TVR

Janssen R&D Ireland · Phase 3 active Small molecule

TVR is a Protease inhibitor Small molecule drug developed by Janssen R&D Ireland. It is currently in Phase 3 development for Chronic hepatitis C, Hepatitis C genotype 1 infection. Also known as: Telaprevir.

TVR is a protease inhibitor that works by blocking the replication of the hepatitis C virus.

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Likelihood of approval

63.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• Baseline phase 3 → approval rate +58.3pp
  Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
• Anti-infectives pathway favourability +2.0pp
  Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
• Big-pharma sponsor +3.0pp
  Janssen R&D Ireland is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	TVR
Also known as	Telaprevir
Sponsor	Janssen R&D Ireland
Drug class	Protease inhibitor
Target	NS5B polymerase
Modality	Small molecule
Therapeutic area	Infectious diseases
Phase	Phase 3

Mechanism of action

TVR is a non-nucleoside inhibitor of the NS5B polymerase, which is essential for the replication of the hepatitis C virus. By blocking this enzyme, TVR prevents the virus from replicating and reduces the viral load in the body.

Approved indications

• Chronic hepatitis C
• Hepatitis C genotype 1 infection

Common side effects

• Fatigue
• Headache
• Nausea
• Diarrhea
• Abdominal pain

Key clinical trials

• Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease
• Evaluation of Patients With Hypertensive Disorders of Pregnancy: An Ambispective Observational Study
• RESOLUTE ONYX China RCT Study (NA)
• RESOLUTE ONYX China Single Arm Study (NA)
• WBV Reflex Latency and Mechanical Load (NA)
• Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair for Anterior Rectocele. (NA)
• Surgical Treatments of Tricuspid Valve Regurgitation After Cardiac Surgery
• China Resolute Integrity 34/38 mm Study (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• TVR CI brief — competitive landscape report
• TVR updates RSS · CI watch RSS
• Janssen R&D Ireland portfolio CI

Frequently asked questions about TVR

What is TVR?

TVR is a Protease inhibitor drug developed by Janssen R&D Ireland, indicated for Chronic hepatitis C, Hepatitis C genotype 1 infection.

How does TVR work?

TVR is a protease inhibitor that works by blocking the replication of the hepatitis C virus.

What is TVR used for?

TVR is indicated for Chronic hepatitis C, Hepatitis C genotype 1 infection.

Who makes TVR?

TVR is developed by Janssen R&D Ireland (see full Janssen R&D Ireland pipeline at /company/janssen-r-d-ireland).

Is TVR also known as anything else?

TVR is also known as Telaprevir.

What drug class is TVR in?

TVR belongs to the Protease inhibitor class. See all Protease inhibitor drugs at /class/protease-inhibitor.

What development phase is TVR in?

TVR is in Phase 3.

What are the side effects of TVR?

Common side effects of TVR include Fatigue, Headache, Nausea, Diarrhea, Abdominal pain.

What does TVR target?

TVR targets NS5B polymerase and is a Protease inhibitor.

Related

• Drug class: All Protease inhibitor drugs
• Target: All drugs targeting NS5B polymerase
• Manufacturer: Janssen R&D Ireland — full pipeline
• Therapeutic area: All drugs in Infectious diseases
• Indication: Drugs for Chronic hepatitis C
• Indication: Drugs for Hepatitis C genotype 1 infection
• Also known as: Telaprevir