Clinical Trials

Numerous clinical trials ranging from Early Phase 1 through Phase 4 evaluate oseltamivir phosphate, backed by academic centers, public health entities, and global hospital networks. Covering completed, recruiting, not yet recruiting, and terminated recruitment statuses, these studies primarily address human and severe influenza, COVID-19 pneumonia, and immune thrombocytopenia. Specific investigations also target pediatric influenza interventions, plasma concentration dynamics in critically ill patients, and metabolic mutations affecting enzymatic conversion.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04381936 RECRUITING
Pneumonia
University of Oxford
 2020-03-19 PHASE3
NCT07496736 ACTIVE_NOT_RECRUITING
Influenza
University Medical Centre Ljubljana
 2025-12-01 PHASE3
NCT04712539 RECRUITING
Hematopoietic and Lymphoid Cell Neoplasm; Influenza
M.D. Anderson Cancer Center
 2021-10-11 PHASE2
NCT07306702 WITHDRAWN
Postoperative Pain Management
Shenyang Sixth People's Hospital
 2026-06-01 PHASE4
NCT07236814 RECRUITING
Influenza
Capital Medical University
 2025-11-28 PHASE3
NCT05648448 RECRUITING
Influenza; Influenza, Human
University of Oxford
 2023-02-22 PHASE2
NCT07113392 NOT_YET_RECRUITING
Influenza
Jiangxi Kvvit Pharmaceutical Co., Ltd.
 2025-08-01 PHASE3
NCT02735707 RECRUITING
Community-acquired Pneumonia, Influenza, COVID-19
UMC Utrecht
 2016-04-11 PHASE3
NCT07357051 RECRUITING
Respiratory Viral Infection
Joincare Pharmaceutical Group Industry Co., Ltd
 2025-11-07 PHASE3
NCT07095257 COMPLETED
Respiratory Viral Infection
Nanjing Zenshine Pharmaceuticals
 2025-10-13 PHASE3
NCT07229807 ACTIVE_NOT_RECRUITING
Influenza a
Guangdong Raynovent Biotech Co., Ltd
 2025-11-22 PHASE3
NCT03900988 UNKNOWN
Influenza
Chinese University of Hong Kong
 2023-05-08 PHASE3
NCT03901001 UNKNOWN
Influenza
Chinese University of Hong Kong
 2023-05-08 PHASE3
NCT06669351 TERMINATED
Respiratory Viral Infection
Nanjing Zenshine Pharmaceuticals
 2024-10-31 PHASE3
NCT06774859 COMPLETED
Influenza
Hoffmann-La Roche
 2024-10-27 PHASE3
NCT06762587 NOT_YET_RECRUITING
Influenza; Influenza Prophylaxis; Nosocomial Infection
Capital Medical University
 2025-01-05
NCT06507813 COMPLETED
Influenza Type A; Influenza Type B
Jiaxing AnDiCon Biotech Co.,Ltd
 2024-08-19 PHASE3
NCT05375864 UNKNOWN
Severe Influenza
Assistance Publique - Hôpitaux de Paris
 2022-12-01
NCT04327791 COMPLETED
Influenza
Bassett Healthcare
 2020-04-03 PHASE2; PHASE3
NCT05818124 COMPLETED
Influenza Infection
Merck Sharp & Dohme LLC
 2023-08-21 PHASE1
NCT05170009 TERMINATED
Influenza
Weill Medical College of Cornell University
 2022-04-22 PHASE2; PHASE3
NCT06057103 COMPLETED
Drug Interaction
Nanjing Zenshine Pharmaceuticals
 2023-08-28 PHASE1
NCT05012189 UNKNOWN
Influenza; Influenza, Human; Influenza -Like Illness
Insight Therapeutics, LLC
 2021-08-06 PHASE4
NCT05789342 COMPLETED
Healthy Volunteers
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
 2023-02-15 PHASE1
NCT04684498 UNKNOWN
ST Elevation Myocardial Infarction; STEMI
Tongji Hospital
 2020-03-01 PHASE4
NCT03787459 COMPLETED
Influenza
Capital Medical University
 2019-01-18 PHASE3
NCT04683406 COMPLETED
Influenza A
Guangdong Raynovent Biotech Co., Ltd
 2020-12-28 PHASE3
NCT05008679 UNKNOWN
Heart Failure
Tongji Hospital
 2021-02-25
NCT05375864 Not yet recruiting
Severe Influenza
Assistance Publique - Hôpitaux de Paris
 2022-12-01 Not Applicable
NCT04982913 COMPLETED
Influenza
Sunshine Lake Pharma Co., Ltd.
 2021-08-24 PHASE1
NCT04516915 COMPLETED
Covid 19
University Hospitals Coventry and Warwickshire NHS Trust
 2020-06-15 PHASE2
NCT03212716 TERMINATED
Flu
University Hospital, Lille
 2017-12-23 PHASE2
NCT05250141 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
 2022-02-14 PHASE1
NCT03754686 UNKNOWN
Influenza
Rambam Health Care Campus
 2019-02-10 PHASE4
NCT04371601 UNKNOWN
COVID-19 Pneumonia
Fuzhou General Hospital
 2020-03-01 EARLY_PHASE1
NCT05083325 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
 2021-10-08 PHASE1
NCT04973462 UNKNOWN
Covid19
Ain Shams University
 2021-08-01 PHASE4
NCT03520049 UNKNOWN
Immune Thrombocytopenia
Unity Health Toronto
 2016-11 PHASE3
NCT04303299 COMPLETED
SARS-COV-2 Infections; COVID-19
Department of Medical Services Ministry of Public Health of Thailand
 2020-08-19 PHASE3
NCT05297968 COMPLETED
Healthy Subjects
The Affiliated Hospital of Qingdao University
 2021-05-13 PHASE1
NCT04183725 UNKNOWN
Influenza in Children
China Academy of Chinese Medical Sciences
 2019-12-01 PHASE4
NCT05108051 COMPLETED
Drug-drug Interaction
Guangdong Raynovent Biotech Co., Ltd
 2020-11-19 PHASE1
NCT04338698 COMPLETED
COVID 19
Shehnoor Azhar
 2020-04-22 PHASE3
NCT03903718 WITHDRAWN
Influenza
MedImmune LLC
 2020-04-03 PHASE2
NCT04558463 UNKNOWN
Covid19
Indonesia University
 2020-04-16 PHASE3
NCT04536415 COMPLETED
Bioequivalence
Austarpharma, LLC
 2020-08-25 PHASE4
NCT04457609 UNKNOWN
COVID; Pulmonary Infection; Sars-CoV2
Indonesia University
 2020-07 PHASE1
NCT03238612 UNKNOWN
Influenza A
The University of Hong Kong
 2018-01-08 PHASE2
NCT04255017 UNKNOWN
2019-nCoV
Tongji Hospital
 2020-02-01 PHASE4
NCT04261270 UNKNOWN
2019-nCoV Pneumonia
Tongji Hospital
 2020-02-01 PHASE3
NCT03899571 COMPLETED
Influenza, Human
University Medical Centre Ljubljana
 2019-01-22
NCT03947411 UNKNOWN
Severe Influenza
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
 2019-03-04
NCT04297462 UNKNOWN
Influenza; Exposure; Prevention
Centre of Postgraduate Medical Education
 2016-11-17
NCT02369159 COMPLETED
Influenza
BioCryst Pharmaceuticals
 2015-03-11 PHASE3
NCT03028909 WITHDRAWN
Influenza - Type A Strains
MedImmune LLC
 2017-07-24 PHASE2
NCT02989012 UNKNOWN
Epidemic Influenza
Dalian Zhen-Ao Bio-Tech Co., Ltd.
 PHASE2
NCT03629184 COMPLETED
Influenza
Hoffmann-La Roche
 2018-11-20 PHASE3
NCT03394209 COMPLETED
Influenza, Human; Critical Illness; Influenza
Capital Medical University
 2018-02-06 PHASE2
NCT03040141 COMPLETED
Influenza A
Visterra, Inc.
 2018-01-03 PHASE2
NCT01715909 COMPLETED
Influenza
Hoffmann-La Roche
 2014-01-22 PHASE1
NCT03365336 UNKNOWN
Influenza
Composite Interceptive Med Science
 2018-02-01
NCT01965626 COMPLETED
Thrombocytopenia
Shandong University
 2016-02-01 PHASE2
NCT01850446 COMPLETED
Influenza
Materia Medica Holding
 2015-02-20 PHASE4
NCT02949011 COMPLETED
Influenza
Shionogi
 2017-01-11 PHASE3
NCT02108366 COMPLETED
Influenza, Human
The University of Hong Kong
 2014-03 PHASE3
NCT01314911 COMPLETED
Influenza, Human
National Institute of Allergy and Infectious Diseases (NIAID)
 2011-04
NCT02662426 UNKNOWN
Influenza
The First Affiliated Hospital of Guangzhou Medical University
 2016-04 PHASE3
NCT02888327 COMPLETED
Influenza in Humans
Alios Biopharma Inc.
 2016-07-31 PHASE1
NCT02609399 COMPLETED
Influenza
Johns Hopkins University
 2015-11-01 PHASE4
NCT02927431 TERMINATED
Virus Diseases
GlaxoSmithKline
 2017-01-19 PHASE2
NCT02293863 COMPLETED
Influenza
Genentech, Inc.
 2015-01-14 PHASE2
NCT00545532 COMPLETED
Influenza, Human
Hoffmann-La Roche
 2008-02-04 PHASE3
NCT03023852 COMPLETED
Healthy
Janssen-Cilag International NV
 2017-02-14 PHASE1
NCT02954354 COMPLETED
Influenza
Shionogi
 2016-12-08 PHASE3
NCT02532283 COMPLETED
Influenza A Virus
Janssen Research & Development, LLC
 2015-12-11 PHASE2
NCT02603952 COMPLETED
Influenza
MedImmune LLC
 2015-12-07 PHASE1; PHASE2
NCT02572583 UNKNOWN
Influenza
Dongfang Hospital Beijing University of Chinese Medicine
 2014-11 PHASE1; PHASE2
NCT02232945 UNKNOWN
Influenza
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
 2012-04 PHASE4
NCT02342249 COMPLETED
Influenza A
Janssen Research & Development, LLC
 2014-12-11 PHASE2
NCT01227967 COMPLETED
Influenza
National Institute of Allergy and Infectious Diseases (NIAID)
 2010-09 PHASE2
NCT01248715 COMPLETED
Influenza; Pneumonia
University of Louisville
 2010-11 PHASE4
NCT02469298 COMPLETED
Virus Diseases
GlaxoSmithKline
 2015-06-01 PHASE2
NCT02561169 TERMINATED
Influenza
McMaster University
 2015-12 PHASE4
NCT01231620 COMPLETED
Influenza, Human
GlaxoSmithKline
 2011-01-15 PHASE3
NCT02282384 WITHDRAWN
Pulmonary Disease; Influenza
McMaster University
 2014-10 PHASE4
NCT01610245 COMPLETED
Influenza
Romark Laboratories L.C.
 2013-03 PHASE3
NCT01546935 WITHDRAWN
Influenza
University of Oxford
 2012-12 PHASE2; PHASE3
NCT02262715 COMPLETED
Healthy
Janssen Infectious Diseases BVBA
 2014-07 PHASE1
NCT01980966 COMPLETED
Healthy Volunteer
Genentech, Inc.
 2013-11-25 PHASE2
NCT01804946 COMPLETED
Influenza
Materia Medica Holding
 2011-02 PHASE4
NCT01902342 COMPLETED
Healthy
Seoul National University Hospital
 2013-07 PHASE1
NCT01053377 UNKNOWN
Influenza
National Institute for Public Health and the Environment (RIVM)
 2009-12 PHASE4
NCT01690637 TERMINATED
Influenza; Human Influenza
Centers for Disease Control and Prevention
 2012-09 PHASE4
NCT01456234 TERMINATED
Influenza
Trial Management Group Inc.
 2011-11 PHASE4
NCT02507648 Completed
Healthy
Genuine Research Center Egypt|Pharmacare PLC Palestine
 2013-03 Phase 1
NCT02507648 COMPLETED
Healthy
Genuine Research Center, Egypt
 2013-03 PHASE1
NCT01053663 TERMINATED
Influenza
Hoffmann-La Roche
 2011-01 PHASE1
NCT01443806 COMPLETED
Metabolic Disease
University of Oxford
 2011-07 PHASE4
NCT01033734 COMPLETED
Influenza
Hoffmann-La Roche
 2010-12 PHASE1
NCT01146535 COMPLETED
Influenza A Virus Infection
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
 2011-01 PHASE2
NCT01050257 COMPLETED
Influenza
Hoffmann-La Roche
 2010-01 PHASE3
NCT01690637 Terminated
Influenza|Human Influenza
Centers for Disease Control and Prevention|Universidad del Valle Guatemala|Hospital Nacional San Juan de Dios de Santa Ana El Salvador|Hospital Nacional San Juan de Dios de San Miguel El Salvador|Hospital Del Nino Panama|Hospital de Especialidades Pediátricas Omar Torrijos Herrera Panama|Hospital Jose Domingo de Obaldia Panama
 2012-09 Phase 4
NCT01130636 COMPLETED
Influenza
Pharmahungary Group
 2010-06 PHASE4
NCT01052961 COMPLETED
Influenza; Respiratory Tract Infections
Chinese University of Hong Kong
 2010-01 PHASE4
NCT01556633 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2012-03 PHASE1
NCT01708369 COMPLETED
Drug Interactions
University of Tennessee
 2012-02 PHASE1
NCT00988325 COMPLETED
Influenza
Hoffmann-La Roche
 2011-01 PHASE1
NCT01249833 COMPLETED
Influenza
Trial Management Group Inc.
 2010-11 PHASE4
NCT01037634 WITHDRAWN
Influenza
National Institute of Allergy and Infectious Diseases (NIAID)
 2010-03 PHASE2
NCT00936013 UNKNOWN
Influenza
Capital Medical University
 2009-08 PHASE4
NCT01443806 Completed
Metabolic Disease
University of Oxford|South East Asia Infectious Disease Clinical Research Network
 2011-07 Phase 4
NCT01010087 TERMINATED
Influenza A Virus
University of Manitoba
 2009-11 PHASE2
NCT00707941 COMPLETED
Influenza; Pneumonia; Lower Respiratory Tract Infection; Upper Respiratory Tract Infection; Viral Shedding
International Centre for Diarrhoeal Disease Research, Bangladesh
 2008-05 PHASE3
NCT01258530 COMPLETED
Influenza, Human
GlaxoSmithKline
 2010-12-20 PHASE1
NCT00555893 COMPLETED
Influenza
Marshfield Clinic Research Foundation
 2008-01
NCT01306773 COMPLETED
Influenza A
The University of Hong Kong
 2009-12
NCT01032837 TERMINATED
Influenza
Hoffmann-La Roche
 2009-11 PHASE4
NCT00949533 COMPLETED
Influenza
Hoffmann-La Roche
 2009-08 PHASE3
NCT00873886 WITHDRAWN
Pregnancy; Influenza
University of Pittsburgh
 2009-04 PHASE1
NCT01179919 COMPLETED
Obesity
Manjunath Prakash Pai
 2010-07 PHASE1; PHASE2
NCT00980109 COMPLETED
Influenza
University of Oxford
 2009-09 PHASE4
NCT01049763 COMPLETED
Healthy
South East Asia Infectious Disease Clinical Research Network
 2010-01 PHASE1
NCT00979667 TERMINATED
Upper Respiratory Tract Infection; Influenza
Chinese University of Hong Kong
 2009-10 PHASE3
NCT02717754 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2009-12 PHASE1
NCT00979251 COMPLETED
Influenza
Adamas Pharmaceuticals, Inc.
 2009-09 PHASE2
NCT00391768 COMPLETED
Influenza
National Institute of Allergy and Infectious Diseases (NIAID)
 2007-01 PHASE1; PHASE2
NCT01172847 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2009-08 PHASE1
NCT00298233 COMPLETED
Influenza; Avian Influenza; Severe Influenza
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-02 PHASE2
NCT01048879 COMPLETED
Critically Ill Renal Failure Requiring CVVHD and Oseltamivir; Critically Ill Requiring ECMO and Oseltamivir
University of Michigan
 2009-10 PHASE4
NCT01002729 COMPLETED
Morbid Obesity
IWK Health Centre
 2009-11
NCT00935194 COMPLETED
Influenza
Capital Medical University
 2009-07 PHASE4
NCT00799760 TERMINATED
Gastric Influenza
Assistance Publique - Hôpitaux de Paris
 2008-12 PHASE3
NCT00921726 COMPLETED
Influenza; Virus Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
 2009-07 PHASE1
NCT00867139 COMPLETED
Influenza
Fred Hutchinson Cancer Center
 2009-03 PHASE1; PHASE2
NCT00830323 TERMINATED
Influenza A Infection
Hospices Civils de Lyon
 2009-01 PHASE2
NCT00844155 WITHDRAWN
Influenza A Virus Infection; Influenza B Virus Infection
University of Manitoba
 2009-03
NCT00593502 COMPLETED
Influenza
Hospital District of Southwestern Finland
 2008-02 PHASE4
NCT00803595 COMPLETED
Influenza, Human
Daiichi Sankyo Co., Ltd.
 2008-11 PHASE3
NCT00453999 COMPLETED
Influenza
BioCryst Pharmaceuticals
 2007-07 PHASE2
NCT02780622 COMPLETED
Drug Therapy, Combination
Hoffmann-La Roche
 2008-02 PHASE4
NCT00412737 COMPLETED
Influenza
Hoffmann-La Roche
 2007-01 PHASE4
NCT00540501 WITHDRAWN
Healthy Subjects
GlaxoSmithKline
 2007-10 PHASE1
NCT00412555 COMPLETED
Influenza
Hoffmann-La Roche
 2006-12 PHASE4
NCT00334529 COMPLETED
Influenza
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-06-05 PHASE2
NCT00436124 TERMINATED
Influenza
Hoffmann-La Roche
 2007-01 PHASE4
NCT00439530 COMPLETED
Avian Influenza A Virus
Mahidol University
 2006-11 PHASE1
NCT00304434 COMPLETED
Influenza
US Department of Veterans Affairs
 2005-02 PHASE4
NCT02617784 COMPLETED
End Stage Renal Disease
Hoffmann-La Roche
 2001-10 PHASE1
NCT00416962 COMPLETED
Healthy
Novartis
 2006-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-21)

Check the Oseltamivir Phosphate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oseltamivir phosphate functions as a competitive inhibitor of viral neuraminidase, preventing the enzymatic cleavage of surface sialic acid residues and suppressing the release of progeny viral particles from infected host cells. By interrupting the propagation and inter-cellular spread of viral infection, this inhibition directly accounts for its therapeutic efficacy in clinical trials targeting severe human influenza and acute viral respiratory infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.