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Cabotegravir Tablets
Cabotegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA.
Cabotegravir is an integrase strand transfer inhibitor (INSTI) 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, HIV-1 prevention (PrEP) in at-risk individuals.
At a glance
| Generic name | Cabotegravir Tablets |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
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. It is designed for long-acting formulations, allowing extended dosing intervals compared to traditional daily antiretrovirals.
Approved indications
- HIV-1 infection in treatment-naive and treatment-experienced adults
- HIV-1 prevention (PrEP) in at-risk individuals
Common side effects
- Diarrhea
- Nausea
- Headache
- Fatigue
- Hypersensitivity reactions
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)
- Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (PHASE2, PHASE3)
- Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
- A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories (PHASE4)
- ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.
- More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (PHASE1, PHASE2)
- CAbotégravir LENacapavir DUal Long Acting (PHASE2)
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 Tablets CI brief — competitive landscape report
- Cabotegravir Tablets updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI