HEPCLUDEX

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

CirrhosisHepatitis BPortal HypertensionViral HepatitisHDV InfectionChronic Hepatitis D

75 competitors in Cirrhosis

#DrugCompanyPhaseTrials

1

Aldactone

Pfizer

Approved

12

Cymbalta

Jazz Pharmaceuticals

Approved

13

Xifaxan

SSalix

Approved

64

Chronulac

SSolvay Pharmaceuticals

Approved

45

Jardiance

Boehringer Ingelheim

Approved

26

Esmeron

FFresenius Kabi USA, LLC

Approved

17

Amoxil

GGlobal Antibiotics Research and Development Partnership

Approved

18

Bridion

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

19

HEPCLUDEX

Gilead

Phase 3

110

Bumex

VValidus Pharmaceuticals

Phase 3

1Show 40 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Chronic Hepatitis6 trials

Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy

Completed·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico··NCT05962307·50 enrolled

Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients

Recruiting·KKarolinska University Hospital··NCT06051045·400 enrolled

HEllenic Multicenter ReAl-life CLInical Study for Bulevirtide Therapy in Chronic Hepatitis D: HERACLIS-BLV

Unknown status·UUniversity of Athens··NCT05928000·80 enrolled

Show 3 more trials

Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)

Completed·Gilead·Phase 3·NCT03852719·150 enrolled

Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)

Completed·Gilead·Phase 2·NCT03852433·175 enrolled

Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)

Recruiting·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico··NCT06122285·100 enrolled

HDV Infection2 trials

A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection

Active, not recruiting·VVir Biotechnology, Inc.·Phase 2·NCT07142811·100 enrolled

Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment

Recruiting·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico··NCT06504485·192 enrolled

Cirrhosis1 trial

Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis

Recruiting·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico··NCT06397859·266 enrolled

Portal Hypertension1 trial

Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)

Active, not recruiting·HHannover Medical School··NCT04863703·11 enrolled

Hepatitis B1 trial

Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D

Recruiting·—··NCT07491848·25 enrolled

6 more indications

Impaired Renal Function1 trial

A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function

Completed·Gilead·Phase 1·NCT05760300·41 enrolled

ESS1 trial

Expanded Access for Bulevirtide

Available·Gilead··NCT06780579

Function1 trial

Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function

Completed·Gilead·Phase 1·NCT05765344·74 enrolled

Chronic Hepatitis D Infection1 trial

A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection

Terminated·Gilead··NCT05718700·170 enrolled

Chronic Hepatitis D1 trial

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

Viral Hepatitis1 trial

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)

Active, not recruiting·VVir Biotechnology, Inc.·Phase 3·NCT07128550·150 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

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