HEPCLUDEX

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

CirrhosisHepatitis BPortal HypertensionViral HepatitisHDV InfectionChronic Hepatitis D

74 competitors in Cirrhosis

#DrugCompanyPhaseTrials

1

Sovaldi

Gilead

Approved

52

Cymbalta

Jazz Pharmaceuticals

Approved

13

Aldactone

Pfizer

Approved

14

Vemlidy

Gilead

Approved

15

Emtriva

Gilead

Approved

16

Inderal

WWyeth-Lederle Vaccines

Approved

47

Esmeron

FFresenius Kabi USA, LLC

Approved

18

Vancocin

HHikma Pharmaceuticals LLC

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

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

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

Recruiting·KKarolinska University Hospital··NCT06051045·400 enrolled

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

Completed·Gilead·Phase 3·NCT03852719·150 enrolled

Show 3 more trials

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

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

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

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

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

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

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

ESS1 trial

Expanded Access for Bulevirtide

Available·Gilead··NCT06780579

6 more indications

Hepatitis B1 trial

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

Recruiting·—··NCT07491848·25 enrolled

Function1 trial

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

Completed·Gilead·Phase 1·NCT05765344·74 enrolled

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

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

Chronic Hepatitis D Infection1 trial

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

Terminated·Gilead··NCT05718700·170 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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