Last reviewed 2026-04-20 · How we verify

Recombinant Coagulation Factor Ix (nonacog alfa)

Nonacog alfa, marketed by Pfizer Ltd, is a recombinant coagulation factor IX used to treat hereditary factor IX deficiency disease, currently holding a position in a specialized segment of the hemophilia B market. Its key strength lies in its mechanism of action, which effectively replaces the deficient clotting factor to prevent excessive bleeding, addressing a critical unmet need. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.

At a glance

Approved indications

• Hereditary factor IX deficiency disease

Common side effects

• Dysgeusia
• Pain in extremity
• Positive furin antibody test
• Low-titer non-neutralizing antibodies against factor IX

Key clinical trials

• Dosage and PD Study of Eftrenonacog-alfa
• ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
• BeneFIX Drug Use Results Survey [All-Case Surveillance]
• RIXUBIS Drug Use-Result Survey (Japan)
• Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B (PHASE3)
• RIXUBIS PMS India (RIXUBIS PMS) (PHASE4)
• A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B (PHASE3)
• Nonacog Alfa Prophylaxis And Treatment Of Bleeding Episodes In Previously Treated Patients With Hemophilia B (PHASE4)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Recombinant Coagulation Factor Ix CI brief — competitive landscape report
• Recombinant Coagulation Factor Ix updates RSS · CI watch RSS
• Pfizer Ltd portfolio CI