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Infectious Disease/Chronic Hepatitis

Infectious Disease

Chronic Hepatitis

83

Pipeline Programs↗

100

Active Trials↗

93

Companies Involved↗

Chronic Hepatitis is a moderately active landscape with 83 programs across 93 companies. The most active players are Gilead, GSK, Fujian Akeylink Biotechnology Co., Ltd.. 18 programs are in Phase 3.

Intelligence

Pipeline Metrics

Competitive Density

73/100

Pipeline Velocity

59/100

Mech. Concentration

40/100

Completion Rate

84/100

Attrition Rate

12/100

Competition

Competitive Landscape

Bubble size = clinical trials

Approved

Phase 3

Phase 2

Phase 1

Preclinical

Key Players

Top Companies

Gilead

3 programs

GSK

2 programs

Fujian Akeylink Biotechnology Co., Ltd.

2 programs

Brii Biosciences Limited

2 programs

Barinthus Biotherapeutics

2 programs

Haisco Pharmaceutical Group Co., Ltd.

1 program

Pipeline

Programs by Phase

Preclinical34

Methylprednisolone

Pfizer

Galactose

Northwell Health

Direct Acting Antivirals

Post Graduate Institute of Medical Education and Research, Chandigarh

Ribavarin

Merck & Co.

Interferon

Sanofi

Phase 18

Hepb Mab19

Rockefeller University

Liocyx-M

Lion TCR Pte. Ltd.

TCR-T

Lion TCR Pte. Ltd.

EPI-003

Epigenic Therapeutics, Inc

Wgc0201

Jiyan Liu

Phase 223

BRII-179

Brii Biosciences Limited

Selgantolimod

Gilead

BRII-835

Brii Biosciences Limited

Nivolumab

Bristol-Myers Squibb

VIR-3434

Vir Biotechnology, Inc.

Phase 318

Peginterferon Alfa-2b

Merck & Co.

Hydronidone

Beijing Continent Pharmaceutical Co, Ltd.

PEG-IFNα

Gilead

Azvudine

Henan Genuine Biotech Co., Ltd.

Bepirovirsen

GSK

Approved

No programs

Analysis

Modality Breakdown

89%

Small molecule

63 of 71 classified programs — the dominant modality here.

Small molecule leads; the ring shows all 71 classified programs, each share of the total. Modality classified for 96% of 83 pipeline programs.

Analysis

Trial Status

1,060

clinical trials

Completed671 · 63%

Unknown status154 · 15%

Terminated96 · 9%

Recruiting44 · 4%

Active, not recruiting34 · 3%

Withdrawn33 · 3%

Other28 · 3%

Clinical Trials

Trial Activity

1060 trials

A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

Recruiting·MMirum Pharmaceuticals, Inc.·Preclinical·NCT07454837·120 enrolled

A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)

Recruiting·TThe Second Affiliated Hospital of Chongqing Medical University·Phase 2·NCT05769816·120 enrolled

A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (B)

Recruiting·TThe Second Affiliated Hospital of Chongqing Medical University·Phase 2·NCT05771402·120 enrolled

ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection

Recruiting·TThe Second Affiliated Hospital of Chongqing Medical University·Approved·NCT07573943·120 enrolled

Safety and Efficacy of Tenofovir Alafenamide to Prevent Mother-to-child Transmission of Hepatitis B Virus in Middle/Late Pregnancies With High Hepatitis B Virus DNA Load: A Prospective Multicenter Cohort Study

Recruiting·—·N/A·NCT05466071·200 enrolled

Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta

Recruiting· Gilead logo

Gilead·Preclinical·NCT07096193·200 enrolled

A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

Recruiting·MMirum Pharmaceuticals, Inc.·Phase 3·NCT07200908·172 enrolled

A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Assess Efficacy and Safety of Libevitug Injection in Participants With Chronic Hepatitis Delta Virus Infection (D-clear Study)

Recruiting·HHuahui Health·Phase 3·NCT07499544·160 enrolled

Prospective, Open-label, Multicenter Long-term Follow-up Study to Evaluate the Durability of Virologic Response in Participants With Chronic Hepatitis B Previously Treated With AHB-137 Injection

Recruiting·AAusper Biopharma Co., Ltd.·N/A·NCT07146100·200 enrolled

A Pilot Study of the Combination of VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B

Recruiting·National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT06092333·50 enrolled

An Open-Label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Low-HBsAg Chronic Hepatitis B

Recruiting·AAusper Biopharma Co., Ltd.·Phase 2·NCT07137910·200 enrolled

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy of Single and Multiple Ascending Doses of IB-001 in Healthy Participants and Participants With Chronic Hepatitis B

Recruiting·IIntegerBio·Phase 1·NCT07389044·80 enrolled

Disease Progression and Clinical Outcomes in Chronic Hepatitis B (CHB) Patients With Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)

Recruiting·HHumanity and Health Research Centre·N/A·NCT02863757·1,500 enrolled

A Randomized, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Combination With Hepatitis B Vaccine or Pegylated Interferon α-2b (Peg-IFN) in Participants With HBeAg-Negative Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogue (NAs)

Recruiting·AAusper Biopharma Co., Ltd.·Phase 2·NCT07069569·200 enrolled

A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function.

Recruiting·AAusper Biopharma Co., Ltd.·Phase 1·NCT07600788·32 enrolled

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Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)