Drugs / Cobicistat
Cobicistat
also known as
COBI · Tybost · Cobicistat component of evotaz · Cobicistat component of genvoya · Cobicistat component of prezcobix · Cobicistat component of rezolsta · Cobicistat component of stribild · Cobicistat component of symtuza · +3 more
Small molecule targets CYP3A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 5 milestones | |||||
| Filed | US (FDA) | PREZCOBIX | HIV infectious disease | 2024-06-04 | “submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of PREZCOBIX®(darunavir/cobicistat)” jnj.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2014-04-21 | “U.S. Food and Drug Administration ( FDA ) acceptance of the company’s refiling of two NDAs for cobicistat and elvitegravir.” gilead.com ↗ |
| Rejected (CRL) | US (FDA) | — | HIV infectious disease | 2013-04-29 | “received Complete Response Letters from the U.S. Food and Drug Administration ( FDA ) for its New Drug Applications (NDAs) for elvitegravir and cobicistat” gilead.com ↗ “Gilead submitted NDAs for cobicistat and elvitegravir in June 2012 . In April 2013 , the company received Complete Response Letters from the FDA .” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2012-06-28 | “announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for marketing approval of cobicistat” gilead.com ↗ “Gilead submitted an NDA to FDA for cobicistat as a standalone agent on June 28, 2012” gilead.com ↗ “Gilead submitted NDAs for cobicistat and elvitegravir in June 2012 .” gilead.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2012-04-26 | “the Marketing Authorisation Application (MAA) for cobicistat, submitted on April 26, 2012, has been validated by the European Medicines Agency (EMA).” gilead.com ↗ “An MAA for cobicistat in the EU was validated for review by EMA on May 22, 2012” gilead.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | TYBOST | — | 2015-11-25 – 2025-06-20 | fda.gov ↗ |
| Approved | EU (EMA) | Stribild | — | 2013-05-24 | europa.eu ↗ |
| Approved | US (FDA) | STRIBILD | — | 2012-08-27 | fda.gov ↗ |
Trials 65 · started per year
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EU approved 2013
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03858491 | Nov 2020 → Oct 2021 | non-small cell lung carcinoma | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 129 trials · 1 met primary | ||||||
| Phase 1 | NCT06726382 | Dec 2024 → Apr 2025 | — | Helsinki University Central Hospital | Completed | No outcome recorded |
| Phase 1 | NCT06385119 | Apr → Dec 2024 | — | Fore Biotherapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05494866 | Dec 2022 → Mar 2024 | pancreatic ductal adenocarcinoma | German Cancer Research Center | Terminated | No outcome recorded |
| Phase 1 | NCT05692570 | Sep → Nov 2022 | — | Pyramid Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT05458102 | Aug 2022 → May 2023 | HIV infectious disease | Gilead Sciences | Terminated | No outcome recorded |
| Phase 1 | NCT05197075 | Aug → Sep 2022 | HIV infectious disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05378906 | Jun → Sep 2022 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05236738 | May → Jul 2022 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04718805 | Jan → Mar 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04661397 | Jan → Jul 2021 | — | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 1 | NCT04263350 | Feb → Nov 2020 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04322214 | Jan → Mar 2020 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 1 | NCT04208061 | Dec 2019 → Mar 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03864406 | Jun 2019 → Dec 2022 | — | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 1 | NCT03094507 | Apr 2017 → Jan 2018 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT04069221 | Feb → May 2017 | malaria | Medicines for Malaria Venture | Completed | No outcome recorded |
| Phase 1 | NCT02985996 | Feb → Nov 2017 | HIV infectious disease | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT02984852 | Dec 2016 → Feb 2017 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02771249 | Jun 2016 → Aug 2021 | latent tuberculosis infection | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 1 | NCT02818348 | Jun → Oct 2016 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 1 | NCT02661373 | Mar 2016 → Mar 2018 | malaria | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02589158 | Nov 2015 → Mar 2016 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT02565888 | Nov 2015 → Jan 2016 | HIV infectious disease, hepatitis C virus infection | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02475135 | Jun → Aug 2015 | — | Janssen Sciences Ireland UC | Completed | No outcome recorded |
| Phase 1 | NCT02307656 | Dec 2014 → Sep 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02277600 | Nov 2014 → Jan 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02219217 | Oct 2014 → Jan 2015 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT02203461 | Jul → Oct 2014 | — | Technical University of Munich | Completed | No outcome recorded |
| Phase 1 | NCT01896622 | Jun 2013 → Jan 2017 | HIV infectious disease | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT06014489 | Jan 2024 → Dec 2028 expected | acute myeloid leukemia | HOVON Foundation | Recruiting | Met primary |
| Phase 2 | NCT00892437 | May → Dec 2009 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT02499978 | May → Jun 2016 | AIDS | Stanford University | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT02276612 | Dec 2014 → Nov 2016 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT02016924 | Jan 2014 → Jun 2025 overdue | AIDS | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT01854775 | May 2013 → May 2020 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 311 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT04653194 | Sep 2020 → Jul 2023 | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Completed | No outcome recorded |
| Phase 3 | NCT04252274 | Jan → Aug 2020 | COVID-19, pneumocystosis | Shanghai Public Health Clinical Center | Unknown | Missed primary |
| Phase 3 | NCT02707601 | Apr 2016 → Sep 2017 | HIV infectious disease, hepatitis C virus infection | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02616029 | Dec 2015 → Oct 2018 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02269917 | Mar 2015 → Feb 2017 | HIV infectious disease | Janssen R&D Ireland | Completed | Met primary |
| Phase 3 | NCT02071082 | Feb 2014 → Jan 2015 | HIV infectious disease, hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01533259 | Jan → Nov 2012 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01495702 | Dec 2011 → Nov 2013 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01363011 | May 2011 → Jan 2013 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01108510 | Apr 2010 → Nov 2011 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT00855335 | Apr 2009 → Aug 2016 | HIV infectious disease, pregnancy disorder | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 416 trials · 3 missed | ||||||
| Phase 4 | NCT06337032 | Aug 2024 → Mar 2034 expected | HIV infectious disease | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT05748093 | Apr 2024 → Jun 2026 overdue | non-small cell lung carcinoma | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05078671 | Dec 2021 → Dec 2025 | cancer | Radboud University Medical Center | Unknown | Missed primary |
| Phase 4 | NCT04388904 | Sep 2021 → Apr 2024 | HIV infectious disease | The Crofoot Research Center, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04442737 | Jul 2020 → Aug 2023 | — | Janssen Scientific Affairs, LLC | Completed | Missed primary |
| Phase 4 | NCT03683524 | Nov 2018 → Aug 2021 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | Missed primary |
| Phase 4 | NCT04225325 | May 2018 → Sep 2019 | HIV infectious disease | ADRIANO LAZZARIN, MD | Unknown | No outcome recorded |
| Phase 4 | NCT03693508 | Apr 2018 → May 2020 | HIV infectious disease, immunodeficiency disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT03447873 | Jun 2017 → Sep 2020 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Completed | No outcome recorded |
| Phase 4 | NCT03163277 | May 2017 → Jun 2020 | HIV infectious disease, cognitive disorder | Giovanni Di Perri | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03123848 | Apr → May 2017 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 4 | NCT02503462 | Jul 2015 → Jan 2017 | AIDS dementia complex | University Hospital, Basel, Switzerland | Terminated | No outcome recorded |
| Phase 4 | NCT02198443 | Jun 2015 → Jul 2016 | HIV infectious disease | Fundacion Clinic per a la Recerca Biomédica | Completed | No outcome recorded |
| Phase 4 | NCT02404233 | Mar 2015 → Sep 2016 | HIV infectious disease | Therapeutic Concepts | Unknown | No outcome recorded |
| Phase 4 | NCT02246998 | Dec 2014 → Jan 2016 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 4 | NCT01855867 | May 2013 → Apr 2014 | HIV infectious disease | Kenneth H. Mayer, MD | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03405194 | May 2018 → May 2020 | HIV infectious disease | Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01929759 | Jan 2014 → Oct 2015 | HIV infectious disease | Massachusetts General Hospital | Completed | No outcome recorded |
| Comparator or background therapy25 trials | ||||||
| Phase 1 | NCT07462559 Comparator | Mar → Dec 2026 expected | — | Helsinki University Central Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05716854 Comparator | Mar → Jun 2023 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT04236453 Background | Jan → Apr 2020 | — | Janssen Pharmaceutica N.V., Belgium | Terminated | No outcome recorded |
| Phase 1 | NCT02556268 Background | Feb → Dec 2016 | — | Bayer | Completed | No outcome recorded |
| Phase 1/2 | NCT04065399 Background | Nov 2019 → Dec 2027 expected | acute lymphoblastic leukemia, mixed phenotype acute leukemia | Syndax Pharmaceuticals | Recruiting | Met primary |
| Phase 1/2 | NCT03251144 Background | Apr 2019 → Jul 2021 | AIDS, mitochondrial disease, poisoning | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 1/2 | NCT03480646 Background | Nov 2017 → Feb 2021 | castration-resistant prostate carcinoma | Constellation Pharmaceuticals | 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 | NCT03045861 Background | Mar 2017 → Apr 2018 | HIV infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01565850 Comparator | Apr 2012 → Jan 2013 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT04475120 Comparator | Apr → Jul 2020 | COVID-19 | University of Rome Tor Vergata | Completed | 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 | NCT03227861 Background | Jul 2017 → Jan 2019 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02987530 Comparator | Apr 2017 → Jul 2019 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | Missed primary |
| Phase 3 | NCT02616783 Comparator | Dec 2015 → Feb 2018 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02603107 Background | Nov 2015 → May 2017 | 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 | NCT02431247 Comparator | Jul 2015 → Mar 2017 | immunodeficiency disease | Janssen Sciences Ireland UC | Completed | Met primary |
| Phase 3 | NCT02469246 Background | Jun 2015 → Dec 2017 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01815736 Comparator | Mar 2013 → Mar 2015 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 4 | NCT07678268 Comparator | Jul 2025 → Jul 2026 overdue | HIV infectious disease | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT03842488 Comparator | Apr 2019 → Mar 2021 | HIV infectious disease | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | Unknown | No outcome recorded |
| Phase 4 | NCT04064632 Background | Feb 2017 → Jun 2019 | HIV infectious disease | A.O. Ospedale Papa Giovanni XXIII | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 2024-06-04 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy PREZCOBIX® jnj.com ↗
Johnson & Johnson today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of PREZCOBIX®(darunavir/cobicistat) to include the treatment of HIV-1 infection in younger children at least 6 years of age weighing at least 25 kg. |
| 2023-07-23 | Gilead Sciences | Results New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic gilead.com ↗
At Week 48, the proportion of participants who were underweight decreased from 20.4% to 14.3%, while the proportion of normal weight participants increased from 67.3% to 73.5%, respectively. |
| 2017-10-25 | Janssen Research & Development, LLC | Results Investigational Darunavir-Based Single-Tablet Regimen Shows Positive Results in Previously Untreated HIV Patients in Pivotal Phase 3 AMBER Clinical Trial jnj.com ↗ |
| 2016-09-12 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency jnj.com ↗ |
| 2015-10-22 | Gilead Sciences | Results Gilead Announces Phase 3 Results for Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV gilead.com ↗
Genvoya was found to be statistically non-inferior to Stribild ® (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF), based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. |
| 2015-07-16 | Bristol-Myers Squibb | Regulatory European Commission Approves Bristol-Myers Squibb’s Evotaz (atazanavir and cobicistat fixed-dose combination) for the Treatment of HIV-1 Infection in Adults bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the European Commission has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir. |
| 2015-01-29 | Janssen Research & Development, LLC | Regulatory PREZCOBIX™ (darunavir/cobicistat) Approved in the U.S. for the Treatment of Adults Living With HIV-1 jnj.com ↗ |
| 2015-01-29 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Bristol-Myers Squibb’s Evotaz™ (atazanavir and cobicistat) for the Treatment of HIV-1 Infection in Adults bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. |
| 2014-11-25 | Janssen Research & Development, LLC | Regulatory European Commission Approves REZOLSTA®▼, A New Once-Daily, Fixed-Dose HIV Therapy Combining Darunavir And Cobicistat jnj.com ↗
Beerse, Belgium, 25 November 2014 - Janssen-Cilag International NV (Janssen) today announced that the European Commission (EC) has approved the use of REZOLSTA® (darunavir/cobicistat) in combination with other antiretroviral (ARV) medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older. |
| 2014-09-29 | Janssen Research & Development, LLC | Regulatory CHMP Announces Positive Opinion For REZOLSTA™, A New Once-Daily, Fixed-Dose HIV Therapy Combining Darunavir And Cobicistat jnj.com ↗
CHMP Announces Positive Opinion For REZOLSTA™, A New Once-Daily, Fixed-Dose HIV Therapy Combining Darunavir And Cobicistat |
| 2014-04-21 | Gilead Sciences | Regulatory Gilead Sciences’ New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA gilead.com ↗ |
| 2014-04-14 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Submits New Drug Application to U.S. FDA for a Fixed-Dose Combination Tablet of Atazanavir Sulfate with Cobicistat for People Living with HIV-1 bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today the submission of a new drug application (NDA) on April 4, 2014 to the U.S. Food and Drug Administration (FDA) for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz ®, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective. |
| 2014-04-01 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat as Part of Combination HIV Therapy jnj.com ↗
Janssen Submits New Drug Application to U.S. FDA for a Fixed -Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat as Part of Combination HIV Therapy |
| 2013-10-15 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat jnj.com ↗ |
| 2013-09-25 | Gilead Sciences | Regulatory European Commission Approves Gilead Sciences’ Tybost™, a New Boosting Agent for HIV Therapy gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for once-daily Tybost™ (cobicistat 150 mg tablets), a pharmacokinetic enhancer that boosts blood levels of certain HIV medicines. |
| 2013-04-29 | Gilead Sciences | Regulatory Gilead Receives Complete Response Letters from U.S. Food and Drug Administration for Elvitegravir and Cobicistat gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has received Complete Response Letters from the U.S. Food and Drug Administration ( FDA ) for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens. |
| 2012-07-24 | Gilead Sciences | Results Gilead’s Boosting Agent Cobicistat for HIV Therapy as Effective as Ritonavir in Pivotal Phase 3 Study gilead.com ↗
The study found that an HIV regimen containing a cobicistat-boosted protease inhibitor was non-inferior to a regimen containing a ritonavir-boosted protease inhibitor at 48 weeks of therapy. |
| 2012-06-28 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. FDA for Boosting Agent Cobicistat gilead.com ↗ |
| 2012-05-23 | Gilead Sciences | Regulatory Gilead Files European Marketing Application for Boosting Agent Cobicistat gilead.com ↗ |
| 2012-05-11 | Gilead Sciences | Regulatory FDA Advisory Committee Supports Approval of Gilead’s Once-Daily Quad Single Tablet Regimen for HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration ( FDA ) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults. |
| 2012-03-08 | Gilead Sciences | Results Data Show Gilead’s Quad Regimen for HIV Non-Inferior to Protease-Based Regimen at 48 Weeks in Second Pivotal Phase 3 Study gilead.com ↗
The study found that the Quad was non-inferior to a protease-based regimen of ritonavir-boosted atazanavir (ATV/r) plus Truvada ® (emtricitabine/tenofovir disoproxil fumarate) at 48 weeks of therapy among HIV-1 infected treatment-naïve adults. |
| 2012-03-07 | Gilead Sciences | Results Gilead’s Quad Single Tablet Regimen for HIV Non-Inferior to Atripla® in Pivotal Phase 3 Study gilead.com ↗
These data show that the Quad is as effective as a current standard of care in HIV therapy. |
| 2011-12-23 | Gilead Sciences | Regulatory U.S. FDA Accepts New Drug Application for Gilead’s Once-Daily, Single-Tablet Quad HIV Regimen gilead.com ↗ |
| 2011-12-20 | Gilead Sciences | Regulatory Gilead Files European Marketing Application for the Quad, a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the Marketing Authorisation Application (MAA) for the Quad single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults, submitted on November 24, 2011 , has been validated by the European Medicines Agency (EMA). |
| 2011-12-05 | Gilead Sciences | Results Gilead’s Boosting Agent, Cobicistat, Meets 48-Week Primary Objective in Pivotal Phase 3 Study gilead.com ↗
Discontinuation rates due to adverse events were 7.3 percent and 7.2 percent in the cobicistat and ritonavir arms of the study, respectively. |
| 2011-10-27 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. FDA for Once-Daily, Single-Tablet "Quad" HIV Regimen gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) |
| 2011-08-15 | Gilead Sciences | Results Gilead's Investigational Antiretroviral Quad Regimen Meets 48-Week Primary Objective in Pivotal Phase 3 Clinical Study 102 gilead.com ↗
The mean 48-week increase in CD4 cell count from baseline was 239 cells/mm 3 in the Quad arm compared to 206 cells/mm 3 in the Atripla arm (p=0.009). |
| 2010-09-13 | Gilead Sciences | Results Gilead's Single-Tablet "Quad" HIV Regimen Maintains High Viral Suppression Through 48 Weeks in Phase II Study gilead.com ↗
At week 48, the proportion of patients who achieved HIV RNA (viral load) less than 50 copies/mL was 90 percent in the Quad arm and 83 percent in the Atripla arm (using an analysis where missing equals failure). |
| 2010-02-17 | Gilead Sciences | Results Gilead's Single-Tablet "Quad" Regimen for HIV Achieves a High Rate of Virologic Suppression in Phase II Study gilead.com ↗
These positive efficacy and safety results indicate that the Quad has the potential to become an important new treatment option in HIV therapy. |
All press releases naming this drug 36 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 94 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cobicistat | “This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide...” NCT02707601 ↗89“The ability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) to maintain virologic suppression in participants with M184V and/or M184I resistance...” PMID 33315694 ↗ Apr 2021 “Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted...” NCT01815736 ↗ “Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir...” NCT05729568 ↗ “The single-tablet, fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is a once-daily, integrase strand transfer inhibitor-based...” PMID 30169223 ↗ Jun 2017 “Cobicistat is a potent inhibitor of the CYP3A4 enzyme, which can significantly increase ketamine bioavailability and reduce interindividual variability by inhibiting ketamine's...” NCT07462559 ↗ “Participants will receive either darunavir (DRV)/ cobicistat (COBI)/emtricitabine (FTC) /tenofovir alafenamide (TAF) fixed dose combination (D/C/F/TAF FDC) or DRV/COBI FDC...” NCT02431247 ↗ “A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults” NCT02071082 ↗ “Once-daily single-tablet regimen containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg.” NCT02269917 ↗ “a fixed-dose combination of tenofovir alafenamide fumarate (TAF) 10 mg plus emtricitabine (FTC) 200 mg, darunavir 800 mg, and cobicistat 150 mg once daily (group A)” PMID 37752816 ↗ Sep 2023 “cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food” NCT01533259 ↗ |
| Known as | COBI | “Participants will receive either darunavir (DRV)/ cobicistat (COBI)/emtricitabine (FTC) /tenofovir alafenamide (TAF) fixed dose combination (D/C/F/TAF FDC) or DRV/COBI FDC...” NCT02431247 ↗24“Once-daily single-tablet regimen containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg.” NCT02269917 ↗ “The CYP3A4 inhibitor cobicistat (COBI) can be used to increase venetoclax exposure, thereby allowing to reduce the dose of venetoclax and thus costs substantially.” NCT06014489 ↗ “cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food” NCT01533259 ↗ “Patents treated with elvitegravir (EVG) 150mg / cobicistat (COBI) 150mg / emtricitabine (FTC) 200mg / tenofovir (TAF) 10mg once a day as the first line treatment.” NCT03693508 ↗ “Darunavir (DRV), Emtricitabine/Tenofovir Alafenamide (F/TAF) and Cobicistat (COBI) tablet under fed condition on Day 1” NCT04661397 ↗ “Participants will receive oral tablet of fixed dose combination (FDC) containing darunavir (DRV)/ cobicistat (COBI).” NCT04208061 ↗ “Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide (TAF) in the presence of cobicistat (COBI)” NCT04236453 ↗ “Cobicistat (COBI) is a mechanism-based inhibitor (MBI) of the cytochrome P450 (CYP)3A subfamily.” NCT05197075 ↗ “a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir” NCT02246998 ↗ “Cobicistat (COBI) is a pharmacoenhancer with no antiretroviral activity in vitro.” PMID 23532097 ↗ Mar 2013 |
| Known as | Cobicistat component of evotaz | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095208 ↗ |
| Known as | Cobicistat component of genvoya | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095208 ↗ |
| Known as | Cobicistat component of prezcobix | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095208 ↗ |
| Known as | Cobicistat component of rezolsta | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095208 ↗ |
| Known as | Cobicistat component of stribild | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095208 ↗ |
| Known as | Cobicistat component of symtuza | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095208 ↗ |
| Known as | Cobicistat on silicon dioxide | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095208 ↗ |
| Known as | Cobicistat, (r,r,s)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095208 ↗ |
| Known as | GS-9350 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095208 ↗ |
| Known as | Tybost | “elvitegravir (EVG; Vitekta®)/cobicistat (c; Tybost®)/TXF/FTC” NCT06630299 ↗3“ATV+cobicistat (COBI; Tybost®) or ATV/COBI FDC” NCT02605954 ↗ “ATV + cobicistat (COBI;Tybost®)” NCT02616783 ↗ “Cobisistat Tybost 150 mg” NCT07462559 ↗ |
| Action | Inhibit | “ritonavir and cobicistat, as inhibitors of P-gp” NCT01896622 ↗ |
| Modality | Small molecule | — CHEMBL2095208 ↗ |
| Route | Oral | “Fixed dose combination (FDC) tablet of TMC114 (darunavir) 800 mg and cobicistat 150 mg once daily” NCT00855335 ↗ |
| Target | CYP3A4 | “single-dose pharmacoboost approach using cobicistat to inhibit CYP3A4, thereby increasing exposure.” PMID 35598441 ↗ May 2022 |