ANDEMBRY (garadacimab-gxii)
Andembry (garadacimab-gxii) is a monoclonal antibody indicated for the prevention of hereditary angioedema (HAE) attacks. The treatment is approved for use in adult and pediatric patients aged 12 years and older. It serves as a prophylactic therapy to reduce the frequency of the inflammatory swelling episodes associated with this condition.
How ANDEMBRY Works
Garadacimab-gxii functions by binding to and inhibiting activated Factor XII (FXIIa), the initial factor in the contact activation pathway. This inhibition prevents the conversion of prekallikrein to kallikrein and subsequently reduces the generation of bradykinin. By lowering bradykinin levels, the drug limits the biological processes that cause inflammation and swelling during HAE attacks.
Details
- Status
- Prescription
- First Approved
- 2025-06-16
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
ANDEMBRY Approval History
What ANDEMBRY Treats
1 indicationsANDEMBRY is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hereditary Angioedema
ANDEMBRY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ANDEMBRY FDA Label Details
Indications & Usage
FDA Label (PDF)ANDEMBRY is indicated for the treatment of Hereditary Angioedema.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.