Baraclude
(Entecavir)ApprovedSmall molecule
Entecavir is used to treat chronic hepatitis B infection by slowing down the virus's ability to reproduce and damage the liver.[2] Baraclude is currently approved and in use across 27 indications[4].[1]
Baraclude is one of 643 small molecule programs targeting Non-Hodgkins Lymphoma. It is currently in Approved.
27
Indications
163
Total Trials
14
Active Trials
642
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 26 indications
Competition
Competitive Landscape
1774 competitors in Lymphoma
#DrugCompanyPhaseTrials
1Baraclude
KKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Approved
Blenoxane
SSequus Pharmaceuticals
Preclinical
Oncaspar
SServier
Preclinical
Zofran
NovartisPreclinical
Norvir
AbbViePreclinical
Wellcovorin
GGlaxo Dba Glaxosmithkline
Preclinical
Tafasitamab
IncytePreclinical
Emend
CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Preclinical
Solu-Medrol
MMassachusetts Eye and Ear Infirmary
Preclinical
Systemic Therapy
Bristol-Myers SquibbPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Chronic Hepatitis80 trials
Show 77 more trials
Clinical and Basic Research of ETV Plus GM-CSF in Chronic Hepatitis B Patients
Terminated·—·N/A·NCT03164889·80 enrolled
Tenofovir vs. Tenofovir Plus Entecavir in Entecavir-Resistant Chronic Hepatitis B
Completed·—·Phase 4·NCT01639092·88 enrolled
Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir
Completed·—·Phase 4·NCT01023217·90 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
Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients With Chronic Hepatitis B
Unknown status·—·Phase 4·NCT01906580·105 enrolled
Telbivudine Versus Entecavir in Reducing Serum HBsAg Levels in Patients With HBeAg-positive Chronic Hepatitis B
Completed·—·Phase 3·NCT01595685·98 enrolled
Tenofovir Plus Entecavir vs. Tenofovir in Adefovir-Resistant Chronic Hepatitis B
Completed·—·Phase 4·NCT01639066·102 enrolled
Antiviral Efficacy of the Combination Treatment With Poly IC and Entecavir for Chronic Hepatitis B
Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 4·NCT02532413·180 enrolled
Simvastatin for the Treatment of Chronic Hepatitis B
Completed·—·Phase 1·NCT00994773·32 enrolled
A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B
Active, not recruiting·
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1/2·NCT06150014·88 enrolled
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1/2·NCT06150014·88 enrolled
Hepatitis B15 trials
Show 12 more trials
A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in CHB
Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·Phase 1/2·NCT02615639·450 enrolled
Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)
Unknown status·—··NCT03680183·300 enrolled
Treatment7 trials
Show 4 more trials
Efficacies of Entecavir Add on HBeAg Negative Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment
Unknown status·—·Phase 4·NCT02365402·180 enrolled
Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment
Unknown status·—·Phase 4·NCT02368288·200 enrolled
Chronic Hepatitis B Virus Infection5 trials
Cirrhosis5 trials
Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
Completed·—·Phase 4·NCT01943617·606 enrolled
Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients
Unknown status·—·Phase 4·NCT02849132·800 enrolled
Show 2 more trials
Optimized Treatment and Regression of HBV-induced Early Cirrhosis
Completed·—·Phase 4·NCT01938820·82 enrolled
Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis
Unknown status·—··NCT01720238·621 enrolled
39 more indications
Itching3 trials
Hepatocellular Carcinoma3 trials
Arabinoxylan Rice Bran (MGN-3/Biobran) for the Treatment of Hepatocellular Carcinoma and Hepatitis B and C Infection
Completed·—·N/A·NCT01018381·130 enrolled
HBV2 trials
Tenofovir2 trials
Fibrosis2 trials
Optimized Treatment and Regression of HBV-induced Liver Fibrosis
Completed·—·Phase 4·NCT01938781·400 enrolled
Liver Disease2 trials
Tenofovir Disoproxil Fumarate2 trials
Acute-on-Chronic Liver Failure2 trials
Colorectal Cancer1 trial
Prophylaxis1 trial
Tics1 trial
Liver Cancer1 trial
Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer
Completed·—·N/A·NCT00824707·200 enrolled
Hepatitis B Virus Infection1 trial
Chronic Kidney Disease1 trial
Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir
Active, not recruiting·—··NCT05423834·1,800 enrolled
Gastric Cancer1 trial
Chronic1 trial
Liver Transplant1 trial
Efficacy1 trial
Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy
Completed·—·Phase 4·NCT02505009·116 enrolled
Safety and Efficacy1 trial
Arthritis1 trial
Clinical Trial1 trial
Phase 11 trial
Intestinal Cancer1 trial
Prognosis1 trial
Combination Therapy1 trial
Portal Hypertension1 trial
Chemotherapy1 trial
Maintenance Treatment1 trial
Hepatitis1 trial
Efficacy and Safety1 trial
ACL1 trial
Hepatic fibrosis1 trial
Regulatory
FDA Approval Timeline[5]
Mar 29, 2005
BARACLUDE
NDA NDA021798
Mar 29, 2005
BARACLUDE
NDA NDA021797
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Baraclude drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Entecavir. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details