VOCABRIA (cabotegravir sodium)
Vocabria (cabotegravir) is an oral integrase strand transfer inhibitor (INSTI) indicated for the short-term treatment of HIV-1 infection (in combination with Edurant) and for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1. It is indicated for adults and adolescents (at least 12 years old and weighing ≥35 kg). For treatment, patients must be virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable regimen with no history of treatment failure or known resistance to cabotegravir or rilpivirine. Vocabria is primarily used as an oral lead-in to assess tolerability prior to administering long-acting injections (Cabenuva or Apretude) or as oral bridging for patients who will miss planned injection dosing.
How VOCABRIA Works
Cabotegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). It inhibits HIV replication by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration. This prevents the HIV-1 DNA from being covalently integrated into the host cell genome, which is essential for the viral replication cycle.
Details
- Status
- Prescription
- First Approved
- 2021-01-21
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
VOCABRIA Approval History
What VOCABRIA Treats
1 indicationsVOCABRIA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
VOCABRIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
Drugs Similar to VOCABRIA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
VOCABRIA FDA Label Details
Indications & Usage
FDA Label (PDF)VOCABRIA is indicated for the treatment of HIV-1 Infection.
VOCABRIA Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for VOCABRIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 2 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.