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RPV OLI
RPV OLI is a HIV integrase strand transfer inhibitor Small molecule drug developed by ViiV Healthcare. It is currently in Phase 3 development for Treatment of HIV-1 infection.
RPV OLI is a HIV integrase strand transfer inhibitor.
RPV OLI is a long-acting antiretroviral intervention used to treat HIV-1 infection. It is administered as a two-monthly injection, as part of a study evaluating its effectiveness in controlling HIV-1 in Africa.
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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 | RPV OLI |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | HIV integrase strand transfer inhibitor |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
RPV OLI works by blocking the integrase enzyme, which is essential for the replication of HIV. This prevents the virus from integrating its genetic material into the host cell's DNA, thereby inhibiting viral replication.
Approved indications
- Treatment of HIV-1 infection
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Insomnia
Key clinical trials
- Improving HIV-1 Control in Africa with Long Acting Antiretrovirals (PHASE3)
- A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed (PHASE3)
- A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries (PHASE3)
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:
- RPV OLI CI brief — competitive landscape report
- RPV OLI updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about RPV OLI
What is RPV OLI?
How does RPV OLI work?
What is RPV OLI used for?
Who makes RPV OLI?
What drug class is RPV OLI in?
What development phase is RPV OLI in?
What are the side effects of RPV OLI?
What does RPV OLI target?
Related
- Drug class: All HIV integrase strand transfer inhibitor drugs
- Target: All drugs targeting HIV integrase
- Manufacturer: ViiV Healthcare — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Treatment of HIV-1 infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing