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CSL312
CSL312 is an apolipoprotein A-I (apoA-I) mimetic that increases HDL cholesterol and promotes reverse cholesterol transport.
CSL312 is an apolipoprotein A-I (apoA-I) mimetic that increases HDL cholesterol and promotes reverse cholesterol transport. Used for Acute coronary syndrome with elevated lipoprotein(a), Cardiovascular risk reduction in patients with low HDL cholesterol.
At a glance
| Generic name | CSL312 |
|---|---|
| Also known as | Garadacimab, Factor XIIa inhibitor monoclonal antibody, garadacimab, Factor XIIa antagonist monoclonal antibody, Gardacimab |
| Sponsor | CSL Behring |
| Drug class | apoA-I mimetic |
| Target | Apolipoprotein A-I pathway; ABCA1 transporter |
| Modality | Biologic |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
CSL312 is designed to mimic the structure and function of apolipoprotein A-I, the major protein component of HDL particles. By enhancing HDL-mediated reverse cholesterol transport, the drug aims to reduce atherosclerotic cardiovascular disease risk. It works by facilitating the removal of cholesterol from peripheral tissues and atherosclerotic plaques, promoting their transport to the liver for excretion.
Approved indications
- Acute coronary syndrome with elevated lipoprotein(a)
- Cardiovascular risk reduction in patients with low HDL cholesterol
Common side effects
- Infusion-related reactions
- Headache
- Nausea
Key clinical trials
- Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab (PHASE4)
- CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema (PHASE3)
- Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks (PHASE3)
- Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study
- Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis (PHASE2)
- CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks (PHASE3)
- A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE) (PHASE2)
- A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects (PHASE1)
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:
- CSL312 CI brief — competitive landscape report
- CSL312 updates RSS · CI watch RSS
- CSL Behring portfolio CI