Drugs / Favipiravir
Favipiravir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | REEQONUS™ | COVID-19 | 2020-12-22 | “According to Health Canada, REEQONUS™ (favipiravir) Tablets are the first oral solid dosage form submitted under the Interim Order.” appilitherapeutics.com ↗ “Dr. Reddy’s Canada has filed an application on behalf of the consortium for REEQONUS™ (favipiravir) Tablets” appilitherapeutics.com ↗ |
Trials 49
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06024421 | May 2024 → Jun 2027 expected | infectious disease | French National Institute of Health and Medical Research | Recruiting | No outcome recorded |
| Phase 1 | NCT01419457 | Aug 2011 → Feb 2013 | — | MDVI, LLC | Completed | No outcome recorded |
| Phase 1/22 trials · 1 missed | ||||||
| Phase 1/2 | NCT04746183 | Jul 2020 → Mar 2027 expected | COVID-19 | University of Liverpool | Recruiting | Missed primary |
| Phase 1/2 | NCT01728753 | Nov 2012 → Feb 2013 | influenza | MDVI, LLC | Completed | No outcome recorded |
| Phase 220 trials · 3 met primary · 4 missed | ||||||
| Phase 2 | NCT06488300 | Jul 2024 → Jan 2027 expected | respiratory syncytial virus infectious disease | University of Oxford | Recruiting | No outcome recorded |
| Phase 2 | NCT05648448 | Feb 2023 → Jan 2027 expected | influenza | University of Oxford | Recruiting | No outcome recorded |
| Phase 2 | NCT04940871 | Nov 2021 | COVID-19 | University of Pecs | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04918927 | Oct 2021 → Mar 2023 | COVID-19 | Coordinación de Investigación en Salud, Mexico | Completed | No outcome recorded |
| Phase 2 | NCT05041907 | Sep 2021 → Jan 2027 expected | COVID-19 | University of Oxford | Recruiting | Mixed |
| Phase 2 | NCT04907682 | Jul 2021 → Nov 2022 | Lassa fever | Bernhard Nocht Institute for Tropical Medicine | Completed | Met primary |
| Phase 2 | NCT04475991 | Jul 2021 → Mar 2022 | COVID-19 | Hospital General de México Dr. Eduardo Liceaga | Terminated | No outcome recorded Stop: Enrollment |
| 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 | NCT04448119 | Oct 2020 → Oct 2021 | COVID-19 | Appili Therapeutics Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04499677 | Sep 2020 → Dec 2021 | COVID-19 | University College, London | Completed | Missed primary |
| Phase 2 | NCT04532931 | Sep 2020 → Aug 2021 | COVID-19 | Shin Poong Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04387760 | Aug 2020 → Mar 2021 | COVID-19 | Royal College of Surgeons in Ireland - Medical University of Bahrain | Completed | Missed primary |
| Phase 2 | NCT04445467 | Jul 2020 → Nov 2021 | COVID-19 | Bayside Health | Unknown | No outcome recorded |
| Phase 2 | NCT04346628 | Jul 2020 → Apr 2021 | COVID-19 | Stanford University | Completed | Missed primary |
| Phase 2 | NCT04358549 | Apr → Sep 2020 | COVID-19 | Fujifilm Pharmaceuticals U.S.A., Inc. | Completed | Met primary |
| Phase 2 | NCT03394209 | Feb 2018 → Feb 2019 | influenza | Capital Medical University | Completed | No outcome recorded |
| Phase 2 | NCT02739477 | Apr → Aug 2016 | Ebola hemorrhagic fever | French National Institute of Health and Medical Research | Terminated | No outcome recorded |
| Phase 2 | NCT02329054 | Dec 2014 → May 2015 | Ebola hemorrhagic fever | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 2 | NCT02662855 | Nov 2014 → Apr 2015 | Ebola hemorrhagic fever | Beijing Institute of Pharmacology and Toxicology | Completed | No outcome recorded |
| Phase 2 | NCT01068912 | Feb 2010 → Apr 2012 | influenza | MDVI, LLC | Completed | Missed primary |
| Phase 2/36 trials | ||||||
| Phase 2/3 | NCT06212336 | May 2025 → Jun 2027 expected | Lassa fever | Irrua Specialist Teaching Hospital | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04464408 | Jul 2020 → Aug 2021 | COVID-19 | King Abdullah International Medical Research Center | Completed | No outcome recorded |
| Phase 2/3 | NCT04402203 | May → Jul 2020 | COVID-19 | Bangladesh Medical Research Council (BMRC) | Unknown | No outcome recorded |
| Phase 2/3 | NCT04434248 | Apr → Jul 2020 | COVID-19 | Chromis LLC | Unknown | No outcome recorded |
| Phase 2/3 | NCT04351295 | Apr → Sep 2020 | COVID-19 | Tanta University | Completed | No outcome recorded |
| Phase 2/3 | NCT04319900 | Mar → Apr 2020 | COVID-19 | Beijing Chao Yang Hospital | Unknown | No outcome recorded |
| Phase 314 trials · 1 met primary · 4 missed | ||||||
| Phase 3 | NCT04818320 | Feb → Jul 2021 | COVID-19 | Penang Hospital, Malaysia | Completed | Missed primary |
| Phase 3 | NCT04600895 | Nov 2020 → Oct 2021 | COVID-19 | Appili Therapeutics Inc. | Completed | Missed primary |
| Phase 3 | NCT04613271 | Oct 2020 → Oct 2021 | COVID-19 | Ina-Respond | Completed | No outcome recorded |
| Phase 3 | NCT05014373 | Oct 2020 → Aug 2021 | COVID-19 | University of the Philippines | Unknown | No outcome recorded |
| Phase 3 | NCT04600999 | Oct → Dec 2020 | COVID-19 | University of Pecs | Completed | No outcome recorded |
| Phase 3 | NCT04529499 | Aug 2020 → Jan 2021 | COVID-19 | Dr. Reddy's Laboratories Limited | Terminated | Missed primary |
| Phase 3 | NCT04425460 | Jun → Aug 2020 | COVID-19 | Zhejiang Hisun Pharmaceutical Co. Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04542694 | May → Aug 2020 | COVID-19 | Promomed, LLC | Completed | Met primary |
| Phase 3 | NCT04501783 | May → Jul 2020 | COVID-19 | R-Pharm | Completed | No outcome recorded |
| Phase 3 | NCT04411433 | May → Dec 2020 | COVID-19 | Ministry of Health, Turkey | Unknown | No outcome recorded |
| Phase 3 | NCT04373733 | May 2020 → Jun 2021 | COVID-19 | Chelsea and Westminster NHS Foundation Trust | Completed | Missed primary |
| Phase 3 | NCT04349241 | Apr → Jun 2020 | COVID-19 | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT04558463 | Apr → Sep 2020 | COVID-19 | Indonesia University | Unknown | No outcome recorded |
| Phase 3 | NCT04336904 | Mar → Jul 2020 | COVID-19 | Giuliano Rizzardini | Unknown | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05502081 | Sep → Dec 2022 | COVID-19 | Mansoura University Hospital | Completed | Mixed |
| Phase 4 | NCT04359615 | Apr → May 2020 | COVID-19 | Shahid Beheshti University of Medical Sciences | Unknown | No outcome recorded |
| Phase not applicable3 trials · 1 missed | ||||||
| — | NCT04392973 | May 2020 → Jan 2021 | COVID-19 | King Abdullah International Medical Research Center | Completed | Missed primary |
| — | NCT04333589 | Apr → Jun 2020 | COVID-19 | Peking University First Hospital | Unknown | No outcome recorded |
| — | NCT04376814 | Mar → Apr 2020 | COVID-19 | Baqiyatallah Medical Sciences University | Completed | No outcome recorded |
| Comparator or background therapy15 trials | ||||||
| Phase 1/2 | NCT05940545 Comparator | Jul → Sep 2023 | Crimean-Congo hemorrhagic fever | Liverpool School of Tropical Medicine | Unknown | No outcome recorded |
| Phase 1/2 | NCT04715360 Background | Dec 2020 → Nov 2021 | COVID-19, acute respiratory distress syndrome | Hayandra Peduli Foundation | Unknown | No outcome recorded |
| Phase 2 | NCT06860334 Comparator | Jul 2025 → Dec 2027 expected | Crimean-Congo hemorrhagic fever | Liverpool School of Tropical Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04718285 Background | May 2021 → May 2022 | COVID-19 | Bahçeşehir University | Unknown | No outcome recorded |
| Phase 2/3 | NCT04828564 Comparator | Apr → Sep 2021 | COVID-19 | The Scientific and Technological Research Council of Turkey | Unknown | No outcome recorded |
| Phase 3 | NCT05279235 Comparator | Mar → Dec 2022 | — | Shanghai Vinnerna Biosciences Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05185284 Comparator | Aug → Dec 2021 | COVID-19 | Promomed, LLC | Completed | No outcome recorded |
| Phase 3 | NCT05187793 Background | Jul 2021 → Oct 2022 | COVID-19 | R-Pharm | Unknown | No outcome recorded |
| Phase 3 | NCT04784559 Comparator | Jun 2021 → Mar 2023 | COVID-19 | PharmaMar | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT05417997 Background | May → Dec 2021 | COVID-19, bacterial pneumonia, influenza | RAAS Nutritionals, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04694612 Comparator | Jan → Mar 2021 | COVID-19 | Nepal Health Research Council | Unknown | No outcome recorded |
| Phase 3 | NCT04981379 Comparator | Nov 2020 → Jan 2021 | COVID-19 | Health Institutes of Turkey | Completed | No outcome recorded |
| Phase 3 | NCT02026349 Comparator | Jan 2014 → Mar 2015 | influenza | MDVI, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02008344 Comparator | Dec 2013 → Jan 2015 | influenza | MDVI, LLC | Completed | No outcome recorded |
| — | NCT04310228 Comparator | Mar → May 2020 | COVID-19 | Peking University First Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2021-11-12 | Appili Therapeutics Inc. | Results Appili Therapeutics Provides Update on Phase 3 PRESECO Clinical Trial Evaluating Avigan®/Reeqonus™ appilitherapeutics.com ↗
the Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial evaluating oral antiviral Avigan®/Reeqonus™(favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery. |
| 2020-12-22 | Appili Therapeutics Inc. | Regulatory Dr. Reddy’s Laboratories, Global Response Aid, and Appili Therapeutics Announce the Filing of an Application for REEQONUS™ (Favipiravir) Tablets for the Treatment of COVID-19 Under Health Canada’s Interim Order appilitherapeutics.com ↗
We are pleased to work with our partners at GRA and Appili to be the first in Canada to file an application for oral solid tablets for COVID-19 treatment under Health Canada’s Interim Order |
| 2020-11-24 | Appili Therapeutics Inc. | Regulatory Health Canada Clears Appili Therapeutics for New Phase 3 Clinical Trial to Evaluate Avigan Tablets (Favipiravir) in the Prevention of COVID-19 in Exposed Individuals in the Community appilitherapeutics.com ↗
Health Canada has provided a ‘No Objection Letter (NOL)’ for Appili’s proposed study; the U.S. FDA accepted a submission of a protocol amendment to conduct the trial in the United States. |
| 2020-09-11 | Appili Therapeutics Inc. | Regulatory Appili Submits Protocol for a Phase 3 Study Evaluating Favipiravir for the Treatment of Patients with COVID-19 Infections to the US FDA appilitherapeutics.com ↗
today announced that it has submitted a new protocol to its open investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to conduct a Phase 3 clinical study evaluating favipiravir in the early treatment outpatient setting for adult COVID-19 infections. |
| 2020-08-10 | Appili Therapeutics Inc. | Regulatory FDA Clears Appili Therapeutics to Expand its Phase 2 Clinical Trial of Favipiravir for the Potential Prevention of COVID-19 at U.S. Long-Term Care Facilities appilitherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to proceed after Appili’s filing of an investigational new drug (IND) application for broad-spectrum antiviral favipiravir. |
| 2020-05-26 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark to commence another new Phase 3 clinical trial on a combination of two anti-viral drugs Favipiravir and Umifenovir in hospitalized patients of moderate COVID-19 in India glenmarkpharma.com ↗
Glenmark received approval from the Indian regulator to initiate the study |
| 2020-05-21 | Appili Therapeutics Inc. | Regulatory Health Canada Clears Appili Therapeutics’ Phase 2 Clinical Trial Evaluating Favipiravir as a Prophylactic Agent Against COVID-19 Outbreaks appilitherapeutics.com ↗
today announced that Health Canada provided regulatory clearance for Appili’s Phase 2 study evaluating FUJIFILM Toyama Chemical’s (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks. |
| 2020-05-11 | Appili Therapeutics Inc. | Regulatory Appili Therapeutics Submits CTA with Health Canada to Sponsor Prophylactic Phase 2 Clinical Trial Evaluating FUJIFILM Toyama Chemical’s Favipiravir as a Preventative Measure Against COVID-19 in Canadian Long-Term Care Facilities appilitherapeutics.com ↗
Appili has filed the clinical trial application (CTA) with Health Canada and expects to initiate the trial as soon as possible following receipt of regulatory clearance. |
| 2020-04-30 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark receives approval from the regulator (DCGI) to conduct Clinical Trials in India on Favipiravir Antiviral tablets for COVID-19 patients glenmarkpharma.com ↗
Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, today announced that it has received approval from the DCGI (Drug Controller General of India), the regulator in India to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 patients. |
All press releases naming this drug 20 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Favipiravir | “standard therapy which included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b.” NCT05184127 ↗61“Favipiravir, 200 mg, film coated tablets” NCT05187793 ↗ |
| Known as | AVIGAN | “Favipiravir (or Avigan) 1800 mg tablet 2x a day on Day 1 then 800 mg 2x a day from Day 2 to maximum of Day 14” NCT05014373 ↗4“Patient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days.” NCT04715360 ↗ “Name: AVIGAN Generic name: Favipiravir” NCT04600999 ↗ |
| Known as | Avigan (favipiravir) | “Avigan® (favipiravir)” NCT04558463 ↗ |
| Known as | Favicovir | “Montelukast plus Favicovir (Favipiravir)” NCT04718285 ↗ |
| Known as | Favipira | “Favipiravir 200 mg (Favipira) tablet will be given orally.” NCT04402203 ↗ |
| Known as | FPV | “Favipiravir (FPV) has shown to be capable to reduce the time of viral clearance by half.” NCT04475991 ↗ |
| Known as | T-705 | “Favipiravir, previously known as T-705, is a prodrug of a purine nucleotide, favipiravir ribofuranosyl-5'-triphosphate.” NCT04359615 ↗ |
| Action | Inhibit | “a viral RNA-dependent RNA polymerase inhibitor.” NCT03394209 ↗ |
| Modality | Small molecule | “pyrazine carboxamide derivative (6-fluoro-3-hydroxy-2-pyrazinecarboxamide)” NCT04349241 ↗ |
| Route | Oral | “Oral Favipiravir Exposure and Pharmacodynamic Effects in Adult Outpatients With Acute Influenza.” PMID 37739792 ↗ Aug 2024 |