TMC435

Phase 3Small molecule

Johnson & Johnson

TMC435 is one of 125 small molecule programs targeting Hepatitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

124

Competitors

Pipeline

Status by Indication[3][1]

Indication

HepatitisActive, not recruiting

Chronic HepatitisActive, not recruiting

Hepatitis CActive, not recruiting

Hepatitis C Virus InfectionActive, not recruiting

HepatitisPhase 2

Active, not recruiting

Chronic HepatitisPhase 3

Active, not recruiting

Hepatitis CPhase 3

Active, not recruiting

Hepatitis C Virus InfectionPhase 2

Active, not recruiting

Competition

Competitive Landscape

624 competitors in Chronic Hepatitis

#DrugCompanyPhaseTrials

TMC435

Johnson & Johnson

Phase 3

4 2

PEG-Intron

Merck & Co.

Preclinical

43 3

Sovaldi

Gilead

Preclinical

34 4

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

199 5

Incivek

Vertex Pharmaceuticals

Preclinical

10 6

Intron a

Sanofi

Preclinical

7 7

Roferon-a

Roche

Preclinical

3 8

Medrol

Pfizer

Preclinical

1 9

Dasabuvir

AbbVie

Preclinical

7 10

SOF/VEL

Gilead

Preclinical

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

Clinical

Trials by Indication[1]

Hepatitis C14 trials

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01289782·395 enrolled

TMC647055HPC1001 - First-in-human Trial to Examine Safety, Tolerability and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses and of Increasing Repeated Oral Doses of TMC647055 in Healthy Volunteers and in Hepatitis C Virus Infected Patients

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01202825·72 enrolled

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01290679·393 enrolled

Show 11 more trials

An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01281839·394 enrolled

A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01323244·142 enrolled

A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 2·NCT00882908·386 enrolled

A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01288209·106 enrolled

A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01292239·183 enrolled

An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01725529·457 enrolled

A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 2·NCT00980330·463 enrolled

A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genotype 1 Hepatitis C Virus

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01724086·90 enrolled

A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01290731·49 enrolled

A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 2·NCT00812331·37 enrolled

A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01366638·79 enrolled

Interaction5 trials

TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01205139·48 enrolled

TMC435-TiDP16-C108 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Digoxin and Between TMC435 and Rosuvastatin

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01288742·33 enrolled

TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01323257·49 enrolled

Show 2 more trials

TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01241773·48 enrolled

A Study to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT00915564·13 enrolled

Chronic Hepatitis4 trials

A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01479868·109 enrolled

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01485991·771 enrolled

A Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01567735·107 enrolled

Show 1 more trial

A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01466790·168 enrolled

Tics3 trials

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With Ritonavir (Part 1) and the Co-administration of TMC435, TMC647055 and Ritonavir (Part 2) in Healthy Japanese Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02064842·24 enrolled

TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese Volunteers

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01224197·32 enrolled

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants.

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02018536·48 enrolled

MPA1 trial

TMC435-TiDP16-C121: A Study Comparing 2 Tablet Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Effect of Food on Blood Levels of TMC435

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01022125·28 enrolled

17 more indications

HCV Infection1 trial

A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01846832·232 enrolled

Hepatitis1 trial

A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00996476·92 enrolled

Antidepressants1 trial

TMC435-TiDP16-C112 - Interaction Trial With Antidepressants

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01090700·20 enrolled

Renal Impairment1 trial

TMC435-TiDP16-C126 - Trial to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics and Safety of TMC435

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01381835·16 enrolled

Tacrolimus1 trial

A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01479881·29 enrolled

Drug1 trial

TMC435-TiDP16-C107: This Study Measures the (Possible) Influence of TMC435 on the Activity of a Selected Set of Drug-degrading Proteins by Measuring the Blood Levels of Drugs That Have Been Taken Together With TMC435 and That Are Known to be Specifically Degraded by These Drug-degrading Proteins.

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT00866853·16 enrolled

Hepatic Impairment1 trial

TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01046058·23 enrolled

Atorvastatin1 trial

A Pharmacokinetic Interaction Study Between TMC435, Atorvastatin and Simvastatin in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01689623·36 enrolled

Female1 trial

A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01486004·18 enrolled

ART1 trial

A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01799603·24 enrolled

Hepatitis C Virus Infection1 trial

A Study of TMC435350 Administered With or Without Standard of Care Therapy in Participants With Genotype 1 Hepatitis C Virus Infection

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 2·NCT00561353·121 enrolled

ARDS1 trial

TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01124799·49 enrolled

Heart1 trial

TMC435-TiDP16-C117: The Effect of TMC435 on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01269294·60 enrolled

Single Dose1 trial

TMC435-TiDP16-C119 - A Study Comparing 2 New Capsule Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Respective Blood Levels of TMC435 Following Single Dose Administration

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01134718·24 enrolled

Oral1 trial

A Study to Examine the Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of TMC435 in Healthy Chinese Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02071355·32 enrolled

ESS1 trial

A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01571570·72 enrolled

Unspecified1 trial

TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01308606·48 enrolled

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for TMC435. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — TMC435 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for TMC435. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Johnson & Johnson

TMC435

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Hepatitis C14 trials

Interaction5 trials

Chronic Hepatitis4 trials

Tics3 trials

MPA1 trial

HCV Infection1 trial

Hepatitis1 trial

Antidepressants1 trial

Renal Impairment1 trial

Tacrolimus1 trial

Drug1 trial

Hepatic Impairment1 trial

Atorvastatin1 trial

Female1 trial

ART1 trial

Hepatitis C Virus Infection1 trial

ARDS1 trial

Heart1 trial

Single Dose1 trial

Oral1 trial

ESS1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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