Tyzeka

(Telbivudine)

ApprovedSmall molecule

Telbivudine is used to treat chronic hepatitis B infection by helping to slow down the virus's ability to reproduce and damage the liver.[2] Tyzeka is currently approved and in use across 8 indications[4].[1]

Tyzeka is one of 217 small molecule programs targeting Cirrhosis of Liver. It is currently in Approved.

Indications

Total Trials

Active Trials

216

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Cirrhosis of LiverApproved

Viral DiseaseActive, not recruiting

Hepatitis B Virus InfectionActive, not recruiting

HepatitisApproved

Kidney TransplantActive, not recruiting

ProteinuriaActive, not recruiting

Hepatocellular CarcinomaUnknown status

CirrhosisUnknown status

Cirrhosis of LiverApproved

Approved

Viral DiseaseApproved

Active, not recruiting

Hepatitis B Virus InfectionApproved

Active, not recruiting

HepatitisApproved

Approved

Kidney TransplantApproved

Active, not recruiting

ProteinuriaPreclinical

Active, not recruiting

Hepatocellular CarcinomaApproved

Unknown status

CirrhosisApproved

Unknown status

Competition

Competitive Landscape

251 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Tyzeka

Novartis

Approved

1 2

Ibrance

Pfizer

Preclinical

1 3

Viread

Gilead

Preclinical

1 4

Sovaldi

Gilead

Preclinical

1 5

Hepsera

Coreg

2 7

Doptelet

AAkarx

Preclinical

1 8

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Preclinical

1 9

Vermox

WWim Janssens

Preclinical

1 10

Statin

Bristol-Myers Squibb

Preclinical

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

Clinical

Trials by Indication[1]

Chronic Hepatitis26 trials

Renoprotective Effects of Telbivudine in Chronic Hepatitis B

Completed·TThe University of Hong Kong·Phase 4·NCT03778567·31 enrolled

An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 4·NCT00467545·44 enrolled

Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection

Completed·CCz Li·N/A·NCT01480492·56 enrolled

Show 23 more trials

A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 3·NCT00057265

To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)

Completed· Novartis logo

Novartis·Phase 4·NCT00537537·100 enrolled

Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 3·NCT00131742

Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine

Terminated·UUniversity Hospital, Basel, Switzerland·Phase 4·NCT01005238·27 enrolled

Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 3·NCT00132652·240 enrolled

Study of Telbivudine in Chronic Hepatitis B

Completed·—··NCT00970216·160 enrolled

Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 2·NCT00128544·130 enrolled

Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 4·NCT00646503·150 enrolled

Telbivudine Versus Entecavir in Reducing Serum HBsAg Levels in Patients With HBeAg-positive Chronic Hepatitis B

Completed·—·Phase 3·NCT01595685·98 enrolled

Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept

Completed· Novartis logo

Novartis·Phase 4·NCT01379508·241 enrolled

An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 2·NCT00124241

Effects of Telbivudine and Tenofovir Disproxil Fumarate on the Kinetics of Hepatitis B Virus DNA in Chronic Hepatitis B (CHB)

Completed·TThe University of Hong Kong·Phase 2·NCT00804622·15 enrolled

Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

Completed· Novartis logo

Novartis·Phase 3·NCT00076336·232 enrolled

Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 4·NCT00781105·2,200 enrolled

Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B

Unknown status·SSeng Gee Lim·Phase 4·NCT02774837·146 enrolled

Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients

Withdrawn·IInstitute of Liver and Biliary Sciences, India·N/A·NCT01260610

Lamivudine Plus Adefovir Versus Telbivudine Plus Adefovir in Lamivudine Resistant Chronic Hepatitis B

Unknown status·YYonsei University·Phase 3·NCT01270165·110 enrolled

Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B

Withdrawn·UUniversity of Ulm·Phase 4·NCT00710216·40 enrolled

Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

Withdrawn· Novartis logo

Novartis·Phase 4·NCT00606099

Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 3·NCT00115245

Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)

Terminated· Novartis logo

Novartis·Phase 3·NCT00412750·159 enrolled

Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)

Unknown status·—·Phase 4·NCT01380951·120 enrolled

Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 3·NCT00412529·44 enrolled

Hepatitis B6 trials

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

Completed· Novartis logo

Novartis·Phase 3·NCT00640588·30 enrolled

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

Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B

Completed·—·Phase 4·NCT01743079·700 enrolled

Show 3 more trials

Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB

Completed· Novartis logo

Novartis·Phase 3·NCT00805675·83 enrolled

Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

Completed·HHua Zhang·Phase 4·NCT01788371·700 enrolled

Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00051090

Pregnancy2 trials

Efficacy of Antiviral Therapy in Pregnancy in Preventing Vertical Transmission of HBV in Mothers With a High Viral Load

Unknown status·—··NCT02253485·600 enrolled

The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children

Unknown status·—··NCT02301650·400 enrolled

Combination Therapy2 trials

Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

Withdrawn· Novartis logo

Novartis·Phase 4·NCT00409019

Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

Terminated· Novartis logo

Novartis·Phase 3·NCT00376259·43 enrolled

Pregnant Women2 trials

The Safety of Anti-viral Therapy in Preventing HBV MTCT in Pregnant Women After Discontinuation

Completed·TThird Affiliated Hospital, Sun Yat-Sen University·Phase 4·NCT03468907·111 enrolled

Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV

Completed·YYi-Hua Zhou·Phase 4·NCT01637844·335 enrolled

12 more indications

Tenofovir1 trial

Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir

Unknown status·PPusan National University Yangsan Hospital·Phase 4·NCT01588912·104 enrolled

Efficacy1 trial

EFFicacy Optimization Research of Telbivudine Therapy

Completed·NNanfang Hospital, Southern Medical University·Phase 4·NCT00962533·606 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

Chronic HBV Infection1 trial

Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection

Unknown status·SSun Yat-sen University·Phase 4·NCT00810524·600 enrolled

Function1 trial

Replacement of Lamivudine by Telbivudine to Improve Renal Function

Completed·—·Phase 2/3·NCT02447705·120 enrolled

Kidney Transplant1 trial

Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment.

Terminated·NNational Taiwan University Hospital·Phase 4·NCT02894554·19 enrolled

Hepatocellular Carcinoma1 trial

Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy

Unknown status·FFudan University·Phase 4·NCT01102335·80 enrolled

Chronic Hepatitis B Virus Infection1 trial

Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection

Terminated· Novartis logo

Novartis·Phase 3·NCT02058108·53 enrolled

Adult1 trial

Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies

Completed· Novartis logo

Novartis·Phase 3·NCT00142298·1,869 enrolled

Efficacy and Safety1 trial

Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

Unknown status·SSoutheast University, China·Phase 4·NCT00939068·180 enrolled

Proteinuria1 trial

Effect of Telbivudine on Renal Function and Proteinuria in Patients With CHB & Chronic Renal Diseases

Withdrawn·—·N/A·NCT02049736

Unspecified2 trials

EFFORT Further Extension Study

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT02826070·130 enrolled

EFFORT Extension Study

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT01529255·576 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 25, 2006

TYZEKA

NDA NDA022011

Apr 28, 2009

TYZEKA

NDA NDA022154

Sources

References

[1]
ClinicalTrials.gov — 51 trial records for Telbivudine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tyzeka drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Telbivudine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Telbivudine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022154). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis 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: Novartis

Tyzeka

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Chronic Hepatitis26 trials

Hepatitis B6 trials

Pregnancy2 trials

Combination Therapy2 trials

Pregnant Women2 trials

Tenofovir1 trial

Efficacy1 trial

Cirrhosis1 trial

Chronic HBV Infection1 trial

Function1 trial

Kidney Transplant1 trial

Hepatocellular Carcinoma1 trial

Chronic Hepatitis B Virus Infection1 trial

Adult1 trial

Efficacy and Safety1 trial

Proteinuria1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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