Hepsera

(Adefovir)

ApprovedSmall molecule

Adefovir is used to treat chronic hepatitis B infection by slowing down the virus's ability to reproduce in the body and reduce liver damage.[2] Hepsera is currently approved and in use across 7 indications[4].[1]

Hepsera is one of 196 small molecule programs targeting HIV infection. It is currently in Approved.

Indications

Total Trials

Active Trials

195

Competitors

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionActive, not recruiting

Hepatitis B Virus InfectionActive, not recruiting

Chronic HepatitisActive, not recruiting

Chronic Hepatitis B Virus InfectionActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

Hepatitis BActive, not recruiting

CirrhosisActive, not recruiting

HIV InfectionPhase 2

Active, not recruiting

Hepatitis B Virus InfectionPhase 3

Active, not recruiting

Chronic HepatitisApproved

Active, not recruiting

Chronic Hepatitis B Virus InfectionPhase 3

Active, not recruiting

Hepatocellular CarcinomaPhase 2

Active, not recruiting

Hepatitis BPhase 2

Active, not recruiting

CirrhosisApproved

Active, not recruiting

Competition

Competitive Landscape

797 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Hepsera

Bristol-Myers Squibb

Approved

1 2

Cysteine Hydrochloride

Novartis

Preclinical

1 3

Ibrance

Pfizer

Preclinical

1 4

Viread

Gilead

Preclinical

1 5

Sovaldi

Gilead

Preclinical

1 6

Doptelet

AAkarx

Preclinical

1 7

Vermox

WWim Janssens

Preclinical

1 8

Opdivo

Bristol-Myers Squibb

Preclinical

2 9

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

PD-1 Inhibitors

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

Clinical

Trials by Indication[1]

Chronic Hepatitis12 trials

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

Completed· Roche logo

Roche·Phase 4·NCT01086085·265 enrolled

Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B

Unknown status· Jiangsu Hansoh Pharmaceutical Co., Ltd. logo

Jiangsu Hansoh Pharmaceutical Co., Ltd.·Phase 3·NCT02366247·463 enrolled

Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus

Terminated·PPharmasset·Phase 3·NCT00496002

Show 9 more trials

Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00065507·195 enrolled

Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00410202·629 enrolled

Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B

Completed· Jiangsu Hansoh Pharmaceutical Co., Ltd. logo

Jiangsu Hansoh Pharmaceutical Co., Ltd.·Phase 2·NCT02366208·116 enrolled

Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B

Unknown status·—·Phase 4·NCT02482272·90 enrolled

Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus

Terminated·PPharmasset·Phase 3·NCT00496158

Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00096785·69 enrolled

Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients

Terminated·IInje University·Phase 4·NCT00798460·30 enrolled

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

Completed· Roche logo

Roche·Phase 4·NCT00922207·280 enrolled

Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir

Completed·—·Phase 4·NCT01023217·90 enrolled

Hepatitis B2 trials

Adefovir Dipivoxil to Treat Hepatitis B in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00013702·30 enrolled

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

Completed· Novartis logo

Novartis·Phase 3·NCT00640588·30 enrolled

Interaction1 trial

Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide

Completed·AAkebia Therapeutics·Phase 1·NCT03801759·62 enrolled

Drug Transporter1 trial

Drug Transporter Interaction Study PHENTRA_2015_KPUK

Completed·UUniversity of Cologne·Phase 4·NCT02743260·24 enrolled

Drug1 trial

Drug Use Investigation for HEPSERA (Adefovir) Tablet

Completed· GSK logo

GSK··NCT01863589·436 enrolled

9 more indications

Safety and Efficacy1 trial

Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine

Completed·GGenexine, Inc.·Phase 1·NCT00513968·27 enrolled

Combination Therapy1 trial

Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

Withdrawn· Novartis logo

Novartis·Phase 4·NCT00409019

LAM1 trial

Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00986778

Hepatocellular Carcinoma1 trial

TACE and Adefovir Compared With Transarterial Chemoembolization (TACE) Alone for Hepatitis B Virus (HBV)-Related Unresectable Hepatocellular Carcinoma (HCC)

Unknown status·TTongji University·Phase 2·NCT00960518·216 enrolled

Tolerance1 trial

A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

Completed· Gilead logo

Gilead·Phase 1·NCT00002115·20 enrolled

Efficacy and Safety1 trial

An Study of Efficacy and Safety of Clevudine

Completed· Eisai logo

Eisai·Phase 3·NCT01192854·288 enrolled

Cirrhosis1 trial

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

Unknown status·LLin Bingliang·Phase 4·NCT01799486·300 enrolled

Effectiveness1 trial

The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients

Completed· Gilead logo

Gilead·Phase 1·NCT00002326·20 enrolled

Unspecified1 trial

An Exploratory Study of RGT Strategy on Optimal NUC-experienced Patients

Unknown status·RRuijin Hospital·Phase 4·NCT02560649·324 enrolled

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Adefovir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Hepsera drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Adefovir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Adefovir. EMBL-EBI & Wellcome Sanger Institute.
[5]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA Polymerase/reverse Transcriptase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bristol-Myers Squibb

Hepsera

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Chronic Hepatitis12 trials

Hepatitis B2 trials

Interaction1 trial

Drug Transporter1 trial

Drug1 trial

Safety and Efficacy1 trial

Combination Therapy1 trial

LAM1 trial

Hepatocellular Carcinoma1 trial

Tolerance1 trial

Efficacy and Safety1 trial

Cirrhosis1 trial

Effectiveness1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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