CSL Behring

CSL Behring works on 17 rare diseases tracked on Trial Friend, including Alpha-1 Antitrypsin Deficiency, Ataxia-Telangiectasia, Chronic Graft-versus-Host Disease and 14 more, with 13 recruiting clinical trials and 2 FDA-approved rare disease drugs.

CSL Behring is a global leader in plasma-derived and recombinant therapies for rare diseases including bleeding disorders, immune deficiencies, and hereditary angioedema. Key products include Hemgenix (etranacogene dezaparvovec), the first gene therapy for hemophilia B, Idelvion (Factor IX) for hemophilia B, Haegarda (C1 esterase inhibitor) for hereditary angioedema, and Hizentra (subcutaneous immunoglobulin) for primary immunodeficiency and CIDP. CSL Behring is part of CSL Limited, which also acquired Vifor Pharma in 2022 to expand into nephrology and iron deficiency.

Type
Diversified Pharma
Ticker
CSL
Headquarters
Melbourne, Australia
Founded
1916
13
Active Rare Disease Trials
2
Approved Rare Disease Drugs
17
Rare Diseases in Portfolio
110
Years Active

CSL Behring Drug Pipeline

CSL Behring has 13 active clinical trials across 4 development stages, with 13 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of CSL Behring's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand CSL Behring's pipeline
Type your own question with a little about your situation, and get an answer with sources.
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4
Phase 24 trials
Non-cystic Fibrosis Bronchiectasis
Recruiting
3
Phase 33 trials
2
Phase 4 / Post-Market2 trials
4
Other4 trials

CSL Behring Clinical Trials (13)

Active and recruiting clinical trials sponsored by CSL Behring, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about CSL Behring's trials
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RECRUITINGPHASE3Recently updatedNCT07080905

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

Intervention: CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua)

This is a phase 3, prospective, open-label, single-arm, single-dose, multicenter study investigating the efficacy, safety, and tolerability of CSL222 (AAV5-hFIXco-Padua) in adolescent male participants with severe or moderately severe hemophilia B.

Ages 138 Months - 206 Months14 locations
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RECRUITINGPHASE3Recently updatedNCT06003387

Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)

Intervention: CSL222 (AAV5-hFIXco-Padua)

The purpose of this study is to assess the risk of bleeding due to failure of expected pharmacological action of CSL222 in adults with severe or moderately severe hemophilia B with detectable pretreatment AAV5 Nabs.

Ages 18 Years+32 locations
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RECRUITINGPHASE2Recently updatedNCT06699849

Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis

Intervention: CSL889, Placebo

This is a phase 2, randomized, multiple-dose, placebo-controlled study designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of CSL889 (human hemopexin) when given intravenously (IV) to adults and adolescents with sickle cell disease (SCD) experiencing vaso-occlusive crises (VOC). The main objectives of the study are to evaluate the safety and tolerability of CSL889 in study participants, and to assess how CSL889 affects the time it takes for VOC to resolve in participants with SCD.

Ages 12 Years+26 locations
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RECRUITINGPHASE2Recently updatedNCT07224360

Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)

Intervention: Anumigilimab, Placebo

This is a phase 2a, global, multicenter, randomized, double-blind, placebo-controlled study investigating the safety of anumigilimab administered subcutaneously (SC) at the maximum tolerated dose (MTD) in adult participants with SCD. The primary aim of the study is to assess the safety of anumigilimab in participants with SCD. Participants will be treated for 64 weeks: for 12 weeks in the dose escalation period, where the dose will be escalated to each participant's individual MTD; and for 52 weeks at the MTD in the maintenance period.

Ages 18 Years+16 locations
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RECRUITINGUpdated a few months agoNCT07001280

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

Intervention: No intervention

This is a multinational, multicenter, prospective, observational cohort study of patients with HAE in the real-world setting. The study will include patients newly initiating garadacimab in routine clinical practice. Each participant will be followed for 48 months after index date (date of the first administration of garadacimab). Patient data will be collected from the HAE eDiary, patient medical records (MRs) and/or during a routine clinical visit and will be entered into the electronic case report form (eCRF) via an electronic data capture (EDC) system. Data pertaining to HAE attacks, prior HAE treatments, retrospective focused safety data collection, and healthcare resource utilization (HCRU) over a look-back period of 12 months prior to the enrollment will be extracted from the MR, and patients will also record retrospective HAE attack related data over a look-back period of 3 months prior to enrollment in the HAE eDiary. The primary aim of this study is to investigate the real-world effectiveness of garadacimab as measured by HAE attack rate before and after garadacimab initiation in patients with HAE over 24 months of follow-up. The study will aim to complement the data available from the clinical development program on the efficacy, safety, and health-related quality-of-life (HRQoL) in patients with HAE taking garadacimab.

Ages 12 Years+22 locations
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RECRUITINGPHASE4Updated a few months agoNCT03684018

Two Dose Levels of Privigen in Pediatric CIDP

Intervention: IgPro10

A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment

Ages 2 Years - 17 Years9 locations
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RECRUITINGPHASE4Updated a few months agoNCT05193552

Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease

Intervention: Hizentra

Although there is evidence in the literature that gammaglobulin replacement therapy can lead to a reduction in the prevalence of pulmonary infection and improved lung function, there is no published study to guide immunologists regarding the use of spirometry in titrating IG therapy to assist in the management of immunodeficiency patients with regards to gammaglobulin replacement therapy. The investigators propose to study the use of spirometry to identify patients that could potentially benefit from an increase in IGRT. The investigators will identify 22 common variable immune deficiency (CVID) study subjects on stable IGRT replacement therapy equivalent to 0.40 to 0.60 gm/kg per 4 weeks who have evidence of mild to moderate obstruction as assessed by an FEF25-75% between 50% and 80% of predicted. Patients who are on Hizentra will be preferentially recruited. Of these 22, 11 will be identified at random and treated for 6 months at their current dose (control population). The remaining 11 study subjects (treatment group) will have their level of IGRT increased by the equivalent of 0.05 gm/kg in dose per 4 weeks, adjusted for bioavailability as per manufacturer's instructions. On average, rounded up to the nearest gram, this will typically increase their dose of Hizentra by 2 gm per week.

Ages 21 Years+1 location
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CSL Behring FDA-Approved Drugs (2)

Medications developed or marketed by CSL Behring that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
GARADACIMABANDEMBRY
subcutaneous
Jun 16, 2025
ETRANACOGENE DEZAPARVOVECHEMGENIX—

CSL Behring Trial Locations

CSL Behring clinical trials are running at 222 sites in 26 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

France
61▼
United States
57▼
China
20▼
United Kingdom
13▼
Japan
11▼
Germany
10▼
Turkey (Türkiye)
9▼
Australia
7▼
Taiwan
5▼
Austria
3▼
Spain
3▼
South Korea
3▼

Rare Disease Focus Areas (17)

Diseases targeted by CSL Behring's clinical trial and drug development programs

Alpha-1 Antitrypsin DeficiencyPulmonary & Respiratory

Alpha-1 antitrypsin deficiency is a genetic disorder affecting the lungs and liver, caused by insufficient production of the protective enzyme alpha-1 antitrypsin. Without adequate protection, neutrop...

Prevalence: 1 in 2,500 to 3,500 people; affects approximately 100,000 Americans
Ataxia-TelangiectasiaNeurological & Neuromuscular

Ataxia-telangiectasia (A-T) is a rare inherited disorder in which the ATM gene, which coordinates DNA repair, does not work. Children lose coordination from early childhood as the cerebellum degenerat...

Prevalence: 1 in 40,000 to 100,000 people worldwide
Chronic Graft-versus-Host DiseaseBlood & Immune

Chronic graft-versus-host disease is an immune-mediated complication after allogeneic stem cell or bone marrow transplant, in which donor immune cells attack the recipient's tissues. It can affect the...

Prevalence: Affects 30 to 70% of patients who receive allogeneic hematopoietic stem cell transplant; approximately 14,000 new cases annually in the U.S.
Chronic Inflammatory Demyelinating PolyneuropathyNeurological & Neuromuscular

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is an autoimmune disorder affecting the peripheral nerves, causing progressive weakness and impaired function in the legs and arms. The immune ...

Prevalence: Approximately 1 per 100,000 to 1 per 50,000 people; estimated 250,000 people have CIDP in North America
Common Variable ImmunodeficiencyBlood & Immune

Common variable immunodeficiency is a primary immunodeficiency disorder characterized by low levels of immunoglobulins and impaired antibody responses. Patients experience recurrent infections affecti...

Prevalence: 1 in 25,000 to 50,000 people
Cystic FibrosisPulmonary & Respiratory

Cystic fibrosis is an autosomal recessive genetic disorder affecting the CFTR protein, which normally regulates chloride transport. Defective CFTR causes thick, sticky secretions in the lungs and dige...

Prevalence: About 30,000 people in the U.S.; 1 in 2,500 to 3,500 births among Caucasians

Patient Resources

Organizations and resources related to CSL Behring's rare disease focus areas

Frequently Asked Questions About CSL Behring

Common questions about CSL Behring's rare disease programs, clinical trials, and treatments.