Drugs / Cabotegravir
Cabotegravir
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 3 milestones | |||||
| Filed | US (FDA) | Cabenuva | HIV infectious disease | 2021-02-24 | “In July, ViiV Healthcare resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the US Food and Drug Administration (FDA)” viivhealthcare.com ↗ “In July, Janssen resubmitted the New Drug Application (NDA) for once-monthly dosing of rilpivirine and cabotegravir to the US Food and Drug Administration (FDA).” jnj.com ↗ “supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) by ViiV Healthcare for the expanded use of CABENUVA” jnj.com ↗ “resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the US Food and Drug Administration (FDA)” viivhealthcare.com ↗ “A supplemental New Drug Application has been submitted to the US Food and Drug Administration for expanding the use of Cabenuva” viivhealthcare.com ↗ |
| Rejected (CRL) | US (FDA) | — | HIV infectious disease | 2019-12-21 | “received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen” viivhealthcare.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2019-07-29 | “today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the investigational, once-monthly, injectable cabotegravir” viivhealthcare.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansions (4) | US (FDA) | VOCABRIA | — | 2021-12-20 – 2024-09-20 | fda.gov ↗ |
| Filed | EU (EMA) | — | HIV prevention | 2022-10-28 | “EMA has validated the company’s marketing authorisation application (MAA) seeking approval of cabotegravir long-acting injectable for pre-exposure prophylaxis” gsk.com ↗ |
| Filed | US (FDA) | — | HIV prevention | 2021-09-28 | “FDA has accepted and granted Priority Review for a New Drug Application (NDA) for investigational, injectable cabotegravir long-acting for pre-exposure prophylaxis” viivhealthcare.com ↗ |
| Approved | US (FDA) | CABENUVA KIT | — | 2021-01-21 | fda.gov ↗ |
| Approved | EU (EMA) | Vocabria | — | 2020-12-17 | europa.eu ↗ |
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| 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 Stop: Business |
| 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 · 1 met primary · 1 missed | ||||||
| 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 overdue | 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 Stop: Enrollment |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT02720094 | Dec 2016 → May 2020 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 322 trials · 7 met primary | ||||||
| Phase 3 | NCT07650916 | Jun 2026 → Sep 2029 expected | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 3 | NCT06694805 | Dec 2024 → Aug 2026 overdue | HIV infectious disease | ViiV Healthcare | Active not 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 | Met primary |
| 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 | HIV infectious disease | MRC/UVRI and LSHTM Uganda Research Unit | Completed | 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 | Met primary |
| 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 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 3 | NCT03164564 | Nov 2017 → Nov 2020 overdue | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | Met primary |
| Phase 3 | NCT03299049 | Oct 2017 → Jun 2019 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | Met primary |
| Phase 3 | NCT02951052 | Oct 2016 → May 2018 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | Met primary |
| Phase 3 | NCT02938520 | Oct 2016 → Aug 2018 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | Met primary |
| Phase 411 trials · 1 met primary | ||||||
| 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 → Jun 2027 expected | — | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Active not 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 | Met primary |
| Phase 4 | NCT05514509 | Oct 2022 → Sep 2025 | HIV infectious disease | ViiV Healthcare | 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 |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT02120352 Comparator | Apr 2014 → Aug 2015 | HIV infectious disease | ViiV Healthcare | Completed | 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 4 | NCT06185452 Comparator | Sep 2023 → May 2025 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| — | NCT06468995 Comparator | Dec 2024 → Jul 2026 overdue | HIV infectious disease, interferon antiviral depressor | IRCCS San Raffaele | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 117
| Date | Issuer | Release |
|---|---|---|
| 2026-10-06 | GlaxoSmithKline | Results ViiV Healthcare’s long-acting HIV treatment Cabenuva (cabotegravir + rilpivirine) meets primary endpoint of superior viral suppression vs. daily oral therapy in people with viremia gsk.com ↗ |
| 2026-10-06 | ViiV Healthcare | Results ViiV HEALTHCARE’S LONG-ACTING HIV TREATMENT CABENUVA (CABOTEGRAVIR + RILPIVIRINE) MEETS PRIMARY ENDPOINT OF SUPERIOR VIRAL SUPPRESSION VS. DAILY ORAL THERAPY IN PEOPLE WITH VIREMIA viivhealthcare.com ↗ |
| 2026-07-29 | GlaxoSmithKline | Results Cabenuva demonstrates superiority to daily oral therapy in adolescents living with HIV, as ViiV Healthcare highlights new long-acting injectable data at AIDS 2026 gsk.com ↗
Confirmed viral rebound occurred in 0.9% (n=2/235) of adolescents receiving CAB+RPV LA versus 6.4% (n=15/241) receiving daily oral therapy. |
| 2026-07-29 | ViiV Healthcare | Results CABENUVA DEMONSTRATES SUPERIORITY TO DAILY ORAL THERAPY IN ADOLESCENTS LIVING WITH HIV, AS ViiV HEALTHCARE HIGHLIGHTS NEW LONG-ACTING INJECTABLE DATA AT AIDS 2026 viivhealthcare.com ↗
Week 96 results from the LATA trial, led by University College London, showed CAB+RPV LA dosed every two months was superior to daily oral dolutegravir/tenofovir disoproxil fumarate/lamivudine (DTG/TDF/3TC) in 476 virologically suppressed adolescents aged 12 to 19 years living with HIV in Kenya, South Africa, Uganda and Zimbabwe. |
| 2026-02-25 | GlaxoSmithKline | Results ViiV Healthcare reports positive 12-month data showing investigational bNAb lotivibart (N6LS) maintains high levels of viral suppression in long-acting HIV treatment regimen gsk.com ↗
GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders,* today announced positive 12-month interim efficacy and tolerability data from the phase IIb EMBRACE study. |
| 2026-02-25 | ViiV Healthcare | Results ViiV HEALTHCARE REPORTS POSITIVE 12-MONTH DATA SHOWING INVESTIGATIONAL BNAB LOTIVIBART (N6LS) MAINTAINS HIGH LEVELS OF VIRAL SUPPRESSION IN LONG-ACTING HIV TREATMENT REGIMEN viivhealthcare.com ↗
94% of adults on stable therapy maintained viral suppression with intravenous lotivibart dosed every four months in combination with long-acting cabotegravir |
| 2026-02-24 | ViiV Healthcare | Results ViiV HEALTHCARE REPORTS LONG-ACTING INJECTABLE CABENUVA EFFECTIVELY MAINTAINS VIRAL SUPPRESSION IN ADOLESCENTS LIVING WITH HIV, WITH >97% PREFERRING INJECTIONS OVER DAILY ORAL TREATMENT viivhealthcare.com ↗ |
| 2026-02-18 | GlaxoSmithKline | Results ViiV Healthcare’s long-acting Cabenuva (cabotegravir + rilpivirine) for HIV demonstrates superior efficacy compared to daily oral therapy for people with adherence challenges; results published in NEJM gsk.com ↗
Final data from LATITUDE study show switch to long-acting injectable treatment reduced the risk of virological failure by nearly half for study participants through 48 weeks, compared to those continuing on daily oral therapy |
| 2026-02-18 | ViiV Healthcare | Results ViiV HEALTHCARE’S LONG-ACTING CABENUVA (CABOTEGRAVIR + RILPIVIRINE) FOR HIV DEMONSTRATES SUPERIOR EFFICACY COMPARED TO DAILY ORAL THERAPY FOR PEOPLE WITH ADHERENCE CHALLENGES; RESULTS PUBLISHED IN NEJM viivhealthcare.com ↗
This is the first randomised study confirming this regimen is superior to daily oral therapy in this population. |
| 2025-10-19 | Gilead Sciences | Results Gilead to Spotlight New Virology Data Across HIV, Viral Hepatitis and Respiratory Diseases at IDWeek 2025 gilead.com ↗
New Data Show Higher Treatment Satisfaction After Switching from IM CAB+RPV to Biktarvy ® |
| 2025-10-17 | ViiV Healthcare | Regulatory NICE ISSUES POSITIVE RECOMMENDATION FOR ViiV HEALTHCARE’S CABOTEGRAVIR FOR PREP, THE FIRST AND ONLY LONG-ACTING HIV PREVENTION OPTION TO BE REIMBURSED IN ENGLAND AND WALES viivhealthcare.com ↗ |
| 2025-10-15 | GlaxoSmithKline | Results ViiV Healthcare’s CLARITY study shows long-acting cabotegravir more acceptable than lenacapavir injections after a single dose, with 90% preferring cabotegravir gsk.com ↗ |
| 2025-10-15 | ViiV Healthcare | Results ViiV HEALTHCARE’S CLARITY STUDY SHOWS LONG-ACTING CABOTEGRAVIR MORE ACCEPTABLE THAN LENACAPAVIR INJECTIONS AFTER A SINGLE DOSE, WITH 90% PREFERRING CABOTEGRAVIR viivhealthcare.com ↗ |
| 2025-07-24 | Shionogi | Results ViiV Healthcare’s Presentation on the VOLITION Study of Long-Acting Injectable Cabenuva in HIV Treatment shionogi.com ↗
Results showed that 89% (n=129/145) of participants chose to switch to Cabenuva. |
| 2025-03-12 | GlaxoSmithKline | Results ViiV Healthcare’s investigational broadly neutralising antibody - N6LS - successfully maintains viral suppression in long-acting treatment of HIV gsk.com ↗
The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. |
| 2025-03-12 | GlaxoSmithKline | Results ViiV Healthcare announces new implementation study data showing zero cases of HIV with Apretude, the only long-acting injectable approved for HIV PrEP gsk.com ↗
New data at CROI 2025 show zero cases of HIV acquisition reported with Apretude (cabotegravir long-acting (CAB LA) for PrEP) in varied clinical settings and populations in two implementation studies in the U.S. and Brazil |
| 2025-03-12 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES NEW IMPLEMENTATION STUDY DATA SHOWING ZERO CASES OF HIV WITH APRETUDE, THE ONLY LONG-ACTING INJECTABLE APPROVED FOR HIV PREP viivhealthcare.com ↗
New data at CROI 2025 show zero cases of HIV acquisition reported with Apretude (cabotegravir long-acting (CAB LA) for PrEP) in varied clinical settings and populations in two implementation studies in the U.S. and Brazil |
| 2025-03-12 | ViiV Healthcare | Results ViiV HEALTHCARE’S INVESTIGATIONAL BROADLY NEUTRALISING ANTIBODY - N6LS - SUCCESSFULLY MAINTAINS VIRAL SUPPRESSION IN LONG-ACTING TREATMENT OF HIV viivhealthcare.com ↗
The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. |
| 2025-03-09 | GlaxoSmithKline | Results ViiV Healthcare continues to deliver long-acting injectable HIV innovation with late-breaking data and real-world insights across pipeline and portfolio at CROI 2025 gsk.com ↗
Real-world and implementation data highlight effectiveness of Cabenuva (cabotegravir + rilpivirine LA) and Apretude (cabotegravir LA (CAB LA) for PrEP), the only approved long-acting injectable therapies for HIV treatment and prevention, among broad range of communities |
| 2025-03-09 | ViiV Healthcare | Results ViiV HEALTHCARE CONTINUES TO DELIVER LONG-ACTING INJECTABLE HIV INNOVATION WITH LATE-BREAKING DATA AND REAL-WORLD INSIGHTS ACROSS PIPELINE AND PORTFOLIO AT CROI 2025 viivhealthcare.com ↗
Real-world and implementation data highlight effectiveness of Cabenuva (cabotegravir + rilpivirine LA) and Apretude (cabotegravir LA (CAB LA) for PrEP), the only approved long-acting injectable therapies for HIV treatment and prevention, among broad range of communities |
| 2025-01-31 | GlaxoSmithKline | Regulatory European Commission authorises ViiV Healthcare’s long-acting injectable Vocabria + Rekambys for HIV treatment in adolescents gsk.com ↗ |
| 2025-01-31 | ViiV Healthcare | Regulatory European CommIssIon authorIses ViiV Healthcare’s long-actIng Injectable VocabrIa + Rekambys for HIV treatment In adolescents viivhealthcare.com ↗ |
| 2024-12-16 | GlaxoSmithKline | Regulatory ViiV Healthcare announces CHMP positive opinion for Vocabria + Rekambys, the first and only complete long-acting HIV treatment, for adolescents in Europe gsk.com ↗ |
| 2024-12-16 | ViiV Healthcare | Regulatory ViiV HEALTHCARE ANNOUNCES CHMP POSITIVE OPINION FOR VOCABRIA + REKAMBYS, THE FIRST AND ONLY COMPLETE LONG-ACTING HIV TREATMENT, FOR ADOLESCENTS IN EUROPE viivhealthcare.com ↗
the Committee for Medicinal Products for Human Use (CHMP) of the Europe Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation |
| 2024-11-12 | Gilead Sciences | Results Scientific Leadership Spotlighted as Gilead Presents Research Data Across Its Broad and Innovative HIV Treatment Portfolio and Pipeline gilead.com ↗
Overall, the analysis found Biktarvy had the highest probability of preventing TE-RAMs, whereas CAB+RPV injected every two months performed similarly to STRs with lower barriers to resistance in relation to the risk of TE-RAMs. |
| 2024-10-16 | GlaxoSmithKline | Results ViiV Healthcare shows more than 99% effectiveness in real-world studies for Apretude (cabotegravir long-acting), the only approved long-acting HIV PrEP, in data presented at IDWeek 2024 gsk.com ↗
Findings from two real-world evidence studies (from OPERA and Trio Health cohorts) showed more than 99% effectiveness of CAB LA for PrEP in nearly 1,300 individuals. |
| 2024-10-16 | ViiV Healthcare | Results ViiV HEALTHCARE SHOWS MORE THAN 99% EFFECTIVENESS IN REAL-WORLD STUDIES FOR APRETUDE (CABOTEGRAVIR LONG-ACTING), THE ONLY APPROVED LONG-ACTING HIV PREP, IN DATA PRESENTED AT IDWEEK 2024 viivhealthcare.com ↗
Findings from two real-world evidence studies (from OPERA and Trio Health cohorts) showed more than 99% effectiveness of CAB LA for PrEP in nearly 1,300 individuals. |
| 2024-03-06 | GlaxoSmithKline | Results ViiV Healthcare announces interim data at CROI indicating superior efficacy of long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine) compared to daily oral therapy in individuals living with HIV who have adherence challenges gsk.com ↗ |
| 2024-03-06 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES INTERIM DATA AT CROI INDICATING SUPERIOR EFFICACY OF LONG-ACTING INJECTABLE HIV TREATMENT CABENUVA (CABOTEGRAVIR + RILPIVIRINE) COMPARED TO DAILY ORAL THERAPY IN INDIVIDUALS LIVING WITH HIV WHO HAVE ADHERENCE CHALLENGES viivhealthcare.com ↗
The findings of the LATITUDE study show that long-acting injectable cabotegravir + rilpivirine could be important for some people in this group, giving them another option to help keep their virus under control and improve their health. |
| 2024-03-04 | GlaxoSmithKline | Results ViiV Healthcare presents phase I clinical trial findings of a cabotegravir long-acting injectable investigational formulation allowing at least four months between doses gsk.com ↗
Data also showed that the intramuscular dosing of CAB-ULA has a safety and pharmacokinetic (PK) profile that supports a longer dose interval. |
| 2024-02-28 | GlaxoSmithKline | Results ViiV Healthcare to present data for its next generation of ultra long-acting treatments for HIV gsk.com ↗
Phase I study of cabotegravir long-acting injectable formulations supports ≥4-monthly dose interval |
| 2024-02-21 | GlaxoSmithKline | Results LATITUDE phase III interim trial data indicates ViiV Healthcare’s long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine) has superior efficacy compared to daily therapy in individuals living with HIV who have adherence challenges gsk.com ↗
They considered the totality of all the study endpoints together and concluded that the evidence indicated superior efficacy of long-acting ART over daily oral standard of care. |
| 2023-10-26 | GlaxoSmithKline | Regulatory ViiV Healthcare receives approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir) used in combination with Rekambys (rilpivirine), the first and only complete long-acting HIV-1 injectable treatment gsk.com ↗
the National Medical Products Administration (NMPA) of China has approved ViiV Healthcare’s Vocabria (cabotegravir injection) used in combination with the Janssen Pharmaceutical Companies of Johnson & Johnson's Rekambys (rilpivirine long-acting injection) for the treatment of HIV-1 infection |
| 2023-10-26 | ViiV Healthcare | Regulatory ViiV HEALTHCARE RECEIVES APPROVAL FROM CHINA’S NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) FOR VOCABRIA (CABOTEGRAVIR) USED IN COMBINATION WITH REKAMBYS (RILPIVIRINE), THE FIRST AND ONLY COMPLETE LONG-ACTING HIV-1 INJECTABLE TREATMENT viivhealthcare.com ↗ |
| 2023-02-23 | GlaxoSmithKline | Results ViiV Healthcare announces positive data demonstrating long-acting injectable Cabenuva (cabotegravir, rilpivirine) is as effective as daily oral Biktarvy (BIC/FTC/TAF) for the treatment of HIV-1 gsk.com ↗
12-month findings from the SOLAR study showed that the every-two-month regimen of CAB+RPV LA demonstrated non-inferior efficacy compared to continuation of daily oral BIC/FTC/TAF |
| 2023-02-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES POSITIVE DATA DEMONSTRATING LONG-ACTING INJECTABLE CABENUVA (CABOTEGRAVIR, RILPIVIRINE) IS AS EFFECTIVE AS DAILY ORAL BIKTARVY (BIC/FTC/TAF) FOR THE TREATMENT OF HIV-1 viivhealthcare.com ↗
Study findings showed that CAB+RPV LA dosed every two months achieved the primary endpoint of non-inferior virologic efficacy versus daily oral BIC/FTC/TAF, while 90% of participants who switched to CAB+RPV LA from BIC/FTC/TAF, and who completed a survey (n=425), preferred the long-acting regimen. |
| 2022-05-31 | GlaxoSmithKline | Regulatory ViiV Healthcare announces marketing approval by Japan’s Ministry of Health, Labour and Welfare for Vocabria (cabotegravir) used in combination with Rekambys (rilpivirine) gsk.com ↗ |
| 2022-05-31 | ViiV Healthcare | Regulatory ViiV HEALTHCARE ANNOUNCES MARKETING APPROVAL BY JAPAN’S MINISTRY OF HEALTH, LABOUR AND WELFARE FOR VOCABRIA (CABOTEGRAVIR) USED IN COMBINATION WITH REKAMBYS (RILPIVIRINE), THE FIRST AND ONLY COMPLETE LONG-ACTING TREATMENT FOR HIV viivhealthcare.com ↗
today announced it obtained approval for Vocabria (cabotegravir injection and tablets) |
| 2022-03-29 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves CABENUVA (cabotegravir and rilpivirine) for Adolescents, Expanding the Indication of the First and Only Complete Long-Acting Injectable HIV Regimen jnj.com ↗
CABENUVA is approved as a once-monthly or every-two-months treatment for HIV-1 in virologically suppressed adults and adolescents. |
| 2022-03-24 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves Streamlined Process for Initiating HIV Therapy with CABENUVA (cabotegravir and rilpivirine), the First and Only Complete Long-Acting Injectable HIV Treatment jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved a label update for CABENUVA (cabotegravir and rilpivirine) |
| 2022-03-24 | GlaxoSmithKline | Regulatory ViiV Healthcare announces label update for its long-acting HIV treatment, Cabenuva (cabotegravir, rilpivirine), to be initiated with or without an oral lead-in period gsk.com ↗
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved a label update for Cabenuva (cabotegravir, rilpivirine) making the oral lead-in with cabotegravir and rilpivirine tablets optional. |
| 2022-03-24 | ViiV Healthcare | Regulatory ViiV HEALTHCARE ANNOUNCES LABEL UPDATE FOR ITS LONG-ACTING HIV TREATMENT, CABENUVA (CABOTEGRAVIR, RILPIVIRINE), TO BE INITIATED WITH OR WITHOUT AN ORAL LEAD-IN PERIOD viivhealthcare.com ↗
today announced that the US Food and Drug Administration (FDA) approved a label update for Cabenuva (cabotegravir, rilpivirine) making the oral lead-in with cabotegravir and rilpivirine tablets optional. |
| 2022-02-01 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves CABENUVA (rilpivirine and cabotegravir) for Use Every Two Months, Expanding the Label of the First and Only Long-Acting HIV Treatment jnj.com ↗
The U.S. FDA Approval allows CABENUVA to be dosed monthly or every two months. |
| 2022-02-01 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves CABENUVA (rilpivirine and cabotegravir) for Use Every Two Months, Expanding the Label of the First and Only LongActing HIV Treatment jnj.com ↗ |
| 2022-02-01 | GlaxoSmithKline | Regulatory ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting HIV treatment gsk.com ↗
The US FDA approval allows Cabenuva to be dosed monthly or every two months. |
| 2022-02-01 | ViiV Healthcare | Regulatory ViiV HEALTHCARE ANNOUNCES US FDA APPROVAL OF CABENUVA (CABOTEGRAVIR, RILPIVIRINE) FOR USE EVERY TWO MONTHS, EXPANDING THE LABEL OF THE FIRST AND ONLY COMPLETE LONG-ACTING HIV TREATMENT viivhealthcare.com ↗
ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva (cabotegravir, rilpivirine) for every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults (HIV-1 RNA less than 50 copies per millilitre [c/ml]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. |
| 2021-10-28 | GlaxoSmithKline | Results ViiV Healthcare presents positive interim data showing Vocabria (cabotegravir) and Rekambys (rilpivirine) can be implemented successfully in a variety of European healthcare settings gsk.com ↗
The majority of healthcare teams across Europe agreed or completely agreed that long-acting cabotegravir and rilpivirine was acceptable, appropriate and feasible to implement (mean scores 4.6, 4.1, 4.2, respectively, on a 5-point Likert scale). |
| 2021-10-28 | ViiV Healthcare | Results ViiV Healthcare presents positive interim data showing Vocabria (cabotegravir) and Rekambys (rilpivirine), the first long-acting HIV-treatment regimen, can be implemented successfully in a variety of European healthcare settings viivhealthcare.com ↗
The majority of healthcare teams across Europe agreed or completely agreed that long-acting cabotegravir and rilpivirine was acceptable, appropriate and feasible to implement (mean scores 4.6, 4.1, 4.2 respectively on a 5-point Likert scale). |
| 2021-10-28 | ViiV Healthcare | Regulatory ViiV Healthcare announces European Commission Decision for Vocabria (cabotegravir) and Rekambys (rilpivirine) injections to be initiated with or without an oral lead-in period for the long-acting treatment of HIV viivhealthcare.com ↗
Oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines, which is now optional with the SmPC update. |
| 2021-09-28 | GlaxoSmithKline | Regulatory FDA grants Priority Review to ViiV Healthcare’s New Drug Application for cabotegravir long-acting for prevention of HIV gsk.com ↗ |
| 2021-09-28 | ViiV Healthcare | Regulatory FDA grants Priority Review to ViiV Healthcare’s New Drug Application for cabotegravir long-acting for prevention of HIV viivhealthcare.com ↗ |
| 2021-07-17 | GlaxoSmithKline | Results ViiV Healthcare study shows new long-acting HIV regimen Cabenuva (cabotegravir/rilpivirine) can be successfully implemented in broad range of US healthcare practices, even during COVID-19 gsk.com ↗
Healthcare teams from a wide variety of US HIV clinics reported that optimal implementation of long-acting cabotegravir and rilpivirine dosed monthly was achieved within 1 – 3 months, and implementation was acceptable, appropriate and feasible |
| 2021-07-17 | ViiV Healthcare | Results ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021 viivhealthcare.com ↗
Changes in metabolic health parameters were similar between the dolutegravir/lamivudine and TBR arms, with changes in lipids generally continuing to favour the dolutegravir/lamivudine arm. |
| 2021-07-17 | ViiV Healthcare | Results ViiV Healthcare study shows new long-acting HIV regimen Cabenuva (cabotegravir/rilpivirine) can be successfully implemented in broad range of US healthcare practices, even during COVID-19 viivhealthcare.com ↗
The study, which included people living with HIV and healthcare teams and overlapped with the COVID-19 pandemic, demonstrated that Cabenuva (a co-pack with two injectable medicines including ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine) can be successfully implemented across a range of healthcare settings in the US. |
| 2021-05-04 | GlaxoSmithKline | Regulatory ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV gsk.com ↗ |
| 2021-05-04 | ViiV Healthcare | Regulatory ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV viivhealthcare.com ↗ |
| 2021-03-06 | Janssen Research & Development, LLC | Results Janssen Announces 96-week Results of Phase 3b Study Demonstrating the Continued Safety and Efficacy of Long-acting HIV Treatment of Rilpivirine and Cabotegravir jnj.com ↗
The 96-week findings of the Antiretroviral Therapy as Long-Acting Suppression Every 2 Months (ATLAS-2M) trial confirmed the primary endpoint, met at Week 48, and met the secondary endpoint, showing efficacy of both monthly dosing and every 2-month dosing over the long-term in virologically suppressed adults with HIV-1. |
| 2021-03-06 | GlaxoSmithKline | Results ViiV Healthcare presents data for long-acting cabotegravir and rilpivirine for the treatment of HIV showing continued virologic suppression to 96 weeks gsk.com ↗ |
| 2021-03-06 | ViiV Healthcare | Results ViiV Healthcare presents data for long-acting cabotegravir and rilpivirine for the treatment of HIV showing continued virologic suppression to 96 weeks viivhealthcare.com ↗ |
| 2021-02-24 | Janssen Research & Development, LLC | Regulatory Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA by ViiV Healthcare for Expanded Use of CABENUVA (rilpivirine and cabotegravir) as an HIV Treatment for Use Every Two Months jnj.com ↗ |
| 2021-02-24 | Janssen Research & Development, LLC | Regulatory Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA by ViiV Healthcare for Expanded Use of CABENUVA (rilpivirine and cabotegravir) as an HIV Treatment for Use Every Two Months jnj.com ↗ |
| 2021-01-21 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV jnj.com ↗ |
| 2021-01-21 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA |
| 2021-01-21 | GlaxoSmithKline | Regulatory ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment gsk.com ↗
Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. |
| 2021-01-21 | ViiV Healthcare | Regulatory ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment viivhealthcare.com ↗
today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. |
| 2020-12-21 | Janssen Research & Development, LLC | Regulatory Janssen Announces European Commission Authorisation of the First Complete Long-Acting Injectable HIV Treatment in Europe jnj.com ↗
Marketing Authorisation granted by European Commission for Janssen’s REKAMBYS® (rilpivirine injection) to be used with ViiV Healthcare’s VOCABRIA® (cabotegravir injection and tablets) |
| 2020-12-21 | GlaxoSmithKline | Regulatory ViiV Healthcare announces the Marketing Authorisation of the first complete long-acting injectable HIV treatment in Europe gsk.com ↗
This authorisation represents the first time people living with HIV in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase. |
| 2020-12-21 | ViiV Healthcare | Regulatory ViiV Healthcare announces the Marketing Authorisation of the first complete long-acting injectable HIV treatment in Europe viivhealthcare.com ↗
This authorisation represents the first time people living with HIV in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase. |
| 2020-11-17 | GlaxoSmithKline | Regulatory ViiV Healthcare receives FDA Breakthrough Therapy Designation for investigational, long-acting cabotegravir for HIV prevention gsk.com ↗
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). |
| 2020-11-17 | ViiV Healthcare | Regulatory ViiV Healthcare receives FDA Breakthrough Therapy Designation for investigational, long-acting cabotegravir for HIV prevention viivhealthcare.com ↗
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). |
| 2020-11-09 | GlaxoSmithKline | Results ViiV Healthcare announces investigational injectable cabotegravir is superior to oral standard of care for HIV prevention in women gsk.com ↗
The study showed cabotegravir was 89% more effective than daily oral FTC/TDF for pre-exposure prophylaxis (PrEP). |
| 2020-11-09 | ViiV Healthcare | Results ViiV Healthcare announces investigational injectable cabotegravir is superior to oral standard of care for HIV prevention in women viivhealthcare.com ↗
The study showed cabotegravir was 89% more effective than daily oral FTC/TDF for pre-exposure prophylaxis (PrEP). |
| 2020-10-22 | GlaxoSmithKline | Results ViiV Healthcare presents positive new findings from two studies of its investigational, long-acting regimen of cabotegravir and rilpivirine, including five-year data showing long-term durability, efficacy, safety, and tolerability gsk.com ↗
The data from LATTE-2 continues to establish the efficacy, tolerability and durability of this long acting regimen. |
| 2020-10-22 | GlaxoSmithKline | Results ViiV Healthcare presents continued positive findings from first-ever implementation science study on integrating an investigational once-monthly injectable HIV treatment into US healthcare practices gsk.com ↗
Interim data presented at IDWeek 2020 showed the majority of patient participants continue to find once-monthly injectable cabotegravir plus rilpivirine to be acceptable for treating their HIV and appropriate for their daily lives |
| 2020-10-22 | ViiV Healthcare | Results ViiV Healthcare presents positive new findings from two studies of its investigational, long-acting regimen of cabotegravir and rilpivirine, including five-year data showing long-term durability, efficacy, safety, and tolerability viivhealthcare.com ↗
Five-year findings from the LATTE-2 study, which is the longest study of long-acting cabotegravir and rilpivirine to date, demonstrated continued high rates of virologic response, long-term durability, and good overall tolerability whether the regimen was administered every two months or once-monthly. |
| 2020-10-22 | ViiV Healthcare | Results ViiV Healthcare presents continued positive findings from first-ever implementation science study on integrating an investigational once-monthly injectable HIV treatment into US healthcare practices viivhealthcare.com ↗
Interim data presented at IDWeek TM 2020 showed the majority of patient participants continue to find once-monthly injectable cabotegravir plus rilpivirine to be acceptable for treating their HIV and appropriate for their daily lives |
| 2020-10-21 | GlaxoSmithKline | Results ViiV Healthcare announces analysis showing no antiretroviral therapy interruptions due to COVID-19 across its clinical development programme for investigational, long-acting cabotegravir and rilpivirine gsk.com ↗
In the midst of the global pandemic, the analysis found no antiretroviral therapy interruptions across the entirety of the ongoing clinical development programme for long-acting cabotegravir and rilpivirine. |
| 2020-10-21 | ViiV Healthcare | Results ViiV Healthcare announces analysis showing no antiretroviral therapy interruptions due to COVID-19 across its clinical development programme for investigational, long-acting cabotegravir and rilpivirine viivhealthcare.com ↗
In the midst of the global pandemic, the analysis found no antiretroviral therapy interruptions across the entirety of the ongoing clinical development programme for long-acting cabotegravir and rilpivirine. |
| 2020-10-16 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for Long-Acting Regimen for the Treatment of HIV jnj.com ↗
has issued a positive opinion recommending Marketing Authorisation for REKAMBYS ® (rilpivirine injection) in combination with ViiV Healthcare’s VOCABRIA® (cabotegravir injection) |
| 2020-10-16 | GlaxoSmithKline | Regulatory ViiV Healthcare receives positive CHMP opinion for long-acting regimen for the treatment of HIV gsk.com ↗
Today’s positive CHMP opinion marks an important step in providing a new option that changes the treatment experience for people living with HIV across Europe. |
| 2020-10-16 | ViiV Healthcare | Regulatory ViiV Healthcare receives positive CHMP opinion for long-acting regimen for the treatment of HIV viivhealthcare.com ↗ |
| 2020-07-07 | GlaxoSmithKline | Results ViiV Healthcare announces superior efficacy of investigational, long-acting injectable formulation of cabotegravir dosed every two months over daily oral PrEP gsk.com ↗
Final analysis has since confirmed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets. |
| 2020-07-07 | ViiV Healthcare | Results ViiV Healthcare announces superior efficacy of investigational, long-acting injectable formulation of cabotegravir dosed every two months over daily oral PrEP viivhealthcare.com ↗
Final analysis has since confirmed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets. |
| 2020-07-04 | GlaxoSmithKline | Results ViiV Healthcare presents positive data from first-ever implementation research study on how best to integrate an investigational once-monthly injectable HIV treatment in US healthcare practices gsk.com ↗
Initial findings presented at AIDS 2020 showed healthcare providers and clinical staff perceived implementation of the investigational treatment as acceptable, feasible and appropriate for people living with HIV. |
| 2020-07-04 | ViiV Healthcare | Results ViiV Healthcare presents positive data from first-ever implementation research study on how best to integrate an investigational once-monthly injectable HIV treatment in US healthcare practices viivhealthcare.com ↗
Initial findings presented at AIDS 2020 showed healthcare providers and clinical staff perceived implementation of the investigational treatment as acceptable, feasible and appropriate for people living with HIV |
| 2020-05-18 | GlaxoSmithKline | Results Global HIV prevention study to stop early after ViiV Healthcare’s long-acting injectable formulation of cabotegravir dosed every two months shows higher efficacy than daily oral PrEP gsk.com ↗ |
| 2020-05-18 | ViiV Healthcare | Results Global HIV prevention study to stop early after ViiV Healthcare’s long-acting injectable formulation of cabotegravir dosed every two months shows higher efficacy than daily oral PrEP viivhealthcare.com ↗
The study achieved its primary objective of non-inferiority with the difference approaching superiority in favour of cabotegravir, pending final analysis. |
| 2020-03-20 | Janssen Research & Development, LLC | Regulatory Janssen Announces Health Canada Approval of CABENUVA™, the First Long-Acting Regimen for the Treatment of HIV jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that Health Canada has approved CABENUVA™ (cabotegravir and rilpivirine extended release injectable suspensions), the first and only once-monthly, long-acting regimen for the treatment of HIV-1 infection in adults. |
| 2020-03-20 | GlaxoSmithKline | Regulatory ViiV Healthcare announces first global regulatory approval of CABENUVA; the first complete, long-acting, regimen for the treatment of HIV gsk.com ↗
These approvals are the first for CABENUVA and VOCABRIA anywhere in the world. |
| 2020-03-20 | ViiV Healthcare | Regulatory "ViiV Healthcare announces first global regulatory approval of CABENUVA; the first complete, long-acting, regimen for the treatment of HIV" viivhealthcare.com ↗
today announced that Health Canada has approved CABENUVA, the first and only once-monthly, complete long-acting regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral (ARV) regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per millilitre [mL]). |
| 2020-03-11 | Janssen Research & Development, LLC | Results Janssen Announces Results of Phase 3 Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen of Rilpivirine And Cabotegravir through 96 Weeks jnj.com ↗
The study – First Long-Acting Injectable Regimen (FLAIR) trial – demonstrated positive 96-week results in long-term safety and efficacy of rilpivirine and cabotegravir. |
| 2020-03-11 | Janssen Research & Development, LLC | Results Janssen Announces 48-week Results of Phase 3b Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment of Rilpivirine and Cabotegravir Administered Every Two Months jnj.com ↗
The global Phase 3b ATLAS-2M study met its primary endpoint, finding that every-eight-week (two-months) dosing of the LA regimen was noninferior to every-four-week (monthly) dosing. |
| 2020-03-09 | GlaxoSmithKline | Results ViiV Healthcare presents positive long-term data from phase III study demonstrating efficacy and safety of cabotegravir and rilpivirine, its investigational, long-acting, injectable treatment regimen in adults living with HIV-1 gsk.com ↗
The study demonstrated that the 2DR of once-monthly cabotegravir and rilpivirine continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC) at Week 96. |
| 2020-03-09 | GlaxoSmithKline | Results ViiV Healthcare presents positive 48-week data from phase III study showing every-two-month regimen of investigational long-acting, injectable cabotegravir and rilpivirine has similar efficacy to once-monthly dosing gsk.com ↗
The study met its primary endpoint at Week 48, showing that the antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks (two months) was non-inferior when compared to its administration every four weeks (monthly). |
| 2020-03-09 | ViiV Healthcare | Results ViiV Healthcare presents positive 48-week data from phase III study showing every-two-month regimen of investigational long-acting, injectable cabotegravir and rilpivirine has similar efficacy to once-monthly dosing viivhealthcare.com ↗
The study met its primary endpoint at Week 48, showing that the antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks (two months) was non-inferior when compared to its administration every four weeks (monthly). |
| 2019-12-21 | Janssen Research & Development, LLC | Regulatory Complete Response Letter Issued from U.S. FDA for Investigational Long-Acting HIV Regimen jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to ViiV Healthcare’s (ViiV) New Drug Application for the two-drug long-acting (LA) injectable regimen of ViiV’s cabotegravir and Janssen’s rilpivirine for the treatment of HIV-1 infection in adults. |
| 2019-12-21 | ViiV Healthcare | Regulatory ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV viivhealthcare.com ↗
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults. |
| 2019-08-22 | Janssen Research & Development, LLC | Results Janssen Reports Positive Top-line Phase 3 Study Results of Investigational, Long-acting Injectable HIV Treatment Regimen Administered Every Two Months jnj.com ↗
ATLAS-2M study met its primary objective of demonstrating similar efficacy of long-acting rilpivirine and cabotegravir administered every two months compared to monthly administration |
| 2019-08-22 | GlaxoSmithKline | Results ViiV Healthcare reports positive phase III study results of investigational, long-acting, injectable HIV-treatment regimen administered every two months gsk.com ↗
The study met its primary endpoint, showing that the long-acting regimen of cabotegravir and rilpivirine, injected every two months, was non-inferior to cabotegravir and rilpivirine administered every month at Week 48. |
| 2019-08-22 | ViiV Healthcare | Results ViiV Healthcare reports positive phase III study results of investigational, long-acting, injectable HIV-treatment regimen administered every two months viivhealthcare.com ↗
The study met its primary endpoint, showing that the long-acting regimen of cabotegravir and rilpivirine, injected every two months, was non-inferior to cabotegravir and rilpivirine administered every month at Week 48. |
| 2019-07-29 | GlaxoSmithKline | Regulatory ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine as the first monthly, injectable treatment for HIV gsk.com ↗
ViiV Healthcare is proud to be sending a regulatory submission to the EMA for what will be a first-of-its-kind treatment. |
| 2019-07-29 | ViiV Healthcare | Regulatory ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine as the first monthly, injectable treatment for HIV viivhealthcare.com ↗ |
| 2019-04-30 | ViiV Healthcare | Regulatory ViiV HEALTHCARE SUBMITS NEW DRUG APPLICATION TO US FDA FOR THE FIRST MONTHLY, INJECTABLE, TWO-DRUG REGIMEN OF CABOTEGRAVIR AND RILPIVIRINE FOR TREATMENT OF HIV viivhealthcare.com ↗ |
| 2019-04-29 | Janssen Research & Development, LLC | Regulatory Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV jnj.com ↗ |
| 2019-04-29 | Janssen Research & Development, LLC | Regulatory Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV jnj.com ↗
Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV |
| 2019-04-29 | GlaxoSmithKline | Regulatory ViiV Healthcare submits New Drug Application to US FDA for the first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine for treatment of HIV gsk.com ↗ |
| 2019-03-07 | GlaxoSmithKline | Results ViiV Healthcare presents positive, 48-week data from two pivotal phase III studies showing long-acting, injectable two-drug regimen of cabotegravir and rilpivirine has similar efficacy to daily, three-drug oral treatment in adults living with HIV-1 infection gsk.com ↗
The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%. 95% CI: -3.7, 4.5). |
| 2019-03-07 | ViiV Healthcare | Results ViiV HEALTHCARE PRESENTS POSITIVE, 48-WEEK DATA FROM TWO PIVOTAL PHASE III STUDIES SHOWING LONG-ACTING, INJECTABLE TWO-DRUG REGIMEN OF CABOTEGRAVIR AND RILPIVIRINE HAS SIMILAR EFFICACY TO DAILY, THREE-DRUG ORAL TREATMENT IN ADULTS LIVING WITH HIV-1 INFECTION viivhealthcare.com ↗
The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%. 95% CI: -3.7, 4.5). |
| 2018-10-30 | GlaxoSmithKline | Results ViiV Healthcare reports positive 48-week results for second phase III study for novel, long-acting, injectable HIV-treatment regimen gsk.com ↗
The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to Triumeq at Week 48 based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre [c/mL] using the FDA Snapshot algorithm. |
| 2018-10-29 | GlaxoSmithKline | Results ViiV Healthcare presents three-year data for investigational long-acting injectable, two-drug HIV regimen gsk.com ↗
At 160 weeks, the long-acting regimen, administered either every eight weeks or every four weeks, demonstrated high rates of virologic response, long-term durability of virologic response and good overall tolerability. |
| 2018-08-15 | GlaxoSmithKline | Results ViiV Healthcare reports positive 48-week results for first pivotal, phase III study for novel, long-acting, injectable HIV-treatment regimen gsk.com ↗
The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to a standard of care, daily, oral three-drug regimen at Week 48. |
| 2017-07-24 | GlaxoSmithKline | Results Phase II study results showed comparable viral suppression rates at 96 weeks for a two-drug regimen of long-acting cabotegravir and rilpivirine and a three-drug regimen in patients with HIV gsk.com ↗ |
| 2016-02-24 | GlaxoSmithKline | Results ViiV Healthcare announces first phase II HIV prevention study results for investigational long-acting injectable cabotegravir gsk.com ↗
Results showed drug concentrations were lower than anticipated at the end of the dosing interval in approximately two-thirds of participants. |
| 2016-02-23 | GlaxoSmithKline | Results ViiV Healthcare announces phase II study results for first two drug, long-acting injectable regimen for HIV-1 treatment gsk.com ↗
Following 32 weeks of maintenance treatment, viral suppression rates (%) for the two drug regimen dosed every eight weeks (95%) or every four weeks (94%) were comparable to the rate observed in patients continuing with a three drug oral regimen (91%). |
| 2015-11-03 | Janssen Research & Development, LLC | Results First Investigational All Injectable Long Acting HIV Combination Regimen Study Results at 32 Weeks Announced jnj.com ↗
Injectable combinations once every 4 or 8 weeks show comparable e cacy versus daily oral combination therapy |
| 2015-11-03 | GlaxoSmithKline | Results ViiV Healthcare announces positive headline results from a study of two drug injectable regimen for HIV maintenance therapy gsk.com ↗
These results show that the investigational, long acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) were comparable in maintaining viral suppression rates to a three drug oral regimen of investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs). |
| 2009-09-13 | GlaxoSmithKline | Results Antiviral Activity of S/GSK1265744, a Once-Daily, Unboosted Integrase Inhibitor in Clinical Development, Evaluated in Phase 1-2a Study in Healthy and HIV-Infected Subjects gsk.com ↗
The data showed a significant decline in viral load in HIV-infected patients, as well as favorable pharmacokinetic and short-term safety profiles in healthy subjects and HIV-infected patients. |
All press releases naming this drug 138 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 138 releases opens the full record — a long page | ||
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 95 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 ↗71“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 ↗ |
| 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 ↗3“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 ↗ “The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure...” NCT05514509 ↗ “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 ↗ |
| 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 | 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 | CABLA | “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 ↗17“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 injectable cabotegravir (CAB LA) given every 2 months” NCT05546242 ↗ “long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP)” NCT05986084 ↗ |
| 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 ↗ |