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Oral CAB
Oral CAB is a Integrase strand transfer inhibitor (INSTI) Small molecule drug developed by ViiV Healthcare. It is currently in Phase 3 development for HIV-1 infection in treatment-naive and treatment-experienced adults (in combination with other antiretroviral agents). Also known as: Cabotegravir, GSK1265744.
Oral CAB is a capsid assembly modulator that inhibits HIV capsid formation, preventing viral replication by disrupting the structural integrity of newly formed HIV particles.
Oral CAB, also known as the "Protect Study," is a pilot study that investigated the use of Periostat, a doxycycline derivative, in protecting the heart during coronary artery bypass grafting. The study was conducted at the University of Alberta and involved conditions such as coronary artery bypass grafting, cardiopulmonary bypass, and reperfusion injury.
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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 CAB |
|---|---|
| Also known as | Cabotegravir, GSK1265744 |
| Sponsor | ViiV Healthcare |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
CAB (cabotegravir) is an integrase strand transfer inhibitor (INSTI) that works by blocking HIV integrase, the enzyme responsible for inserting viral DNA into the host genome. The oral formulation allows for daily dosing as an alternative to long-acting injectable formulations. It is often used in combination antiretroviral therapy to suppress HIV replication.
Approved indications
- HIV-1 infection in treatment-naive and treatment-experienced adults (in combination with other antiretroviral agents)
Common side effects
- Diarrhea
- Nausea
- Headache
- Fatigue
- Hypersensitivity reactions
Key clinical trials
- FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants) (NA)
- 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)
- Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (PHASE2, PHASE3)
- Randomized Active-Controlled Trial Evaluating Fexuprazan (Fexuclue Tab) for Prevention Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy After Coronary Intervention (NA)
- Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
- Safety and Potency of a High Cabergoline Dosage in Microprolactinomas (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)
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 CAB CI brief — competitive landscape report
- Oral CAB updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about Oral CAB
What is Oral CAB?
How does Oral CAB work?
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Who makes Oral CAB?
Is Oral CAB also known as anything else?
What drug class is Oral CAB in?
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What does Oral CAB target?
Related
- Drug class: All Integrase strand transfer inhibitor (INSTI) drugs
- Target: All drugs targeting HIV integrase
- Manufacturer: ViiV Healthcare — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection in treatment-naive and treatment-experienced adults (in combination with other antiretroviral agents)
- Also known as: Cabotegravir, GSK1265744
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing