Tamiflu

(Oseltamivir)

ApprovedSmall molecule

Oseltamivir is used to treat and prevent influenza (flu) infections. It works by stopping the flu virus from spreading in your body and can reduce how long you're sick.[2] Tamiflu is currently approved and in use across 9 indications[4].[1]

Tamiflu is one of 314 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

102

Total Trials

Active Trials

313

Competitors

112

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Viral DiseaseActive, not recruiting

ThrombocytopeniaApproved

PneumoniaUnknown status

Hematopoietic and Lymphoid Cell NeoplasmRecruiting

Heart FailureActive, not recruiting

InfluenzaCompleted

ObesityApproved

Chronic Kidney DiseaseApproved

Autoimmune Thrombocytopenic PurpuraApproved

Viral DiseaseApproved

Active, not recruiting

ThrombocytopeniaApproved

Approved

PneumoniaApproved

Unknown status

Hematopoietic and Lymphoid Cell NeoplasmPhase 2

Recruiting

Heart FailurePreclinical

Active, not recruiting

InfluenzaApproved

Completed

ObesityApproved

Approved

Chronic Kidney DiseaseApproved

Approved

Autoimmune Thrombocytopenic PurpuraApproved

Approved

Competition

Competitive Landscape

198 competitors in Heart Failure

#DrugCompanyPhaseTrials

Tamiflu

CConrado Roberto Hoffmann Filho

Approved

1 2

Bayer Aspirin

Bayer

Preclinical

2 3

Brethine

Sanofi

Preclinical

1 4

Medrol

Pfizer

Preclinical

1 5

Activase

Zemplar

Adriamycin

Savaysa

Xylocaine

1 10

Potassium Iodide

MMeda Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Influenza

NCT03901001

Q1 2027

Phase 2Recruiting

Influenza

NCT05648448

Phase 3Recruiting

Influenza

NCT07236814

Q1 2028

Phase 2Recruiting

Hematopoietic and Lymphoid Cell Neoplasm

NCT04712539

Q2 2036

Phase 3Recruiting

COVID-19

NCT04381936

Clinical

Trials by Indication[1]

Influenza56 trials

A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza

Completed· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT02603952·126 enrolled

Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza

Completed·BBioCryst Pharmaceuticals·Phase 3·NCT02369159·137 enrolled

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

Completed· Roche logo

Roche·Phase 3·NCT06774859·100 enrolled

Show 53 more trials

A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

Completed· Roche logo

Roche·Phase 3·NCT00545532·228 enrolled

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

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05818124·161 enrolled

A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza

Completed· GSK logo

GSK·Phase 3·NCT01231620·626 enrolled

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

Completed·RRomark Laboratories L.C.·Phase 3·NCT01610245·1,941 enrolled

Effect of Oseltamivir on Cognitive Function in Subjects With Influenza

Completed·TTrial Management Group Inc.·Phase 4·NCT01249833·122 enrolled

Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study

Completed·—·Phase 4·NCT00935194·102 enrolled

Phase III Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of JKN2301 Dry Suspension in Pediatric Patients Aged 2 to Under 12 Years With Influenza

Recruiting·JJoincare Pharmaceutical Group Industry Co., Ltd·Phase 3·NCT07357051·177 enrolled

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms

Completed· Roche logo

Roche·Phase 3·NCT03629184·173 enrolled

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

Terminated·WWeill Medical College of Cornell University·Phase 2/3·NCT05170009·2 enrolled

Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

Unknown status·IInsight Therapeutics, LLC·Phase 4·NCT05012189·1,000 enrolled

A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection

Completed· Roche logo

Roche·Phase 2·NCT02293863·168 enrolled

Efficacy and Safety of Combination Therapies With Oseltamivir & Zanamivir or Oseltamivir & Amantadine Versus Oseltamivir Monotherapy in the Treatment of Seasonal Influenza A Infection

Terminated·HHospices Civils de Lyon·Phase 2·NCT00830323·60 enrolled

Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

Completed·—·Phase 4·NCT00593502·409 enrolled

A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02532283·102 enrolled

Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza

Completed·MMateria Medica Holding·Phase 4·NCT01850446·184 enrolled

Efficacy and Safety of ZSP1273 in Children 2-11 Years Old With Influenza A

Active, not recruiting·GGuangdong Raynovent Biotech Co., Ltd·Phase 3·NCT07229807·119 enrolled

Efficacy Study of Early Versus Late Oseltamivir Administration for Treating and Preventing Influenza

Completed·MMarshfield Clinic Research Foundation·N/A·NCT00555893·194 enrolled

Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

Completed·MMateria Medica Holding·Phase 4·NCT01804946·161 enrolled

A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection

Completed· Roche logo

Roche·Phase 1·NCT01715909·20 enrolled

Oseltamivir Versus Paracetamol for Influenza-like Illness During the Influenza Season

Unknown status·RRambam Health Care Campus·Phase 4·NCT03754686·436 enrolled

Influenza Resistance Information Study

Completed· Roche logo

Roche··NCT00884117·4,561 enrolled

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

Not yet recruiting·—·N/A·NCT06762587·372 enrolled

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

Completed· Shionogi logo

Shionogi·Phase 3·NCT02954354·1,436 enrolled

Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1)Pneumonia: Multi-centre, Prospective, Randomized Controlled Study

Unknown status·—·Phase 4·NCT00936013·400 enrolled

Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Type A Influenza.

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 2·NCT03028909

A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

Completed· Roche logo

Roche·Phase 4·NCT00412737·477 enrolled

A Study on Higher-dose Oseltamivir Treatment's Impact on Viral Clearance and Clinical Recovery in Adults Hospitalized With Influenza

Completed·—·Phase 4·NCT01052961·157 enrolled

Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection.

Terminated·UUniversity Hospital, Lille·Phase 2·NCT03212716·85 enrolled

A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model

Completed· Roche logo

Roche·Phase 2·NCT01980966·101 enrolled

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

Terminated· GSK logo

GSK·Phase 2·NCT02927431·10 enrolled

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

Completed·GGuangdong Raynovent Biotech Co., Ltd·Phase 3·NCT04683406·750 enrolled

A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

Completed· Roche logo

Roche·Phase 1·NCT01033734·8 enrolled

A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza

Completed· Roche logo

Roche·Phase 3·NCT01050257·118 enrolled

A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.

Terminated· Roche logo

Roche·Phase 4·NCT00436124

Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00391768·87 enrolled

Influenza Management With Polyherbal Formulation

Unknown status·CComposite Interceptive Med Science·N/A·NCT03365336·100 enrolled

A Pharmacokinetics Study of Favipiravir in Patients With Severe Influenza

Completed·—·Phase 2·NCT03394209·34 enrolled

A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.

Completed· Roche logo

Roche·Phase 4·NCT00412555·52 enrolled

Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02342249·292 enrolled

Evaluation of the Safety and Efficacy of a Monoclonal Antibody to Treat Influenza

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 2·NCT03903718

Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During Lactation

Completed·PPharmahungary Group·Phase 4·NCT01130636·6 enrolled

A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain

Terminated· Roche logo

Roche·Phase 4·NCT01032837·102 enrolled

Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting

Recruiting·—·Phase 3·NCT07236814·384 enrolled

Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza

Completed·BBioCryst Pharmaceuticals·Phase 2·NCT00453999·137 enrolled

Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Completed·AAinos, Inc. (f/k/a Amarillo Biosciences Inc.·Phase 2·NCT01146535·40 enrolled

ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir

Completed·JJohns Hopkins University·Phase 4·NCT02609399·180 enrolled

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

Recruiting·UUniversity of Oxford·Phase 2·NCT05648448·3,000 enrolled

Treatment of Severe Influenza A Infection

Completed·TThe University of Hong Kong·Phase 3·NCT02108366·107 enrolled

A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza

Completed· Roche logo

Roche·Phase 3·NCT00949533·37 enrolled

A Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza

Terminated·MMcMaster University·Phase 4·NCT02561169·1 enrolled

Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT01314911·716 enrolled

Trial Comparing High Versus Standard Dose Oseltamivir in Severe Influenza Infection in ICU

Terminated·UUniversity of Manitoba·Phase 2·NCT01010087·59 enrolled

A Randomized Controlled Trial of Adjunctive Sirolimus and Oseltamivir Versus Oseltamivir Alone for Treatment of Influenza

Active, not recruiting·CChinese University of Hong Kong·Phase 3·NCT03901001·160 enrolled

COVID-195 trials

Randomised Evaluation of COVID-19 Therapy

Recruiting·UUniversity of Oxford·Phase 3·NCT04381936·70,000 enrolled

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

Unknown status·IIndonesia University·Phase 3·NCT04558463·100 enrolled

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

Unknown status·IIndonesia University·Phase 1·NCT04457609·40 enrolled

Show 2 more trials

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

Completed·UUniversity Hospitals Coventry and Warwickshire NHS Trust·Phase 2·NCT04516915·38 enrolled

Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT

Completed·SShehnoor Azhar·Phase 3·NCT04338698·550 enrolled

Interaction3 trials

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

Completed·AAlios Biopharma Inc.·Phase 1·NCT02888327·68 enrolled

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

Completed·GGuangdong Raynovent Biotech Co., Ltd·Phase 1·NCT05108051·36 enrolled

A Study to Assess the Drug-Drug Interaction Between VX-787 and Oseltamivir

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02262715·38 enrolled

Pneumonia3 trials

Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019

Unknown status·FFuzhou General Hospital·Phase 1·NCT04371601·60 enrolled

A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia

Unknown status·TTongji Hospital·Phase 4·NCT04255017·400 enrolled

A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia

Unknown status·TTongji Hospital·Phase 3·NCT04261270·60 enrolled

Efficacy2 trials

Oseltamivir Randomised Controlled Efficacy Trial

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 3·NCT00707941·1,190 enrolled

A Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Suraxavir Marboxil for Suspension

Not yet recruiting·JJiangxi Kvvit Pharmaceutical Co., Ltd.·Phase 3·NCT07113392·144 enrolled

26 more indications

Adult Subject2 trials

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

Completed·NNanjing Zenshine Pharmaceuticals·Phase 1·NCT06057103·18 enrolled

Open-Label Pharmacokinetic of Oseltamivir in Healthy Obese Thai Adult Subjects

Completed·SSouth East Asia Infectious Disease Clinical Research Network·Phase 1·NCT01049763·24 enrolled

CAR2 trials

Characterisation of the Human Carboxylesterase 1 (CES1) Mutations in Thailand

Completed·UUniversity of Oxford·Phase 4·NCT01443806·1 enrolled

A Bioequivalence Study of Oseltamivir From Oseltamivir 75 mg Caps (Pharmacare PLC, Palestine) and Tamiflu® 75 mg Caps (Hoffmann-La Roche, Switzerland)

Completed·GGenuine Research Center, Egypt·Phase 1·NCT02507648·24 enrolled

Tics2 trials

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

Completed· Roche logo

Roche·Phase 1·NCT02717754·99 enrolled

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

Completed· Roche logo

Roche·Phase 4·NCT02780622·20 enrolled

Complication2 trials

Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications

Completed· Shionogi logo

Shionogi·Phase 3·NCT02949011·2,184 enrolled

Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01227967·881 enrolled

Obese1 trial

Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects

Completed·MManjunath Prakash Pai·Phase 1/2·NCT01179919·21 enrolled

Avian Influenza1 trial

High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00298233·326 enrolled

Drug Metabolism1 trial

Alcohol Inhibits Drug Metabolism by Carboxylesterases

Completed·UUniversity of Tennessee·Phase 1·NCT01708369·19 enrolled

Single Dose1 trial

A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03023852·45 enrolled

Respiratory tract infection1 trial

Oseltamivir for Influenza Lower Respiratory Tract Infection in Children Under One

Withdrawn·UUniversity of Oxford·Phase 2/3·NCT01546935

ESS1 trial

Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)

Terminated·TTrial Management Group Inc.·Phase 4·NCT01456234·48 enrolled

Drug Interactions1 trial

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

Completed·JJiangxi Qingfeng Pharmaceutical Co. Ltd.·Phase 1·NCT05789342·54 enrolled

Randomized1 trial

A Multicenter Randomized Open-label Study of Oseltamivir Combined With HD-DEX Versus HD-DEX in the Management of ITP

Completed·SShandong University·Phase 2·NCT01965626·96 enrolled

Immune Thrombocytopenia1 trial

Proof-of-Concept: A Pilot, Randomized, Double-Blind Study of Oseltamivir Versus Placebo for Immune Thrombocytopenia

Unknown status·UUnity Health Toronto·Phase 3·NCT03520049·30 enrolled

Heart Failure1 trial

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

Unknown status·TTongji Hospital·N/A·NCT05008679·388 enrolled

Newborns1 trial

Pharmacokinetics of Oseltamivir in Newborns and Infants

Completed·—··NCT01388439·19 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Oseltamivir in Children Younger Than One Year of Age

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01037634

Pregnancy1 trial

A Study of the Pharmacology of Oseltamivir (Tamiflu) in Pregnancy

Withdrawn·UUniversity of Pittsburgh·Phase 1·NCT00873886

Intensive Care Unit1 trial

Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit

Withdrawn·UUniversity of Manitoba·N/A·NCT00844155

Treatment1 trial

Rapid Empiric Treatment With Oseltamivir Study (RETOS)

Completed·UUniversity of Louisville·Phase 4·NCT01248715·1,107 enrolled

Peritoneal Dialysis1 trial

A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)

Completed· Roche logo

Roche·Phase 1·NCT02617784·24 enrolled

Swine Influenza1 trial

A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection

Terminated·—·Phase 3·NCT00979667·4 enrolled

Pilot Study1 trial

An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.

Withdrawn·MMcMaster University·Phase 4·NCT02282384

Intravenous1 trial

Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00921726·17 enrolled

TED1 trial

A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers

Completed· GSK logo

GSK·Phase 1·NCT01258530·28 enrolled

Hematopoietic and Lymphoid Cell Neoplasm1 trial

Efficacy of Combination Baloxovir and Oseltamivir Therapy in Influenza Infected Immunocompromised Hosts

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04712539·60 enrolled

Unspecified4 trials

Evaluation of Alternative Oseltamivir (Tamiflu) Dosing Strategies.

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00304434·48 enrolled

Pharmacologic Study of Oseltamivir in Healthy Volunteers

Completed·MMahidol University·Phase 1·NCT00439530·21 enrolled

Alternative Oseltamivir Dosing Strategies

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00334529·48 enrolled

Show 1 more trial

A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01172847·24 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 27, 1999

TAMIFLU

NDA NDA021087

Nov 9, 2000

TAMIFLU

NDA NDA021087

Nov 17, 2000

TAMIFLU

NDA NDA021087

Mar 6, 2001

TAMIFLU

NDA NDA021087

Jul 5, 2001

TAMIFLU

NDA NDA021246

Jul 13, 2001

TAMIFLU

NDA NDA021087

Jul 24, 2001

TAMIFLU

NDA NDA021246

Jul 24, 2001

TAMIFLU

NDA NDA021087

Jul 24, 2001

TAMIFLU

NDA NDA021246

Jul 24, 2001

TAMIFLU

NDA NDA021087

Jul 24, 2001

TAMIFLU

NDA NDA021087

Nov 5, 2001

TAMIFLU

NDA NDA021246

Nov 5, 2001

TAMIFLU

NDA NDA021087

Mar 4, 2002

TAMIFLU

NDA NDA021246

Mar 28, 2002

TAMIFLU

NDA NDA021087

Apr 26, 2002

TAMIFLU

NDA NDA021087

Apr 26, 2002

TAMIFLU

NDA NDA021246

May 7, 2002

TAMIFLU

NDA NDA021087

Feb 14, 2003

TAMIFLU

NDA NDA021246

Feb 14, 2003

TAMIFLU

NDA NDA021087

Feb 28, 2003

TAMIFLU

NDA NDA021087

Mar 10, 2003

TAMIFLU

NDA NDA021087

Apr 24, 2004

TAMIFLU

NDA NDA021087

Apr 26, 2004

TAMIFLU

NDA NDA021087

Apr 26, 2004

TAMIFLU

NDA NDA021246

Jun 24, 2004

TAMIFLU

NDA NDA021087

Jun 24, 2004

TAMIFLU

NDA NDA021246

Aug 12, 2004

TAMIFLU

NDA NDA021246

Aug 12, 2004

TAMIFLU

NDA NDA021087

Oct 19, 2004

TAMIFLU

NDA NDA021246

Oct 19, 2004

TAMIFLU

NDA NDA021087

Jan 18, 2005

TAMIFLU

NDA NDA021246

Jan 18, 2005

TAMIFLU

NDA NDA021087

Apr 20, 2005

TAMIFLU

NDA NDA021087

May 19, 2005

TAMIFLU

NDA NDA021246

May 19, 2005

TAMIFLU

NDA NDA021087

Aug 16, 2005

TAMIFLU

NDA NDA021087

Oct 14, 2005

TAMIFLU

NDA NDA021246

Oct 14, 2005

TAMIFLU

NDA NDA021087

Oct 14, 2005

TAMIFLU

NDA NDA021087

Oct 27, 2005

TAMIFLU

NDA NDA021087

Dec 1, 2005

TAMIFLU

NDA NDA021087

Dec 1, 2005

TAMIFLU

NDA NDA021246

Dec 21, 2005

TAMIFLU

NDA NDA021087

Dec 21, 2005

TAMIFLU

NDA NDA021246

Jun 23, 2006

TAMIFLU

NDA NDA021246

Jun 23, 2006

TAMIFLU

NDA NDA021087

Nov 13, 2006

TAMIFLU

NDA NDA021087

Nov 13, 2006

TAMIFLU

NDA NDA021246

Dec 14, 2006

TAMIFLU

NDA NDA021246

Dec 19, 2006

TAMIFLU

NDA NDA021087

Feb 1, 2007

TAMIFLU

NDA NDA021087

Feb 1, 2007

TAMIFLU

NDA NDA021246

Feb 27, 2007

TAMIFLU

NDA NDA021087

Mar 12, 2007

TAMIFLU

NDA NDA021246

Mar 12, 2007

TAMIFLU

NDA NDA021087

Mar 22, 2007

TAMIFLU

NDA NDA021087

Mar 22, 2007

TAMIFLU

NDA NDA021246

Mar 26, 2007

TAMIFLU

NDA NDA021246

Mar 26, 2007

TAMIFLU

NDA NDA021087

Jul 2, 2007

TAMIFLU

NDA NDA021246

Jul 2, 2007

TAMIFLU

NDA NDA021087

Jul 2, 2007

TAMIFLU

NDA NDA021087

Oct 5, 2007

TAMIFLU

NDA NDA021246

Oct 5, 2007

TAMIFLU

NDA NDA021087

Dec 3, 2007

TAMIFLU

NDA NDA021087

Jan 17, 2008

TAMIFLU

NDA NDA021246

Jan 17, 2008

TAMIFLU

NDA NDA021087

May 5, 2008

TAMIFLU

NDA NDA021087

Jun 10, 2008

TAMIFLU

NDA NDA021087

Sep 25, 2008

TAMIFLU

NDA NDA021087

Sep 25, 2008

TAMIFLU

NDA NDA021246

Feb 23, 2009

TAMIFLU

NDA NDA021246

Feb 22, 2010

TAMIFLU

NDA NDA021087

Feb 22, 2010

TAMIFLU

NDA NDA021087

Feb 22, 2010

TAMIFLU

NDA NDA021246

Feb 22, 2010

TAMIFLU

NDA NDA021246

Nov 5, 2010

TAMIFLU

NDA NDA021246

Nov 5, 2010

TAMIFLU

NDA NDA021087

Dec 15, 2010

TAMIFLU

NDA NDA021246

Dec 15, 2010

TAMIFLU

NDA NDA021087

Feb 7, 2011

TAMIFLU

NDA NDA021246

Feb 7, 2011

TAMIFLU

NDA NDA021087

Mar 21, 2011

TAMIFLU

NDA NDA021246

Mar 21, 2011

TAMIFLU

NDA NDA021087

Mar 21, 2011

TAMIFLU

NDA NDA021246

Aug 16, 2012

TAMIFLU

NDA NDA021246

Aug 16, 2012

TAMIFLU

NDA NDA021087

Dec 21, 2012

TAMIFLU

NDA NDA021087

Dec 21, 2012

TAMIFLU

NDA NDA021246

Jan 29, 2013

TAMIFLU

NDA NDA021087

Jan 29, 2013

TAMIFLU

NDA NDA021246

Feb 7, 2013

TAMIFLU

NDA NDA021246

Dec 20, 2013

TAMIFLU

NDA NDA021087

May 30, 2014

TAMIFLU

NDA NDA021087

May 30, 2014

TAMIFLU

NDA NDA021246

Oct 8, 2014

TAMIFLU

NDA NDA021087

Oct 14, 2014

TAMIFLU

NDA NDA021087

Oct 14, 2014

TAMIFLU

NDA NDA021246

Nov 26, 2014

TAMIFLU

NDA NDA021087

Nov 26, 2014

TAMIFLU

NDA NDA021246

Dec 15, 2014

TAMIFLU

NDA NDA021087

Mar 16, 2015

TAMIFLU

NDA NDA021246

Jun 20, 2016

TAMIFLU

NDA NDA021087

Jun 20, 2016

TAMIFLU

NDA NDA021246

Apr 4, 2018

TAMIFLU

NDA NDA021246

Apr 4, 2018

TAMIFLU

NDA NDA021087

Dec 12, 2018

TAMIFLU

NDA NDA021246

Dec 12, 2018

TAMIFLU

NDA NDA021087

Aug 2, 2019

TAMIFLU

NDA NDA021246

Aug 2, 2019

TAMIFLU

NDA NDA021087

Aug 10, 2021

TAMIFLU

NDA NDA021246

Sources

References

[1]
ClinicalTrials.gov — 102 trial records for Oseltamivir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tamiflu drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Oseltamivir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Oseltamivir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021246). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Neuraminidase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CConrado Roberto Hoffmann Filho

Tamiflu

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q1 2028

Q2 2036

Trials by Indication[1]

Influenza56 trials

COVID-195 trials

Interaction3 trials

Pneumonia3 trials

Efficacy2 trials

Adult Subject2 trials

CAR2 trials

Tics2 trials

Complication2 trials

Obese1 trial

Avian Influenza1 trial

Drug Metabolism1 trial

Single Dose1 trial

Respiratory tract infection1 trial

ESS1 trial

Drug Interactions1 trial

Randomized1 trial

Immune Thrombocytopenia1 trial

Heart Failure1 trial

Newborns1 trial

Safety and Efficacy1 trial

Pregnancy1 trial

Intensive Care Unit1 trial

Treatment1 trial

Peritoneal Dialysis1 trial

Swine Influenza1 trial

Pilot Study1 trial

Intravenous1 trial

TED1 trial

Hematopoietic and Lymphoid Cell Neoplasm1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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