Data updated: May 26, 2026
RILPIVIRINE
Trial Activity: Declining 1 active trials
Infectious Disease
Approved 2026-01-29
Development Insights
Janssen R&D Ireland conducting 3 trials (21%)
13 indications explored (Broad Platform)
→ hiv (3 trials)
→ healthy (2 trials)
→ hiv infections (2 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2026-01-29
- Routes
- ORAL
- Dosage Forms
- TABLET
RILPIVIRINE Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Jan 2026 ORIGINAL
Update
What RILPIVIRINE Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (Jan 2026) New
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Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02494986 | CR107451 TMC278IFD3004, 2014-002471-28 | Ph 2 | active not recruiting | A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies |
| NCT02470650 | Cost-Effect-Clinic 2014-004820-24 | Ph 4 | withdrawn | Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive |
| NCT04012931 results posted | CR108606 2018-004301-32, TMC278HTX2002 | Ph 2 | completed | A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed |
| NCT03127189 | CR108302 TMC278LAHTX1002 | Ph 1 | completed | A Study to Investigate the Effect of Different Particle Sizes on the Single-dose Pharmacokinetics of Rilpivirine After Intramuscular Injection of a Long-acting Nanosuspension in Healthy Participants |
| NCT00799864 results posted | CR002677 TMC278-TiDP38-C213, 2008-001696-30 | Ph 2 | completed | A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years |
| NCT01975012 | P1111 11902 | Ph 1, Ph 2 | withdrawn | Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age |
| NCT01266902 results posted | CR017434 TMC278-TiDP6-C222, 2010-021209-18 | Ph 3 | completed | A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1 |
| NCT01709084 SALIF results posted | CR100875 TMC278IFD3002 | Ph 3 | completed | A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment |
| NCT02165202 TMC278LA results posted | HPTN 076 1015131, UM1AI068619 | Ph 2 | completed | Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis |
| NCT00855335 results posted | CR015442 TMC114HIV3015 | Ph 3 | completed | A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women |
| NCT01585038 results posted | TMC278HIV4002 | Ph 4 | completed | Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress |
| NCT01562886 results posted | 278_CSF 2011-004026-98 | Ph 1 | completed | The Rilpivirine Cerebrospinal-fluid (CSF) Study |
| NCT01615614 | CR100812 TMC278IFD1003, 2012-000141-12 | Ph 1 | completed | A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants |
| NCT01719614 | CR100909 TMC278IFD1004 | Ph 1 | completed | A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
RILPIVIRINE FDA Label Details
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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