Drugs / Rilpivirine
Regulatory milestones approvals, filings & regulatory actions · 17 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 8 milestones | |||||
| Rejected (CRL) | US (FDA) | — | HIV infectious disease | 2019-12-21 | “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 ↗ “Rilpivirine and Cabotegravir - U.S. FDA issues Complete Response Letter Issued for Investigational Two-Drug Long-Acting HIV Regimen” jnj.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2019-10-15 | “Rilpivirine and Cabotegravir - Janssen Submits Application to EMA for Monthly, Injectable, Two Drug Regimen for Treatment of HIV (EU)” jnj.com ↗ “Long-acting injectable cabotegravir + rilpivirine submitted to EMA as the first monthly treatment for HIV” gsk.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2019-07-29 | “ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine” viivhealthcare.com ↗ “Janssen Submits Regulatory Application to European Medicines Agency for Rilpivirine Long Acting” jnj.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2019-07-03 | “ViiV Healthcare submits New Drug Application to US FDA for the first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine” viivhealthcare.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2019-04-29 | “Long-acting cabotegravir+rilpivirine filed in the US for treatment of HIV.” gsk.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2017-07-26 | “HIV two drug regimen (dolutegravir and rilpivirine) filed for approval in US and EU” gsk.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2017-07-26 | “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 ↗ “resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the US Food and Drug Administration (FDA)” viivhealthcare.com ↗ “resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the US Food and Drug Administration” viivhealthcare.com ↗ “recent submission of a New Drug Application (NDA) for the 2DR of cabotegravir and rilpivirine” viivhealthcare.com ↗ “HIV two drug regimen (dolutegravir and rilpivirine) filed for approval in US and EU” gsk.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2015-08-20 | “rilpivirine 25 mg (R/F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA).” gilead.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (7) | US (FDA) | EDURANT | — | 2012-12-07 – 2024-03-15 | fda.gov ↗ |
| Approved | EU (EMA) | Eviplera | — | 2011-11-27 | europa.eu ↗ |
| Approved | US (FDA) | EDURANT | — | 2011-05-20 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 131 trials | ||||||
| Phase 1 | NCT05418868 | Jun 2022 → Jun 2027 expected | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 1 | NCT07001488 | Feb → May 2022 | — | Henan Genuine Biotech Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05112939 | Nov 2021 → May 2024 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05358756 | Oct → Nov 2021 | — | Aptorum International Limited | Completed | No outcome recorded |
| Phase 1 | NCT04371380 | Sep 2020 → Dec 2021 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT03984838 | Jun → Aug 2019 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT03127189 | Apr 2017 → Apr 2018 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02561936 | Oct 2015 → Apr 2016 | — | Janssen Sciences Ireland UC | Completed | No outcome recorded |
| Phase 1 | NCT02547870 | Aug 2015 → Apr 2016 | HIV infectious disease | Janssen Infectious Diseases BVBA | Completed | No outcome recorded |
| Phase 1 | NCT02373930 | Feb → Sep 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01796431 | Mar → Jul 2013 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT01656018 | Nov 2012 → Jan 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01719614 | Oct 2012 → Jan 2013 | — | Janssen R&D Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01593046 | May 2012 → Nov 2013 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01615614 | Apr → Sep 2012 | — | Janssen R&D Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01562886 | Mar → Nov 2012 | HIV infectious disease | Imperial College London | Completed | No outcome recorded |
| Phase 1 | NCT01519128 | Jan → Apr 2012 | — | Janssen R&D Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01467531 | Nov 2011 → Feb 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01336829 | Mar → Sep 2011 | HIV infectious disease, hepatitis C virus infection | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01288755 | Feb → May 2011 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01275443 | Jan 2011 → Jun 2012 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT01205139 | Nov 2010 → Mar 2011 | chronic hepatitis C virus infection | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01268839 | Jan → May 2010 | HIV infectious disease | Tibotec, Inc | Completed | No outcome recorded |
| Phase 1 | NCT01001247 | Jan → Apr 2010 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01031589 | Jan 2010 → Jul 2011 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00812292 | Jan → Apr 2009 | — | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00744770 | Oct 2008 → Jun 2009 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00744809 | Aug 2008 → Jan 2009 | — | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00741741 | Jul 2008 → Nov 2009 | — | Tibotec Pharmaceuticals, Ireland | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT00739622 | Jul → Dec 2008 | AIDS | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00736905 | Jun 2008 → Sep 2009 | AIDS | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| 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 1/2 | NCT01975012 | Sep 2014 → May 2018 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01049932 | Mar → May 2010 | HIV infectious disease | St Stephens Aids Trust | Terminated | No outcome recorded |
| Phase 212 trials · 1 missed | ||||||
| Phase 2 | NCT07637877 | Jun 2026 → Dec 2028 expected | immunodeficiency disease | Beijing 302 Hospital | 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 | NCT05991622 | Apr 2022 → Aug 2025 | HIV infectious disease, opiate dependence | Rhode Island Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04012931 | Jul 2019 → Feb 2023 | HIV infectious disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT03589040 | Sep 2018 → Jun 2019 | HIV infectious disease | Makerere University | Unknown | No outcome recorded |
| Phase 2 | NCT03639311 | Sep 2018 → Dec 2019 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT03589027 | Aug 2018 → Jun 2019 | HIV infectious disease | Makerere University | Unknown | No outcome recorded |
| Phase 2 | NCT02494986 | Jul 2015 → Aug 2026 overdue | HIV infectious disease | Janssen Sciences Ireland UC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01641809 | Aug 2012 → Oct 2013 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT00799864 | Jan 2011 → Aug 2022 | — | Janssen Sciences Ireland UC | Completed | No outcome recorded |
| Phase 2 | NCT01286740 | Jan → Jul 2011 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00110305 | Jun 2005 → Dec 2011 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | Missed primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03033368 | Jul 2015 → Jun 2017 | HIV infectious disease | Mahidol University | Unknown | No outcome recorded |
| Phase 2/3 | NCT02069834 | May 2014 → Oct 2017 | HIV infectious disease | Nantes University Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 331 trials · 13 met primary · 1 missed | ||||||
| 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 | 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 | NCT05896761 | Oct 2021 → Aug 2022 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT04867083 | Jun 2021 → Jul 2023 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Unknown | Missed primary |
| 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 | NCT05349838 | Nov 2018 → Nov 2021 | HIV infectious disease | NEAT ID Foundation | Completed | No outcome recorded |
| Phase 3 | NCT03563742 | Sep 2018 → Jun 2021 | HIV infectious disease | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| 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 3 | NCT02707601 | Apr 2016 → Sep 2017 | HIV infectious disease, hepatitis C virus infection | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02422797 | Apr 2015 → Sep 2016 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT02429791 | Apr 2015 → Sep 2016 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT02345226 | Jan 2015 → Jun 2016 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01792570 | Sep 2014 → Dec 2018 | HIV infectious disease | ASST Fatebenefratelli Sacco | Completed | No outcome recorded |
| Phase 3 | NCT01709084 | Oct 2013 → Oct 2015 | HIV infectious disease | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 3 | NCT01701882 | Sep 2012 → Nov 2013 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 3 | NCT01309243 | Feb 2011 → Sep 2012 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01266902 | Feb 2011 → Feb 2020 | HIV infectious disease | Janssen R&D Ireland | Completed | No outcome recorded |
| Phase 3 | NCT00855335 | Apr 2009 → Aug 2016 | HIV infectious disease, pregnancy disorder | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00543725 | Jun 2008 → Jan 2010 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | Met primary |
| Phase 3 | NCT00540449 | May 2008 → Feb 2010 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | Met primary |
| Phase 416 trials · 1 met primary | ||||||
| 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 | NCT05898841 | May 2023 → Jul 2025 | HIV infectious disease, metabolic dysfunction-associated steatotic liver disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT04982445 | Nov 2021 → Jan 2024 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT04431518 | Apr 2021 → Jul 2023 | HIV infectious disease, end stage renal failure | Indiana University | Completed | No outcome recorded |
| Phase 4 | NCT03567304 | Jul 2018 → Jul 2020 | HIV infectious disease, cognitive disorder | Chiang Mai University | Unknown | No outcome recorded |
| Phase 4 | NCT04064632 | Feb 2017 → Jun 2019 | HIV infectious disease | A.O. Ospedale Papa Giovanni XXIII | Unknown | Met primary |
| Phase 4 | NCT02529059 | Nov 2015 → May 2017 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 4 | NCT02547844 | Sep 2015 → Oct 2016 | — | Hospital Universitari Vall d'Hebron Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02530060 | Aug → Sep 2015 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 4 | NCT02042001 | Jul 2015 → Jul 2017 | HIV infectious disease, cognitive disorder, mixed anxiety and depressive disorder | Azienda Ospedaliera San Gerardo di Monza | Completed | No outcome recorded |
| Phase 4 | NCT02447016 | May 2015 → Dec 2016 | HIV infectious disease | Sheba Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT02404233 | Mar 2015 → Sep 2016 | HIV infectious disease | Therapeutic Concepts | Unknown | No outcome recorded |
| Phase 4 | NCT01804244 | Mar 2013 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 4 | NCT01715636 | Dec 2012 → Jul 2014 | — | Andrew Carr | Completed | No outcome recorded |
| Phase 4 | NCT01736761 | Dec 2012 → Mar 2015 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 4 | NCT00955968 | Jan 2010 → Aug 2016 | HIV infectious disease | International Maternal Pediatric Adolescent AIDS Clinical Trials Group | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05044962 | Nov 2021 → Mar 2027 expected | HIV infectious disease | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| — | NCT03251690 | Oct 2016 → Apr 2018 | HIV infectious disease, hyperlipidemia | Mahidol University | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03847376 | — | HIV infectious disease | Janssen Sciences Ireland UC | Approved for marketing | No outcome recorded |
| Comparator or background therapy25 trials | ||||||
| Phase 1 | NCT03060447 Background | May 2017 → Feb 2020 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02556268 Background | Feb → Dec 2016 | — | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT06338826 Background | Feb 2025 → Sep 2027 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05729568 Background | May 2023 → Jul 2024 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02165202 Comparator | Oct 2014 → Apr 2015 | HIV infectious disease | PATH | Completed | No outcome recorded |
| Phase 2 | NCT02120352 Comparator | Apr 2014 → Aug 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2/3 | NCT02104700 Comparator | Apr 2014 → May 2016 | HIV infectious disease | Philip Grant | 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 | NCT06630299 Comparator | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT03256422 Background | Sep 2017 → Aug 2019 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 3 | NCT02616783 Comparator | Dec 2015 → Feb 2018 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02605954 Comparator | Nov 2015 → Jun 2017 | HIV infectious disease | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT02469246 Background | Jun 2015 → Dec 2017 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02397096 Background | Jun 2015 → Feb 2018 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02345252 Background | Jan 2015 → Jun 2016 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02302547 Comparator | Dec 2014 → Aug 2017 | HIV infectious disease | University Hospital, Tours | Completed | No outcome recorded |
| Phase 3 | NCT02157311 Background | Jul 2014 → Jan 2016 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 3 | NCT02121795 Background | May 2014 → Aug 2015 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01495702 Comparator | Dec 2011 → Nov 2013 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 4 | NCT06185452 Comparator | Sep 2023 → May 2025 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 4 | NCT02470650 Comparator | Jun 2015 → Jul 2017 | poisoning | Juan A. Arnaiz | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01585038 Comparator | Jul 2012 → May 2014 | cardiovascular disorder | Indiana University | 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 |
| — | NCT03664440 Comparator | Dec 2016 → Oct 2017 | — | Mahidol University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 121
| 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. |
| 2026-02-24 | 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. |
| 2025-07-24 | 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. |
| 2025-07-14 | GlaxoSmithKline | Results ViiV Healthcare data show 89% of treatment-naïve people with HIV choose to switch to long-acting injectable Vocabria + Rekambys from daily pills after achieving rapid viral suppression gsk.com ↗
Multiple real-world studies show consistent high effectiveness of Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) across a broad range of populations |
| 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 ↗
Real-world data were also presented for Cabenuva, the only approved, complete long-acting injectable treatment regimen, showing its effectiveness in the three years since it has been available. |
| 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 ↗
Real-world data were also presented for Cabenuva, the only approved, complete long-acting injectable treatment regimen, showing its effectiveness in the three years since it has been available. |
| 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 |
| 2024-10-28 | Janssen Research & Development, LLC | Regulatory European Commission Approves Expanded Use of HIV-1 Therapy EDURANT® (rilpivirine) in Younger Pediatric Patients jnj.com ↗ |
| 2024-10-10 | ViiV Healthcare | Results GSK AND ViiV HEALTHCARE TO SHOWCASE ADVANCES ACROSS INDUSTRY-LEADING INFECTIOUS DISEASE PORTFOLIO AT IDWEEK 2024 viivhealthcare.com ↗
CD4 T-cell, CD4/CD8 Ratio Improvement and a General Reduction in Inflammatory Biomarkers with Low-Level Viremia (LLV) up to Week 192 with Fostemsavir (FTR)-Based Regimens in Individuals with Multidrug-Resistant (MDR) HIV-1 |
| 2024-03-19 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves EDURANT® PED (rilpivirine) for Certain Pediatric Patients Living with HIV-1 jnj.com ↗
Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved EDURANT® PED (rilpivirine) for the treatment of HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) at least 2 years of age and weighing at least 14 kg and less than 25 kg. |
| 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. |
| 2024-02-28 | GlaxoSmithKline | Results ViiV Healthcare to present data for its next generation of ultra long-acting treatments for HIV gsk.com ↗
The NIAID/ACTG also announced a modification to the study, where further randomisation has been stopped and participants in the SOC arm are being given the option to switch to the long-acting therapy arm. |
| 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 marketing authorisation for rilpivirine long-acting injection was received on the 18 October 2023 |
| 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 ↗ |
| 2023-07-28 | Janssen Research & Development, LLC | Regulatory Janssen Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy EDURANT® jnj.com ↗
A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe. |
| 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. |
| 2021-07-17 | 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 ↗
CAB-LA and FTC/TDF tablets were both well tolerated throughout the study, with most adverse events being mild or moderate in severity and with the frequency largely balanced between both treatment arms. |
| 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. |
| 2021-03-06 | 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 (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. |
| 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. |
| 2020-10-22 | 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 ↗ |
| 2020-07-04 | 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 |
| 2020-03-20 | 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. |
| 2019-11-06 | GlaxoSmithKline | Results EACS 2019: ViiV Healthcare to present 17 abstracts from its portfolio addressing the diverse needs of people living with HIV gsk.com ↗
SWORD 1&2: Maintenance or improvement in renal function in PLWH through 148 weeks after switch to the dolutegravir + rilpivirine 2-drug regimen |
| 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 | Janssen Research & Development, LLC | Regulatory Janssen Submits Regulatory Application to European Medicines Agency for Rilpivirine Long Acting, to Be Used in Combination with Cabotegravir Long Acting, as the First Monthly Injectable Treatment for HIV jnj.com ↗
Janssen Submits Regulatory Application to European Medicines Agency for Rilpivirine Long Acting, to Be Used in Combination with Cabotegravir Long Acting, as the First Monthly Injectable Treatment for HIV |
| 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 ↗ |
| 2019-04-04 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES JULUCA (DOLUTEGRAVIR/RILPIVIRINE) MAINTAINS HIV VIRAL SUPPRESSION AT 148-WEEKS viivhealthcare.com ↗
With the SWORD data we now have three year data showing the excellent effectiveness and tolerability of Juluca, the first approved dolutegravir-based 2-drug regimen. |
| 2019-04-03 | GlaxoSmithKline | Results ViiV Healthcare announces Juluca (dolutegravir/rilpivirine) maintains HIV viral suppression at 148-weeks gsk.com ↗
ViiV Healthcare today presented three year results from the SWORD 1 & 2 studies, demonstrating that 84% (432/513) of participants who switched from their current three- or four-drug antiretroviral regimen to a 2-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson) maintained viral suppression (viral load ≤50 copies/mL). |
| 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). |
| 2018-11-26 | GlaxoSmithKline | Regulatory Juluca (dolutegravir/rilpivirine), the first single pill, 2-drug regimen, for the maintenance treatment of HIV, granted marketing approval by Japan Ministry of Health, Labour and Welfare gsk.com ↗
This regulatory approval demonstrates our commitment to bringing new medicines for people living with HIV, as they now have the opportunity to maintain their viral suppression with only two drugs within a single-pill. |
| 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. |
| 2018-07-24 | GlaxoSmithKline | Results ViiV Healthcare announces SWORD 100-week data for Juluca (dolutegravir/rilpivirine) at AIDS 2018 gsk.com ↗
The results confirm the ability of Juluca to maintain efficacy over a 100-week period and importantly support that the long-term safety profile of this regimen is consistent with the respective labels of the component medicines. |
| 2018-03-23 | GlaxoSmithKline | Regulatory ViiV Healthcare gains CHMP positive opinion for Juluca (dolutegravir/rilpivirine) in Europe gsk.com ↗
today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) |
| 2017-11-21 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of First and Only Complete, Single-Pill, Two-Drug Regimen, JULUCA® (Dolutegravir and Rilpivirine), for the Treatment of HIV-1 In jnj.com ↗
“Today’s approval of JULUCA® marks a significant milestone in the treatment of HIV,” said Brian Woodfall, Global Head of Late Development, Janssen Research & Development. |
| 2017-11-21 | GlaxoSmithKline | Regulatory Juluca® (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill - a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection gsk.com ↗
The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care. |
| 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 ↗ |
| 2017-06-01 | GlaxoSmithKline | Regulatory ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines gsk.com ↗ |
| 2017-02-13 | GlaxoSmithKline | Results ViiV Healthcare announces detailed positive phase III results for investigational two-drug regimen of dolutegravir and rilpivirine for HIV treatment gsk.com ↗
Virologic suppression rates were similar between treatment arms. |
| 2016-12-19 | GlaxoSmithKline | Results ViiV Healthcare announces positive results from first phase III studies of two-drug HIV treatment regimen gsk.com ↗ |
| 2016-07-21 | Gilead Sciences | Results Gilead’s Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) Meets Primary 48-Week Objective in Two Phase 3b Studies gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that two Phase 3b switch studies evaluating Odefsey ® (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) for the treatment of HIV-1 infection met their primary objectives. |
| 2016-04-29 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗ |
| 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 ↗
Issued: London London, UK, 23 February 2016 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today presented positive results from the LATTE-2 study at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. |
| 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). |
| 2013-12-13 | Gilead Sciences | Regulatory U.S. FDA Approves Gilead’s Once-Daily Single Tablet HIV-1 Regimen Complera® for Patients Switching from a Stable Regimen gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved the single tablet HIV-1 regimen Complera ® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA |
| 2012-07-24 | Gilead Sciences | Results Gilead’s Once-Daily Single Tablet Regimen Complera® Maintains HIV Suppression Among Patients Switching From Protease Inhibitor-Based Regimens gilead.com ↗
The study met its 24-week primary endpoint, which found that switching to Complera was non-inferior to remaining on a ritonavir-boosted protease inhibitor regimen. |
| 2011-11-28 | Gilead Sciences | Regulatory Gilead Receives European Marketing Authorization for Eviplera(R), a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naive Adults gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Eviplera ® (emtricitabine/rilpivirine/tenofovir disoproxil), a complete once-daily single-tablet regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL. |
| 2011-09-23 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Eviplera(R), a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection gilead.com ↗
The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union (EU). |
| 2011-08-10 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead Sciences' Complera(TM), a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults gilead.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved Complera(TM) (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults. |
| 2011-02-10 | Gilead Sciences | Regulatory Gilead Sciences Refiles New Drug Application with the FDA for Single-Tablet Regimen of Truvada(R) and TMC278 gilead.com ↗
Specifically, the FDA requested additional information on the analytical methodology and qualification data used to establish acceptable levels of recently identified degradants related to emtricitabine; this information has been included in the refiling. |
| 2011-01-25 | Gilead Sciences | Regulatory Gilead Sciences Receives Refuse to File Notification From U.S. FDA on New Drug Application for Single-Tablet Regimen of Truvada(R) and TMC278 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that it has received a "refuse to file" notification from the U.S. Food and Drug Administration (FDA) regarding Gilead's New Drug Application (NDA) for the single-tablet regimen of Truvada (R) (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. |
| 2010-11-23 | Gilead Sciences | Regulatory Gilead Sciences Submits New Drug Application to U.S. FDA for Once-Daily Single-Tablet Regimen of Truvada(R) and TMC278 for HIV gilead.com ↗ |
| 2010-09-03 | Gilead Sciences | Regulatory Gilead Sciences Submits European Marketing Application for Once-Daily Single-Tablet Regimen of Truvada(R) and TMC278 for the Treatment of HIV Infection gilead.com ↗
An MAA for TMC278 also is being submitted today by Tibotec to the EMA for review. |
| 2010-04-27 | Gilead Sciences | Results Gilead Finalizes Selection of Bioequivalent Formulation for the Fixed-Dose Regimen of Truvada(R) and Tibotec Pharmaceuticals' TMC278 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg). |
| 2010-04-20 | Gilead Sciences | Results Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada(R) and Tibotec Pharmaceuticals' TMC278 gilead.com ↗
Pivotal Phase III Studies of TMC278 Met Primary Objective |
All press releases naming this drug 135 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 135 releases opens the full record — a long page | ||
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 135 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rilpivirine | “This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide...” NCT02707601 ↗106“Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose...” NCT00955968 ↗ “A Pilot Randomized Controlled Trial of Switch to Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus Continue TDF/FTC/Efavirenz (EFV) Treatment Among...” NCT02042001 ↗ “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 ↗ “Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir...” NCT05729568 ↗ “In a two-panel, two-way, crossover study, healthy volunteers were randomized to receive etravirine 200 mg twice daily ± telaprevir 750 mg every 8 hours or rilpivirine 25 mg...” PMID 25975423 ↗ May 2014 “The pharmacokinetics (PK) of dolutegravir (DTG) and rilpivirine (RPV), the components of JULUCA, in patients with end stage renal disease (ESRD) requiring hemodialysis (HD)...” NCT04431518 ↗ “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 “one oral tablet of 25 mg RPV daily administered concomitantly with DTG along with a meal. Each RPV tablet contained 27.5 mg of rilpivirine hydrochloride, which was equivalent...” NCT02422797 ↗ “Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily” NCT01286740 ↗ |
| Known as | Edurant | “They may be administered in combination as 50/25 mg/day tablets (Juluca 50/25) or separately as Dolutegravir 50 mg/d tablets together with Rilpivirine 25 mg/d tablets (Tivicay...” NCT05898841 ↗3“Treatment C: Edurant, 150 mg (6 × 25 mg rilpivirine, oral tablets), fed” NCT05358756 ↗ “rilpivirine (RPV; Edurant®)” NCT02605954 ↗ “rilpivirine (RPV;Edurant®)” NCT02616783 ↗ |
| Known as | Edurant ped | ChEMBL registry synonym — accepted as the source's own label CHEMBL175691 ↗ |
| Known as | G002 | “Rilpivirine G002 formulation as 10 g of 2.5 milligram per gram (mg/gm) granules.” NCT02561936 ↗ |
| Known as | G007 | “Rilpivirine G007 formulation as 10\*2.5 mg tablets.” NCT02561936 ↗ |
| Known as | G009-01 | “Rilpivirine G009-01 formulation as 10\*2.5 mg tablets.” NCT02561936 ↗ |
| Known as | R 278474 | ChEMBL registry synonym — accepted as the source's own label CHEMBL175691 ↗ |
| Known as | Rekambys | “Hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as standard of care.” NCT06185452 ↗ |
| Known as | rilpivirina | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02547844 ↗ |
| Known as | Rilpivirine (as hydrochloride) | ChEMBL registry synonym — accepted as the source's own label CHEMBL175691 ↗ |
| Known as | Rilpivirine component of cabenuva | ChEMBL registry synonym — accepted as the source's own label CHEMBL175691 ↗ |
| Known as | Rilpivirine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL175691 ↗ |
| Known as | rilpivirine hydrochloride | “Levels of the active ingredients, Tenofovir disoproxil fumarate, emtricitabine, rilpivirine hydrochloride will be measured in in blood after the drug intake has been stopped in...” NCT01796431 ↗ |
| Known as | Rilpivirine hydrochloride component of complera | ChEMBL registry synonym — accepted as the source's own label CHEMBL175691 ↗ |
| Known as | Rilpivirine hydrochloride component of eviplera | ChEMBL registry synonym — accepted as the source's own label CHEMBL175691 ↗ |
| Known as | Rilpivirine hydrochloride component of juluca | ChEMBL registry synonym — accepted as the source's own label CHEMBL175691 ↗ |
| Known as | Rilpivirine hydrochloride component of odefsey | ChEMBL registry synonym — accepted as the source's own label CHEMBL175691 ↗ |
| Known as | Rilpivirine Long-Acting Parenteral Formulation | “rilpivirine long-acting parenteral formulation (RPV-LA)” NCT02547870 ↗ |
| Known as | RPV | “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 ↗44“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 ↗ “Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose...” NCT00955968 ↗ “A Pilot Randomized Controlled Trial of Switch to Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus Continue TDF/FTC/Efavirenz (EFV) Treatment Among...” NCT02042001 ↗ “The aim of this study is to assess the efficacy and tolerability of a dual combined therapy of Dolutegravir (DTG) 50 mg Once Daily (OD) + Rilpivirine (RPV) 25 mg OD in...” NCT05349838 ↗ “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 ↗ “Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are...” NCT03984838 ↗ “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 ↗ “Participants will continue to receive oral tablets of rilpivirine (RPV) 25 milligram once daily (mg qd) or a weight-adjusted dose, in combination with an investigator selected...” NCT02494986 ↗ “Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg...” NCT01641809 ↗ “A long-acting injectable formulation of rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor, is currently under investigation for use in human immunodeficiency...” PMID 33191765 ↗ Jan 2021 |
| Known as | RPV LA | “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 ↗7“RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.” NCT04542070 ↗ “long acting injectable rilpivirine (RPV LA) plus long acting injectable cabotegravir” NCT05546242 ↗ “Rilpivirine Long-Acting (RPV LA) will be given IM into the opposite buttock.” NCT05154747 ↗ “rilpivirine long-acting parenteral formulation (RPV-LA)” NCT02547870 ↗ “Rilpivirine Long Acting (RPV LA) injectable suspension” NCT03847376 ↗ “Drug: Long-Acting Injectable Rilpivirine (RPV LA)” NCT03497676 ↗ “Rilpivirine - Injectable Suspension (RPV LA)” NCT05896748 ↗ |
| Known as | RPV ULA | “Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA)” NCT07650916 ↗ |
| Known as | TMC-278 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL175691 ↗ |
| Known as | TMC278 | “A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children...” NCT00799864 ↗22“Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV.” NCT02165202 ↗ “TMC278 (rilpivirine) One 25 mg tablet once daily up to 12 weeks postpartum.” NCT00855335 ↗ “TMC278 (Rilpivirine) LA; Placebo” NCT01031589 ↗ |
| Action | Inhibit | “TMC278 is a next-generation nonnucleoside reverse transcriptase inhibitor highly active against wild-type and nonnucleoside reverse transcriptase inhibitor-resistant HIV-1 in vitro.” PMID 19926964 ↗ Jan 2010 |
| Modality | Small molecule | “TMC278 is a diarylpyrimidine (DAPY - a class of molecule that resembles the pyrimidine nucleotides found in DNA, and which have shown potency in inhibiting the activity of HIV...” NCT01049932 ↗ |
| Route | Oral | “to receive oral rilpivirine 25 mg once daily or efavirenz 600 mg once daily” PMID 21763935 ↗ Jul 2011 |
| Target | CARD8 | “It activates the CARD8 inflammasome - an intracellular "kill switch" - triggering pyroptosis selectively in HIV-infected cells.” NCT07637877 ↗ |