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Cabotegravir Injectable Suspension
Cabotegravir is an integrase strand transfer inhibitor that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA.
Cabotegravir is an integrase strand transfer inhibitor that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA. Used for HIV-1 infection in treatment-naive and treatment-experienced adults (as part of combination antiretroviral therapy), HIV-1 prevention in at-risk individuals (PrEP).
At a glance
| Generic name | Cabotegravir Injectable Suspension |
|---|---|
| Also known as | Vocabria |
| Sponsor | ViiV Healthcare |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| 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 cell genome, thereby halting HIV replication. The long-acting injectable formulation provides sustained drug levels, enabling dosing every 2 months after an oral lead-in period.
Approved indications
- HIV-1 infection in treatment-naive and treatment-experienced adults (as part of combination antiretroviral therapy)
- HIV-1 prevention in at-risk individuals (PrEP)
Common side effects
- Injection site reactions (pain, induration, erythema)
- Headache
- Fatigue
- Nausea
- Pyrexia
- Myalgia
Key clinical trials
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
- Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults (PHASE3)
- Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults (PHASE3)
- SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension (PHASE4)
- Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study (PHASE3)
- Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa (PHASE3)
- A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects (PHASE2)
- 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)
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 Injectable Suspension CI brief — competitive landscape report
- Cabotegravir Injectable Suspension updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI