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APRETUDE (cabotegravir)
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 that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA. Used for HIV-1 prevention in at-risk individuals (pre-exposure prophylaxis, PrEP), HIV-1 treatment in combination antiretroviral therapy.
At a glance
| Generic name | APRETUDE (cabotegravir) |
|---|---|
| Sponsor | Massachusetts General Hospital |
| 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 binds to HIV integrase and inhibits the strand transfer step of viral integration into the host genome. By blocking this critical step in the HIV replication cycle, the drug prevents establishment of persistent infection. Apretude is a long-acting injectable formulation designed for HIV pre-exposure prophylaxis (PrEP) and treatment, administered as an intramuscular injection.
Approved indications
- HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals
- HIV-1 treatment in combination antiretroviral therapy
Common side effects
- Injection site reactions (pain, erythema, induration)
- Headache
- Fatigue
- Nausea
- Pyrexia
Key clinical trials
- Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs (PHASE4)
- Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana (PHASE4)
- A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories (PHASE4)
- Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus) (PHASE3)
- A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States (PHASE4)
- Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP
- Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.
- Parrying the Pitfalls of PrEP: Project PEACH (PHASE4)
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:
- APRETUDE (cabotegravir) CI brief — competitive landscape report
- APRETUDE (cabotegravir) updates RSS · CI watch RSS
- Massachusetts General Hospital portfolio CI