Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Ecallantide (Kalbitor, DX-88): what the evidence says

Name: Ecallantide (Kalbitor, DX-88)
Published: 2026-10-27

At a glance

What it is: a 60-amino-acid recombinant protein (made in yeast) that blocks plasma kallikrein, the enzyme that drives bradykinin release during hereditary angioedema (HAE) attacks. Approved as Kalbitor (Dec 2009) to treat acute HAE attacks in patients 12 years and older. ^{R1, R2}

What the evidence says: Human two placebo-controlled phase 3 trials (EDEMA3 and EDEMA4) found faster symptom relief at 4 hours than placebo; a pooled analysis confirmed this across attack sites. ^{R3, R4, R5}

Biggest risks: boxed warning: anaphylaxis (in about 4% of treated patients), so it must be given by a healthcare professional ready to manage anaphylaxis and HAE. ^R2

Rating


Human Human evidence	Strong: two phase 3 RCTs plus pooled analysis ^{R3, R4, R5}
Animal Animal / lab evidence	Not reviewed
Regulatory	FDA-approved ^R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R6, R7, R8} · not named by WADA ^R9
Established human dose	Yes, label dose (see Study details)

Evidence verdict: Acute hereditary angioedema attacks: Strong (two phase 3 RCTs) · Other uses: No human data reviewed

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: two adequate RCTs on patient-reported symptom scores; it treats attacks and does not prevent them.

What is it?

Related pages: icatibant.

Does it work?

Human EDEMA3: median treatment outcome score at 4 hours 50 vs 0 with placebo. ^{R3, R10}
Human EDEMA4 (96 patients): symptom-severity change −0.8 vs −0.4; outcome score 53.4 vs 8.1. ^{R4, R11}
Human Pooled analysis: benefit at all attack sites; adverse events similar to placebo. ^R5

Is it safe?

Boxed warning: anaphylaxis; give only where anaphylaxis can be managed. ^R2
Most common: headache, nausea, diarrhea, fever, injection-site reactions, nasopharyngitis. ^R2

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: FDA-approved, prescription (Kalbitor), given by a healthcare professional. ^{R1, R2}
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R6, R7, R8}
Sport: not named on WADA's 2026 Prohibited List. ^R9

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
EDEMA3 (Cicardi 2010)	72 patients with an acute HAE attack	SC	30 mg single dose	4 to 24 hours	Outcome score 50 vs 0 at 4 h	PMID 20818887
EDEMA4 (Levy 2010)	96 patients with an acute HAE attack	SC	30 mg single dose	4 to 24 hours	Severity change −0.8 vs −0.4; outcome score 53.4 vs 8.1	PMID 20568386
Sheffer 2011 (pooled)	EDEMA3 + EDEMA4	SC	30 mg single dose	24 hours	Severity −0.97 vs −0.47 at 4 h	PMID 21481442

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)

^R1 Drugs@FDA, Kalbitor (ecallantide), application BLA125277 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=BLA125277
^R2 Kalbitor prescribing information, label published Jul 3, 2025 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f56aec67-c662-477c-b866-bfc23e8809cf
^R3 Cicardi M, et al. N Engl J Med. 2010. PMID 20818887
^R4 Levy RJ, et al. Ann Allergy Asthma Immunol. 2010. PMID 20568386
^R5 Sheffer AL, et al. J Allergy Clin Immunol. 2011. PMID 21481442
^R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R8 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R9 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R10 ClinicalTrials.gov NCT00262080, EDEMA3, phase 3, completed, 91 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT00262080
^R11 ClinicalTrials.gov NCT00457015, EDEMA4, phase 3, completed, 96 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT00457015

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Ecallantide (Kalbitor, DX-88). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).