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Cabotegravir OLI
Cabotegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing the virus from inserting its genetic material into human host cell DNA.
Cabotegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing the virus from inserting its genetic material into human host cell DNA. Used for HIV-1 infection in treatment-experienced adults, HIV-1 prevention (PrEP) in at-risk individuals.
At a glance
| Generic name | Cabotegravir OLI |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Cabotegravir inhibits HIV integrase, an enzyme essential for viral replication. By blocking integrase activity, the drug prevents integration of viral DNA into the host genome, thereby halting HIV replication. The OLI (once-daily integrase inhibitor) formulation is designed for convenient daily oral dosing in HIV treatment and prevention regimens.
Approved indications
- HIV-1 infection in treatment-experienced adults
- HIV-1 prevention (PrEP) in at-risk individuals
Common side effects
- Diarrhea
- Nausea
- Headache
- Insomnia
- Hypersensitivity reactions
Key clinical trials
- A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories (PHASE4)
- A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States (PHASE4)
- Improving HIV-1 Control in Africa with Long Acting Antiretrovirals (PHASE3)
- A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed (PHASE3)
- Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants (PHASE1)
- A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries (PHASE3)
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:
- Cabotegravir OLI CI brief — competitive landscape report
- Cabotegravir OLI updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI