BLASUBCUTANEOUSINJECTABLE
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
3/8 — Basic
Drug data last refreshed 13h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ANDEMBRY (garadacimab) is a monoclonal antibody approved in June 2025 for subcutaneous injection. It is indicated for hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent episodes of severe swelling. The drug works by targeting a specific pathway involved in HAE pathogenesis to prevent or reduce angioedema attacks.
Launch
Early-stage launch product with moderate competitive pressure (30/100) indicates active team expansion and opportunity for commercial and medical affairs roles.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)
Started Jul 2025
200 enrolled
Hereditary Angioedemas
Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab
Started Apr 2025
18 enrolled
Hereditary Angioedema
Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
Started Feb 2022
81 enrolled
Idiopathic Pulmonary Fibrosis
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
Started Mar 2021
171 enrolled
Hereditary Angioedema
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
Started Jan 2021
64 enrolled
Hereditary Angioedema
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.