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Oral RPV
Oral RPV is a Non-nucleoside reverse transcriptase inhibitor (NNRTI) Small molecule drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 3 development for HIV-1 infection (treatment-naive and treatment-experienced patients). Also known as: Rilpivirine.
Oral RPV (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor that blocks HIV reverse transcriptase to prevent viral replication.
Oral RPV (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor that blocks HIV reverse transcriptase to prevent viral replication. Used for HIV-1 infection (treatment-naive and treatment-experienced patients).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Oral RPV |
|---|---|
| Also known as | Rilpivirine |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Drug class | Non-nucleoside reverse transcriptase inhibitor (NNRTI) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
RPV binds to the non-nucleoside binding pocket of HIV reverse transcriptase, inhibiting the enzyme's ability to convert viral RNA into DNA. This prevents integration of viral genetic material into the host cell genome and blocks HIV replication. It is used as part of combination antiretroviral therapy for HIV-1 infection.
Approved indications
- HIV-1 infection (treatment-naive and treatment-experienced patients)
Common side effects
- Rash
- Nausea
- Headache
- Diarrhea
- Elevated liver enzymes
Key clinical trials
- 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 Participants (PHASE3)
- A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies (PHASE2)
- A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1 (PHASE3)
- HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
- Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER) (PHASE4)
- Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs (PHASE2)
- More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oral RPV CI brief — competitive landscape report
- Oral RPV updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI
Frequently asked questions about Oral RPV
What is Oral RPV?
How does Oral RPV work?
What is Oral RPV used for?
Who makes Oral RPV?
Is Oral RPV also known as anything else?
What drug class is Oral RPV in?
What development phase is Oral RPV in?
What are the side effects of Oral RPV?
What does Oral RPV target?
Related
- Drug class: All Non-nucleoside reverse transcriptase inhibitor (NNRTI) drugs
- Target: All drugs targeting HIV reverse transcriptase
- Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for HIV-1 infection (treatment-naive and treatment-experienced patients)
- Also known as: Rilpivirine