Hepatitis B, Chronic

Infectious Diseases
35
Pipeline Programs
19
Companies
50
Clinical Trials
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
2
13
0
5
12
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 33 programs with unclassified modality

On Market (3)

Approved therapies currently available

GS
DESCOVYApproved
emtricitabine and tenofovir alafenamide
Gilead Sciences
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]oral2016
Novartis
TYZEKAApproved
telbivudine
Novartis
oral2006
GS
VEMLIDYApproved
tenofovir alafenamide
Gilead Sciences
oral2016

Competitive Landscape

19 companies ranked by most advanced pipeline stage

GS
Gilead SciencesFOSTER CITY, CA
4 programs
4
TDFPhase 41 trial
DESCOVY(Tenofovir Alafenamide)Phase 45 trials
Tenofovir AlafenamidePhase 4
antiviral prophylaxis with Tenofovir Alafenamide FumaratePhase 41 trial
Active Trials
NCT02081469Completed100Est. Aug 2019
NCT07476339Not Yet Recruiting200Est. Oct 2026
NCT06613685Active Not Recruiting675Est. Aug 2030
+4 more trials
Roche
RocheSTAVANGER NORWAY, Norway
3 programs
1
1
1
AdefovirPhase 4Small Molecule1 trial
peginterferon alfa-2a [Pegasys]Phase 35 trials
NucleosPhase 21 trial
Active Trials
NCT04225715Completed281Est. Jul 2024
NCT01519960Completed165Est. Oct 2021
NCT01579019Withdrawn0Est. Mar 2014
+4 more trials
Alliance Pharmaceuticals
3 programs
3
EmtricitabinePhase 41 trial
EmtricitabinePhase 43 trials
Emtricitabine plus adefovir dipivoxilPhase 41 trial
Active Trials
NCT02327676Unknown200Est. Jul 2016
NCT02327715Unknown200Est. Jul 2016
NCT02327702Unknown200Est. Jul 2017
+2 more trials
Novartis
NovartisBASEL, Switzerland
1 program
1
telbivudinePhase 45 trials
Active Trials
NCT00409019Withdrawn0
NCT00710216Withdrawn40
NCT02826070Unknown130Est. Oct 2017
+2 more trials
Grifols
GrifolsNEW YORK, NY
2 programs
1
1
Specific intravenous anti-hepatitis B immunoglobulinPhase 31 trial
intramuscular hepatitis B virus immune globulinPhase 21 trial
Active Trials
NCT00895713CompletedEst. Jul 2005
NCT00838071CompletedEst. Aug 2004
M&
Merck & Co.RAHWAY, NJ
2 programs
2
PEG-Intron™Phase 31 trial
pegylated interferon alpha-2bPhase 33 trials
Active Trials
NCT01641926Terminated402Est. Jan 2016
NCT01727271Withdrawn0Est. Aug 2017
NCT01758588Terminated8Est. Jun 2017
+1 more trials
Biotest Pharmaceuticals
Biotest PharmaceuticalsGermany - Dreieich
1 program
1
Nabi-HBPhase 31 trial
Active Trials
NCT00800787WithdrawnEst. Sep 2010
Vir Biotechnology
Vir BiotechnologyCA - San Francisco
4 programs
1
3
BRII-835Phase 2
VIR-2218Phase 2
VIR-2218Phase 21 trial
VIR-3434Phase 1/21 trial
Active Trials
NCT05612581CompletedEst. Aug 2025
NCT04856085Active Not RecruitingEst. Mar 2026
Brii Biosciences
Brii BiosciencesCA - San Mateo
2 programs
2
BRII-835Phase 2
VIR-2218Phase 2
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
2 programs
2
pradefovir mesylatePhase 21 trial
pradefovir mesylatePhase 21 trial
Active Trials
NCT00230503CompletedEst. Dec 2006
NCT00230490TerminatedEst. May 2007
Arrowhead Pharmaceuticals
1 program
1
ARC-520Phase 21 trial
Active Trials
NCT02065336Terminated58Est. Jan 2017
VBI Vaccines
VBI VaccinesMA - Cambridge
1 program
1
BRII-835Phase 21 trial
Active Trials
NCT04749368CompletedEst. Jul 2023
Genomics
GenomicsUK - Oxford
1 program
1
HydronidonePhase 21 trial
Active Trials
NCT02499562Completed168Est. Nov 2020
Alnylam Pharmaceuticals
1 program
1
VIR-2218Phase 21 trial
Active Trials
NCT04507269Completed21Est. Sep 2021
CT
1 program
1
TQA3038 injection/placeboPhase 1/21 trial
Active Trials
NCT06452693Not Yet RecruitingEst. Sep 2026
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
1
DCR-HBVSPhase 11 trial
Active Trials
NCT03772249Completed82Est. Jul 2022
Dynavax Technologies
Dynavax TechnologiesCA - Emeryville
1 program
1
DV-601Phase 11 trial
Active Trials
NCT01023230Completed14Est. May 2011
Immunocore
ImmunocoreOXFORDSHIRE, United Kingdom
1 program
1
IMC-I109V Single Ascending DosePhase 11 trial
Active Trials
NCT05867056Withdrawn0Est. Dec 2024
Bristol Myers Squibb
2 programs
Systematic Review of Antiretroviral Treatments for Chronic Hepatitis B (CHB)N/A1 trial
follow-upN/A2 trials
Active Trials
NCT01155427Completed100Est. Apr 2010
NCT02974829Unknown4,000
NCT02839629Completed5,657Est. May 2021

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Gilead SciencesTenofovir Alafenamide
Gilead SciencesTenofovir Alafenamide
Gilead Sciencesantiviral prophylaxis with Tenofovir Alafenamide Fumarate
Gilead SciencesTenofovir Alafenamide
Gilead SciencesTenofovir Alafenamide
Novartistelbivudine
Alliance PharmaceuticalsEmtricitabine
Alliance PharmaceuticalsEmtricitabine
Alliance PharmaceuticalsEmtricitabine plus adefovir dipivoxil
Alliance PharmaceuticalsEmtricitabine
Alliance PharmaceuticalsEmtricitabine
Gilead SciencesTDF
Merck & Co.pegylated interferon alpha-2b
Novartistelbivudine
Rochepeginterferon alfa-2a [Pegasys]

Showing 15 of 48 trials with date data

Clinical Trials (50)

Total enrollment: 22,190 patients across 50 trials

NCT00409019Novartistelbivudine

Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

0
Phase 4Withdrawn
NCT00710216Novartistelbivudine

Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B

40 patients
Phase 4Withdrawn
NCT07476339Gilead SciencesTenofovir Alafenamide

REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE: A Multi-Center, Single-Arm, Open-Label, Phase 4 Study Assessing the Safety and Efficacy of B/F/TAF in HIV-Positive Adults Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks

Start: Mar 2026Est. completion: Oct 2026200 patients
Phase 4Not Yet Recruiting
NCT04551573Gilead SciencesTenofovir Alafenamide

A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects

Start: May 2021Est. completion: Nov 20210
Phase 4Withdrawn
NCT05177926Gilead Sciencesantiviral prophylaxis with Tenofovir Alafenamide Fumarate

Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)

Start: Apr 2021Est. completion: Dec 2023330 patients
Phase 4Unknown
NCT04538040Gilead SciencesTenofovir Alafenamide

Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

Start: Dec 2019Est. completion: Nov 202120 patients
Phase 4Completed
NCT03471624Gilead SciencesTenofovir Alafenamide

Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)

Start: May 2018Est. completion: Apr 2022270 patients
Phase 4Completed
NCT02826070Novartistelbivudine

EFFORT Further Extension Study

Start: Apr 2015Est. completion: Oct 2017130 patients
Phase 4Unknown
NCT02327715Alliance PharmaceuticalsEmtricitabine

Emtricitabine for Prevention of Vertical Transmission of HBV in Chinese Pregnant HBsAg Positive Patients

Start: Jan 2015Est. completion: Jul 2016200 patients
Phase 4Unknown
NCT02327676Alliance PharmaceuticalsEmtricitabine

Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

Start: Jan 2015Est. completion: Jul 2016200 patients
Phase 4Unknown
NCT02327689Alliance PharmaceuticalsEmtricitabine plus adefovir dipivoxil

Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

Start: Jan 2015Est. completion: Jul 2017400 patients
Phase 4Unknown
NCT02327702Alliance PharmaceuticalsEmtricitabine

Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

Start: Jan 2015Est. completion: Jul 2017200 patients
Phase 4Unknown
NCT02327663Alliance PharmaceuticalsEmtricitabine

Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

Start: Dec 2014Est. completion: Dec 20172,000 patients
Phase 4Unknown
NCT02081469Gilead SciencesTDF

Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy

Start: Mar 2014Est. completion: Aug 2019100 patients
Phase 4Completed
NCT01727271Merck & Co.pegylated interferon alpha-2b

A Study to Compare Efficacy and Safety of Tenofovir Used Alone or in Combination With Pegylated Interferon Alpha-2b in Participants With Chronic Hepatitis B and Elevated Alanine Aminotransferase (MK-4031-384)

Start: Aug 2013Est. completion: Aug 20170
Phase 4Withdrawn
NCT01799486Novartistelbivudine

Telbivudine Renoprotective Effect in Patients With the HBV-related Liver Cirrhosis: a Randomized Controlled Trial

Start: Feb 2013Est. completion: Mar 2015300 patients
Phase 4Unknown
NCT01585324Rochepeginterferon alfa-2a [Pegasys]

A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a)

Start: Jan 2012Est. completion: Jan 201430 patients
Phase 4Completed
NCT01529255Novartistelbivudine

EFFORT Extension Study

Start: Aug 2011Est. completion: Dec 2015576 patients
Phase 4Unknown
NCT01379508Novartistelbivudine

Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept

Start: Mar 2011Est. completion: Dec 2015241 patients
Phase 4Completed
NCT01086085RocheAdefovir

A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

Start: Apr 2010Est. completion: Mar 2013265 patients
Phase 4Completed
NCT01033448Rochepeginterferon alfa-2a [Pegasys]

A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

Start: Dec 2009Est. completion: Jun 201359 patients
Phase 4Completed
NCT00962533Novartistelbivudine

EFFicacy Optimization Research of Telbivudine Therapy

Start: Aug 2009Est. completion: Aug 2012606 patients
Phase 4Completed
NCT00927082Rochepeginterferon alfa-2a [Pegasys]

A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B

Start: Apr 2009Est. completion: Nov 2014383 patients
Phase 4Completed
NCT00862706Novartistelbivudine

Efficacy of Telbivudine in Blacks/African Americans and Hispanics/Latinos With Compensated Chronic Hepatitis B During 52 Weeks

Start: Apr 2009Est. completion: Apr 20110
Phase 4Withdrawn
NCT00940485Rochepeginterferon alfa-2a [Pegasys]

A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B

Start: Apr 2009Est. completion: Dec 2011200 patients
Phase 4Completed
NCT00877149Novartistelbivudine

Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B

Start: Mar 200980 patients
Phase 4Completed
NCT01429792Rochepeginterferon alfa-2a [Pegasys]

A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

Start: Sep 2008Est. completion: Jun 20131,013 patients
Phase 4Completed
NCT00781105Novartistelbivudine

Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

Start: Aug 2008Est. completion: Sep 20102,200 patients
Phase 4Completed
NCT00646503Novartistelbivudine

Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B

Start: Mar 2008Est. completion: Sep 2009150 patients
Phase 4Completed
NCT00651209Novartistelbivudine

A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB)

Start: Feb 2008105 patients
Phase 4Completed
NCT00606099Novartistelbivudine

Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

Start: Nov 20070
Phase 4Withdrawn
NCT00614471Rochepeginterferon alfa-2a [Pegasys]

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.

Start: Aug 2007Est. completion: Oct 2009219 patients
Phase 4Completed
NCT00537537Novartistelbivudine

To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)

Start: Aug 2007100 patients
Phase 4Completed
NCT00467545Novartistelbivudine

An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

Start: Apr 2007Est. completion: Sep 200944 patients
Phase 4Completed
NCT01519921Rochepeginterferon alfa-2a [Pegasys]

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.

Start: Oct 2005Est. completion: Jun 2008150 patients
Phase 4Completed
NCT00087607Rochepeginterferon alfa-2a [Pegasys]

Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).

Start: Jan 2004Est. completion: Apr 2006385 patients
Phase 4Completed
NCT00077636Rochepeginterferon alfa-2a [Pegasys]

ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.

Start: Dec 2003Est. completion: Mar 20061,469 patients
Phase 4Completed
NCT00475072Rochepeginterferon alfa-2a [Pegasys]

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.

Start: Jun 2003Est. completion: Jul 200614 patients
Phase 4Completed
NCT00087568Rochepeginterferon alfa-2a [Pegasys]

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin

Start: Jan 2003Est. completion: Mar 200657 patients
Phase 4Completed
NCT00940420Rochepeginterferon alfa-2a [Pegasys]

A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C

Start: Oct 2002Est. completion: Nov 20092,695 patients
Phase 4Completed
NCT04994509Gilead SciencesTenofovir Alafenamide

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

Start: Aug 2021Est. completion: Jan 20285,368 patients
Phase 3Active Not Recruiting
NCT03489239Gilead SciencesTenofovir Alafenamide

Entecavir to TAF Switch

Start: Nov 2017Est. completion: Sep 202027 patients
Phase 3Active Not Recruiting
NCT02607930Gilead SciencesTenofovir Alafenamide

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Start: Nov 2015Est. completion: Jul 2021631 patients
Phase 3Completed
NCT02058108Novartistelbivudine

Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection

Start: Oct 2014Est. completion: Jan 201953 patients
Phase 3Terminated
NCT01641926Merck & Co.PEG-Intron™

A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)

Start: Nov 2012Est. completion: Jan 2016402 patients
Phase 3Terminated
NCT01519960Rochepeginterferon alfa-2a [Pegasys]

A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Start: Jul 2012Est. completion: Oct 2021165 patients
Phase 3Completed
NCT00800787Biotest PharmaceuticalsNabi-HB

Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation

Start: Apr 2010Est. completion: Sep 2010
Phase 3Withdrawn
NCT01296971Rochepeginterferon alfa-2a [Pegasys]

A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)

Start: Dec 2009Est. completion: Dec 20090
Phase 3Withdrawn
NCT00805675Novartistelbivudine

Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB

Start: Nov 200883 patients
Phase 3Completed
NCT00640588Novartistelbivudine

Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine

Start: Mar 2008Est. completion: Dec 200930 patients
Phase 3Completed

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
19 companies competing in this space

Related Indications

HIV Infections(449)COVID-19(223)Hepatitis C(191)Influenza(173)HIV(138)HIV-1-infection(115)Hepatitis C, Chronic(94)Chronic Hepatitis B(93)Chronic Hepatitis C(91)Covid19(79)