RUKOBIA (fostemsavir tromethamine) · VIIV HLTHCARE
RUKOBIA is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults. It is used in combination with other antiretroviral agents for patients with multidrug-resistant HIV-1 who are failing their current regimen. This therapy is specifically reserved for cases where treatment failure is driven by resistance, intolerance, or safety considerations.
How RUKOBIA Works
RUKOBIA is an HIV-1 antiretroviral agent that functions as a gp120-directed attachment inhibitor. By targeting the gp120 protein on the virus, the medication prevents the virus from attaching to host cells. This inhibition of the attachment phase provides a mechanism to treat HIV-1 infection in patients with limited treatment options.
Details
- Status
- Prescription
- First Approved
- 2020-07-02
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
RUKOBIA Approval History
What RUKOBIA Treats
1 indicationsRUKOBIA is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus Type 1
RUKOBIA 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.
VIIV HLTHCARE's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
RUKOBIA FDA Label Details
Indications & Usage
FDA Label (PDF)RUKOBIA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations [see Clinical Studies ]. RUKOBIA, a human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistan...
Pro Intelligence Preview
Deep insights for RUKOBIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • 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.