Product Description
Glecaprevir-pibrentasvir showed high efficacy and an acceptable safety profile in these studies although responses were less common in the few patients with HCV genotype 3b. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/32682494/)
Mechanisms of Action: HCV-NS5A Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not 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 | Norway | 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: None
Known Adverse Events: None
Company: AbbVie
Company Location: NORTH CHICAGO IL 60064
Company CEO: Richard A. Gonzalez
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Brazil, Canada, France, Germany, Italy, Spain, United States
Active Clinical Trial Count: 4
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Hepatitis A|Hepatitis C
Phase 2: Communicable Diseases|HIV Infections
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| IMPAACT 2041 | P2 |
Not yet recruiting |
Hepatitis A|Hepatitis C |
2027-07-30 |
12% |
2025-06-28 |
Primary Endpoints |
| PURGE-C | P2 |
Completed |
Hepatitis C|HIV Infections|Communicable Diseases|Hepatitis A |
2023-05-18 |
42% |
2024-07-12 |
Primary Endpoints|Start Date|Treatments |
| M20-350 | P3 |
Completed |
Hepatitis C|Hepatitis A |
2024-09-17 |
24% |
2025-04-08 |
|
| 2020-005777-27 | P3 |
Completed |
Hepatitis C |
2024-09-02 |
24% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |