KALBITOR (ecallantide)
KALBITOR is indicated for the treatment of Hereditary Angioedema.
How KALBITOR Works
In patients with hereditary angioedema, unregulated plasma kallikrein activity results in the excessive generation of bradykinin, a vasodilator responsible for localized swelling and pain. KALBITOR functions as a selective and reversible inhibitor that binds to plasma kallikrein and blocks its binding site. This action prevents the protease from converting high molecular weight (HMW) kininogen into bradykinin. By directly inhibiting this process, the drug reduces bradykinin levels to treat symptoms during acute episodic attacks.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-12-01
- Patent Cliff
- 2021
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
KALBITOR Approval History
What KALBITOR Treats
1 indicationsKALBITOR is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hereditary Angioedema
KALBITOR Boxed Warning
ANAPHYLAXIS Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hyperse...
WARNING: ANAPHYLAXIS Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR. [ see Contraindications (4) , Warnings and Precautions (5.1) , and Adverse Reactions (6) ] WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning Anaphylaxis has been reported after administration of KALBITOR ® . Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR [ see Contraindications (4) , Warnings and Precautions (5.1) , and Adverse Reactions (6) ].
KALBITOR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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.
Drugs Similar to KALBITOR
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01253382 | DX-88/26 2010-022716-39 | Ph 2, Ph 3 | withdrawn | Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema |
| NCT00816023 CONSERV-1 results posted | ECAL-PCPB-08-02 | Ph 2 | completed | A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume |
| NCT00888940 CONSERV-2 results posted | ECAL-CCPB-08-07 | Ph 2 | completed | 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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
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.
KALBITOR FDA Label Details
Indications & Usage
FDA Label (PDF)KALBITOR is indicated for the treatment of Hereditary Angioedema.
WARNING: ANAPHYLAXIS Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment