Drugs / Oseltamivir
Oseltamivir
also known as
Tamiflu · oseltamivir phosphate · Agucort · Ebilfumin · GS 4104 · GS-4071 ETHYL ESTER · Oseltamivir (as phosphate) · Oseltamiviri phosphas · +6 more
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed influenza 3 milestones | |||||
| Filed | EU (EMA) | Tamiflu | influenza | 2001-02-27 | “Roche has submitted Tamiflu™ (oseltamivir phosphate), the first neuraminidase inhibitor in pill form, to the European authorities (CPMP) for regulatory approval” gilead.com ↗ “Additionally, Roche submitted its application to European authorities for approval of Tamiflu for the treatment of influenza A and B in adults and children” gilead.com ↗ “has also recently filed for marketing authorization of Tamiflu in the European Union under the centralized procedure.” gilead.com ↗ |
| Filed | Japan (PMDA) | Tamiflu | influenza | 2000-08-02 | “Roche has submitted Tamiflu (oseltamivir phosphate) to the Japanese Ministry for Health and Welfare (MHW)” gilead.com ↗ |
| Filed | US (FDA) | Tamiflu | influenza | 2000-05-23 | “In April, Gilead Sciences and Hoffmann-La Roche announced that Roche submitted a NDA to the FDA for approval to market oseltamivir phosphate” gilead.com ↗ “Roche has submitted an application to the U.S. Food and Drug Administration (FDA) for a new indication for its influenza antiviral Tamiflu™” gilead.com ↗ “Tamiflu™ (oseltamivir phosphate) NDA for the Treatment of Influenza Submitted” gilead.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | TAMIFLU | — | 2000-11-17 – 2019-08-02 | fda.gov ↗ |
| Approved | EU (EMA) | Tamiflu | — | 2002-06-20 | europa.eu ↗ |
| Approved | US (FDA) | TAMIFLU | — | 1999-10-27 | fda.gov ↗ |
Trials 73 · started per year
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EU approved 2002
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 124 trials | ||||||
| Phase 1 | NCT06057103 | Aug → Dec 2023 | — | Nanjing Zenshine Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05789342 | Feb → Sep 2023 | — | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05083325 | Oct 2021 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1 | NCT04982913 | Aug 2021 → Oct 2022 | influenza | Sunshine Lake Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05108051 | Nov 2020 → Mar 2021 | — | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03023852 | Feb → Apr 2017 | — | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 1 | NCT02888327 | Jul 2016 → May 2017 | influenza | Alios Biopharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02262715 | Jul → Oct 2014 | — | Janssen Infectious Diseases BVBA | Completed | No outcome recorded |
| Phase 1 | NCT01715909 | Jan 2014 → Jun 2018 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01902342 | Jul → Dec 2013 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01556633 | Mar → Jun 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01708369 | Feb → May 2012 | — | University of Tennessee | Completed | No outcome recorded |
| Phase 1 | NCT00988325 | Jan 2011 → Apr 2012 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01053663 | Jan 2011 → Jan 2013 | influenza | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT01033734 | Dec 2010 → Dec 2012 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01049763 | Jan → Sep 2010 | — | South East Asia Infectious Disease Clinical Research Network | Completed | No outcome recorded |
| Phase 1 | NCT02717754 | Dec 2009 → May 2010 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01172847 | Aug 2009 → Feb 2010 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT00921726 | Jul → Oct 2009 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00873886 | Apr 2009 → Sep 2010 | influenza, pregnancy disorder | University of Pittsburgh | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00540501 | Oct 2007 | — | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT00439530 | Nov 2006 → Apr 2007 | avian influenza | Mahidol University | Completed | No outcome recorded |
| Phase 1 | NCT00416962 | Aug → Dec 2006 | — | Novartis | Completed | No outcome recorded |
| Phase 1 | NCT02617784 | Oct 2001 → Jun 2002 | end stage renal failure | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02603952 | Dec 2015 → Dec 2016 | influenza | MedImmune LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT01179919 | Jul → Sep 2010 | obesity disorder | Manjunath Prakash Pai | Completed | No outcome recorded |
| Phase 1/2 | NCT00391768 | Jan 2007 → Mar 2010 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 210 trials · 1 missed | ||||||
| Phase 2 | NCT05648448 | Feb 2023 → Jan 2027 expected | influenza | University of Oxford | Recruiting | No outcome recorded |
| Phase 2 | NCT04516915 | Jun 2020 → May 2022 | COVID-19 | University Hospitals Coventry and Warwickshire NHS Trust | Completed | No outcome recorded |
| Phase 2 | NCT03903718 | Apr → Oct 2020 | influenza | MedImmune LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02469298 | Jun 2015 → Apr 2016 | viral infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01146535 | Jan 2011 → Dec 2012 | influenza | Ainos, Inc. (f/k/a Amarillo Biosciences Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01037634 | Mar 2010 → Mar 2012 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 2 | NCT01010087 | Nov 2009 → May 2011 | influenza | University of Manitoba | Terminated | No outcome recorded |
| Phase 2 | NCT00830323 | Jan → Aug 2009 | influenza | Hospices Civils de Lyon | Terminated | No outcome recorded |
| Phase 2 | NCT00453999 | Jul 2007 → Sep 2008 | influenza | BioCryst Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT00334529 | Jun 2006 → Apr 2007 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01546935 | Dec 2012 → Dec 2014 | influenza | University of Oxford | Withdrawn | No outcome recorded |
| Phase 312 trials · 2 missed | ||||||
| Phase 3 | NCT07236814 | Nov 2025 → Mar 2027 expected | influenza | Capital Medical University | Recruiting | No outcome recorded |
| Phase 3 | NCT04338698 | Apr → Nov 2020 | COVID-19 | Shehnoor Azhar | Completed | No outcome recorded |
| Phase 3 | NCT04530422 | Apr → Jul 2020 | COVID-19 | Almaza Military Fever Hospital | Completed | No outcome recorded |
| Phase 3 | NCT04261270 | Feb → May 2020 | COVID-19 | Tongji Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03520049 | Nov 2016 → Sep 2021 | autoimmune thrombocytopenia | Unity Health Toronto | Unknown | No outcome recorded |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 3 | NCT01231620 | Jan 2011 → Mar 2015 | influenza | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT01050257 | Jan 2010 → Sep 2012 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00979667 | Oct 2009 → Aug 2010 | influenza, upper respiratory tract disorder | Chinese University of Hong Kong | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00949533 | Aug 2009 → Oct 2010 | influenza | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT00707941 | May 2008 → Mar 2011 | influenza, pneumonia, viral exanthem | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | Mixed |
| Phase 3 | NCT00545532 | Feb 2008 → May 2017 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 418 trials · 1 met primary · 3 missed | ||||||
| Phase 4 | NCT04684498 | Mar 2020 → Jun 2023 | ST-elevation myocardial infarction | Tongji Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04255017 | Feb → Jun 2020 | COVID-19 | Tongji Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04141917 | Nov 2019 → Mar 2021 | influenza | University of Washington | Terminated | Missed primary |
| Phase 4 | NCT02561169 | Dec 2015 → Mar 2016 | influenza | McMaster University | Terminated | No outcome recorded |
| Phase 4 | NCT02609399 | Nov 2015 → May 2017 | influenza | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT02282384 | Oct 2014 → Mar 2015 | influenza, lung disorder | McMaster University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01456234 | Nov 2011 → May 2013 | influenza | Trial Management Group Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01443806 | Jul 2011 → Dec 2012 | metabolic disease | University of Oxford | Completed | No outcome recorded |
| Phase 4 | NCT01248715 | Nov 2010 → May 2016 | influenza, pneumonia | University of Louisville | Completed | Missed primary |
| Phase 4 | NCT01130636 | Jun 2010 → Jul 2012 | influenza | Pharmahungary Group | Completed | No outcome recorded |
| Phase 4 | NCT01032837 | Nov 2009 → Oct 2010 | influenza | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 4 | NCT00936013 | Aug 2009 → Jul 2011 | influenza | Capital Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT00935194 | Jul → Nov 2009 | influenza | Capital Medical University | Completed | Met primary |
| Phase 4 | NCT02780622 | Feb → Jul 2008 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00436124 | Jan → Apr 2007 | influenza | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00412737 | Jan 2007 → May 2008 | influenza | Hoffmann-La Roche | Completed | Missed primary |
| Phase 4 | NCT00412555 | Dec 2006 → May 2007 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00304434 | Feb 2005 → Feb 2007 | influenza | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase not applicable5 trials · 2 met primary | ||||||
| — | NCT06762587 | Jan → Apr 2025 overdue | influenza, nosocomial infection | Capital Medical University | Not yet recruiting | No outcome recorded |
| — | NCT05008679 | Feb 2021 → Feb 2023 | heart failure | Tongji Hospital | Unknown | No outcome recorded |
| — | NCT04297462 | Nov 2016 → Mar 2020 | influenza | Centre of Postgraduate Medical Education | Unknown | Met primary |
| — | NCT01314911 | Apr 2011 → Nov 2017 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| — | NCT00555893 | Jan 2008 → Feb 2011 | influenza | Marshfield Clinic Research Foundation | Completed | No outcome recorded |
| Comparator or background therapy59 trials | ||||||
| Phase 0 | NCT04371601 Background | Mar 2020 → Dec 2021 | pneumonia | Fuzhou General Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05818124 Comparator | Aug 2023 → Jun 2024 | influenza | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 1 | NCT04457609 Background | Jul → Aug 2020 | COVID-19, pneumonia | Indonesia University | Unknown | No outcome recorded |
| Phase 1/2 | NCT00867139 Comparator | Mar → Aug 2009 | influenza | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT04712539 Background | Oct 2021 → Feb 2028 expected | hematopoietic and lymphoid cell neoplasm, influenza | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03394209 Background | Feb 2018 → Feb 2019 | influenza | Capital Medical University | Completed | No outcome recorded |
| Phase 2 | NCT03238612 Background | Jan 2018 → Jul 2020 | influenza | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 2 | NCT03212716 Background | Dec 2017 → May 2022 | influenza | University Hospital, Lille | Terminated | No outcome recorded |
| Phase 2 | NCT03028909 Background | Jul 2017 → Jul 2019 | — | MedImmune LLC | Withdrawn | No outcome recorded |
| Phase 2 | NCT02927431 Background | Jan → May 2017 | viral infectious disease | GlaxoSmithKline | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01965626 Comparator | Feb 2016 → May 2018 | thrombocytopenia | Shandong University | Completed | No outcome recorded |
| Phase 2 | NCT02532283 Background | Dec 2015 → Feb 2017 | influenza | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02293863 Background | Jan 2015 → May 2017 | influenza | Genentech, Inc. | Completed | Missed primary |
| Phase 2 | NCT02342249 Comparator | Dec 2014 → May 2016 | influenza | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01980966 Comparator | Nov 2013 → Jun 2014 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01227967 Comparator | Sep 2010 → May 2016 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 2 | NCT00979251 Comparator | Sep 2009 → May 2010 | influenza | Adamas Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00298233 Comparator | Feb 2006 → Jan 2010 | avian influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/3 | NCT05170009 Comparator | Apr 2022 → Jan 2024 | influenza | Weill Medical College of Cornell University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT07496736 Comparator | Dec 2025 → Mar 2028 expected | influenza | University Medical Centre Ljubljana | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07229807 Comparator | Nov → Dec 2025 overdue | influenza | Guangdong Raynovent Biotech Co., Ltd | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07357051 Comparator | Nov 2025 → Jan 2026 overdue | viral respiratory tract infection | Joincare Pharmaceutical Group Industry Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT07095257 Comparator | Oct 2025 → Jan 2026 | viral respiratory tract infection | Nanjing Zenshine Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT07113392 Comparator | Aug 2025 → Aug 2026 overdue | influenza | Jiangxi Kvvit Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06669351 Comparator | Oct 2024 → Jul 2025 | viral respiratory tract infection | Nanjing Zenshine Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT06774859 Comparator | Oct 2024 → May 2025 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03901001 Comparator | May 2023 → Oct 2025 | influenza | Chinese University of Hong Kong | Unknown | No outcome recorded |
| Phase 3 | NCT03900988 Comparator | May 2023 → Oct 2025 | influenza | Chinese University of Hong Kong | Unknown | No outcome recorded |
| Phase 3 | NCT04683406 Comparator | Dec 2020 → Apr 2023 | influenza | Guangdong Raynovent Biotech Co., Ltd | Completed | Met primary |
| Phase 3 | NCT04349241 Comparator | Apr → Jun 2020 | COVID-19 | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT04558463 Comparator | Apr → Sep 2020 | COVID-19 | Indonesia University | Unknown | No outcome recorded |
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
| Phase 3 | NCT03629184 Comparator | Nov 2018 → Apr 2019 | influenza | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT02949011 Comparator | Jan 2017 → Apr 2018 | influenza | Shionogi | Completed | Met primary |
| Phase 3 | NCT02954354 Comparator | Dec 2016 → Apr 2017 | influenza | Shionogi | Completed | Mixed |
| Phase 3 | NCT02662426 Comparator | Apr 2016 → Nov 2017 | influenza | The First Affiliated Hospital of Guangzhou Medical University | Unknown | No outcome recorded |
| Phase 3 | NCT02369159 Comparator | Mar 2015 → Oct 2019 | influenza | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02108366 Background | Mar 2014 → Mar 2018 | influenza | The University of Hong Kong | Completed | No outcome recorded |
| Phase 3 | NCT01610245 Comparator | Mar 2013 → Mar 2015 | influenza | Romark Laboratories L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00799760 Comparator | Dec 2008 → Nov 2009 | viral gastritis | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| Phase 3 | NCT00803595 Comparator | Nov 2008 → Mar 2009 | influenza | Daiichi Sankyo | Completed | Met primary |
| Phase 4 | NCT05012189 Comparator | Aug 2021 → Dec 2023 | influenza | Insight Therapeutics, LLC | Unknown | No outcome recorded |
| Phase 4 | NCT04973462 Comparator | Aug → Sep 2021 | COVID-19 | Ain Shams University | Unknown | No outcome recorded |
| Phase 4 | NCT04183725 Comparator | Dec 2019 → Jun 2021 | — | China Academy of Chinese Medical Sciences | Unknown | No outcome recorded |
| Phase 4 | NCT03754686 Comparator | Feb 2019 → Jan 2022 | influenza | Rambam Health Care Campus | Unknown | No outcome recorded |
| Phase 4 | NCT01850446 Comparator | Feb 2015 → Apr 2018 | influenza | Materia Medica Holding | Completed | Met primary |
| Phase 4 | NCT01690637 Comparator | Sep 2012 → Nov 2013 | influenza | Centers for Disease Control and Prevention | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02232945 Comparator | Apr 2012 → Aug 2016 | influenza | Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited | Unknown | No outcome recorded |
| Phase 4 | NCT01804946 Comparator | Feb 2011 → Apr 2014 | influenza | Materia Medica Holding | Completed | No outcome recorded |
| Phase 4 | NCT01249833 Comparator | Nov 2010 → Apr 2012 | influenza | Trial Management Group Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01052961 Comparator | Jan 2010 → Jun 2012 | influenza | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT01053377 Comparator | Dec 2009 → Dec 2013 | influenza | National Institute for Public Health and the Environment (RIVM) | Unknown | No outcome recorded |
| Phase 4 | NCT00980109 Comparator | Sep 2009 → Sep 2010 | influenza | University of Oxford | Completed | No outcome recorded |
| Phase 4 | NCT00593502 Comparator | Feb 2008 → Jun 2009 | influenza | Hospital District of Southwestern Finland | Completed | No outcome recorded |
| — | NCT03947411 Comparator | Mar 2019 → Mar 2020 | influenza | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Unknown | No outcome recorded |
| — | NCT03899571 Comparator | Jan 2019 → Mar 2020 | influenza | University Medical Centre Ljubljana | Completed | No outcome recorded |
| — | NCT03365336 Background | Feb → May 2018 | influenza | Composite Interceptive Med Science | Unknown | No outcome recorded |
| — | NCT01306773 Comparator | Dec 2009 → Dec 2010 | influenza | The University of Hong Kong | Completed | No outcome recorded |
| — | NCT00844155 Comparator | Mar → Jul 2009 | influenza | University of Manitoba | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 33
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | Alembic Pharmaceuticals Ltd. | Regulatory 26th June, 2026 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. |
| 2026-05-06 | Guangdong Raynovent Biotech Co., Ltd | Results 昂拉地韦颗粒儿童/片剂青少年两项III期临床试验获得顶线分析数据结果！ raynovent.com ↗
昂拉地韦颗粒组和奥司他韦组发生流感相关并发症例数分别为0例（0%）和2例（5.3%）。 |
| 2023-12-04 | TrippBio, Inc. | Results TrippBio Publishes Data Comparing the invitro and in vivo Activity of PanCytoVir™versus Oseltamivir trippbio.com ↗
PanCytoVir™ was uniformly more potent than oseltamivir when tested in vitro across various cell lines. |
| 2019-09-02 | Hoffmann-La Roche | Results Roche presents positive phase III study results for one-dose Xofluza in children with flu roche.com ↗
In Xofluza-treated participants, 46.1% experienced at least one treatment-emergent AE compared to 53.4% in the oseltamivir arm. |
| 2019-06-01 | Alembic Pharmaceuticals Ltd. | Regulatory 25th June, 2019, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2018-10-04 | Hoffmann-La Roche | Results Positive phase III results for baloxavir marboxil in people at high risk of complications from influenza to be presented at IDWeek 2018 roche.com ↗
In the subpopulation of patients with influenza type B, a subgroup where some antiviral treatments have shown only limited efficacy or inconclusive data, baloxavir marboxil was significantly more efficacious than oseltamivir in reducing the time to improvement of symptoms (median time of 74.6 hours versus 101.6 hours; p<0.05). |
| 2018-06-07 | Upsher-Smith Laboratories | Regulatory MHLW Approves New Indication for OSELTAMIVIR Capsules 75mg [SAWAI] / Dry Syrup 3% [SAWAI] upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approval of partial change applications by the Ministry of Health, Labour and Welfare (MHLW) for OSELTAMIVIR Capsules 75mg [SAWAI] and OSELTAMIVIR Dry Syrup 3% [SAWAI]*. |
| 2018-03-01 | Impax Laboratories, LLC | Regulatory Amneal Launches Generic for Tamiflu® Oral Suspension amneal.com ↗
“Approval and launch of this liquid form should be of great assistance to patients and caregivers,” states Amneal EVP of Commercial Operations Andy Boyer. |
| 2018-02-20 | Lupin Limited | Regulatory Lupin receives FDA approval for generic Tamiflu® for Oral Suspension lupin.com ↗
Pharma major Lupin announced that it has received final approval for its Oseltamivir Phosphate for Oral Suspension from the United States Food and Drug Administration (FDA) to market the generic version of Hoffman-La Roche, Inc.’s Tamiflu for Oral Suspension, 6 mg/mL. |
| 2018-02-15 | Upsher-Smith Laboratories | Regulatory Sawai Pharmaceutical Receives Approvals for Eight Molecules in 19 Presentations of Generic Drugs upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approvals by the Ministry of Health, Labour and Welfare for eight molecules in 19 presentations of generic drugs. |
| 2018-01-10 | Lupin Limited | Regulatory Lupin receives FDA approval for generic Tamiflu Capsules lupin.com ↗
Mumbai: Pharma Major Lupin announced that it has received final approval for its Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base) from the United States Food and Drug Administration (FDA) to market a generic version of Hoffman-La Roche, Inc.’s Tamiflu Capsules, 30 mg, 45 mg, and 75 mg. |
| 2017-11-02 | Alvogen Korea | Regulatory Alvogen first to market with generic equivalent to Tamiflu® powder for oral suspension alvogen.com ↗
Alvogen is first to market and has received final approval for the generic equivalent to Tamiflu® (oseltamivir phosphate) 6 mg/ml powder for oral suspension in the United States. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results Data from Phase 2 Study of Peramivir in Patients Hospitalized with Influenza Presented at the XI International Symposium on Respiratory Viral Infections biocryst.com ↗
As reported in October 2008, there were no statistically significant differences in any of the efficacy endpoints between the three treatment arms, and peramivir was generally safe and well-tolerated at these dose levels. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Reports Results From the First-Ever Completed Active-Controlled Phase 2 Study in Hospitalized Influenza biocryst.com ↗
There were no statistically significant differences in any of the efficacy endpoints between the three treatment arms. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst to Present Peramivir Data at the 50th Annual ICAAC Meeting biocryst.com ↗
No Pharmacokinetic Interactions Observed between Intravenous Peramivir and Oral Oseltamivir or Rimantadine in Humans |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Announces RAPIVAB® (peramivir injection) and Galidesivir Presentations at IDWeek 2017™ biocryst.com ↗
Treatment-emergent adverse events possibly, probably or definitely related to study drug were reported in 9% of peramivir treated subjects vs 17% of oseltamivir treated subjects. |
| 2017-03-24 | Chugai Pharmaceutical | Regulatory Anti-Influenza Drug, “Tamiflu ® Dry Syrup 3%,” Obtained Approval for Additional Dosage and Administration for Newborns and Infants chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it obtained an approval for anti-influenza drug “Tamiflu ® Dry Syrup 3%” (oseltamivir phosphate) for the dosage and administration of treatment of influenza type A or B virus infection to newborns and infants from the Japanese Ministry of Health, Labour and Welfare. |
| 2016-12-16 | Chugai Pharmaceutical | Regulatory Anti-Influenza Drug, Tamiflu ® Filed for Additional Dosage and Administration for Newborns and Infants by Public Knowledge-Based Application chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has filed public knowledge-based applications for anti-influenza drug “Tamiflu ® Dry Syrup 3%” |
| 2011-02-09 | Alvogen Korea | Regulatory Alvogen and Natco secure first-to-file status on generic version of Tamiflu® alvogen.com ↗
Natco Pharma Limited, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for the generic version of Tamiflu® (oseltamivir phosphate). |
| 2011-02-07 | Gilead Sciences | Regulatory Gilead Sciences Announces Notification of ANDA Filing for Tamiflu(R) gilead.com ↗
Natco Pharma Limited submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) |
| 2001-02-27 | Gilead Sciences | Regulatory Roche Submits Oral Flu Drug Tamiflu for Regulatory Approval in Europe gilead.com ↗
Roche and Gilead Sciences, Inc. announced today that Roche has submitted Tamiflu™ (oseltamivir phosphate), the first neuraminidase inhibitor in pill form, to the European authorities (CPMP) for regulatory approval |
| 2001-02-14 | Gilead Sciences | Results JAMA Study Reveals Roche's Tamiflu™ Effective In Protecting People Exposed to Influenza gilead.com ↗
In this post-exposure study of more than 950 patients, Tamiflu, when taken within two days of symptom onset in the index case, had an overall protection rate of 89 percent against clinical influenza in individuals. |
| 2000-12-14 | Gilead Sciences | Regulatory Tamiflu™ Granted FDA Approval for Treatment of Flu in Children gilead.com ↗
Hoffmann-La Roche Inc. and Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Roche marketing approval for a pediatric treatment indication for Tamiflu™ (oseltamivir phosphate), the number one prescribed antiviral treatment for influenza in adults. |
| 2000-12-12 | Gilead Sciences | Regulatory Roche's Oral Flu Drug Tamiflu™ Gets Approval in Japan gilead.com ↗
Roche and Gilead Sciences, Inc. (Nasdaq: GILD) announced today that Roche has received regulatory approval for Tamiflu™ (oseltamivir phosphate), the first neuraminidase inhibitor available in pill form, from the Japanese Ministry for Health and Welfare (MHW), for the treatment of influenza A and B virus infection in adults. |
| 2000-11-20 | Gilead Sciences | Regulatory Roche's Tamiflu™ Granted FDA Approval for the Prevention of Influenza gilead.com ↗
Hoffmann-La Roche Inc. and Gilead Sciences, Inc. (NASDAQ:GILD), announced today that the U.S. Food and Drug Administration (FDA) has granted Roche marketing approval for a prophylaxis indication for its influenza antiviral Tamiflu™ (oseltamivir phosphate). |
| 2000-09-18 | Gilead Sciences | Results New Tamiflu™ Data Shows Early Treatment Optimizes Benefit for Flu Sufferers gilead.com ↗
Tamiflu, taken within the first 12 hours of symptom onset, reduced the total duration of illness by greater than three days compared to treatment at 48 hours. |
| 2000-08-02 | Gilead Sciences | Regulatory Roche Submits Tamiflu for Regulatory Approval in Japan; First Oral Neuraminidase Inhibitor for the Treatment and Prevention of Influenza gilead.com ↗ |
| 2000-06-16 | Gilead Sciences | Regulatory Roche Seeks to Broaden Tamiflu Treatment Indication with Pediatric Application gilead.com ↗ |
| 2000-05-26 | Gilead Sciences | Regulatory Roche to Submit Additional Data on Tamiflu for the Treatment of Influenza to the European Regulatory Authorities gilead.com ↗
Roche and Gilead Sciences, Inc. (Nasdaq: GILD) announced today that Roche has decided to withdraw the European application for the antiviral Tamiflu (oseltamivir) for the treatment of influenza in order to have more time to submit further data. |
| 2000-05-23 | Gilead Sciences | Regulatory Roche Seeks New Tamiflu Indication for the Prevention of Influenza gilead.com ↗ |
| 1999-11-08 | Gilead Sciences | Results Roche Announces New Data on Recently Approved Tamiflu™, First Pill to Treat the Most Common Strains of Influenza (A & B) gilead.com ↗
A treatment study (n=695) in pediatrics, 1-12 years of age, showed the drug met the primary clinical endpoints of the study and results indicated statistically significant differences between active and placebo arms. |
| 1999-10-27 | Gilead Sciences | Regulatory Roche Receives FDA Approval Of TAMIFLU™, First Pill To Treat The Most Common Strains Of Influenza (A&B) gilead.com ↗
Hoffmann-La Roche Inc. and Gilead Sciences, Inc. (NASDAQ:GILD), announced today that Roche’s TAMIFLU™ (oseltamivir phosphate) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of influenza A&B, which includes all common strains of influenza. |
| 1999-09-24 | Gilead Sciences | Regulatory First Approval of Roche’s Tamiflu™, a New Flu Treatment gilead.com ↗
Hoffmann-La Roche Inc. and Gilead Sciences, Inc. (NASDAQ: GILD), announced today that Roche’s Tamiflu™ (oseltamivir phosphate) was approved by the Swiss Regulatory Authority (Interkantonale Kontrollstelle für Heilmittel) for the treatment of influenza. |
All press releases naming this drug 40 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 136 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | oseltamivir | “Participants will receive Oseltamivir 75 mg (1\*75 mg) oral capsule (reference) in Treatment D of Panel 2 and Oseltamivir 75 mg administered as JNJ-63623872/37.5 mg Oseltamivir...” NCT03023852 ↗129“An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu®) in the Treatment of Infants 0 to <12 Months of Age With Confirmed...” NCT00988325 ↗ “Eligible patients in group 2 will receive oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to...” NCT04349241 ↗ “A triple-combination antiviral drug (TCAD) regimen consisting of amantadine (AMT), oseltamivir (OSL) and ribavirin (RBV) demonstrated good efficacy in an animal model.” PMID 23264438 ↗ Dec 2012 “The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects” NCT04982913 ↗ “baloxavir for those aged ≥12 years, or oseltamivir for those aged \<12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed” NCT04141917 ↗ “Oseltamivir is a first-line antiviral drug, especially in primary hospitals of military medical hospitals.” NCT04973462 ↗ “Oseltamivir capsules (75 mg per capsule), one capsule daily by mouth (PO) for 112 days.” NCT00980109 ↗ “the antiviral oseltamivir was evaluated in two prospective open-label studies.” PMID 26042486 ↗ Jul 2015 “Oseltamivir will be administered as oral suspension BID for 5 days.” NCT03629184 ↗ “Post-exposition prophylaxis with oseltamivir or placebo.” NCT01053377 ↗ |
| Known as | Agucort | ChEMBL registry synonym — accepted as the source's own label CHEMBL1229 ↗ |
| Known as | Ebilfumin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1229 ↗ |
| Known as | GS 4104 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1229 ↗ |
| Known as | GS-4071 ETHYL ESTER | ChEMBL registry synonym — accepted as the source's own label CHEMBL1229 ↗ |
| Known as | Oseltamivir (as phosphate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1229 ↗ |
| Known as | oseltamivir phosphate | “Oseltamivir phosphate capsule (tamiflu) (98.5mg/capsule, equals to 75mg oseltamivir, license number J20090076)” NCT02662426 ↗4“Oseltamivir phosphate capsule was administered as a single drug, 75 mg twice daily, for 5 days,Oral” NCT06057103 ↗ “75 mg oral oseltamivir phosphate capsules twice daily” PMID 40489986 ↗ Jun 2025 |
| Known as | Oseltamiviri phosphas | ChEMBL registry synonym — accepted as the source's own label CHEMBL1229 ↗ |
| Known as | OSL | “A triple-combination antiviral drug (TCAD) regimen consisting of amantadine (AMT), oseltamivir (OSL) and ribavirin (RBV) demonstrated good efficacy in an animal model.” PMID 23264438 ↗ Dec 2012 |
| Known as | OST (oseltamivir) | “OST (oseltamivir)” NCT01610245 ↗ |
| Known as | OSV | “oseltamivir (OSV)” NCT02469298 ↗ |
| Known as | RO 64-0796/002 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1229 ↗ |
| Known as | Ro 64-0796/GS4104 | “The pharmacokinetics and tolerability of the oral neuraminidase inhibitor oseltamivir (Ro 64-0796/GS4104) in healthy adult and elderly volunteers.” PMID 10934667 ↗ Aug 2000 |
| Known as | RO 640796 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1229 ↗ |
| Known as | Tamiflu | “An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu®) in the Treatment of Infants 0 to <12 Months of Age With Confirmed...” NCT00988325 ↗17“Oseltamivir (Tamiflu - manufactured by Roche) formulation is available as 75 mg Capsule and as powder for oral suspension.” NCT02927431 ↗ “Oseltamivir phosphate capsule (tamiflu) (98.5mg/capsule, equals to 75mg oseltamivir, license number J20090076)” NCT02662426 ↗ “Oseltamivir (Tamiflu®) is not an experimental drug, but is US Federal Drug Administration (FDA) approved” NCT00707941 ↗ “Oseltamivir (Tamiflu) Dosing Strategies for Use During Influenza Prophylaxis (VA01)” NCT00304434 ↗ “Oseltamivir (Tamiflu) is used most often to treat flu” NCT01227967 ↗ “oseltamivir (Tamiflu(Registered Trademark))” NCT00334529 ↗ “Drug: oseltamivir (Tamiflu®)” NCT00391768 ↗ “Oseltamivir (TAMIFLU®)” NCT05648448 ↗ “Drug: Tamiflu (verum)” NCT01053377 ↗ “oseltamivir [Tamiflu]” NCT01172847 ↗ |
| Action | Inhibit | “potently and specifically inhibits the viral neuraminidases” NCT00298233 ↗ |
| Modality | Small molecule | — CHEMBL1229 ↗ |
| Route | Oral | “Oseltamivir will be administered orally” NCT00298233 ↗ |