BLAINJECTIONINJECTABLEPriority Review
Approved
Dec 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
5/8 — Partial
Priority Review
KALBITOR (ecallantide) by Dyax Corp. is kallikrein inhibitors [moa]. First approved in 2009.
Drug data last refreshed 3h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KALBITOR (ecallantide) is a plasma kallikrein inhibitor administered by injection for the treatment of hereditary angioedema (HAE). It works by blocking kallikrein, a key enzyme in the contact system pathway that triggers angioedema attacks. The drug is indicated for acute treatment of HAE episodes in patients with or without C1-esterase inhibitor deficiency.
$0.025BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Medicare utilization (371 claims in 2023), indicating a mature niche market with consolidating commercial infrastructure.
Mechanism of Action
Kallikrein Inhibitors
Pharmacologic Class:
Plasma Kallikrein Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema
Started Jun 2012
0Hereditary Angioedema (HAE)
Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
Started Jun 2011
79 enrolled
ACE Inhibitor Induced Angioedema
Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
Started Feb 2010
81 enrolled
Hereditary Angioedema (HAE)
Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery
Started Jun 2009
243 enrolled
BloodlossSurgical Procedures, Operative
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
Started Mar 2009
276 enrolled
BloodlossSurgical Procedures, Operative
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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.