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CAB-LA Maintenance Dose
CAB-LA Maintenance Dose is a Integrase strand transfer inhibitor (INSTI) Small molecule drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 3 development for HIV-1 infection maintenance treatment in virologically suppressed adults (as part of combination antiretroviral therapy). Also known as: Cabotegravir Long-Acting Injectable.
CAB-LA is a long-acting injectable formulation of cabotegravir, an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase to prevent viral replication.
CAB-LA is used in the treatment of HIV-1-infection. The maintenance dose of CAB-LA is part of the treatment regimen in combination with other medications, such as Oral RPV and Standard of Care (SOC) Oral ART, as studied in the LATITUDE Study (NCT03635788).
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 Maintenance Dose |
|---|---|
| Also known as | Cabotegravir Long-Acting Injectable |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Cabotegravir inhibits HIV integrase, the enzyme responsible for integrating viral DNA into the host genome. The long-acting (LA) formulation provides sustained drug levels via intramuscular injection, enabling maintenance therapy with extended dosing intervals. This allows for reduced pill burden and improved adherence in HIV treatment.
Approved indications
- HIV-1 infection maintenance treatment in virologically suppressed adults (as part of combination antiretroviral therapy)
Common side effects
- Injection site reactions (pain, induration, erythema)
- Headache
- Fatigue
- Nausea
- Pyrexia
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)
- Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study
- The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE (PHASE3)
- Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1 (PHASE2)
- Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study (PHASE3)
- Improving HIV-1 Control in Africa with Long Acting Antiretrovirals (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 Maintenance Dose CI brief — competitive landscape report
- CAB-LA Maintenance Dose updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI
Frequently asked questions about CAB-LA Maintenance Dose
What is CAB-LA Maintenance Dose?
How does CAB-LA Maintenance Dose work?
What is CAB-LA Maintenance Dose used for?
Who makes CAB-LA Maintenance Dose?
Is CAB-LA Maintenance Dose also known as anything else?
What drug class is CAB-LA Maintenance Dose in?
What development phase is CAB-LA Maintenance Dose in?
What are the side effects of CAB-LA Maintenance Dose?
What does CAB-LA Maintenance Dose target?
Related
- Drug class: All Integrase strand transfer inhibitor (INSTI) drugs
- Target: All drugs targeting HIV integrase
- Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for HIV-1 infection maintenance treatment in virologically suppressed adults (as part of combination antiretroviral therapy)
- Also known as: Cabotegravir Long-Acting Injectable
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing