RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection

Active, not recruiting·WWest China Hospital·Phase 4·NCT04032860·104 enrolled

HIV Pre-Exposure Prophylaxis1 trial

Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand

Completed·CCenters for Disease Control and Prevention·Phase 2/3·NCT00119106·2,413 enrolled

Treatment1 trial

DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)

Completed·HHumanity and Health Research Centre·Phase 2/3·NCT02555943·23 enrolled

Immunodeficiency1 trial

A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03563742·58 enrolled

Tenofovir1 trial

Tenofovir to Prevent HBV Reactivation

Unknown status·UUniversity Health Network, Toronto·Phase 3·NCT02186574·184 enrolled

Drug Resistance1 trial

HIV Drug Resistance Among Individuals Failing Tenofovir/Lamivudine and Dolutegravir First Line Regimen in Brazil

Active, not recruiting·FFederal University of São Paulo··NCT04453436·2,500 enrolled

Tenofovir Disoproxil Fumarate1 trial

A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers

Completed· Boryung Pharmaceutical Co., Ltd logo

Boryung Pharmaceutical Co., Ltd·Phase 1·NCT02920931·50 enrolled

Hepatocellular Carcinoma1 trial

Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis

Unknown status·QQing XIe··NCT04160897·4,000 enrolled

Solid Organ Transplant1 trial

Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients

Completed·FFundacion Clinic per a la Recerca Biomédica·Phase 4·NCT03360682·19 enrolled

Pilot Study1 trial

Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection

Completed·UUniversity of Alabama at Birmingham·N/A·NCT00734344·18 enrolled

Weight Gain1 trial

Early Metabolic Effects of Antiretroviral Drugs in Healthy Volunteers: A Phase 2 Randomized Study

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05652478·120 enrolled

Chronic Hepatitis b1 trial

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial With an Open-Label Extension to Evaluate the Efficacy and Safety of TQA3605 Tablets in Chronic Hepatitis B Virus-Infected Patients With Low-Level Viremia or Suboptimal Response After at Least 12 Months of NAs Therapy

Not yet recruiting· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 3·NCT07797231·930 enrolled

Hepatitis D, Chronic1 trial

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04535544·52 enrolled

Unspecified1 trial

An Exploratory Study of RGT Strategy on Optimal NUC-experienced Patients

Unknown status·RRuijin Hospital·Phase 4·NCT02560649·324 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 2, 2002

VIREAD

NDA NDA021356

Aug 15, 2003

VIREAD

NDA NDA021356

Oct 14, 2003

VIREAD

NDA NDA021356

Oct 31, 2003

VIREAD

NDA NDA021356

Jul 1, 2004

VIREAD

NDA NDA021356

May 12, 2005

VIREAD

NDA NDA021356

Nov 30, 2005

VIREAD

NDA NDA021356

Mar 8, 2006

VIREAD

NDA NDA021356

May 21, 2007

VIREAD

NDA NDA021356

May 16, 2008

VIREAD

NDA NDA021356

Aug 11, 2008

VIREAD

NDA NDA021356

Nov 4, 2008

VIREAD

NDA NDA021356

Oct 7, 2009

VIREAD

NDA NDA021356

Nov 10, 2009

VIREAD

NDA NDA021356

Jan 15, 2010

VIREAD

NDA NDA021356

Mar 24, 2010

VIREAD

NDA NDA021356

Oct 1, 2010

VIREAD

NDA NDA021356

Oct 14, 2010

VIREAD

NDA NDA021356

Sep 19, 2011

VIREAD

NDA NDA021356

Nov 18, 2011

VIREAD

NDA NDA021356

Jan 18, 2012

VIREAD

NDA NDA021356

Jan 18, 2012

VIREAD

NDA NDA022577

Jan 18, 2012

VIREAD

NDA NDA022577

Jan 18, 2012

VIREAD

NDA NDA021356

Aug 7, 2012

VIREAD

NDA NDA021356

Aug 16, 2012

VIREAD

NDA NDA021356

Aug 16, 2012

VIREAD

NDA NDA022577

Mar 12, 2013

VIREAD

NDA NDA021356

Apr 2, 2013

VIREAD

NDA NDA022577

Apr 2, 2013

VIREAD

NDA NDA021356

Jul 24, 2013

VIREAD

NDA NDA022577

Jul 24, 2013

VIREAD

NDA NDA021356

Oct 23, 2013

VIREAD

NDA NDA021356

Oct 23, 2013

VIREAD

NDA NDA022577

May 29, 2015

VIREAD

NDA NDA022577

May 29, 2015

VIREAD

NDA NDA021356

Nov 18, 2015

VIREAD

NDA NDA021356

Dec 2, 2015

VIREAD

NDA NDA022577

Feb 16, 2016

VIREAD

NDA NDA022577

Feb 16, 2016

VIREAD

NDA NDA021356

Mar 10, 2016

VIREAD

NDA NDA021356

Apr 7, 2017

VIREAD

NDA NDA021356

Apr 7, 2017

VIREAD

NDA NDA022577

Jul 30, 2018

VIREAD

NDA NDA021356

Jul 30, 2018

VIREAD

NDA NDA022577

Dec 11, 2018

VIREAD

NDA NDA021356

Dec 11, 2018

VIREAD

NDA NDA022577

Apr 24, 2019

VIREAD

NDA NDA022577

Apr 24, 2019

VIREAD

NDA NDA021356

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Tenofovir disoproxil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Viread drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tenofovir disoproxil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tenofovir disoproxil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022577). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor; DNA Polymerase/reverse Transcriptase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Gilead

Viread

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2029

Q1 2030

Trials by Indication[1]

Chronic Hepatitis8 trials

Chronic Hepatitis B Virus Infection4 trials

Hepatitis B3 trials

ART1 trial

HIV Prevention1 trial

Prevention1 trial

Prognosis1 trial

HIV Pre-Exposure Prophylaxis1 trial

Treatment1 trial

Immunodeficiency1 trial

Tenofovir1 trial

Drug Resistance1 trial

Tenofovir Disoproxil Fumarate1 trial

Hepatocellular Carcinoma1 trial

Solid Organ Transplant1 trial

Pilot Study1 trial

Weight Gain1 trial

Chronic Hepatitis b1 trial

Hepatitis D, Chronic1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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