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

Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product

First Posted Date
2021-10-19
Last Posted Date
2021-10-28
Lead Sponsor
Laboratorios Andromaco S.A.
Target Recruit Count
36
Registration Number
NCT05083325
Locations
🇮🇳

Azidus Laboratories Ltd., Chennai, Tamil Nadu, India

Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

Phase 4
Active, not recruiting
Conditions
Influenza, Human
Influenza
Influenza -Like Illness
Interventions
First Posted Date
2021-08-19
Last Posted Date
2023-03-15
Lead Sponsor
Insight Therapeutics, LLC
Target Recruit Count
1000
Registration Number
NCT05012189
Locations
🇺🇸

Insight Therapeutics, LLC, Norfolk, Virginia, United States

The Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure

Not Applicable
Conditions
Heart Failure
Interventions
First Posted Date
2021-08-17
Last Posted Date
2021-08-17
Lead Sponsor
Tongji Hospital
Target Recruit Count
388
Registration Number
NCT05008679
Locations
🇨🇳

Tongji Hospital, Wuhan, Hubei, China

Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients

Phase 2
Recruiting
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Influenza
Interventions
First Posted Date
2021-01-15
Last Posted Date
2025-01-24
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
60
Registration Number
NCT04712539
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients

Phase 4
Conditions
STEMI
ST Elevation Myocardial Infarction
Interventions
First Posted Date
2020-12-24
Last Posted Date
2020-12-24
Lead Sponsor
Tongji Hospital
Target Recruit Count
382
Registration Number
NCT04684498
Locations
🇨🇳

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

A Study of ZSP1273 Tablets in Patients With Acute Uncomplicated Influenza A

Phase 3
Completed
Conditions
Influenza A
Interventions
Drug: Oseltamivir(oral)
Drug: ZSP1273 600 mg
Drug: Placebo to ZSP1273
First Posted Date
2020-12-24
Last Posted Date
2023-06-27
Lead Sponsor
Guangdong Raynovent Biotech Co., Ltd
Target Recruit Count
750
Registration Number
NCT04683406
Locations
🇨🇳

Third Military Medical University, Chongqing, Chongqing, China

🇨🇳

Foshan First People's Hospital, Foshan, Guangdong, China

🇨🇳

Huizhou Central People's Hospital, Huizhou, Guangdong, China

and more 73 locations

The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19

Phase 3
Conditions
Covid19
Interventions
First Posted Date
2020-09-22
Last Posted Date
2020-09-22
Lead Sponsor
Indonesia University
Target Recruit Count
100
Registration Number
NCT04558463
Locations
🇮🇩

Cipto Mangunkusumo National Referral Hospital, Jakarta, DKI Jakarta, Indonesia

Bioequivalence Study of Oseltamivir Phosphate and TAMIFLU Under Fed Condition in Healthy Volunteers

Phase 4
Completed
Conditions
Bioequivalence
Interventions
First Posted Date
2020-09-02
Last Posted Date
2023-02-02
Lead Sponsor
Austarpharma, LLC
Target Recruit Count
96
Registration Number
NCT04536415
Locations
🇺🇸

Austarpharma Llc, Edison, New Jersey, United States

IMU-838 and Oseltamivir in the Treatment of COVID-19

Phase 2
Completed
Conditions
Covid 19
Interventions
First Posted Date
2020-08-18
Last Posted Date
2023-08-22
Lead Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Target Recruit Count
38
Registration Number
NCT04516915
Locations
🇬🇧

University Hospital Coventry and Warwickshire NHS Trust, Coventry, West Midlands, United Kingdom

Administration of Allogenic UC-MSCs as Adjuvant Therapy for Critically-Ill COVID-19 Patients

Phase 1
Conditions
Pulmonary Infection
Sars-CoV2
COVID
Interventions
Biological: Umbilical Cord Mesenchymal Stem Cells
First Posted Date
2020-07-07
Last Posted Date
2020-07-07
Lead Sponsor
Indonesia University
Target Recruit Count
40
Registration Number
NCT04457609
Locations
🇮🇩

Sulianti Saroso Center for Infectious Disease, Jakarta, DKI Jakarta, Indonesia

🇮🇩

Universitas Indonesia Hospital, Depok, West Java, Indonesia

🇮🇩

Persahabatan General Hospital, Jakarta, DKI Jakarta, Indonesia

and more 1 locations
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