Treats HIV-1 infection. Sold as Vocabria. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Cabotegravir Sodium (sold as Vocabria), first approved Jan 21, 2021, with 8 new uses approved and 1 published complete response letter.
| 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 AdultsInfection, Human Immunodeficiency Virus, HIV Infections · ViiV Healthcare | Phase 3 | Active, not recruiting | Nov 1, 2016 |
| 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 ParticipantsHIV Infections · ViiV Healthcare | Phase 3 | Active, not recruiting | Oct 19, 2016 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jan 21, 2021 | VocabriaNDA 212887 · New dosage form | Viiv Hlthcare | 11 | Marketed |
| Letter | Product | Now |
|---|---|---|
| Dec 19, 2019 | VOCABRIA (cabotegravir)Product Quality | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
