Drug Profile

Fibrinogen concentrate - Biotest AG

Alternative Names: BT 524; Prufibry

Latest Information Update: 25 Nov 2025

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At a glance

Originator Biotest AG
Developer Biotest AG; Grifols
Class Acute-phase proteins; Antihaemorrhagics; Blood coagulation factors; Coagulants
Mechanism of Action Fibrinogen replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Registered Afibrinogenaemia

Most Recent Events

13 Nov 2025 Fibrinogen concentrate is expected to be available to patients in Germany by the end of 2025
13 Nov 2025 Registered for Afibrinogenaemia (In infants, In children, In adolescents) in Germany (IV)
13 Nov 2025 Biotest AG anticipates approval of the pending FDA for fibrinogen concentrate in USA by end of 2025

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