Drugs / Remdesivir
Remdesivir
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed COVID-19 1 milestone | |||||
| Filed | US (FDA) | Veklury | COVID-19 | 2020-08-10 | “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Veklury ® (remdesivir)” gilead.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | VEKLURY | — | 2022-01-21 – 2024-02-28 | fda.gov ↗ |
| Approved | US (FDA) | VEKLURY | — | 2020-10-22 | fda.gov ↗ |
| Approved | EU (EMA) | Veklury | — | 2020-07-03 | europa.eu ↗ |
Trials 48
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04560231 | Jun → Nov 2020 | Orthocoronavirinae infectious disease | Lahore General Hospital | Unknown | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT04480333 | Sep → Dec 2020 | COVID-19, neurodegenerative disease, neuronitis, pneumonia +1 | Biomed Industries, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT05925140 | Mar 2020 → Dec 2024 | COVID-19 | Lebanese University | Unknown | No outcome recorded |
| Phase 1/22 trials · 2 missed | ||||||
| Phase 1/2 | NCT04539262 | Sep 2020 → Feb 2021 | COVID-19 | Gilead Sciences | Completed | Missed primary |
| Phase 1/2 | NCT04746183 | Jul 2020 → Mar 2027 expected | COVID-19 | University of Liverpool | Recruiting | Missed primary |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT06551844 | Apr 2026 → Dec 2029 expected | dengue disease | Oxford University Clinical Research Unit, Vietnam | Recruiting | No outcome recorded |
| Phase 2 | NCT06817889 | Dec 2025 → Nov 2027 expected | autoimmune disease, hematopoietic and lymphoid system neoplasm, respiratory syncytial virus infectious disease | Fred Hutchinson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07197164 | Sep 2025 → Dec 2026 expected | COVID-19 | Fight AIDS and Infectious Diseases Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT06873633 | Jul 2025 → Jun 2026 overdue | respiratory syncytial virus infectious disease | PENTA Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT05587894 | Apr 2023 → Jun 2026 overdue | COVID-19, immunodeficiency disease | ANRS, Emerging Infectious Diseases | Recruiting | No outcome recorded |
| Phase 2 | NCT05041907 | Sep 2021 → Jan 2027 expected | COVID-19 | University of Oxford | Recruiting | Mixed |
| Phase 2 | NCT04385719 | May → Jul 2021 | Ebola hemorrhagic fever, HIV infectious disease | Makerere University | Completed | No outcome recorded |
| Phase 2 | NCT05184127 | Apr → Sep 2021 | COVID-19 | National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia | Completed | Met primary |
| Phase 2 | NCT04596839 | Sep 2020 → Apr 2021 | COVID-19 | Dr. Md. Alimur Reza | Completed | No outcome recorded |
| Phase 2 | NCT04321993 | Apr 2020 → Apr 2024 | COVID-19 | Lisa Barrett | Unknown | No outcome recorded |
| Phase 2/36 trials · 2 met primary | ||||||
| Phase 2/3 | NCT04431453 | Jul 2020 → Feb 2023 | COVID-19 | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT04575064 | Jun 2020 → Mar 2022 | COVID-19 | Professor Dr. Bernd Mühlbauer | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT04345419 | Jun → Dec 2020 | COVID-19 | Tanta University | Completed | No outcome recorded |
| Phase 2/3 | NCT04351724 | Apr 2020 → Dec 2021 | COVID-19 | Medical University of Vienna | Unknown | Met primary |
| Phase 2/3 | NCT04349410 | Apr → Sep 2020 | COVID-19 | The Camelot Foundation | Completed | No outcome recorded |
| Phase 2/3 | NCT03719586 | Nov 2018 → Sep 2019 | Ebola hemorrhagic fever | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 318 trials · 1 met primary · 5 missed | ||||||
| Phase 3 | NCT07013474 | Jul 2025 → Sep 2027 expected | COVID-19 | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT06729593 | Apr 2021 → Aug 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04843761 | Apr 2021 → Aug 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT04832880 | Apr 2021 → Mar 2022 | COVID-19 | ASST Fatebenefratelli Sacco | Unknown | No outcome recorded |
| Phase 3 | NCT04745351 | Mar 2021 → Apr 2022 | COVID-19 | Gilead Sciences | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT04610541 | Oct 2020 → Oct 2021 | COVID-19 | University of Pecs | Unknown | No outcome recorded |
| Phase 3 | NCT04501952 | Sep 2020 → May 2021 | COVID-19 | Gilead Sciences | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT04693026 | Sep 2020 → Feb 2021 | COVID-19, acute respiratory distress syndrome | M Abdur Rahim Medical College and Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04678739 | Aug 2020 → Jan 2021 | COVID-19, acute respiratory distress syndrome | M Abdur Rahim Medical College and Hospital | Completed | No outcome recorded |
| Phase 3 | NCT04483960 | Jul 2020 → Jul 2025 | COVID-19 | University of Melbourne | Unknown | No outcome recorded |
| Phase 3 | NCT04853901 | Jul 2020 → Jan 2021 | COVID-19 | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT04315948 | Mar 2020 → Jul 2022 | COVID-19 | French National Institute of Health and Medical Research | Completed | Missed primary |
| Phase 3 | NCT04292730 | Mar → Apr 2020 | COVID-19 | Gilead Sciences | Completed | Mixed |
| Phase 3 | NCT04292899 | Mar → Apr 2020 | COVID-19 | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT04280705 | Feb → May 2020 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT04252664 | Feb → Apr 2020 | COVID-19 | Capital Medical University | Suspended | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04257656 | Feb → Mar 2020 | COVID-19 | Capital Medical University | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 44 trials | ||||||
| Phase 4 | NCT06792214 | Jan 2025 → Jan 2026 overdue | long COVID-19 | Mount Sinai Hospital, Canada | Recruiting | No outcome recorded |
| Phase 4 | NCT05911906 | Oct 2024 → Sep 2025 | COVID-19 | University of Derby | Completed | No outcome recorded |
| Phase 4 | NCT05502081 | Sep → Dec 2022 | COVID-19 | Mansoura University Hospital | Completed | Mixed |
| Phase 4 | NCT04978259 | Jul 2021 → Feb 2023 | COVID-19 | Clinical Urology and Epidemiology Working Group | Unknown | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06610643 | Sep 2024 → Sep 2026 overdue | COVID-19, immunodeficiency disease | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05024006 | Apr 2020 → Apr 2021 | COVID-19 | University of the Philippines | Completed | No outcome recorded |
| — | NCT04492501 | Apr → Jul 2020 | COVID-19, acute respiratory distress syndrome, cytokine release syndrome | UNICEF | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT04302766 | — | COVID-19 | U.S. Army Medical Research and Development Command | No longer available | No outcome recorded |
| — | NCT04323761 | — | COVID-19 | Gilead Sciences | Approved for marketing | No outcome recorded |
| Comparator or background therapy39 trials | ||||||
| Phase 1 | NCT06860282 Comparator | Dec 2022 → Mar 2023 | COVID-19, viral pneumonia | Heronova Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT04790240 Comparator | Jan 2025 → Dec 2026 expected | COVID-19 | All Natural Medicine Clinic, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT04988035 Background | Aug 2021 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT04391309 Background | Apr 2021 → Feb 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT04647695 Comparator | Nov 2020 → Jul 2021 | COVID-19 | The University of Hong Kong | Unknown | Met primary |
| Phase 2 | NCT04583956 Background | Oct 2020 → Sep 2021 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT04583969 Background | Oct 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT04488081 Background | Jul 2020 → Jul 2028 expected | COVID-19 | QuantumLeap Healthcare Collaborative | Active not recruiting | Missed primary |
| Phase 2 | NCT04410354 Comparator | Jun → Dec 2020 | COVID-19 | ViralClear Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02818582 Comparator | Jul 2016 → Aug 2020 | Ebola hemorrhagic fever | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/3 | NCT04395170 Background | Sep → Dec 2020 | COVID-19 | Lifefactors Zona Franca, SAS | Unknown | No outcome recorded |
| Phase 2/3 | NCT04321616 Comparator | Mar → Aug 2020 | COVID-19, adult acute respiratory distress syndrome | Oslo University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT05271929 Background | Apr 2022 → Jan 2024 | COVID-19 | German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT05780541 Background | Sep 2021 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 3 | NCT05185284 Comparator | Aug → Dec 2021 | COVID-19 | Promomed, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04970719 Background | Jul → Dec 2021 | pneumonia | Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders | Withdrawn | No outcome recorded |
| Phase 3 | NCT05780463 Background | Jun 2021 → Feb 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04784559 Comparator | Jun 2021 → Mar 2023 | COVID-19 | PharmaMar | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT04647669 Comparator | Jun → Nov 2021 | COVID-19 | The University of The West Indies | Unknown | No outcome recorded |
| Phase 3 | NCT05780437 Background | Feb 2021 → Jan 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04713176 Background | Feb 2021 → May 2022 | COVID-19 | Daewoong Pharmaceutical Co. LTD. | Terminated | No outcome recorded |
| Phase 3 | NCT04694612 Comparator | Jan → Mar 2021 | COVID-19 | Nepal Health Research Council | Unknown | No outcome recorded |
| Phase 3 | NCT04675086 Background | Jan → Sep 2021 | COVID-19, viral pneumonia | Blessing Corporate Services, Inc | Withdrawn | No outcome recorded |
| Phase 3 | NCT05780281 Background | Dec 2020 → Jun 2021 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT05780424 Background | Dec 2020 → Jun 2021 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04640168 Background | Dec 2020 → May 2021 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04593940 Comparator | Oct 2020 → Jan 2022 | COVID-19 | Daniel Benjamin | Completed | No outcome recorded |
| Phase 3 | NCT04546581 Background | Oct 2020 → May 2021 | COVID-19, severe acute respiratory syndrome | University of Minnesota | Completed | Missed primary |
| Phase 3 | NCT05780268 Background | Aug 2020 → Feb 2021 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04492475 Background | Aug → Dec 2020 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04501978 Background | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04409262 Background | Jun 2020 → Feb 2021 | pneumonia | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT04401579 Background | May → Jul 2020 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 3 | NCT04351152 Background | May 2020 → Mar 2021 | COVID-19 | Humanigen, Inc. | Unknown | Met primary |
| Phase 4 | NCT04738045 Comparator | Nov 2020 → Mar 2021 | COVID-19 | Ahmed Essam | Unknown | No outcome recorded |
| Phase 4 | NCT04779047 Comparator | Oct 2020 → Mar 2021 | COVID-19, pneumonia | October 6 University | Unknown | No outcome recorded |
| — | NCT04865237 Background | Mar 2021 → Jul 2022 | COVID-19 | Imperial College London | Completed | No outcome recorded |
| — | NCT04980534 Background | Jan → Jun 2021 | COVID-19, pneumonia | Catalysis SL | Completed | No outcome recorded |
| — | NCT04871633 Comparator | Aug → Nov 2020 | COVID-19 | King Edward Medical University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 45
| Date | Issuer | Release |
|---|---|---|
| 2024-10-09 | Gilead Sciences | Results Gilead to Present Late-Breaking Data Highlighting Antiviral Portfolio, Innovative Research Pipeline and HIV Leadership at IDWeek 2024 gilead.com ↗
Real World Evidence in COVID-19 Reinforce Veklury (remdesivir) as the Antiviral Standard of Care for the Treatment of People Hospitalized for COVID-19 |
| 2024-03-05 | Gilead Sciences | Results New Real-World Data Further Support the Use of Veklury® (Remdesivir) for People Hospitalized With COVID-19 gilead.com ↗ |
| 2024-02-26 | Gilead Sciences | Results Gilead to Present Late-Breaking Data and Real-World Evidence Highlighting Innovative Antiviral Portfolio and Research Pipeline at CROI 2024 gilead.com ↗
Gilead remains committed to understanding the COVID-19 treatment landscape and will present multiple RWE analyses, including on the impact of Veklury ® (remdesivir) in reducing mortality in immunocompromised people hospitalized for COVID-19 during the Omicron period (Dec’21 - April’23). |
| 2023-12-20 | RedHill Biopharma Limited | Results RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola redhillbio.com ↗ |
| 2023-10-03 | Gilead Sciences | Results Gilead to Present Latest Innovative Virology Data on Current and Potentially Transformative Therapies Across HIV and COVID-19 at IDWeek 2023 gilead.com ↗
Data Reinforces Veklury’s Strong Safety Profile and Continued In Vitro Activity Against New Variants |
| 2023-09-19 | Gilead Sciences | Regulatory CHMP Adopts Positive Opinion to Extend the Use of Veklury® (Remdesivir) to Treat COVID-19 in People With Hepatic Impairment gilead.com ↗ |
| 2023-08-24 | Gilead Sciences | Regulatory FDA Approves Veklury® (Remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment gilead.com ↗ |
| 2023-07-14 | Gilead Sciences | Regulatory FDA Approves Veklury® (Remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury ® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. |
| 2023-05-26 | Gilead Sciences | Regulatory CHMP Adopts Positive Opinion to Extend the Use of Veklury® (Remdesivir) to Treat COVID-19 in People With Severe Renal Impairment, Including Those on Dialysis gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury ® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. |
| 2023-04-16 | Gilead Sciences | Results Veklury® (Remdesivir) Efficacy and Safety Profile Further Demonstrated in Vulnerable Patient Populations gilead.com ↗
A Phase 3 clinical study demonstrated that Veklury ® (remdesivir) was generally well tolerated in people with moderate to severe renal impairment. |
| 2023-02-21 | Gilead Sciences | Results Veklury® (Remdesivir) Reduced Risk of Mortality in Hospitalized COVID-19 Patients Across all Variant Time Periods in a Real World Study of More than 500,000 Hospitalized Patients gilead.com ↗ |
| 2022-09-16 | Gilead Sciences | Regulatory CHMP Adopts Positive Opinion to Extend Indication of Veklury® (Remdesivir) for the Treatment of Pediatric Patients with COVID-19 gilead.com ↗
We are proud of today’s CHMP opinion that represents a positive step toward bridging the treatment gap for children and helping them recover from COVID-19 more quickly. |
| 2022-09-15 | Gilead Sciences | Regulatory WHO Expands Recommendation for Veklury® (Remdesivir) to Patients With Severe Disease in Latest Update to COVID-19 Guideline gilead.com ↗ |
| 2022-07-22 | Gilead Sciences | Regulatory CHMP Adopts Positive Opinion Recommending Veklury® (Remdesivir) Receive Full Marketing Authorization for the Treatment of Patients With COVID-19 gilead.com ↗ |
| 2022-04-25 | Gilead Sciences | Regulatory Veklury® (Remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19 gilead.com ↗ |
| 2022-04-24 | Gilead Sciences | Results Several New Studies Presented at ECCMID 2022 Confirm Veklury® (Remdesivir) Activity in Treating COVID-19 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced findings from two studies, which provide further insights on the use of Veklury ® (remdesivir) for the treatment of hospitalized and non-hospitalized patients with COVID-19. |
| 2022-02-11 | Gilead Sciences | Results Veklury® (Remdesivir) Retains Antiviral Activity Against Omicron, Delta and Other Emergent SARS-CoV-2 Variants in Multiple In Vitro Studies gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today released data demonstrating the in vitro activity of Veklury ® (remdesivir) against ten SARS-CoV-2 variants, including Omicron. |
| 2022-02-11 | Gilead Sciences | Results Phase 2/3 Interim Data Evaluating the Safety, Tolerability and Clinical Outcomes of Veklury® (Remdesivir) in Pediatric Patients With COVID-19 Presented at CROI 2022 gilead.com ↗
These latest data demonstrate that Veklury was generally well tolerated among pediatric patients hospitalized with COVID-19 with a high proportion of participants showing clinical improvement and recovery. |
| 2022-01-21 | Gilead Sciences | Regulatory FDA Approves Veklury® (Remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression gilead.com ↗ |
| 2021-12-22 | Gilead Sciences | Results Gilead Announces New England Journal of Medicine Publication of Data Demonstrating Veklury® (Remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients With COVID-19 gilead.com ↗
The study includes new subgroup analyses which showed consistent efficacy of Veklury for patients irrespective of their key risk factors for severe COVID-19. |
| 2021-12-21 | Gilead Sciences | Regulatory European Commission Expands Indication for Veklury (Remdesivir) for the Treatment of Adults Not on Supplemental Oxygen and Considered High Risk for COVID-19 Disease Progression gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has approved a variation to the Conditional Marketing Authorization for Veklury ® (remdesivir) to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19. |
| 2021-11-22 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Publication of Paper on Antiviral SARS-CoV-2 Inhibitor, TNX-3500, in JCI Insight tonixpharma.com ↗
When tested in combination with remdesivir, both drugs had additive rather than competitive effect against SARS-CoV-2. |
| 2021-09-22 | Gilead Sciences | Results Veklury® (Remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients with COVID-19 gilead.com ↗
Results also showed an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 for participants treated with Veklury (1.6% [4/246]) compared with placebo (8.3% [21/252]) p=0.002. |
| 2021-07-15 | Lexaria Bioscience Corp. | Results Lexaria Completes Successful Antiviral Drug Molecular Characterization Study With Canada's National Research Council lexariabioscience.com ↗
The NRC has successfully confirmed Lexaria’s study objectives, demonstrating DehydraTECH™ processing and formulation technology does not create a covalently bonded new molecular entity (“NME”) and that each drug tested remained stable and did not undergo change in chemical structure. |
| 2021-06-21 | Gilead Sciences | Results Gilead’s Veklury® (Remdesivir) Associated With a Reduction in Mortality Rate in Hospitalized Patients With COVID-19 Across Three Analyses of Large Retrospective Real-World Data Sets gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive data from three retrospective studies of the real-world treatment of patients hospitalized with COVID-19, adding to the body of mortality and hospital discharge data for patients treated with Veklury ® (remdesivir). |
| 2021-06-15 | Lexaria Bioscience Corp. | Results Lexaria Drug Delivery Platform Enables up to Three-Fold Increase in Oral Delivery of Antiviral Drugs lexariabioscience.com ↗
Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (CSE:LXX) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, is pleased to announce positive results from its tolerability and pharmacokinetic (“PK”) animal study VIRAL-A20-2, evaluating DehydraTECH-enabled remdesivir and ebastine. |
| 2021-06-03 | Lexaria Bioscience Corp. | Results Lexaria's DehydraTECH(TM)-Enabled Remdesivir and Ebastine Effectively Inhibit the COVID-19 SARS-CoV-2 Virus lexariabioscience.com ↗
Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW)(CSE:LXX) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, announces that remdesivir and ebastine processed with DehydraTECH were effective at inhibiting the COVID-19 SARS-CoV-2 virus using an in vitro screening assay in infected cells in Lexaria study VIRAL-C21-3. |
| 2021-03-11 | Hoffmann-La Roche | Results Roche provides update on the phase III REMDACTA trial of Actemra/RoActemra plus Veklury in patients with severe COVID-19 pneumonia roche.com ↗
The REMDACTA clinical trial of Actemra/RoActemra plus Veklury did not meet its primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia or its key secondary endpoints compared to Veklury alone |
| 2021-03-11 | Chugai Pharmaceutical | Results Chugai Provides Update on the Phase III REMDACTA Study of Actemra Plus Remdesivir in Patients with Severe COVID-19 Pneumonia chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that the global phase III randomized, double-blind, multicenter REMDACTA study of Actemra ® (tocilizumab) plus remdesivir, versus placebo plus remdesivir, did not meet its primary endpoint. |
| 2021-03-10 | Genentech, Inc. | Results Genentech Provides Update on the Phase III REMDACTA Trial of Actemra Plus Veklury in Patients With Severe COVID-19 Pneumonia gene.com ↗
The REMDACTA clinical trial of Actemra plus Veklury did not meet its primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia or its key secondary endpoints compared to Veklury alone |
| 2020-12-11 | Eli Lilly and Company | Results Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the EUA Published in New England Journal of Medicine lilly.com ↗
Results of this study demonstrated baricitinib in combination with remdesivir provided a faster median recovery time and reduced progression to ventilation or death compared to remdesivir alone in hospitalized COVID-19 patients on oxygen. |
| 2020-10-22 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Antiviral Veklury® (remdesivir) for Treatment of COVID-19 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury ® (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. |
| 2020-10-08 | Gilead Sciences | Results Final Results of National Institute of Allergy and Infectious Diseases’ ACTT-1 Trial Published in New England Journal of Medicine Expand Clinical Benefits of Veklury® (remdesivir) for the Treatment of COVID-19 gilead.com ↗
The study met its primary endpoint, demonstrating Veklury plus standard of care was superior in shortening the time to recovery through Day 29 compared with placebo plus standard of care. |
| 2020-09-14 | Eli Lilly and Company | Results Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial lilly.com ↗
Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir. |
| 2020-08-28 | Gilead Sciences | Regulatory Gilead’s Investigational Antiviral Veklury® (Remdesivir) Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19 gilead.com ↗
Today’s action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury. |
| 2020-08-10 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury® (Remdesivir) for the Treatment of COVID-19 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) for Veklury ® (remdesivir), an investigational antiviral for the treatment of patients with COVID-19. |
| 2020-07-10 | Gilead Sciences | Results Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19 gilead.com ↗
In this analysis, remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care – an important finding that requires confirmation in prospective clinical trials. |
| 2020-07-03 | Gilead Sciences | Regulatory European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury® (remdesivir) for the Treatment of COVID-19 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted conditional marketing authorization for Veklury ® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19. |
| 2020-06-03 | Implicit Bioscience | Regulatory FDA approves COVID-19 study implicitbioscience.com ↗
On June 3, the US FDA approved an Investigative New Drug (IND) application for IC14 together with remdesivir in 300 COVID-19 patients at risk of acute respiratory distress syndrome (ARDS). |
| 2020-06-01 | Gilead Sciences | Results Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. |
| 2020-05-07 | Gilead Sciences | Regulatory Gilead Announces Approval of Veklury® (remdesivir) in Japan for Patients With Severe COVID-19 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury ® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, under an exceptional approval pathway. |
| 2020-05-01 | Gilead Sciences | Regulatory Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. |
| 2020-04-29 | Gilead Sciences | Results Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19 gilead.com ↗
We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing. |
| 2020-04-29 | Gilead Sciences | Results Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19 gilead.com ↗
The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 – 1.12] on Day 14). |
| 2020-04-10 | Gilead Sciences | Results Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in New England Journal of Medicine gilead.com ↗
Treatment with remdesivir resulted in an improvement in oxygen support class for 68 percent of patients (n=36/53) over a median follow-up of 18 days from the first dose of remdesivir. |
All press releases naming this drug 59 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 91 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | remdesivir | “Remdesivir (marketed by Gilead under de brand name Veklury®) is indicated in patients with pneumonia requiring supplemental oxygen (inpatients), as well as in outpatients who...” NCT05587894 ↗86“Participants were randomized 1:1 to receive intravenous remdesivir (GS-5734; Gilead Sciences) or matching placebo administered once daily by intravenous infusion over 1 hour on...” PMID 33709142 ↗ Nov 2021 “standard therapy which included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b.” NCT05184127 ↗ “Standard of care therapy can include remdesivir and/or dexamethasone per institutional treatment guidelines or written policies” NCT04351152 ↗ “remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab \& Imdevimab.” NCT04790240 ↗ “To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.” NCT04395170 ↗ “Remdesivir IV 200 mg for the first day and then 100 mg daily for the next 4 days” NCT04980534 ↗ “Remdesivir inhibits the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp; Nsp12).” PMID 39699245 ↗ Dec 2024 “A combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir” NCT06610643 ↗ “GS-5734 (Remdesivir) is an antiviral drug” NCT04480333 ↗ “The Antiviral treatment is Remdesivir.” NCT04675086 ↗ |
| Known as | GS-443902 | “Remdesivir (GS-443902) is a nucleoside analogue - RNA dependent RNA polymerase inhibitor.” NCT06551844 ↗ |
| Known as | GS-5734 | “Remdesivir (GS-5734), a nucleoside analogue prodrug” PMID 32423584 ↗ Apr 2020 |
| Known as | RDV | “Remdesivir (RDV,GS-5734) is a monophosphoramidate prodrug of an adenosine analog with potent activity against an array of RNA virus families including Filoviridae,...” NCT04302766 ↗5“The primary objective of this study is to characterize the impact of inhaled remdesivir (RDV) on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in...” NCT04539262 ↗ “Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)” NCT04323761 ↗ “Remdesivir (RDV)” NCT05925140 ↗ “Remdesivir (RDV)” NCT07197164 ↗ “Remdesivir (RDV)” NCT04501952 ↗ |
| Known as | Veklury | “Remdesivir (marketed by Gilead under de brand name Veklury®) is indicated in patients with pneumonia requiring supplemental oxygen (inpatients), as well as in outpatients who...” NCT05587894 ↗1“remdesivir (Veklury)” NCT04790240 ↗ |
| Action | Inhibit | “Remdesivir is an antiviral medicine with properties to inhibit viral replication of SARS-CoV-2.” PMID 34350582 ↗ Aug 2021 |
| Modality | Small molecule | “Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses” PMID 32423584 ↗ Apr 2020 |
| Route | Intravenous | “Daily GS-5734 delivered intravenously (IV) for 5 days” NCT02818582 ↗ |