Influenza

Infectious Diseases
156
Pipeline Programs
18
Companies
50
Clinical Trials
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
21
12
43
4
43
33
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
7983%
Small Molecule
88%
RNA Therapeutic
66%
Cell Therapy
22%
+ 71 programs with unclassified modality

On Market (4)

Approved therapies currently available

U
OSELTAMIVIR PHOSPHATEApproved
oseltamivir
Unknown Company
oral2017
BioCryst Pharmaceuticals
RAPIVABApproved
peramivir
BioCryst Pharmaceuticals
Neuraminidase Inhibitor [EPC]intravenous2014
Roche
TAMIFLUApproved
oseltamivir phosphate
Roche
oral2000
Roche
XOFLUZAApproved
baloxavir marboxil
Roche
oral2018

Competitive Landscape

17 companies ranked by most advanced pipeline stage

Sanofi
SanofiPARIS, France
47 programs
2
17
9
15
FluzonePhase 41 trial
Fluzone Quadrivalent vaccine, 2018-2019 formulationPhase 4Vaccine1 trial
Fluzone Quadrivalent vaccine, No PreservativePhase 4Vaccine1 trial
Fluzone Quadrivalent vaccine, no preservativePhase 4Vaccine1 trial
Fluzone® Quadrivalent vaccine, 2014-2015 formulationPhase 4Vaccine1 trial
+42 more programs
Active Trials
NCT05542004Completed964,870Est. May 2023
NCT04460781Completed96,175Est. Feb 2022
NCT04570904Completed470Est. Sep 2021
+67 more trials
Novartis
NovartisBASEL, Switzerland
44 programs
7
2
10
3
17
4
Fluad_MF59-adjuvanted trivalent influenza subunit vaccinePhase 4Vaccine1 trial
FluvirinPhase 41 trial
InfluenzaPhase 41 trial
live attenuated and inactivated influenza vaccinesPhase 4
Adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjectsPhase 3Vaccine1 trial
+39 more programs
Active Trials
NCT01424371Unknown1,000Est. Jun 2013
NCT00735020Completed72Est. Aug 2008
NCT00848887Completed410Est. May 2009
+46 more trials
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
23 programs
4
3
5
1
6
2011-2012 Fluzone IIV3Phase 41 trial
FluMistPhase 41 trial
FluMist®Phase 41 trial
FluzonePhase 41 trial
Fluzone® standard IIV3Phase 41 trial
+18 more programs
Active Trials
NCT04668417CompletedEst. Apr 2021
NCT00428493CompletedEst. Jan 2008
NCT01056185CompletedEst. Aug 2024
+20 more trials
BioCryst Pharmaceuticals
8 programs
2
1
5
1
PeramivirPhase 3Small Molecule1 trial
PeramivirPhase 3Small Molecule1 trial
PeramivirPhase 3Small Molecule1 trial
PeramivirPhase 3Small Molecule1 trial
Peramivir 150mgPhase 31 trial
+3 more programs
Active Trials
NCT00419263Completed344Est. Sep 2007
NCT00453999Completed137Est. Aug 2009
NCT02665351Completed16Est. Mar 2014
+5 more trials
Pfizer
PfizerNEW YORK, NY
5 programs
1
2
1
Fluad and Prevenar13Phase 41 trial
CAIV-TPhase 35 trials
Cold-adapted influenza vaccine trivalentPhase 3Vaccine1 trial
Investigational Influenza VaccinePhase 1/2Vaccine1 trial
Arm 1: E-portal message with IVR callN/A1 trial
Active Trials
NCT02266277Completed30,000Est. Dec 2016
NCT06821061Completed2,650Est. Dec 2025
NCT00192166Completed1,200Est. May 2003
+6 more trials
Roche
RocheSTAVANGER NORWAY, Norway
5 programs
3
1
oseltamivirPhase 4Small Molecule1 trial
XOFLUZA(Baloxavir Marboxil)Phase 31 trial
XOFLUZA(Baloxavir Marboxil)Phase 34 trials
Oseltamivir IVPhase 31 trial
TAMIFLU(Oseltamivir)N/ASmall Molecule5 trials
Active Trials
NCT00988325Completed65Est. Apr 2012
NCT01053663Terminated9Est. Jan 2013
NCT01249833Completed122Est. Apr 2012
+9 more trials
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
2 programs
2
FluMist trivalentPhase 41 trial
Monovalent Influenza VaccinePhase 4Vaccine1 trial
Active Trials
NCT03143101Completed200Est. Sep 2017
NCT03158038Completed300Est. Dec 2017
GC Biopharma
GC BiopharmaKorea - Yongin
7 programs
3
4
GC3106Phase 31 trial
GC3110APhase 31 trial
GC3110APhase 31 trial
MG1109Phase 31 trial
Quadrivalent cell-culture based influenza vaccinPhase 1/21 trial
+2 more programs
Active Trials
NCT02249221CompletedEst. Nov 2014
NCT02121782CompletedEst. Jun 2014
NCT01389466CompletedEst. Dec 2011
+4 more trials
Medigen Vaccine Biologics
1 program
1
GC FLU QuadrivalentPhase 31 trial
Active Trials
NCT03718468CompletedEst. Jul 2019
Abbott
AbbottABBOTT PARK, IL
1 program
1
Trivalent influenza subunit vaccine InfluvacPhase 3Vaccine4 trials
Active Trials
NCT02381418Completed120Est. Mar 2015
NCT01633749Completed120Est. Jul 2012
NCT01146015Completed121Est. Jul 2010
+1 more trials
Vaxart
VaxartSOUTH SAN FRANCISCO, CA
7 programs
4
1
2
40 mg Laninamivir OctanoatePhase 21 trial
VXA-A1.1Phase 21 trial
20 mg laninamivir octanoatePhase 1/21 trial
CS-8958Phase 11 trial
CS-8958 formulated as dry powderPhase 11 trial
+2 more programs
Active Trials
NCT00995826CompletedEst. Nov 2009
NCT00311714CompletedEst. Dec 2007
NCT00657111CompletedEst. Oct 2009
+4 more trials
Moderna
ModernaCAMBRIDGE, MA
7 programs
2
1
4
mRNA-1010Phase 2RNA Therapeutic1 trial
mRNA-1010Phase 2RNA Therapeutic1 trial
mRNA-1083Phase 2RNA Therapeutic1 trial
mRNA-1083 Composition 1 Dose A Lot APhase 2RNA Therapeutic1 trial
mRNA-1018 for H5N8Phase 1/2RNA Therapeutic1 trial
+2 more programs
Active Trials
NCT03345043Completed156Est. Aug 2018
NCT03076385Completed201Est. Oct 2018
NCT05972174Completed1,504Est. Jul 2024
+4 more trials
Ansun BioPharma
Ansun BioPharmaCA - San Diego
3 programs
1
2
DAS181 dry powder, formulation F02Phase 21 trial
DAS181-F02 formulationPhase 21 trial
DAS181Phase 11 trial
Active Trials
NCT00527865Completed36Est. Jan 2009
NCT01037205Completed264Est. Sep 2011
NCT01740063Completed423Est. Jan 2014
Harmony Biosciences
Harmony BiosciencesPLYMOUTH MEETING, PA
2 programs
1
OVX836 480µgPhase 21 trial
Nasopharyngeal swabsN/A1 trial
Active Trials
NCT06779981CompletedEst. Jun 2025
NCT05284799CompletedEst. Dec 2022
Takeda
TakedaTOKYO, Japan
1 program
1
TAK-850Phase 1/21 trial
Active Trials
NCT02111252Completed55Est. Apr 2014
C
CureVacGermany - Tübingen
1 program
1
CVSQIVPhase 11 trial
Active Trials
NCT05252338Completed240Est. Sep 2022
Plus Therapeutics
2 programs
KagocelN/ACell Therapy1 trial
KagocelN/ACell Therapy1 trial
Active Trials
NCT04651491CompletedEst. Sep 2016
NCT02983019CompletedEst. Sep 2016

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
SanofiHigh-Dose Influenza Vaccine
SanofiQuadrivalent influenza vaccine
SanofiQuadrivalent influenza vaccine
SanofiFluzone Quadrivalent vaccine, no preservative
SanofiQuadrivalent influenza vaccine
SanofiFluzone Quadrivalent vaccine, 2018-2019 formulation
SanofiSP Shz TIV
AstraZenecaMonovalent Influenza Vaccine
AstraZenecaFluMist trivalent
SanofiFluzone Quadrivalent vaccine, No Preservative
SanofiSeasonal influenza vaccine
SanofiQuadrivalent influenza vaccine
SanofiQuadrivalent influenza vaccine
Allergy TherapeuticsInfluenza Virus Vaccine Inactivated
SanofiFluzone® Quadrivalent vaccine, 2014-2015 formulation

Showing 15 of 49 trials with date data

Clinical Trials (50)

Total enrollment: 878,357 patients across 50 trials

NCT06506812SanofiHigh-Dose Influenza Vaccine

Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes

Start: May 2025Est. completion: Aug 2025466,320 patients
Phase 4Completed
NCT05517174SanofiQuadrivalent influenza vaccine

A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults

Start: Sep 2022Est. completion: Aug 2025332,438 patients
Phase 4Completed
NCT05154383SanofiQuadrivalent influenza vaccine

Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) Versus Standard-Dose (QIV-SD), in Subjects 65 Years of Age and Older on Innate Immunity, Including Gene Expression

Start: Nov 2021Est. completion: Jul 202260 patients
Phase 4Completed
NCT04109222SanofiFluzone Quadrivalent vaccine, no preservative

Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively

Start: Sep 2019Est. completion: Dec 201990 patients
Phase 4Completed
NCT03965195SanofiQuadrivalent influenza vaccine

Recombinant Influenza Vaccination in U.S. Nursing Homes

Start: Jul 2019Est. completion: Dec 20231,989 patients
Phase 4Unknown
NCT03617523SanofiFluzone Quadrivalent vaccine, 2018-2019 formulation

Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations

Start: Sep 2018Est. completion: Nov 2018240 patients
Phase 4Completed
NCT03344029SanofiSP Shz TIV

Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years

Start: Nov 2017Est. completion: May 20181,600 patients
Phase 4Completed
NCT03158038AstraZenecaMonovalent Influenza Vaccine

Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season

Start: May 2017Est. completion: Dec 2017300 patients
Phase 4Completed
NCT03143101AstraZenecaFluMist trivalent

Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age

Start: May 2017Est. completion: Sep 2017200 patients
Phase 4Completed
NCT02915302SanofiFluzone Quadrivalent vaccine, No Preservative

Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children

Start: Sep 2016Est. completion: Mar 20171,950 patients
Phase 4Completed
NCT02563184SanofiSeasonal influenza vaccine

Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease

Start: Sep 2015Est. completion: Feb 2016100 patients
Phase 4Unknown
NCT02539108SanofiQuadrivalent influenza vaccine

Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children

Start: Aug 2015Est. completion: Jul 201660 patients
Phase 4Completed
NCT03546192SanofiQuadrivalent influenza vaccine

Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)

Start: Jun 2015Est. completion: Jul 2015120 patients
Phase 4Completed
NCT02385123Allergy TherapeuticsInfluenza Virus Vaccine Inactivated

Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers

Start: Apr 2015Est. completion: Dec 2020
Phase 4Terminated
NCT02258334SanofiFluzone® Quadrivalent vaccine, 2014-2015 formulation

Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults

Start: Oct 2014Est. completion: Dec 2014208 patients
Phase 4Completed
NCT02215863PfizerFluad and Prevenar13

Immunogenicity and Safety of PCV13 and Fluad in Adults Aged ≥60 Years

Start: Sep 2014Est. completion: Mar 20151,195 patients
Phase 4Completed
NCT02222870SanofiQuadrivalent influenza vaccine

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine

Start: Aug 2014Est. completion: Jun 201560 patients
Phase 4Completed
NCT03266237SanofiVaxigrip®

The Immune Response to Influenza Vaccinations in Elderly Individuals

Start: Dec 2013Est. completion: May 2016240 patients
Phase 4Completed
NCT01946425SanofiInfluenza Virus Vaccine

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine

Start: Sep 2013Est. completion: Jul 201460 patients
Phase 4Completed
NCT03023176Allergy TherapeuticsFluzone® standard IIV3

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013

Start: Sep 2013Est. completion: Nov 2013
Phase 4Completed
NCT01867021NovartisFluvirin

Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above

Start: May 2013Est. completion: Dec 20132,902 patients
Phase 4Completed
NCT03023683Allergy TherapeuticsFluMist®

Protective Mechanisms Against a Pandemic Respiratory Virus (SLVP024)

Start: Oct 2012Est. completion: Nov 2012
Phase 4Completed
NCT01665807SanofiIntanza

A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine

Start: Sep 2012Est. completion: Dec 2012868 patients
Phase 4Completed
NCT01691326SanofiFluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

Start: Sep 2012Est. completion: Feb 201360 patients
Phase 4Completed
NCT02987374Allergy Therapeutics2011-2012 Fluzone IIV3

Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization

Start: May 2012Est. completion: Dec 2012
Phase 4Completed
NCT01430819SanofiInfluenza Virus Vaccine: Fluzone® 2011-2012 Formulation

Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults

Start: Sep 2011Est. completion: Feb 2012300 patients
Phase 4Completed
NCT01427309SanofiHigh Dose Trivalent Inactivated Influenza Vaccine

A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

Start: Sep 2011Est. completion: Nov 201331,989 patients
Phase 4Completed
NCT01249833RocheOseltamivir

Effect of Oseltamivir on Cognitive Function in Subjects With Influenza

Start: Nov 2010Est. completion: Apr 2012122 patients
Phase 4Completed
NCT01222403NovartisFluad_MF59-adjuvanted trivalent influenza subunit vaccine

A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older

Start: Oct 2010Est. completion: Oct 2014767 patients
Phase 4Completed
NCT01215669SanofiVaxigrip®

Study of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea

Start: Oct 2010Est. completion: Apr 2011240 patients
Phase 4Completed
NCT03020498Allergy TherapeuticsFluzone

B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)

Start: Sep 2010Est. completion: Dec 2011
Phase 4Completed
NCT01130636RocheOseltamivir

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

Start: Jun 2010Est. completion: Jul 20126 patients
Phase 4Completed
NCT00743275SanofiSplit, Inactivated, Trivalent Influenza Vaccine

A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

Start: Aug 2008Est. completion: Nov 2008120 patients
Phase 4Completed
NCT00593502Rocheoseltamivir

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

Start: Feb 2008Est. completion: Jun 2009409 patients
Phase 4Completed
NCT00561002SanofiInfluenza Virus Vaccine

Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine

Start: Oct 2007Est. completion: Jun 200834 patients
Phase 4Completed
NCT00538512SanofiFluzone

Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

Start: Sep 2007Est. completion: May 20081,952 patients
Phase 4Completed
NCT00412555RocheOseltamivir

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

Start: Dec 2006Est. completion: May 200752 patients
Phase 4Completed
NCT00389857SanofiInfluenza Virus Vaccine

Trial to Collect Safety Data and Sera for Immunogenicity Testing

Start: Oct 2006Est. completion: Jul 200831 patients
Phase 4Completed
NCT00389532SanofiInfluenza Virus Vaccine

Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

Start: Oct 2006Est. completion: Sep 2008116 patients
Phase 4Completed
NCT00385281Allergy TherapeuticsFluMist

Proteomic Profiling for Influenza Vaccination - FluMist

Start: Oct 2006Est. completion: Apr 2007
Phase 4Completed
NCT00311428NovartisInfluenza

Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to <36 Months

Start: Oct 2005270 patients
Phase 4Completed
NCT00258817SanofiInfluenza Virus Vaccine

Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

Start: Oct 2005Est. completion: Aug 200730 patients
Phase 4Completed
NCT00258830SanofiInfluenza Virus Vaccine

Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

Start: Sep 2005Est. completion: Mar 2007120 patients
Phase 4Completed
NCT00831675SanofiInfluenza Vaccine 2004-2005 Paediatric Formulation

Study of Safety and Immunogenicity of Fluzone® in Healthy Children

Start: Sep 2004Est. completion: Apr 200630 patients
Phase 4Completed
NCT00831987SanofiInfluenza Virus Vaccine

Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

Start: Aug 2004Est. completion: Feb 2006120 patients
Phase 4Completed
NCT00836953SanofiInfluenza Virus Vaccine

Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

Start: Sep 2003Est. completion: Jul 200433 patients
Phase 4Completed
NCT00835926SanofiInfluenza Virus Vaccine

A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

Start: Jul 2003Est. completion: Sep 2003121 patients
Phase 4Completed
NCT00138294Sanofilive attenuated and inactivated influenza vaccines

Control of Epidemic Influenza Through a School-based Influenza Vaccination Program

Start: Oct 1998Est. completion: Jun 201029,255 patients
Phase 4Completed
NCT00486980BioCryst PharmaceuticalsPeramivir 150mg

Intramuscular Peramivir for the Treatment of Uncomplicated Influenza

Phase 3Withdrawn
NCT06641180SanofiHigh-Dose Influenza Vaccine

Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age

Start: Nov 2024Est. completion: Jun 20251,180 patients
Phase 3Completed

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

43 late-stage (Phase 3) programs — potential near-term approvals
Vaccine is the dominant modality (83% of programs)
18 companies competing in this space

Related Indications

HIV Infections(449)COVID-19(223)Hepatitis C(191)HIV(138)HIV-1-infection(115)Hepatitis C, Chronic(94)Chronic Hepatitis B(93)Chronic Hepatitis C(91)Covid19(79)HIV Infection(75)