Data updated: May 26, 2026
INCIVEK (telaprevir)
Trial Activity: Declining
Infectious Disease
Approved 2011-05-23
INCIVEK (telaprevir) was a hepatitis C virus (HCV) NS3/4A protease inhibitor for chronic hepatitis C genotype 1. Discontinued in 2014 due to availability of better treatments.
Source: FDA Label • Vertex Pharmaceuticals
Development Insights
Vertex Pharmaceuticals Incorporated conducting 14 trials (27%)
25 indications explored (Broad Platform)
→ hepatitis c (21 trials)
→ hepatitis c, chronic (8 trials)
→ chronic hepatitis c (3 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
15
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2011-05-23
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET
INCIVEK Approval History
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
11 FDA actions from 2011 to 2014
Mar 2014 SUPPL Priority
Mfg · Manufacturing (CMC)
Jul 2013 SUPPL Priority
Mfg · Manufacturing (CMC)
May 2013 SUPPL Priority
Mfg
Nov 2012 SUPPL Priority
Mfg
What INCIVEK Treats
2 FDA approvalsOriginally approved for its first indication in 2011 . Covers 2 distinct patient populations.
- Other (2)
📋
Clinical Trial Registry
49 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01332955 TelapreVIH | ANRS HC26 TelapreVIH 2010-023287-41 | Ph 2 | completed | Telaprevir in HIV-HCV Coinfected Patients Who Had Previously Failed a Peginterferon-Ribavirin Regimen |
| NCT02087111 TIG3 | 9132 2013-003729-27, 13/LO/1473 | Ph 4 | completed | Telaprevir in Genotype 3 HCV |
| NCT00758043 results posted | VX08-950-111 EudraCT 2008-003836-39 | Ph 3 | completed | A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response |
| NCT01841502 ROLEX | AKF UMCN 12.02 | Ph 2 | terminated | Interaction Between Paroxetine and Telaprevir |
| NCT01080222 | VX09-222-103 | Ph 2 | terminated | A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection |
| NCT01821963 results posted | 2012-0977 | Ph 3 | terminated | Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC) |
| NCT01598090 PEDESTAL results posted | AI452-020 2011-004695-11 | Ph 3 | completed | Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir |
| NCT01854528 MALACHITE II results posted | M13-862 2012-003738-18 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults |
| NCT01854697 MALACHITE 1 results posted | M13-774 2012-003754-84 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before |
| NCT01355289 results posted | E5501-G000-203 | Ph 2 | completed | Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501 |
| NCT01657552 | 116010 | Ph 1 | completed | Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects |
| NCT01648140 HAI115879 results posted | 115879 | Ph 2 | completed | Dose Ranging of GSK2336805 in Combination Therapy |
| NCT01415141 | M11-219 | Ph 4 | withdrawn | Peginterferon and Ribavirin, With or Without Telaprevir, for Genotype 1 Hepatitis C and IL28B CC Polymorphism |
| NCT01482390 | NV27779 2011-002715-28 | Ph 2 | completed | A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C |
| NCT02006745 CHAT | SSAT 052 | Ph 3 | completed | Open Label Trial of PEG-IFN, RBV & TVR vs. PEG-IFN & RBV Alone in Tx of HCV-1 in HIV-1 Co-infected Patients (CHAT) |
| NCT01500616 | CR018787 VX-950HPC3005, 2011-003593-85 | Ph 3 | completed | Telaprevir Open-Label Study in Co-Infected Patients |
| NCT01701063 results posted | VX11-950-118 | Ph 1, Ph 2 | terminated | An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus |
| NCT01571583 REPLACE | CR018721 VX-950HPC3006, 2011-004724-35 | Ph 3 | completed | An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation |
| NCT01592006 results posted | 12-0156 | Ph 4 | terminated | Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients |
| NCT01492426 COMMAND-3 results posted | AI444-052 2011-004237-14 | Ph 3 | completed | Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection |
| NCT01513941 INSIGHT | CR100778 VX-950HPC3008, 2011-004928-35 | Ph 3 | completed | An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1) |
| NCT01718158 STRUCTURE | AI452-021 2011-005409-65 | Ph 3 | completed | Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy |
| NCT01718145 | AI447-031 | Ph 3 | completed | A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects |
| NCT01467492 results posted | VX11-950-116 | Ph 4 | terminated | Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C |
| NCT01467505 results posted | VX11-950-117 | Ph 2 | terminated | An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients |
| NCT01459913 CONCISE results posted | VX11-950-114 | Ph 3 | terminated | Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype |
| NCT01704521 HCV/Hemophil results posted | 12053004 R34HL109334 | Ph 1 | completed | Viral Kinetics in HCV Clearance in Subjects With Hemophilia |
| NCT00892697 results posted | 0810010040 | Ph 2 | completed | Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV) |
| NCT01467479 results posted | VX11-950-115 | Ph 3 | terminated | A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV) |
| NCT01498068 results posted | CR100676 VX-950HPC3007 | Ph 3 | completed | Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C |
| NCT01516918 | VX11-222-106 | Ph 2 | completed | A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis |
| NCT01766115 | 2012P000954 | Ph 4 | withdrawn | Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers |
| NCT00627926 results posted | VX07-950-108 | Ph 3 | completed | A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV) |
| NCT01581138 | VX11-222-108 | Ph 2 | completed | VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C |
| NCT01241760 results posted | CR013711 OPTIMIZE-HCV, VX-950-C211 | Ph 3 | completed | VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection |
| NCT01890772 | 1217 | Ph 2, Ph 3 | withdrawn | Vitamin D + Telaprevir + Peginterferon + Ribavirin for of Hepatitis C Genotype 1 |
| NCT01858961 | 1241.37 2012-004544-30 | Ph 3 | withdrawn | Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients |
| NCT00703118 results posted | CR014842 VX-950-TIDP24-C216 | Ph 3 | completed | A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment |
| NCT01600976 | CR100872 VX-950HPC1001, 2012-001627-13 | Ph 1 | completed | A Study to Assess Safety and Pharmacokinetics of Telaprevir in Patients With Hepatic Impairment |
| NCT01635829 | CR100830 VX-950HPC1002, 2012-001411-23 | Ph 1 | completed | A Study to Investigate the Potential Pharmacokinetic Interactions Between Phenytoin or Carbamazepine and Telaprevir |
| NCT00580801 results posted | CR013714 VX-950-TiDP24-C210 | Ph 2 | completed | An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection |
| NCT01054573 results posted | CR016678 VX-TiDP24-C219, 2009-012613-21 | Ph 3 | completed | VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo |
| NCT01786382 | PPI-668-102 | Ph 1 | completed | A Drug Interaction Study of the Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole |
| NCT00933283 | CR015931 VX-950-TiDP24-C135 | Ph 1 | completed | A Study to Investigate the Potential Interaction Between Telaprevir and Methadone, at Steady-State |
| NCT01646489 | SPC3649-206 | Ph 1 | completed | Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects |
| NCT01275599 | VX10-950-024 | Ph 1 | completed | Drug-Drug Interaction Study Between Telaprevir and Buprenorphine |
| NCT00903773 | CR016123 | Ph 1 | completed | VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir. |
| NCT01038167 | VX09-950-021 | Ph 1 | completed | A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults |
| NCT00958152 | VX09-222-002 | Ph 1 | completed | Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INCIVEK FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
23 international docs across 14 countries
INCIVEK Patents & Exclusivity
Latest Patent: May 2028
Patents (1 active)
US8431615
Expires May 30, 2028
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for INCIVEK
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 1 active patents
Trial Analysis
- • 52 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment