MedPath

CSL Behring

🇧🇪Belgium
Ownership
-
Employees
-
Market Cap
-
Website
http://www.cslbehring.com/

Clinical Trials

143

Active:10
Completed:98

Trial Phases

5 Phases

Phase 1:28
Phase 2:30
Phase 3:47
+2 more phases

Drug Approvals

32

SFDA:31
FDA:1

Drug Approvals

HEMGENIX

Approval Date
May 4, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (120 trials with phase data)• Click on a phase to view related trials

Phase 3
47 (39.2%)
Phase 2
30 (25.0%)
Phase 1
28 (23.3%)
Phase 4
11 (9.2%)
Not Applicable
4 (3.3%)

Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)

Not Applicable
Not yet recruiting
Conditions
Complex Cardiovascular Surgery With Cardiopulmonary Bypass
Interventions
Biological: FFP
First Posted Date
2025-07-30
Last Posted Date
2025-07-30
Lead Sponsor
CSL Behring
Target Recruit Count
200
Registration Number
NCT07094087

Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B

Not Applicable
Recruiting
Conditions
Hemophilia B
First Posted Date
2025-07-23
Last Posted Date
2025-08-07
Lead Sponsor
CSL Behring
Target Recruit Count
18
Registration Number
NCT07080905
Locations
🇺🇸

University of Florida - 84000399, Gainesville, Florida, United States

🇺🇸

University of Michigan Medical Center - 84000491, Ann Arbor, Michigan, United States

An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)

Not Applicable
Recruiting
Conditions
Primary Immunodeficiency
Interventions
Biological: IgPro
First Posted Date
2025-07-22
Last Posted Date
2025-07-30
Lead Sponsor
CSL Behring
Target Recruit Count
8
Registration Number
NCT07076446
Locations
🇺🇸

84000890 - Research Solutions of AZ, Litchfield Park, Arizona, United States

🇺🇸

84000910 - Immunoe Health Centers, Centennial, Colorado, United States

🇺🇸

84000918 - Midwest Immunology, Plymouth, Minnesota, United States

and more 2 locations

Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)

Not Applicable
Not yet recruiting
Conditions
Non-cystic Fibrosis Bronchiectasis
Interventions
Drug: Placebo
Device: Nebulizer
First Posted Date
2025-07-02
Last Posted Date
2025-07-02
Lead Sponsor
CSL Behring
Target Recruit Count
450
Registration Number
NCT07048262

A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)

Recruiting
Conditions
Hereditary Angioedemas
First Posted Date
2025-06-03
Last Posted Date
2025-08-08
Lead Sponsor
CSL Behring
Target Recruit Count
200
Registration Number
NCT07001280
Locations
🇩🇪

Charite, Berlin, Germany

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News

CSL Behring's Australian Plasma Facility Wins Global Manufacturing Excellence Award for Advanced Automation

CSL Behring's $900 million plasma fractionation facility in Broadmeadows, Victoria, has been named 2025 Facility of the Year in the Pharma 4.0 category by the International Society for Pharmaceutical Engineering.

Iovance Biotherapeutics Names Corleen Roche as CFO During Commercial Launch of First FDA-Approved TIL Therapy

Iovance Biotherapeutics appointed Corleen Roche as Chief Financial Officer effective August 6, 2025, during the commercial launch of its groundbreaking TIL therapy.

FDA Approves CSL's ANDEMBRY for Hereditary Angioedema Prevention with Novel Factor XIIa Targeting

The FDA approved ANDEMBRY (garadacimab-gxii), the first and only prophylactic HAE treatment targeting factor XIIa, offering once-monthly dosing for patients 12 years and older.

ISPE Celebrates 20th Anniversary with Announcement of 2025 Facility of the Year Awards Winners

Six pharmaceutical facilities received category awards for innovation, operations, and social impact at the 2025 ISPE Europe Annual Conference, marking the 20th anniversary of the prestigious FOYA program.

Injectable Drug Delivery Market Projected to Reach $1.14 Trillion by 2029 as Industry Leaders Convene for Innovation Summit

The injectable drug delivery market is projected to reach $1,139.4 billion by 2029, driven by complex biologics and increased demand for patient self-administration.

Non-Cystic Fibrosis Bronchiectasis Market Expected to Reach USD 7.5 Billion by 2035, Driven by Novel Therapies

The Non-Cystic Fibrosis Bronchiectasis (NCFB) market is projected to grow from USD 1.7 billion in 2024 to USD 7.5 billion by 2035, representing a robust CAGR of 14.62%.

Major Advances in Angioedema Pipeline: Intellia's Gene Therapy Enters Phase 3 as Multiple Companies Race for Novel Treatments

Intellia Therapeutics has initiated Phase 3 trials for NTLA-2002, a groundbreaking CRISPR-based gene therapy for hereditary angioedema, with potential U.S. launch targeted for 2027.

Pfizer Discontinues Beqvez Gene Therapy for Hemophilia B Amid Low Market Demand

Pfizer has announced the cessation of development and commercialization of Beqvez, its FDA-approved gene therapy for hemophilia B, citing limited interest from patients and healthcare providers.

Hemgenix Gene Therapy Shows Sustained Efficacy in Hemophilia B Patients After Four Years

Data from the HOPE-B trial demonstrates that Hemgenix (etranacogene dezaparvovec-drlb) provides long-term bleed protection for adults with hemophilia B.

Major Breakthroughs in HAE Treatment: 2024 Highlights Gene Editing and Novel Therapeutics

2024 marked significant advances in hereditary angioedema (HAE) treatment, with Intellia's gene-editing therapy NTLA-2002 showing a remarkable 95% reduction in monthly attacks. The year also saw important developments in multiple therapeutic candidates, including donidalorsen and garadacimab, while established treatments like Takhzyro demonstrated continued efficacy in adolescent populations.

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