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Zepatier (GRAZOPREVIR)
Zepatier blocks the NS3/4A protease enzyme, preventing the hepatitis C virus from replicating.
Zepatier (Grazoprevir) is a small molecule medication developed by Merck Sharp Dohme, approved by the FDA in 2016 for the treatment of chronic hepatitis C. It is a combination therapy that works by inhibiting the NS3/4A protease enzyme, which is essential for the replication of the hepatitis C virus. Zepatier is a patented medication, and its commercial status is not off-patent. Key safety considerations include potential interactions with other medications and monitoring for liver function. In plain English, Zepatier works by blocking a specific enzyme that the hepatitis C virus needs to multiply.
At a glance
| Generic name | GRAZOPREVIR |
|---|---|
| Sponsor | Merck & Co. |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | discontinued |
| First approval | 2016 |
Mechanism of action
Imagine the hepatitis C virus is like a machine that needs a specific tool to work. Zepatier is like a lock that blocks the tool, preventing the machine from making copies of itself. This helps to slow down the spread of the virus in the body.
Approved indications
- Chronic hepatitis C
Common side effects
- Pancreas transplant rejection
Key clinical trials
- Pembrolizumab (MK-3475) in Hepatocellular Carcinoma (PHASE2)
- Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients. (PHASE3)
- Zepatier in Patients with Substance Use
- Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003) (PHASE2)
- Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021) (PHASE2)
- Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012) (PHASE2)
- HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant (PHASE4)
- Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients (PHASE1,PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zepatier CI brief — competitive landscape report
- Zepatier updates RSS · CI watch RSS
- Merck & Co. portfolio CI