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Rilpivirine Tablets
Rilpivirine Tablets is a Non-nucleoside reverse transcriptase inhibitor (NNRTI) Small molecule drug developed by ViiV Healthcare. It is currently in Phase 3 development for Treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older, Prevention of HIV-1 infection in adults at high risk.
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that works by blocking the replication of the HIV virus.
Rilpivirine is a medication used to treat HIV-1 infection, HIV, and HIV/AIDS. It is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that works by inhibiting the replication of the virus.
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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 | Rilpivirine Tablets |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Non-nucleoside reverse transcriptase inhibitor (NNRTI) |
| Target | Reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
It does this by binding to the reverse transcriptase enzyme, preventing the conversion of viral RNA into DNA. This ultimately inhibits the replication of the virus, reducing the viral load in the body.
Approved indications
- Treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older
- Prevention of HIV-1 infection in adults at high risk
Common side effects
- Nausea
- Fatigue
- Headache
- Dizziness
- Insomnia
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- 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)
- More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (PHASE1, PHASE2)
- Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults (PHASE3)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
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:
- Rilpivirine Tablets CI brief — competitive landscape report
- Rilpivirine Tablets updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about Rilpivirine Tablets
What is Rilpivirine Tablets?
How does Rilpivirine Tablets work?
What is Rilpivirine Tablets used for?
Who makes Rilpivirine Tablets?
What drug class is Rilpivirine Tablets in?
What development phase is Rilpivirine Tablets in?
What are the side effects of Rilpivirine Tablets?
What does Rilpivirine Tablets target?
Related
- Drug class: All Non-nucleoside reverse transcriptase inhibitor (NNRTI) drugs
- Target: All drugs targeting Reverse transcriptase
- Manufacturer: ViiV Healthcare — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older
- Indication: Drugs for Prevention of HIV-1 infection in adults at high risk
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing