H5N1 pISV

ApprovedBiologic

NNational Institute of Allergy and Infectious Diseases (NIAID)

H5N1 pISV is one of 26 biologic programs targeting Influenza. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

InfluenzaActive, not recruiting

Avian InfluenzaActive, not recruiting

InfluenzaPhase 1

Active, not recruiting

Avian InfluenzaApproved

Active, not recruiting

Competition

Competitive Landscape

1053 competitors in Influenza

#DrugCompanyPhaseTrials

H5N1 pISV

NNational Institute of Allergy and Infectious Diseases (NIAID)

Approved

4 2

Fluzone

Sanofi

Preclinical

16 3

Trexall

Alnylam Pharmaceuticals

Preclinical

1 4

Crestor

AstraZeneca

Preclinical

1 5

Avigan

AAppili Therapeutics Inc.

Preclinical

6 6

Quadrivalent Influenza Vaccine

Sanofi

Preclinical

30 7

COMIRNATY

Pfizer

Preclinical

1 8

Antihistamine

Arrowhead Pharmaceuticals

Preclinical

1 9

Influenza A/H5N1

NNational Institute of Allergy and Infectious Diseases (NIAID)

Preclinical

14 10

Diphtheria-Tetanus-Acellular Pertussis Vaccine

CanSino Biologics Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Influenza

NCT07240558

Q3 2027

Post-ApprovalActive, not recruiting

Avian Influenza

NCT07275060

Clinical

Trials by Indication[1]

Influenza4 trials

Evaluating the Safety and Immune Response to an H5N1 Influenza Vaccine in People Who Have Previously Received an H5N1 or H7N3 Influenza Vaccine and in People Who Have Never Received a Live Attenuated Influenza Vaccine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01443663·69 enrolled

Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

Recruiting·UUniversity Health Network, Toronto·Phase 3·NCT07240558·120 enrolled

Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01910519·50 enrolled

Show 1 more trial

Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT03816878·32 enrolled

Avian Influenza1 trial

Immunogenicity and Safety of 2 Doses of Avian Influenza A (H5N1) Vaccine Administered 3 vs. 8 Weeks Apart

Active, not recruiting·CCanadian Immunization Research Network·Phase 4·NCT07275060·312 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for H5N1 pISV. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — H5N1 pISV compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for H5N1 pISV. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — National Institute of Allergy and Infectious Diseases (NIAID) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Approved[1]
Company: NNational Institute of Allergy and Infectious Diseases (NIAID)

H5N1 pISV

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Trials by Indication[1]

Influenza4 trials

Avian Influenza1 trial

Immune Response1 trial

Treatment1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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