Drug Profile

Fibrinogen concentrate - Biotest AG

Alternative Names: BT 524

Latest Information Update: 09 Jul 2025

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At a glance

Originator Biotest AG
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

Preregistration Afibrinogenaemia

Most Recent Events

23 Jun 2025 Biotest AG anticipates approval of the pending FDA for fibrinogen concentrate in USA, in early 2026
23 Jun 2025 Biotest AG plans to launch fibrinogen concentrate in Europe, in late 2025
23 Jun 2025 Grifols announces intention to submit regulatory applications for approval for Afibrinogenaemia in USA and Europe, in 2025

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