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 7 indications, with its most advanced program in Approved.[1]

Olysio is one of 225 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

224

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Viral DiseaseActive, not recruiting

Liver TransplantActive, not recruiting

Chronic HepatitisActive, not recruiting

Hepatitis CActive, not recruiting

Chronic Kidney DiseaseApproved

Chronic Hepatitis C Virus InfectionActive, not recruiting

Hepatitis C Virus InfectionActive, not recruiting

Viral DiseaseApproved

Active, not recruiting

Liver TransplantPhase 2

Active, not recruiting

Chronic HepatitisPhase 2

Active, not recruiting

Hepatitis CApproved

Active, not recruiting

Chronic Kidney DiseaseApproved

Approved

Chronic Hepatitis C Virus InfectionPhase 3

Active, not recruiting

Hepatitis C Virus InfectionPhase 3

Active, not recruiting

Competition

Competitive Landscape

624 competitors in Chronic Hepatitis

#DrugCompanyPhaseTrials

Olysio

WWim Janssens

Approved

12 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

Dasabuvir

AbbVie

Preclinical

7 9

SOF/VEL

Gilead

Preclinical

4 10

Keyhole-Limpet Hemocyanin

Bristol-Myers Squibb

Preclinical

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

Clinical

Trials by Indication[1]

Chronic Hepatitis12 trials

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

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

Withdrawn·SStanford University·Phase 4·NCT02485080

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

Show 9 more trials

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

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

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

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

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

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

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

Interaction5 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

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

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

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

Hepatitis C Virus Infection3 trials

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

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

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

Chronic Hepatitis C Virus Infection2 trials

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

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

Hepatitis C2 trials

The SIM-SOF Trial for Hepatitis C

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

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

9 more indications

Tics2 trials

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

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

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

Age1 trial

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

Completed·—·N/A·NCT03549832·40 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

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

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

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

Jul 28, 2026

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

Hepatitis C2 trials

Tics2 trials

Efficacy and Safety1 trial

Chronic1 trial

Liver Transplant1 trial

Age1 trial

Efficacy1 trial

Intravenous1 trial

Female1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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