CABENUVA is a complete long-acting regimen indicated for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older weighing at least 35 kg. It is used to replace a stable antiretroviral regimen in patients who are currently virologically suppressed with HIV-1 RNA levels below 50 copies per mL. Eligible patients must
Details
- Status
- Prescription
- First Approved
- 2021-01-21
- Patent Cliff
- 2038
- Routes
- INTRAMUSCULAR
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
CABENUVA KIT Approval History
What CABENUVA KIT Treats
1 indicationsCABENUVA KIT is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
CABENUVA KIT Competitive Set
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Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05996471 EMBRACE | 209639 | Ph 2 | active not recruiting | A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV) |
| NCT03149848 results posted | 205712 2017-000103-25 | Ph 1 | completed | Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects |
| NCT02462772 CAPRISA014 | CAPRISA 014 | Ph 2 | withdrawn | Safety and Acceptability of Cabotegravir in HIV Uninfected Women in KwaZulu-Natal, South Africa |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CABENUVA KIT FDA Label Details
Indications & Usage
FDA Label (PDF)CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine [see Microbiology , Clinical Studies ] . CABENUVA, a 2-drug co-packaged product of cabotegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, an HI...
CABENUVA KIT Patents & Exclusivity
Patents (8 active)
Exclusivity
Pro Intelligence Preview
Deep insights for CABENUVA KIT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 32 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.