Cabotegravir
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (6) | US (FDA) | VOCABRIA | — | 2021-12-20 – 2024-09-20 | fda.gov ↗ |
| Approved | US (FDA) | CABENUVA KIT | — | 2021-01-21 | fda.gov ↗ |
| Approved | EU (EMA) | Vocabria | — | 2020-12-17 | europa.eu ↗ |
Trials 81 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 128 trials | ||||||
| Phase 1 | NCT07672717 | Jul 2026 → Dec 2030 expected | HIV infectious disease | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 1 | NCT06970223 | Apr → Jul 2025 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06786520 | Jan 2025 → Mar 2027 expected | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06033547 | Sep 2023 → Jul 2025 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT05776108 | Mar → Jun 2023 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT05418868 | Jun 2022 → Jun 2027 expected | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 1 | NCT05112939 | Nov 2021 → May 2024 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04371380 | Sep 2020 → Dec 2021 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT04484337 | Jul 2020 → May 2023 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT03422172 | Apr 2018 → Apr 2020 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT03149848 | Jun → Sep 2017 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02478463 | Feb 2017 → Jul 2019 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02799264 | Jun → Aug 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02354937 | Jul 2015 → Nov 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02354950 | Jun 2015 → Sep 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02345707 | Mar → Jun 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02159131 | Aug → Dec 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02059031 | Feb → Jun 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02027454 | Jan → Jun 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01848340 | May → Jul 2013 | AIDS dysmorphic syndrome | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01754116 | Jan 2013 → Apr 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01648257 | Aug → Nov 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01593046 | May 2012 → Nov 2013 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01467531 | Nov 2011 → Feb 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01756131 | Sep 2010 → Dec 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT00920296 | Jul → Sep 2009 | HIV infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00812318 | Jun → Aug 2008 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT00659191 | Feb → Nov 2008 | HIV infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07275606 | Apr 2026 → Oct 2029 expected | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06336434 | May 2025 → Jan 2028 | HIV infectious disease, pregnancy disorder, puerperal disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05660980 | Jan 2024 → Oct 2026 expected | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03497676 | Apr 2019 → Feb 2023 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT06657885 | Jan 2025 → Jul 2026 | HIV infectious disease | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | Withdrawn | No outcome recorded |
| Phase 2 | NCT06741397 | Dec 2024 → Sep 2026 expected | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06411223 | Aug 2024 → Mar 2027 expected | HIV infectious disease | Yale University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05996471 | Aug 2023 → May 2026 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05991622 | Apr 2022 → Aug 2025 | HIV infectious disease, opiate dependence | Rhode Island Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT04824131 | Nov 2020 → Jan 2023 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT04692077 | Feb 2020 → Jul 2023 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT03739996 | Dec 2019 → Apr 2024 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT03639311 | Sep 2018 → Dec 2019 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT02462772 | Oct 2015 → Sep 2018 | HIV infectious disease | Centre for the AIDS Programme of Research in South Africa | Withdrawn | No outcome recorded |
| Phase 2 | NCT02178800 | Feb 2015 → Apr 2017 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT02076178 | Mar 2014 → May 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT01641809 | Aug 2012 → Oct 2013 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT00920426 | Jun → Aug 2009 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02720094 | Dec 2016 → May 2020 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 322 trials | ||||||
| Phase 3 | NCT07650916 | Jun 2026 → Sep 2029 expected | HIV infectious disease | ViiV Healthcare | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06694805 | Dec 2024 → Aug 2026 overdue | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 3 | NCT06507059 | Jul 2024 → Jul 2025 overdue | HIV infectious disease | Chang Gung Memorial Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT06134362 | May 2024 → Jan 2029 expected | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 3 | NCT06273943 | Apr 2024 → Oct 2025 overdue | — | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06133686 | Apr 2024 → Dec 2025 overdue | HIV infectious disease | MRC/UVRI and LSHTM Uganda Research Unit | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06250504 | Feb 2024 → Apr 2026 overdue | HIV infectious disease | Africa Health Research Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT05917509 | Jul 2023 → Sep 2025 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT05154747 | Jun 2023 → Mar 2025 | HIV infectious disease | University College, London | Unknown | No outcome recorded |
| Phase 3 | NCT05601128 | Jan 2023 → Apr 2025 | HIV infectious disease | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Completed | No outcome recorded |
| Phase 3 | NCT05546242 | Dec 2022 → Apr 2025 overdue | HIV infectious disease | MRC/UVRI and LSHTM Uganda Research Unit | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05896748 | Nov 2022 → Sep 2023 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT05515770 | Sep 2022 → Oct 2025 overdue | HIV infectious disease | Evandro Chagas National Institute of Infectious Disease | Recruiting | No outcome recorded |
| Phase 3 | NCT05896761 | Oct 2021 → Aug 2022 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT04542070 | Nov 2020 → Jul 2022 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT04399551 | Sep 2020 → Mar 2022 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT04001803 | Jul 2019 → Oct 2020 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT03635788 | Mar 2019 → Feb 2024 overdue | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03164564 | Nov 2017 → Nov 2020 overdue | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03299049 | Oct 2017 → Jun 2019 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02951052 | Oct 2016 → May 2018 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02938520 | Oct 2016 → Aug 2018 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT06854029 | Jul 2026 → Dec 2029 expected | HIV infectious disease, opiate dependence | Duke University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07199335 | Feb 2026 → Dec 2028 expected | HIV infectious disease, substance-related disorder | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06646562 | Mar 2025 → Jan 2026 overdue | — | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Recruiting | No outcome recorded |
| Phase 4 | NCT06474364 | Aug 2024 → Aug 2028 expected | HIV infectious disease | MU-JHU CARE | Recruiting | No outcome recorded |
| Phase 4 | NCT06158126 | Apr 2024 → Dec 2026 expected | pregnancy disorder | University of North Carolina, Chapel Hill | Recruiting | No outcome recorded |
| Phase 4 | NCT05986084 | Nov 2023 → Aug 2027 expected | — | Beth Israel Deaconess Medical Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05549726 | Jan → Dec 2023 | HIV infectious disease | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT05374525 | May 2022 → Aug 2024 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT05072093 | Nov 2021 → Mar 2025 | HIV infectious disease, bacterial sexually transmitted disease | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT04982445 | Nov 2021 → Jan 2024 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05044962 | Nov 2021 → Mar 2027 expected | HIV infectious disease | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03462810 | — | HIV infectious disease | ViiV Healthcare | Available | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02120352 Comparator | Apr 2014 → Aug 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07658976 Background | Sep 2026 → Sep 2029 expected | HIV infectious disease | HIV Prevention Trials Network | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07682961 Comparator | Jul 2026 → Mar 2029 expected | HIV infectious disease | Gilead Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06138600 Comparator | Nov 2023 → Oct 2025 | HIV infectious disease | University of Witwatersrand, South Africa | Unknown | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06185452 Comparator | Sep 2023 → May 2025 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 4 | NCT05514509 Background | Oct 2022 → Sep 2025 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06468995 Comparator | Dec 2024 → Jul 2026 overdue | HIV infectious disease, interferon antiviral depressor | IRCCS San Raffaele | Active not recruiting | No outcome recorded |
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 97 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cabotegravir | “A Phase 1, Single-blind, Randomized, Parallel-group Study in Healthy Participants to Investigate the Single-dose Pharmacokinetics, Safety and Tolerability of Rilpivirine After...” NCT05112939 ↗70“This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV)...” NCT06336434 ↗ “Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2...” NCT03639311 ↗ “This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine...” NCT03164564 ↗ “In phase 1 trials, the HIV-1 integrase strand transfer inhibitor cabotegravir (GSK1265744) was well tolerated, both alone, and in combination with the non-nucleoside reverse...” PMID 26201299 ↗ Jul 2015 “Feasibility, Fidelity, and Effectiveness of Administering Long-Acting Cabotegravir + Rilpivirine in Infusion Centers in the United States: Findings From the Phase 4 GLACIER...” PMID 42117620 ↗ May 2026 “GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable...” NCT02120352 ↗ “Cabotegravir (GSK1265744) is an integrase strand transfer inhibitor in development as a long-acting (LA) intramuscular injectable suspension for HIV-1 pre-exposure prophylaxis (PrEP).” PMID 30445896 ↗ Nov 2018 “A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)” NCT06741397 ↗ “Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)” NCT06134362 ↗ “Cabotegravir long-acting + rilpivirine long-acting (CAB LA + RPV LA) is a licensed new drug, already used in clinical practice, for the treatment of HIV infection.” NCT06468995 ↗ “For men who are interested in injectable PrEP, they will be referred to local providers to access Apretude (Cabotegravir injection) every two months.” NCT05072093 ↗ “A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1” NCT06694805 ↗ “Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI).” NCT04001803 ↗ “new long-acting medications such as cabotegravir co-administered with rilpivirine (CAB/RPV) and extended-release buprenorphine (XR-B)” NCT05991622 ↗ “Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and prevention of HIV infection.” NCT03422172 ↗ “CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) Intramuscular (IM) Administered Monthly and Every 2 Months” NCT05601128 ↗ “The experimental drugs used in this study are cabotegravir, marketed as Vocabria®, and lenacapavir, marketed as Sunlenca®.” NCT06657885 ↗ “receive commercially available Cabotegravir PrEP via prescription from the PrEP provider at the corresponding site” NCT05374525 ↗ “A Phase 1/2 Study of the Safety, Tolerability, and Pharmacokinetics of Cabotegravir in Neonates Exposed to HIV-1” NCT07275606 ↗ “Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA)” NCT06786520 ↗ “long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI])” PMID 34379922 ↗ Aug 2021 “with rilpivirine (RPV) LA and cabotegravir (CAB) LA versus all-oral standard of care (SOC).” NCT03635788 ↗ “Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA)” NCT07650916 ↗ “Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables” NCT04399551 ↗ “long-acting injectable cabotegravir (CAB-LA)” NCT06158126 ↗ “Cabotegravir and Rilpivirine” NCT05660980 ↗ |
| Known as | 744 | “GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development for both the treatment and prevention of human immunodeficiency virus (HIV) infection.” NCT02354937 ↗1“GSK1265744 (744) oral administration” NCT02159131 ↗ |
| Known as | APRETUDE | “For men who are interested in injectable PrEP, they will be referred to local providers to access Apretude (Cabotegravir injection) every two months.” NCT05072093 ↗4“PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as oral lead in (OLI).” NCT05514509 ↗ “APRETUDE (cabotegravir) 600 mg\3 mL” NCT06250504 ↗ “Cabotegravir Injection [Apretude]” NCT05986084 ↗ |
| Known as | CAB | “The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is...” NCT02938520 ↗23“This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB)...” NCT02345707 ↗ “The purpose of this study is to evaluate CABENUVA (Long-acting Cabotegravir (CAB) Plus Long-acting Rilpivirine (RPV)) pharmacokinetics (movement of drugs within the body),...” NCT05601128 ↗ “This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV)...” NCT06336434 ↗ “Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2...” NCT03639311 ↗ “A parenteral LA formulation of cabotegravir (CAB) and rilpivirine (RPV) given by intramuscular (IM) injection every 2 months (CAB LA + RPV LA Q2M) has shown safety and efficacy...” PMID 41040645 ↗ Mar 2025 “Cabotegravir plus rilpivirine (CAB + RPV) is a guideline-recommended long-acting (LA) injectable regimen for the maintenance of human immunodeficiency virus-1 (HIV-1) virologic...” PMID 39052748 ↗ Jul 2024 “Cabotegravir (CAB) LA 600mg and Rilpivirine (RPV) LA 900mg will be administered intramuscularly every 2 months after an induction phase with a single administration in months 1 and 2.” NCT06646562 ↗ “Cabotegravir long-acting + rilpivirine long-acting (CAB LA + RPV LA) is a licensed new drug, already used in clinical practice, for the treatment of HIV infection.” NCT06468995 ↗ “A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1” NCT06694805 ↗ “Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI).” NCT04001803 ↗ “long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A)” NCT05418868 ↗ “Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and prevention of HIV infection.” NCT03422172 ↗ “CAB tablets were available as film coated tablets for oral administration.” NCT04542070 ↗ “oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD)” NCT02120352 ↗ “Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables” NCT04399551 ↗ “Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation” NCT05776108 ↗ “cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA).” NCT05917509 ↗ “Drug: Oral Cabotegravir (CAB)” NCT03497676 ↗ “Cabotegravir (CAB) tablet” NCT04692077 ↗ “Cabotegravir (CAB) tablet” NCT02951052 ↗ “Oral Cabotegravir (CAB)” NCT03739996 ↗ “Oral cabotegravir (CAB)” NCT04824131 ↗ “Cabotegravir (CAB)” NCT06741397 ↗ |
| Known as | CAB ULA | “Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA)” NCT06786520 ↗1“Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA)” NCT07650916 ↗ |
| Known as | CAB-LA | “A parenteral LA formulation of cabotegravir (CAB) and rilpivirine (RPV) given by intramuscular (IM) injection every 2 months (CAB LA + RPV LA Q2M) has shown safety and efficacy...” PMID 41040645 ↗ Mar 202518“Participants receive lead-in injections comprising cabotegravir LA during month one and injections of a new formulation of CAB LA at Month 3, Month 5 and every 4 months...” NCT06741397 ↗ “Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)” NCT06134362 ↗ “Cabotegravir long-acting + rilpivirine long-acting (CAB LA + RPV LA) is a licensed new drug, already used in clinical practice, for the treatment of HIV infection.” NCT06468995 ↗ “Cabotegravir, a is new long-acting antiretroviral (CABLA) and highly efficacious PrEP choice that can mitigate barriers to use of daily oral PrEP.” NCT06474364 ↗ “CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection.” NCT04542070 ↗ “The overall purpose of this SEARCH CAB-LA (Cabotegravir Injectable Suspension) randomized extension study” NCT05549726 ↗ “Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA)” NCT06786520 ↗ “Long-acting injectable cabotegravir (CAB-LA) offers a promising alternative to daily oral PrEP.” PMID 42325473 ↗ Jun 2026 “Cabotegravir Long-Acting (CAB LA) will be given IM into one buttock” NCT05154747 ↗ “long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP)” NCT05986084 ↗ “Drug: Long-Acting Injectable Cabotegravir (CAB LA)” NCT03497676 ↗ “Cabotegravir - Injectable Suspension (CAB LA)” NCT05896748 ↗ “Long-acting injectable cabotegravir (CAB-LA)” NCT06133686 ↗ “Long-Acting Injectable Cabotegravir (CAB LA)” NCT03739996 ↗ “Long-acting injectable cabotegravir (CAB-LA)” NCT06273943 ↗ “Cabotegravir Injectable Suspension (CAB LA)” NCT07672717 ↗ “Long-acting cabotegravir (CAB LA)” PMID 42437832 ↗ Jul 2026 |
| Known as | CAB200 | “Long-acting (LA) cabotegravir 200-mg/mL (CAB200) injections are approved for HIV-1 prevention and as a complete LA HIV-1 treatment regimen with rilpivirine.” PMID 40296638 ↗ Apr 2025 |
| Known as | CAB400-D | “A high-concentration suspension formulation, cabotegravir 400 mg/mL (CAB400-D), was developed to enable less frequent dosing and self-administration.” PMID 40296638 ↗ Apr 2025 |
| Known as | Cabotegravir component of cabenuva | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403238 ↗ |
| Known as | Cabotegravir sodium | “Cabotegravir sodium (Oral Lead In)” NCT04484337 ↗ |
| Known as | GSK-1265744A | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403238 ↗ |
| Known as | GSK1265744 | “An Open Label, Phase 1 Study to Evaluate the PK, Safety, Tolerability and Acceptability of Long Acting Injections of the HIV Integrase Inhibitor, Cabotegravir (CAB; GSK1265744)...” NCT03422172 ↗20“GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable...” NCT02120352 ↗ “Cabotegravir (GSK1265744) is an integrase strand transfer inhibitor in development as a long-acting (LA) intramuscular injectable suspension for HIV-1 pre-exposure prophylaxis (PrEP).” PMID 30445896 ↗ Nov 2018 “GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV” NCT03462810 ↗ |
| Known as | GSK1265744B | “Cabotegravir (GSK1265744B ) is available as white to almost white, oval shaped, film coated tablet, of weight 515 mg.” NCT02799264 ↗ |
| Known as | GSK744 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403238 ↗ |
| Known as | S-265744 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403238 ↗ |
| Known as | S-265744B | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403238 ↗ |
| Known as | Vocabria | “Hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as standard of care.” NCT06185452 ↗1“The experimental drugs used in this study are cabotegravir, marketed as Vocabria®, and lenacapavir, marketed as Sunlenca®.” NCT06657885 ↗ |
| Action | Inhibit | “Dolutegravir (DTG) and GSK1265744 are HIV integrase inhibitors (INIs) in clinical development.” PMID 23979733 ↗ Aug 2013 |
| Modality | Small molecule | — CHEMBL2403238 ↗ |
| Route | Oral | “GSK1265744 10 mg oral solution” NCT00812318 ↗ |