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Kalbitor (ECALLANTIDE)
Kalbitor works by blocking the plasma kallikrein enzyme, which is involved in the production of bradykinin, a key mediator of HAE symptoms.
Ecallantide (Kalbitor), marketed by Dyax Corp., is a plasma kallikrein inhibitor indicated for the treatment of acute hereditary angioedema (HAE) attacks. Its key strength lies in its mechanism of action, directly blocking the plasma kallikrein enzyme, which is crucial in mediating HAE symptoms. The primary risk is the competitive landscape, with off-patent icatibant and patent-protected lanadelumab and berotralstat, all of which are in the same class and offer alternative treatment options.
At a glance
| Generic name | ECALLANTIDE |
|---|---|
| Sponsor | Dyax Corp. |
| Drug class | Plasma Kallikrein Inhibitor [EPC] |
| Target | Plasma kallikrein |
| Modality | Recombinant protein |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2009 |
Mechanism of action
Hereditary angioedema (HAE) is rare genetic disorder caused by mutations to C1-esterase-inhibitor (C1-INH) located on Chromosome 11q and inherited as an autosomal dominant trait. HAE is characterized by low levels of C1-INH activity and low levels of C4. C1-INH functions to regulate the activation of the complement and intrinsic coagulation (contact system pathway) and is major endogenous inhibitor of plasma kallikrein. The kallikrein-kinin system is complex proteolytic cascade involved in the initiation of both inflammatory and coagulation pathways. One critical aspect of this pathway is the conversion of High Molecular Weight (HMW) kininogen to bradykinin by the protease plasma kallikrein. In HAE, normal regulation of plasma kallikrein activity and the classical complement cascade is therefore not present. During attacks, unregulated activity of plasma kallikrein results in excessive bradykinin generation. Bradykinin is vasodilator which is thought by some to
Approved indications
- Acute HAE Attacks
Boxed warnings
- 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) ].
Common side effects
- Anaphylaxis
- Headache
- Nausea
- Fatigue
- Diarrhea
- Upper respiratory tract infection
- Injection site reactions
- Nasopharyngitis
- Vomiting
- Pyrexia
- Pruritus
- Upper abdominal pain
Key clinical trials
- Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary Angioedema (PHASE2)
- Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema (PHASE2)
- Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE) (PHASE3)
- Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE) (PHASE3)
- Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE) (PHASE3)
- Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
- Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema (PHASE2,PHASE3)
- EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema (PHASE2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Kalbitor CI brief — competitive landscape report
- Kalbitor updates RSS · CI watch RSS
- Dyax Corp. portfolio CI