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CAB LA + RPV LA
CAB LA + RPV LA is a Antiretroviral combination (integrase inhibitor + non-nucleoside reverse transcriptase inhibitor) Small molecule drug developed by ViiV Healthcare. It is currently in Phase 3 development for HIV-1 infection in treatment-experienced adults with suppressed viral load.
CAB LA and RPV LA are long-acting injectable antiretroviral agents that inhibit HIV reverse transcriptase and integrase to suppress viral replication.
CAB LA and RPV LA are injectable suspensions used to treat Human Immunodeficiency Virus Type 1 (HIV-1) and HIV Infections. They are part of a sub-study evaluating the pharmacokinetics, tolerability, and efficacy of cabotegravir and rilpivirine in HIV-infected participants.
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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 | CAB LA + RPV LA |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Antiretroviral combination (integrase inhibitor + non-nucleoside reverse transcriptase inhibitor) |
| Target | HIV integrase and HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Cabotegravir (CAB) is an integrase strand transfer inhibitor that blocks HIV integration into host cell DNA, while rilpivirine (RPV) is a non-nucleoside reverse transcriptase inhibitor that prevents reverse transcription of viral RNA. Together as long-acting formulations administered intramuscularly, they provide sustained HIV suppression with extended dosing intervals.
Approved indications
- HIV-1 infection in treatment-experienced adults with suppressed viral load
Common side effects
- Injection site reactions
- Headache
- Fatigue
- Nausea
- Diarrhea
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 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)
- Implementation of Long-acting Cabotegravir + Rilpivirine Administration Out of "HIV Units". (NA)
- 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)
- Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study
- 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)
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:
- CAB LA + RPV LA CI brief — competitive landscape report
- CAB LA + RPV LA updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about CAB LA + RPV LA
What is CAB LA + RPV LA?
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Who makes CAB LA + RPV LA?
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What does CAB LA + RPV LA target?
Related
- Drug class: All Antiretroviral combination (integrase inhibitor + non-nucleoside reverse transcriptase inhibitor) drugs
- Target: All drugs targeting HIV integrase and HIV reverse transcriptase
- Manufacturer: ViiV Healthcare — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection in treatment-experienced adults with suppressed viral load
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing