Olysio

(Simeprevir)

ApprovedSmall molecule

Olysio is a small molecule that works as a Hepatitis C Virus Serine Protease, NS3/NS4A Inhibitor.[2] It is being used across 3 indications, with its most advanced program in Approved.[1]

Olysio is one of 120 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

119

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Viral DiseaseActive, not recruiting

Chronic Kidney DiseaseApproved

Hepatitis CCompleted

Viral DiseaseApproved

Active, not recruiting

Chronic Kidney DiseaseApproved

Approved

Hepatitis CApproved

Completed

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Olysio

WWim Janssens

Approved

34 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Activase

Flomax

Januvia

ZZydus Therapeutics Inc.

Preclinical

1 10

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

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

Clinical

Trials by Indication[1]

Chronic Hepatitis12 trials

A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01938625·35 enrolled

A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02993250·33 enrolled

Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02349048·68 enrolled

Show 9 more trials

An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02397395

A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02421211·41 enrolled

Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1

Withdrawn·SStanford University·Phase 4·NCT02485080

Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01628692·230 enrolled

Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02765490·365 enrolled

An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

Terminated· Roche logo

Roche··NCT02118597·19 enrolled

Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01852604·143 enrolled

A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02268864·106 enrolled

An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02262728·40 enrolled

Interaction5 trials

Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02824315·22 enrolled

A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02945020·15 enrolled

Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers

Completed·UUniversity of Colorado, Denver·N/A·NCT02404805·25 enrolled

Show 2 more trials

Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01813513·42 enrolled

Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01907724·34 enrolled

Hepatitis C Virus Infection3 trials

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02250807·40 enrolled

Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection

Completed·—·Phase 2·NCT02253550·30 enrolled

An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02278419·63 enrolled

Chronic Hepatitis C Virus Infection2 trials

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02114151·103 enrolled

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02114177·310 enrolled

Tics2 trials

Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03059303·72 enrolled

A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers

Completed·AAlios Biopharma Inc.·Phase 1·NCT02512562·32 enrolled

9 more indications

Hepatitis C2 trials

Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection

Completed·TTanta University·Phase 4·NCT02992457·10,000 enrolled

The SIM-SOF Trial for Hepatitis C

Completed·CCenter For Hepatitis C, Atlanta, GA·Phase 4·NCT02168361·93 enrolled

Age1 trial

Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

Completed·—·N/A·NCT03549832·40 enrolled

Intravenous1 trial

A Study to Assess the Absolute Bioavailability and Pharmacokinetics of Simeprevir (TMC435) Administered as Single Oral Doses of TMC435 and an Intravenous Microdose of [3H]-TMC435 in Healthy Male Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01707342·6 enrolled

Efficacy1 trial

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir

Completed·AAlios Biopharma Inc.·Phase 2·NCT02569710·161 enrolled

Female1 trial

To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02885454·24 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

Completed·VValme University Hospital··NCT02333292·1,128 enrolled

Chronic1 trial

Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC

Unknown status·NNational Hepatology & Tropical Medicine Research Institute·Phase 3·NCT02771405·150 enrolled

Liver Transplant1 trial

An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02165189·46 enrolled

Unspecified1 trial

SMV + SOF With/Without RBV for IFN-II Patients With CHC

Completed·SSC Liver Research Consortium, LLC·Phase 4·NCT02214420·24 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 22, 2013

OLYSIO

NDA NDA205123

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Simeprevir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Simeprevir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Simeprevir. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA205123). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Olysio. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Hepatitis C Virus Serine Protease, NS3/NS4A Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: WWim Janssens

Patent Landscape[5]

Patent Cliff

Sep 5, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9623022Jul 28, 2026

8754106Jul 28, 2026

8741926Jul 28, 2026

9040562Jul 28, 2026

9856265Jul 28, 2026

3 more patents

8349869Jul 28, 2026

9353103Jul 28, 2026

8148399Sep 5, 2029

Olysio

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Chronic Hepatitis12 trials

Interaction5 trials

Hepatitis C Virus Infection3 trials

Chronic Hepatitis C Virus Infection2 trials

Tics2 trials

Hepatitis C2 trials

Age1 trial

Intravenous1 trial

Efficacy1 trial

Female1 trial

Efficacy and Safety1 trial

Chronic1 trial

Liver Transplant1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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