HEPCLUDEX

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Chronic HepatitisHepatitis BCirrhosisPortal HypertensionViral HepatitisChronic Hepatitis D

624 competitors in Chronic Hepatitis

#DrugCompanyPhaseTrials

1

HEPCLUDEX

Gilead

Phase 3

72

PEG-Intron

Merck & Co.

Preclinical

433

Sovaldi

Gilead

Preclinical

344

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

1995

Intron a

Sanofi

Preclinical

76

Roferon-a

Roche

Preclinical

37

Medrol

Pfizer

Preclinical

18

Dasabuvir

AbbVie

Preclinical

79

SOF/VEL

Gilead

Preclinical

410

Pegintron

Merck & Co.

Preclinical

15Show 18 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Chronic Hepatitis7 trials

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

Completed·Gilead·Phase 3·NCT03852719·150 enrolled

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

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

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

Recruiting·KKarolinska University Hospital··NCT06051045·400 enrolled

Show 4 more 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 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

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Active, not recruiting·Gilead··NCT05718700·170 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

ESS1 trial

Expanded Access for Bulevirtide

Available·Gilead··NCT06780579

5 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

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

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

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

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

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