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

Phase IIaTrials of GanMaoKangNing Granules

Phase 2
Conditions
Epidemic Influenza
Interventions
Drug: GanMaoKangNing Granules
Drug: Analogous GanMaoKangNing Granules
First Posted Date
2016-12-12
Last Posted Date
2016-12-12
Lead Sponsor
Dalian Zhen-Ao Bio-Tech Co., Ltd.
Target Recruit Count
96
Registration Number
NCT02989012
Locations
🇨🇳

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing Shi, Beijing, China

A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza

First Posted Date
2016-11-03
Last Posted Date
2019-05-08
Lead Sponsor
Shionogi
Target Recruit Count
1436
Registration Number
NCT02954354

Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: HGP0919
First Posted Date
2016-10-21
Last Posted Date
2016-10-21
Lead Sponsor
Hanmi Pharmaceutical Company Limited
Target Recruit Count
32
Registration Number
NCT02941731
Locations
🇰🇷

Korea University Anam Hospital, Seoul, Korea, Republic of

Study to Evaluate the Efficacy and Safety of Danirixin Co-administered With Oseltamivir in the Treatment of Adults Hospitalized With Influenza

Phase 2
Terminated
Conditions
Virus Diseases
Interventions
First Posted Date
2016-10-07
Last Posted Date
2020-11-30
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
10
Registration Number
NCT02927431
Locations
🇸🇪

GSK Investigational Site, Lund, Sweden

A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872

First Posted Date
2016-09-05
Last Posted Date
2025-02-03
Lead Sponsor
Alios Biopharma Inc.
Target Recruit Count
68
Registration Number
NCT02888327
Locations
🇬🇧

Hammersmith Medicines Research, London, United Kingdom

A Pharmacokinetics, Pharmacodynamics and Safety Study of Warfarin in Combination With Tamiflu (Oseltamivir)

Phase 4
Completed
Conditions
Drug Therapy, Combination
Interventions
First Posted Date
2016-05-23
Last Posted Date
2016-10-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
20
Registration Number
NCT02780622

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Phase 3
Recruiting
Conditions
Community-acquired Pneumonia, Influenza, COVID-19
Interventions
Other: No systemic corticosteroid
Other: No antiviral agent for COVID-19
Other: No immune modulation for COVID-19
Drug: Standard course macrolide
Other: No antiviral agent for influenza
Drug: Local standard venous thromboprophylaxis
Other: No immunoglobulin
Other: No simvastatin
Other: No cysteamine
Other: No Immune Modulator for Influenza
Other: No vitamin C
Other: No antiplatelet
Procedure: Clinician-preferred mechanical ventilation strategy
Other: No renin-angiotensin system inhibitor
Other: No endothelial modulator
Drug: Extended course macrolide
Biological: Convalescent plasma
Drug: Therapeutic dose anticoagulation
Procedure: Protocolised mechanical ventilation strategy
Drug: P2Y12 inhibitor
Drug: Conventional low dose thromboprophylaxis
Biological: Delayed administration of convalescent plasma
Drug: Intermediate dose thromboprophylaxis
Drug: ARB + DMX-200
Drug: Amoxicillin-clavulanate
Drug: Continuation of therapeutic dose anticoagulation
First Posted Date
2016-04-13
Last Posted Date
2024-07-12
Lead Sponsor
UMC Utrecht
Target Recruit Count
20000
Registration Number
NCT02735707
Locations
🇨🇦

Toronto Western Hospital, Toronto, Ontario, Canada

🇺🇸

University of Illinois Health, Chicago, Illinois, United States

🇦🇺

Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia

and more 405 locations

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Participants

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
Drug: Placebo
First Posted Date
2016-03-24
Last Posted Date
2016-06-27
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
99
Registration Number
NCT02717754

Lingdancao Granules in the Treatment of Seasonal Influenza

Phase 3
Conditions
Influenza
Interventions
Drug: Lingdancao granules
Drug: analogous Lingdancao granules
First Posted Date
2016-01-25
Last Posted Date
2016-02-17
Lead Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Target Recruit Count
318
Registration Number
NCT02662426
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