Hepsera
(Adefovir Dipivoxil)ApprovedSmall molecule
GileadAdefovir dipivoxil is used to treat chronic hepatitis B infection by helping to slow down the virus and reduce liver damage.[2] Hepsera is currently approved and in use across 9 indications[4].[1]
Hepsera is one of 258 small molecule programs targeting HIV infection. It is currently in Approved.
9
Indications
48
Total Trials
0
Active Trials
257
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
797 competitors in Hepatocellular Carcinoma
#DrugCompanyPhaseTrials
1Hepsera
GileadApproved
Ibrance
PfizerPreclinical
Viread
GileadPreclinical
Sovaldi
GileadPreclinical
Doptelet
AAkarx
Preclinical
Miraclid
TTechpool Bio-Pharma Co., Ltd.
Preclinical
Vermox
WWim Janssens
Preclinical
Apatinib
LLaNova Medicines Zhejiang Co., Ltd.
Preclinical
Opdivo
Bristol-Myers SquibbPreclinical
PD-1 Inhibitor
Johnson & JohnsonPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Clinical
Trials by Indication[1]
Chronic Hepatitis18 trials
Lamivudine and Adefovir to Treat Chronic Hepatitis B Infection in People With and Without HIV Infection
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00023153·100 enrolled
Show 15 more trials
Effectiveness10 trials
Show 7 more trials
The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001082·505 enrolled
The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000843·24 enrolled
Drug3 trials
A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000912·475 enrolled
A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000892·300 enrolled
Hepatitis B2 trials
Safety and Efficacy2 trials
12 more indications
Chemotherapy1 trial
Liver Transplant1 trial
Treatment1 trial
HIV1 trial
Tolerance1 trial
Chronic HBV Infection1 trial
Efficacy and Safety1 trial
Adolescent1 trial
Unspecified2 trials
Regulatory
FDA Approval Timeline[5]
Sep 20, 2002
HEPSERA
NDA NDA021449
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Hepsera drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Adefovir Dipivoxil. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]