Oseltamivir
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1999
- First approval year
- 1999
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Oseltamivir
- Molecular weight
- 312.41
- Structure (SMILES)
- CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1
- gs 4071 ethyl ester
- gs 4104
- GS 4104
- GS-4071 ETHYL ESTER
- GS-4104
- gs4104
- GS4104
- oseltamivir
- Oseltamivir
- OSELTAMIVIR [EMA EPAR]
- OSELTAMIVIR [HSDB]
- oseltamivir [INN]
- OSELTAMIVIR [MI]
- OSELTAMIVIR [VANDF]
- Oseltamivir [WHO-DD]
- oseltamivir ema epar
- oseltamivir hsdb
- oseltamivir inn
- oseltamivir mi
- oseltamivir vandf
- oseltamivir who dd
- ro 64 0796
- ro 640796
- RO 640796
- RO-64-0796
And 3 more, listed on the interactive page.
- ATC classification codes
- J05AH02
Sources for recorded values
- CAS registry numbers
- 196618-13-0
- ChEMBL ID
- CHEMBL1229
- InChIKey
- VSZGPKBBMSAYNT-RRFJBIMHSA-N
- PubChem compound IDs
- 65028
- FDA ingredient codes (UNII)
- 20O93L6F9H
- 259275
- 260101
- Applicant
- ROCHE
- Approval date
- 27 Oct 1999
- Application number
- NDA021087
- Status
- Authorised
- Status date
- 20 Jun 2002
- Authorisation date
- 20 Jun 2002
- Approved indications
- Treatment of influenza Tamiflu 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 first onset of symptoms.Prevention of influenza 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. The appropriate use of Tamiflu for prevention of influenza should be determined on a case-by-case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic-influenza outbreak. Tamiflu is not a substitute for influenza vaccination. The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations.
- Product number
- EMEA/H/C/000402
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 1
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Influenza, Human
European medicines record
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- United States (FDA)
- Approved
- European Union (EMA)
- Authorised
- Pharmacology name
- oseltamivir
- Type
- Synthetic organic
- Drug name stem
- -vir
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
Open Targets mechanisms
- Mechanism
- Neuraminidase inhibitor
- Action type
- Inhibitor
- Target
- Neuraminidase
- Action type
- Inhibitor
- Protein identifier
- P03468
- Organism
- Influenza A virus (strain A/Puerto Rico/8/1934 H1N1)
- Action type
- Inhibitor
- Protein identifier
- P03474
- Organism
- Influenza B virus (strain B/Lee/1940)
- Condition
- Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Virus Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000763
- Subject identifier
- D014777
- Condition
- Obesity
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Pneumonia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003106
- Subject identifier
- D011014
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Influenza in Birds
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005222
- Subject identifier
- D005585
- Condition
- Purpura, Thrombocytopenic, Idiopathic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007160
- Subject identifier
- D016553
- Condition
- Influenza, Human
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007328
- Subject identifier
- D007251
- Condition
- Thrombocytopenia
- Highest recorded phase
- 2
- Condition identifier
- HP:0001873
- Subject identifier
- D013921
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000763
- Condition identifier
- EFO_0001073
- Condition identifier
- EFO_0003144
- Condition identifier
- EFO_0003884
- Highest recorded phase
- 1
- Condition identifier
- EFO_0005222
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007160
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007328
- Condition identifier
- EFO_0007411
- Highest recorded phase
- 4
- Condition identifier
- EFO_1001488
- Highest recorded phase
- 3
- Condition identifier
- HP_0001873
- Highest recorded phase
- 2
- Condition identifier
- HP_0002783
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005108
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005249
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005252
- Condition identifier
- MONDO_0005460
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005812
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0008558
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0020753
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0100096
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0100163
- Highest recorded phase
- 3
- Event
- acne infantile
- Reports
- 3
- Reporting signal score
- 17.7481
- Event
- apgar score low
- Reports
- 8
- Reporting signal score
- 20.9894
- Event
- arthralgia
- Reports
- 3
- Reporting signal score
- 23.3506
- Event
- atrial septal defect
- Reports
- 19
- Reporting signal score
- 33.1426
- Event
- bradycardia
- Reports
- 94
- Reporting signal score
- 135.778
- Event
- bronchopleural fistula
- Reports
- 5
- Reporting signal score
- 18.8237
- Event
- bronchopulmonary aspergillosis
- Reports
- 20
- Reporting signal score
- 47.3326
- Event
- caesarean section
- Reports
- 27
- Reporting signal score
- 48.6035
- Event
- congenital intestinal obstruction
- Reports
- 3
- Reporting signal score
- 18.5014
- Event
- cryptorchism
- Reports
- 8
- Reporting signal score
- 22.7929
- Event
- death neonatal
- Reports
- 4
- Reporting signal score
- 18.3892
- Event
- delirium
- Reports
- 31
- Reporting signal score
- 32.6196
- Event
- drug effective for unapproved indication
- Reports
- 11
- Reporting signal score
- 22.8789
- Event
- drug hypersensitivity
- Reports
- 3
- Reporting signal score
- 18.5339
- Event
- electrocardiogram qt prolonged
- Reports
- 25
- Reporting signal score
- 18.5133
- Event
- enterocolitis haemorrhagic
- Reports
- 9
- Reporting signal score
- 23.2039
- Event
- fatigue
- Reports
- 14
- Reporting signal score
- 28.4714
- Event
- foetal distress syndrome
- Reports
- 10
- Reporting signal score
- 24.187
- Event
- heterotaxia
- Reports
- 5
- Reporting signal score
- 21.6226
- Event
- hypofibrinogenaemia
- Reports
- 7
- Reporting signal score
- 18.8499
- Event
- injection site pain
- Reports
- 1
- Reporting signal score
- 18.1477
- Event
- intestinal malrotation
- Reports
- 6
- Reporting signal score
- 24.4063
- Event
- live birth
- Reports
- 20
- Reporting signal score
- 47.5919
- Event
- low birth weight baby
- Reports
- 29
- Reporting signal score
- 65.6631
- Event
- maternal exposure timing unspecified
- Reports
- 8
- Reporting signal score
- 18.1138
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And 20 more, listed on the interactive page.
- Dose
- 75 mg
- Route
- Oral
- How often
- Twice daily for 5 days
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 2
- Polar surface area
- 90.65
- Calculated partition coefficient (ALogP)
- 1.29
- Calculated partition coefficient (XLogP)
- 1.1
- Prodrug
- Yes
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 7
- Heavy atoms
- 22
- Molecular formula
- C16H28N2O4
- Monoisotopic mass
- 312.20490738
- Natural product
- Yes
- Recorded assays
- 1,727
- Active assays
- 400
Active assay types
- Confirmatory
- Antiviral Agents
- Enzyme Inhibitors
Distribution coefficient (LogD)
- Median
- 0.36
- Mean
- 0.36
- Minimum
- 0.36
- Maximum
- 0.36
- Unit
- unitless
- Assays
- 2
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- LogD
Oral bioavailability
- Median
- 51.4
- Mean
- 54.8
- Minimum
- 35
- Maximum
- 80
- Unit
- %
- Assays
- 6
- Standard deviation
- 20.7601
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- F
Related records
Trials (116)
- A Bioequivalence Study of Oseltamivir From Oseltamivir 75 mg Caps (Pharmacare PLC, Palestine) and Tamiflu® 75 mg Caps (Hoffmann-La Roche, Switzerland)
- A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection
- A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir
- A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872
- A Multicenter Randomized Open-label Study of Oseltamivir Combined With HD-DEX Versus HD-DEX in the Management of ITP
- A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
- A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers
- A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection
- A Pharmacokinetics Study of Favipiravir in Patients With Severe Influenza
- A Pharmacokinetics, Pharmacodynamics and Safety Study of Warfarin in Combination With Tamiflu (Oseltamivir)
- A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza
- A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
- A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia
- A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia
- A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance
- A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza
- A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
- A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
- A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection
- A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model
In development for (13)
- Autoimmune thrombocytopenic purpura Phase 3
- Avian influenza Phase 2
- Chronic kidney disease Phase 1
- COVID-19 Phase 3
- COVID-19–associated multisystem inflammatory syndrome in children Phase 3
- Influenza Phase 3
- Obesity disorder Phase 1
- Orthocoronavirinae infectious disease Phase 3
- Pneumonia Phase 3
- Severe acute respiratory syndrome Phase 3
- Swine influenza Phase 3
- Thrombocytopenia Phase 2
- Viral infectious disease Phase 3