Product Description
an integrase strand-transfer inhibitor [INSTI]; for HIV Prevention in Cisgender Men and Transgender Women (Sourced from: https://www.nejm.org/doi/full/10.1056/NEJMoa2101016)
Mechanisms of Action: HIV Integrase Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Intramuscular
FDA Designation: Breakthrough Therapy - HIV InfectionsPriority Review - HIV Infections *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Canada | Chile | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Mexico | Netherlands | Norway | Poland | Portugal | Romania | Russia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Kingdom | United States
Approved Indications: Headache Disorders | Abdominal Pain | Back Pain | Dizziness | Headache | Pain Unspecified | Respiratory Tract Infections | Myalgia | Flatulence | HIV Infections
Known Adverse Events: Headache Disorders | Abdominal Pain | Back Pain | Dizziness | Headache | Pain Unspecified | Respiratory Tract Infections | Myalgia | Diarrhea | Flatulence | HIV Infections
Company: ViiV Healthcare
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Botswana, Brazil, Canada, Chile, France, Germany, Ireland, Italy, Japan, Kenya, Korea, Malawi, Mexico, Netherlands, New Zealand, Peru, Puerto Rico, Russia, South Africa, Spain, Sweden, Switzerland, Thailand, Uganda, United Kingdom, United States, Unknown Location, Vietnam, Zimbabwe
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Acquired Immunodeficiency Syndrome|Communicable Diseases|Deficiency Diseases|HIV Infections
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| PALISADE | P3 |
Recruiting |
HIV Infections |
2028-06-26 |
|
| 221611 | P3 |
Unknown Status |
HIV Infections |
2027-12-08 |
|
| 219700 | P3 |
Unknown Status |
HIV Infections |
2026-08-25 |
|
| NCT05418868 | P1 |
Recruiting |
HIV Infections |
2026-08-03 |