Last reviewed 2026-04-22 · How we verify

BT524 (Part I)

Biotest · Phase 3 active Small molecule

BT524 (Part I) is a Monoclonal antibody (anti-TFPI) Small molecule drug developed by Biotest. It is currently in Phase 3 development for Rare bleeding disorders associated with TFPI dysregulation, Hemophilia or other coagulation factor deficiencies (investigational). Also known as: Human Fibrinogen Concentrate.

BT524 is a human monoclonal antibody that binds to and neutralizes tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and hemostasis.

BT524 is a human monoclonal antibody that binds to and neutralizes tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and hemostasis. Used for Rare bleeding disorders associated with TFPI dysregulation, Hemophilia or other coagulation factor deficiencies (investigational).

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	BT524 (Part I)
Also known as	Human Fibrinogen Concentrate
Sponsor	Biotest
Drug class	Monoclonal antibody (anti-TFPI)
Target	Tissue Factor Pathway Inhibitor (TFPI)
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 3

Mechanism of action

BT524 works by inhibiting TFPI, a natural anticoagulant that suppresses the tissue factor-initiated coagulation cascade. By blocking TFPI, the drug restores or enhances thrombin generation, promoting clot formation in patients with bleeding disorders. This mechanism is intended to improve hemostatic function in conditions characterized by impaired coagulation.

Approved indications

Rare bleeding disorders associated with TFPI dysregulation
Hemophilia or other coagulation factor deficiencies (investigational)

Common side effects

Thrombotic events
Infusion-related reactions
Injection site reactions

Key clinical trials

Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

BT524 (Part I) CI brief — competitive landscape report
BT524 (Part I) updates RSS · CI watch RSS
Biotest portfolio CI

Frequently asked questions about BT524 (Part I)

What is BT524 (Part I)?

BT524 (Part I) is a Monoclonal antibody (anti-TFPI) drug developed by Biotest, indicated for Rare bleeding disorders associated with TFPI dysregulation, Hemophilia or other coagulation factor deficiencies (investigational).

How does BT524 (Part I) work?

BT524 is a human monoclonal antibody that binds to and neutralizes tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and hemostasis.

What is BT524 (Part I) used for?

BT524 (Part I) is indicated for Rare bleeding disorders associated with TFPI dysregulation, Hemophilia or other coagulation factor deficiencies (investigational).

Who makes BT524 (Part I)?

BT524 (Part I) is developed by Biotest (see full Biotest pipeline at /company/biotest).

Is BT524 (Part I) also known as anything else?

BT524 (Part I) is also known as Human Fibrinogen Concentrate.

What drug class is BT524 (Part I) in?

BT524 (Part I) belongs to the Monoclonal antibody (anti-TFPI) class. See all Monoclonal antibody (anti-TFPI) drugs at /class/monoclonal-antibody-anti-tfpi.

What development phase is BT524 (Part I) in?

BT524 (Part I) is in Phase 3.

What are the side effects of BT524 (Part I)?

Common side effects of BT524 (Part I) include Thrombotic events, Infusion-related reactions, Injection site reactions.

What does BT524 (Part I) target?

BT524 (Part I) targets Tissue Factor Pathway Inhibitor (TFPI) and is a Monoclonal antibody (anti-TFPI).

Drug class: All Monoclonal antibody (anti-TFPI) drugs
Target: All drugs targeting Tissue Factor Pathway Inhibitor (TFPI)
Manufacturer: Biotest — full pipeline
Therapeutic area: All drugs in Hematology
Indication: Drugs for Rare bleeding disorders associated with TFPI dysregulation
Indication: Drugs for Hemophilia or other coagulation factor deficiencies (investigational)
Also known as: Human Fibrinogen Concentrate

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing