Product Description
Glecaprevir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS3/4A protease inhibitor that targets the the viral RNA replication. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Glecaprevir)
Mechanisms of Action: HCV-NS3/4A Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: Liver Cirrhosis | Hepatitis | Hepatitis, Chronic | Hepatitis C | Hepatitis C, Chronic
Known Adverse Events: Headache
Company: AbbVie
Company Location: NORTH CHICAGO IL 60064
Company CEO: Richard A. Gonzalez
Additonal Commercial Interests: Enanta
Clinical Description
Countries in Clinic: Australia, Austria, Brazil, Canada, China, France, Germany, Italy, Korea, New Zealand, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Hepatitis A|Hepatitis C|Hepatitis C, Chronic
Phase 2: Communicable Diseases|HIV Infections|Kidney Failure, Chronic
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| M20-350 | P3 |
Active, not recruiting |
Hepatitis C|Hepatitis A |
2024-08-26 |
32% |
| M20-350 | P3 |
Active, not recruiting |
Hepatitis C|Hepatitis A |
2024-08-26 |
32% |
| 2020-005777-27 | P3 |
Active, not recruiting |
Hepatitis C |
2024-04-22 |
|
| PURGE-C | P2 |
Completed |
Hepatitis C|Hepatitis A|Communicable Diseases|HIV Infections |
2023-05-18 |
|
| THINKER | P2 |
Completed |
Kidney Failure, Chronic|Hepatitis C, Chronic |
2022-03-01 |