MedPath

Oseltamivir

Generic Name
Oseltamivir
Brand Names
Ebilfumin, Tamiflu
Drug Type
Small Molecule
Chemical Formula
C16H28N2O4
CAS Number
196618-13-0
Unique Ingredient Identifier
20O93L6F9H
Background

Oseltamivir (marketed as the product TamifluⓇ), is an antiviral neuraminidase inhibitor used for the treatment and prophylaxis of infection with influenza viruses A (including pandemic H1N1) and B. Oseltamivir exerts its antiviral activity by inhibiting the activity of the viral neuraminidase enzyme found on the surface of the virus, which prevents budding from the host cell, viral replication, and infectivity.

The clinical benefit of use of oseltamivir is greatest when administered within 48 hours of the onset of influenza symptoms since effectiveness decreases significantly after that point in time; there is generally no benefit in use beyond 48 hours for healthy, low-risk individuals as influenza is a self-limiting illness. However, antiviral treatment might be beneficial when initiated after 48 hours for patients with severe, complicated or progressive illness or for hospitalized patients. According to the CDC, data from clinical trials and observational studies have demonstrated that early antiviral treatment can shorten the duration of fever and illness symptoms, and may reduce the risk of some complications (including pneumonia and respiratory failure). They recommend the use of oseltamivir in people with a higher risk of developing complications including children younger than 2 years, people over 65 years, people with some chronic conditions or immunosuppression, pregnant women, residents of long term care facilities, and indigenous communities for example.

The benefits of oseltamivir use are controversial; a 2014 Cochrane Review of the evidence found that oseltamivir treatment had limited benefit. The authors concluded that oseltamivir use in healthy adults had small, non-specific effects on symptoms (where the time to first alleviation of symptoms was only reduced from 7 to 6.3 days), it had no effect on hospitalizations, and that there was no evidence for any reductions in complications of influenza such as pneumonia. Due to the risk of adverse effects such as nausea, vomiting, psychiatric effects and renal adverse events in adults and vomiting in children, the harms are generally considered to outweigh the small clinical benefit of use of oseltamivir.

Notably, in 2017, the World Health Organization downgraded oseltamivir from its essential medicines list from a "core" drug to a "complementary" drug, due to limited cost-effectiveness. Yearly vaccination with the influenza vaccine is still considered the best preventative measure.

Indication

According to FDA prescribing information, oseltamivir is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours . In particular, this agent is indicated in adults and children including full-term neonates who present with symptoms typical of influenza when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of the first onset of symptoms.

Oseltamivir is also indicated for the prophylaxis of influenza in patients one year and older . Specifically, post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community qualifies for such prophylactic therapy. Oseltamivir would only be indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak.

Associated Conditions
Flu caused by Influenza, Influenza A Virus Infection, Influenza A, Influenza B, Influenza Type B

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms

Phase 3
Completed
Conditions
Influenza
Interventions
First Posted Date
2025-01-14
Last Posted Date
2025-05-18
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
100
Registration Number
NCT06774859
Locations
🇨🇳

The First People's Hospital of Changde, Changde, China

🇨🇳

Peoples Hospital of Hunan Province, Changsha, China

🇨🇳

Hunan Provincial Maternal and Child Health Care Hospital, Changsha, China

and more 15 locations

Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting

Not Applicable
Not yet recruiting
Conditions
Influenza
Influenza Prophylaxis
Nosocomial Infection
Interventions
First Posted Date
2025-01-07
Last Posted Date
2025-01-07
Lead Sponsor
Capital Medical University
Target Recruit Count
372
Registration Number
NCT06762587
Locations
🇨🇳

China-Japan Friendship Hospital, Beijing, Beijing, China

Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza

Phase 3
Recruiting
Conditions
Influenza Type A
Influenza Type B
Interventions
Drug: ADC189 tablets
Drug: Placebo of Baloxavir Marboxil tablets
Drug: Placebo of ADC189 tablets
Drug: Placebo of ADC189 granules
First Posted Date
2024-07-18
Last Posted Date
2024-07-18
Lead Sponsor
Jiaxing AnDiCon Biotech Co.,Ltd
Target Recruit Count
165
Registration Number
NCT06507813
Locations
🇨🇳

Beijing Children's Hospital,Capital Medical University, Beijing, Beijing, China

A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects

Phase 1
Completed
Conditions
Drug Interaction
Interventions
First Posted Date
2023-09-28
Last Posted Date
2024-11-04
Lead Sponsor
Nanjing Zenshine Pharmaceuticals
Target Recruit Count
18
Registration Number
NCT06057103
Locations
🇨🇳

Peking University Third Hospital, Beijing, Beijing, China

Efficacy and Safety of Molnupiravir in Healthy Participants Inoculated With Experimental Influenza Virus (MK-4482-019)

Phase 1
Completed
Conditions
Influenza Infection
Interventions
Drug: Molnupiravir
Biological: Influenza A Virus
First Posted Date
2023-04-18
Last Posted Date
2024-07-11
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
162
Registration Number
NCT05818124
Locations
🇬🇧

hVIVO Services ( Site 0001), London, London, City Of, United Kingdom

A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2023-03-29
Last Posted Date
2023-11-14
Lead Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Target Recruit Count
54
Registration Number
NCT05789342
Locations
🇨🇳

China-Japan Friendship Hospital, Beijing, China

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

First Posted Date
2022-12-13
Last Posted Date
2024-10-17
Lead Sponsor
University of Oxford
Target Recruit Count
3000
Registration Number
NCT05648448
Locations
🇧🇷

Universidade Federal de Minas Gerais, Minas Gerais, Brazil

🇱🇦

Laos-Oxford-Mahosot Wellcome Trust Research unit, Vientiane, Lao People's Democratic Republic

🇳🇵

Sukraraj Tropical & Infectious Disease Hospital, Kathmandu, Nepal

and more 1 locations

Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

First Posted Date
2022-03-28
Last Posted Date
2022-03-28
Lead Sponsor
The Affiliated Hospital of Qingdao University
Target Recruit Count
72
Registration Number
NCT05297968
Locations
🇨🇳

Phase I Clinical Research Center, Qingdao, Shandong, China

Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza

Phase 2
Terminated
Conditions
Influenza
Interventions
First Posted Date
2021-12-27
Last Posted Date
2025-02-26
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
2
Registration Number
NCT05170009
Locations
🇺🇸

Weill Cornell Medicine, New York, New York, United States

Study to Investigate the Potential Drug-Drug Interaction Between ZSP1273 and Oseltamivir

Phase 1
Completed
Conditions
Drug-drug Interaction
Interventions
First Posted Date
2021-11-04
Last Posted Date
2021-11-04
Lead Sponsor
Guangdong Raynovent Biotech Co., Ltd
Target Recruit Count
36
Registration Number
NCT05108051
Locations
🇨🇳

Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, China

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