Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 ↗ |
Trials 100 · started per year
| 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 | NCT01031589 | Jan 2010 → Jul 2011 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01001247 | Jan → Apr 2010 | 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 |
| 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 |
| 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 | ||||||
| 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 |
| 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 | NCT01286740 | Jan → Jul 2011 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00799864 | Jan 2011 → Aug 2022 | — | Janssen Sciences Ireland UC | Completed | No outcome recorded |
| Phase 2 | NCT00110305 | Jun 2005 → Dec 2011 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| 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 |
| Phase 331 trials | ||||||
| Phase 3 | NCT07650916 | Jun 2026 → Sep 2029 expected | HIV infectious disease | ViiV Healthcare | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06694805 | Dec 2024 → Aug 2026 overdue | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 3 | NCT06507059 | Jul 2024 → Jul 2025 overdue | HIV infectious disease | Chang Gung Memorial Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05917509 | Jul 2023 → Sep 2025 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT05154747 | Jun 2023 → Mar 2025 | HIV infectious disease | University College, London | Unknown | No outcome recorded |
| Phase 3 | NCT05601128 | Jan 2023 → Apr 2025 | HIV infectious disease | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Completed | No outcome recorded |
| Phase 3 | NCT05546242 | Dec 2022 → Apr 2025 overdue | HIV infectious disease | MRC/UVRI and LSHTM Uganda Research Unit | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05896748 | Nov 2022 → Sep 2023 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | 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 | No outcome recorded |
| Phase 3 | NCT04542070 | Nov 2020 → Jul 2022 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT04399551 | Sep 2020 → Mar 2022 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT04001803 | Jul 2019 → Oct 2020 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT03635788 | Mar 2019 → Feb 2024 overdue | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 3 | 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 | No outcome recorded |
| Phase 3 | NCT02951052 | Oct 2016 → May 2018 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02938520 | Oct 2016 → Aug 2018 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02707601 | Apr 2016 → Sep 2017 | HIV infectious disease, hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02422797 | Apr 2015 → Sep 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT02429791 | Apr 2015 → Sep 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT02345226 | Jan 2015 → Jun 2016 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00540449 | May 2008 → Feb 2010 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 416 trials | ||||||
| Phase 4 | NCT06646562 | Mar 2025 → Jan 2026 overdue | — | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Recruiting | No outcome recorded |
| Phase 4 | 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 25 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 24 trials | ||||||
| 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 2/31 trial | ||||||
| Phase 2/3 | NCT02104700 Comparator | Apr 2014 → May 2016 | HIV infectious disease | Philip Grant | Completed | No outcome recorded |
| Phase 313 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02605954 Comparator | Nov 2015 → Jun 2017 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02469246 Background | Jun 2015 → Dec 2017 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02397096 Background | Jun 2015 → Feb 2018 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02345252 Background | Jan 2015 → Jun 2016 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01495702 Comparator | Dec 2011 → Nov 2013 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| 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 |
| Phase 4 | NCT01585038 Comparator | Jul 2012 → May 2014 | cardiovascular disorder | Indiana University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | 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 |
Press releases naming this drug 14 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-07-21 | Gilead Sciences | Gilead’s Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) Meets Primary 48-Week Objective in Two Phase 3b Studies gilead.com ↗ |
| 2016-06-23 | Gilead Sciences | European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV gilead.com ↗ |
| 2016-04-29 | Gilead Sciences | European CHMP Adopts Positive Opinion for Gilead’s TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗ |
| 2016-03-01 | Gilead Sciences | U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗ |
| 2015-08-20 | Gilead Sciences | European Medicines Agency Validates Gilead’s Marketing Application for Single Tablet Regimen Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) for HIV Treatment gilead.com ↗ |
| 2015-07-01 | Gilead Sciences | Gilead Submits New Drug Application to U.S. Food and Drug Administration for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) gilead.com ↗ |
| 2011-02-10 | Gilead Sciences | Gilead Sciences Refiles New Drug Application with the FDA for Single-Tablet Regimen of Truvada(R) and TMC278 gilead.com ↗ |
| 2011-01-25 | Gilead Sciences | 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 ↗ |
| 2011-01-25 | Gilead Sciences | 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 ↗ |
| 2010-11-23 | Gilead Sciences | 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 | 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 ↗ |
| 2010-04-27 | Gilead Sciences | Gilead Finalizes Selection of Bioequivalent Formulation for the Fixed-Dose Regimen of Truvada(R) and Tibotec Pharmaceuticals' TMC278 gilead.com ↗ |
| 2010-04-20 | Gilead Sciences | Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada(R) and Tibotec Pharmaceuticals' TMC278 gilead.com ↗ |
| 2009-07-16 | Gilead Sciences | Gilead Sciences Announces Agreement With Tibotec Pharmaceuticals to Develop and Commercialize New Fixed-Dose Combination of Truvada(R) and TMC278 gilead.com ↗ |
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 136 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 ↗ “The following agents are allowed as part of the ART regimen: nucleoside reverse transcriptase inhibitors, raltegravir, dolutegravir (DTG), rilpivirine, and maraviroc.” NCT03060447 ↗ “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 ↗ “Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen administered orally once daily with a meal” NCT01309243 ↗ “The oral formulation of rilpivirine (RPV), a nonnucleoside reverse transcriptase inhibitor (NNRTI), has been approved for treatment-naive HIV infection.” PMID 23979733 ↗ Aug 2013 “Rilpivirine will be supplied as a white to off-white, film-coated, round biconvex tablet with a unit dose strength of 25 mg to be administered orally” NCT02373930 ↗ “Tenofovir+Emtricitabine+Third agent (Including a non nucleoside reverse transcriptase inhibitor: efavirenz or nevirapine or etravirine or rilpivirine” NCT02302547 ↗ “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 ↗ “Baseline regimen of antiretroviral therapy with a NNRTI (efavirenz, nevirapine, or rilpivirine) administered according to the product circular” NCT02397096 ↗ “The efficacy and hepatic safety of the non-nucleoside reverse transcriptase inhibitors rilpivirine (TMC278) and efavirenz were compared” PMID 22532465 ↗ Apr 2012 “new long-acting medications such as cabotegravir co-administered with rilpivirine (CAB/RPV) and extended-release buprenorphine (XR-B)” NCT05991622 ↗ “CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) Intramuscular (IM) Administered Monthly and Every 2 Months” NCT05601128 ↗ “efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)” NCT02469246 ↗ “200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily” NCT02556268 ↗ “Each RPV tablet contained 27.5 mg of rilpivirine hydrochloride, which was equivalent to 25 mg of RPV.” NCT02429791 ↗ “Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration.” NCT02120352 ↗ “with rilpivirine (RPV) LA and cabotegravir (CAB) LA versus all-oral standard of care (SOC).” NCT03635788 ↗ “non nucleoside reverse transcriptase inhibitors : efavirenz, rilpivirine ou etravirine” NCT03256422 ↗ “Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA)” NCT07650916 ↗ “TMC278 (also called rilpivirine) is a new drug being developed to treat HIV.” NCT01275443 ↗ “A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants” NCT05112939 ↗ “single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E)” NCT05418868 ↗ “Dolutegravir 50 mg/j + Rilpivirine 25 mg/j qd orally (intake during meal)” NCT02069834 ↗ “allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.” NCT01495702 ↗ “Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables” NCT04399551 ↗ “Name of Active Ingredients: Rilpivirine, tenofovir, emtricitabine” NCT02529059 ↗ “the drug of rilpivirine (TMC278) 25 mg once daily (q.d.).” NCT01268839 ↗ “Treatment A: SACT-1, 150 mg rilpivirine oral suspension” NCT05358756 ↗ “NNRTI = efavirenz, rilpivirine, etravirine, doravirine” NCT06338826 ↗ “2. Dolutégravir 50mg / Rilpivirine 25mg per day” NCT04867083 ↗ “RVP: rilpivirine; brand name: EdurantTM.” NCT01792570 ↗ “Cabotegravir and Rilpivirine” NCT05660980 ↗ “rilpivirine (RPV; Edurant®)” NCT02121795 ↗ “rilpivirine (RPV; Edurant®)” NCT02605954 ↗ “rilpivirine (RPV;Edurant®)” NCT02616783 ↗ “rilpivirine (RPV)/TXF/FTC” NCT06630299 ↗ “Drug: Rilpivirine” NCT00855335 ↗ “rilpivirine (RPV)” NCT03631732 ↗ “rilpivirine (RPV)” PMID 30101539 ↗ Aug 2018 “rilpivirine,” NCT02157311 ↗ |
| 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 ↗45“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 “A parenteral LA formulation of cabotegravir (CAB) and rilpivirine (RPV) given by intramuscular (IM) injection every 2 months (CAB LA + RPV LA Q2M) has shown safety and efficacy...” PMID 41040645 ↗ Mar 2025 “Rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor drug, could be a favourable drug for maintenance therapy in HIV-infected adolescents because it has few...” PMID 28994660 ↗ 2018 “BACKGROUND: In the ECHO/THRIVE 96-week efficacy analysis, the response rate was 78% with rilpivirine (RPV) and efavirenz (EFV) plus two nucleoside/nucleotide reverse...” PMID 23714781 ↗ May 2013 “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 ↗ “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 ↗ “coformulated emtricitabine (FTC), rilpivirine (RPV), and tenofovir disoproxil fumarate (TDF) as a 3-drug, single-tablet regimen for PEP in men who have sex with men (MSM).” PMID 26123937 ↗ Jun 2015 “The purpose of this study is to evaluate the pharmacokinetics (PK) of rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of Complera” NCT02530060 ↗ “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 ↗ “Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen administered orally once daily with a meal” NCT01309243 ↗ “The oral formulation of rilpivirine (RPV), a nonnucleoside reverse transcriptase inhibitor (NNRTI), has been approved for treatment-naive HIV infection.” PMID 23979733 ↗ Aug 2013 “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 ↗ “efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)” NCT02469246 ↗ “Patients will receive rilpivirine (RPV) tablet 25 milligram dose or an adjusted dose orally once daily” NCT00799864 ↗ “Each RPV tablet contained 27.5 mg of rilpivirine hydrochloride, which was equivalent to 25 mg of RPV.” NCT02429791 ↗ “Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration.” NCT02120352 ↗ “Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI)” NCT02373930 ↗ “Rilpivirine (RPV), a newer non-nucleoside reverse transcriptase inhibitor” NCT03664440 ↗ “Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables” NCT04399551 ↗ “cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA).” NCT05917509 ↗ “with RPV (Rilpivirine) as an alternative in this class of drug” NCT03251690 ↗ “Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day” NCT05898841 ↗ “RPV was administered as tablets for oral administration.” NCT04542070 ↗ “a rilpivirine (RPV; TMC278) long-acting (LA) formulation” PMID 25988676 ↗ May 2015 “ritonavirboosted darunavir(DRV/r) and rilpivirine (RPV)” NCT01736761 ↗ “Azvudine Tablets (FNC) and Rilpivirine Tablets (RPV)” NCT07001488 ↗ “Drug: Oral Rilpivirine (RPV)” NCT03497676 ↗ “rilpivirine (RPV; Edurant®)” NCT02605954 ↗ “rilpivirine (RPV;Edurant®)” NCT02616783 ↗ “Rilpivirine (RPV) tablet” NCT02951052 ↗ “rilpivirine (RPV)” PMID 30101539 ↗ Aug 2018 “Rilpivirine (RPV)” NCT02547870 ↗ “rilpivirine (RPV)” NCT03631732 ↗ |
| Known as | RPV ULA | “Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA)” NCT07650916 ↗ |
| Known as | RPV-LA | “A parenteral LA formulation of cabotegravir (CAB) and rilpivirine (RPV) given by intramuscular (IM) injection every 2 months (CAB LA + RPV LA Q2M) has shown safety and efficacy...” PMID 41040645 ↗ Mar 20257“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 ↗ “RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.” NCT04542070 ↗ “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 | 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 ↗ |