EDURANT (rilpivirine hydrochloride)
Edurant (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older weighing at least 14 kg with a viral load (HIV-1 RNA) $\le$ 100,000 copies/mL. It is also indicated for use in combination with Vocabria (cabotegravir) as a short-term treatment for virologically suppressed HIV-1 infection (RNA < 50 copies/mL) in adults and adolescents 12 years and older weighing at least 35 kg who are on a stable regimen with no history of treatment failure or known resistance to either component.
How EDURANT Works
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1. It works by binding non-competitively directly to the HIV-1 reverse transcriptase (RT) enzyme. This inhibits the enzyme's RNA-dependent and DNA-dependent DNA polymerase activities, which are essential for converting viral RNA into DNA, thereby blocking viral replication. It does not inhibit human DNA polymerases $\alpha$, $\beta$, or $\gamma$.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-05-20
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- TABLET
EDURANT Approval History
What EDURANT Treats
1 indicationsEDURANT is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
EDURANT 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.
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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.
EDURANT FDA Label Details
Indications & Usage
FDA Label (PDF)EDURANT is indicated for the treatment of HIV-1 Infection.
EDURANT Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment