Skin & aging Plasma kallikrein inhibitor
Ecallantide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Ecallantide (sold as Kalbitor) is a protein that blocks plasma kallikrein, used to treat acute attacks of hereditary angioedema. By stopping kallikrein, it reduces production of the bradykinin that drives the swelling. It has been FDA-approved in the U.S. since 2009, is given by a healthcare professional, and carries a boxed warning for anaphylaxis.
At a glance
- What it is
- A plasma kallikrein inhibitor (a recombinant Kunitz-domain protein)
- Approved for
- Acute attacks of hereditary angioedema in patients 12 and older
- Key fact
- In a pivotal trial it significantly improved symptom scores versus placebo
- Route
- Subcutaneous injection, administered by a healthcare professional
- Evidence strength
- FDA approved
Summary
Ecallantide is an FDA-approved plasma kallikrein inhibitor for acute hereditary angioedema attacks. Learn how it works, who gives it, and its boxed warning.
What is ecallantide?
Ecallantide, sold under the brand Kalbitor, is a recombinant 60-amino-acid protein that inhibits plasma kallikrein, an enzyme central to the swelling of hereditary angioedema (HAE). It is used to treat acute HAE attacks. Because it can cause anaphylaxis, it is given by a healthcare professional rather than self-administered. It was developed under the code DX-88 and approved in the United States in 2009.
How does ecallantide work?
Ecallantide blocks plasma kallikrein, an enzyme that cleaves a protein called high-molecular-weight kininogen to release bradykinin. Bradykinin is the mediator that causes the blood vessels to leak and the tissues to swell in hereditary angioedema. By inhibiting kallikrein, ecallantide reduces the generation of bradykinin and thereby controls the acute attack.
This upstream action distinguishes it from drugs that block the bradykinin receptor directly. In the EDEMA3 trial, ecallantide significantly improved both symptom-severity and treatment-outcome scores compared with placebo. Because the molecule can provoke severe allergic reactions that may resemble an HAE attack, administration in a supervised setting is required.
Is it FDA-approved?
Editor’s note
Status: Yes. Ecallantide is FDA-approved, and its age range has widened since approval: Year | FDA action | Who it covers 2009 | Approved for acute attacks of hereditary angioedema | Patients 16 and older 2014 | Age lowered | Patients 12 and older It carries a boxed warning for anaphylaxis and must be administered by a healthcare professional equipped to manage anaphylaxis; it is not for self-injection.
Category: FDA-approved · Primary body area: Skin & aging
Yes. Ecallantide is FDA-approved, and its age range has widened since approval:
| Year | FDA action | Who it covers |
|---|---|---|
| 2009 | Approved for acute attacks of hereditary angioedema | Patients 16 and older |
| 2014 | Age lowered | Patients 12 and older |
It carries a boxed warning for anaphylaxis and must be administered by a healthcare professional equipped to manage anaphylaxis; it is not for self-injection.
What is ecallantide prescribed for?
Ecallantide is prescribed to treat acute attacks of hereditary angioedema in people aged 12 and older. It is given in a clinical setting because of the risk of serious allergic reactions.
What are the side effects?
According to the prescribing information, common side effects include:
- Headache
- Nausea and diarrhea
- Fever
- Injection-site reactions and nasopharyngitis
More serious considerations include:
- A boxed warning for anaphylaxis, which is why it is administered by a healthcare professional
- Allergic reactions that can be hard to distinguish from an HAE attack
Sources: FDA prescribing information for Kalbitor; the EDEMA3 trial (Cicardi et al., The New England Journal of Medicine, 2010, DOI: 10.1056/NEJMoa0905079), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
Compare every peptide’s status in the peptide regulatory status database
More for Skin & aging
View all skin & aging peptides →- Cosmetic & topical Skin & aging
Acetyl-Hexapeptide-8
Argireline
Acetyl hexapeptide-8, sold in skincare as Argireline, is a synthetic peptide modeled on the nerve protein SNAP-25 and marketed as a topical, "Botox-like" way to soften the appearance of expression lines. In lab and small clinical studies it interferes with the SNARE complex that nerves use to trigger muscle contraction, and a 2013 randomized study found it reduced the appearance of peri-orbital wrinkles over four weeks. It is a cosmetic ingredient rather than a drug, so it does not require FDA approval, and its evidence is rated Moderate.
- Cosmetic & topical Skin & aging
Acetyl-Octapeptide-3
SNAP-8
Acetyl octapeptide-3, sold in skincare as SNAP-8, is a synthetic eight-amino acid peptide modeled on the nerve protein SNAP-25 and marketed as a stronger successor to Argireline for softening the appearance of expression lines. Like Argireline, it is designed to interfere with the SNARE complex that nerves use to trigger muscle contraction, but its own published human evidence is thin and comes mostly from the manufacturer. It is a cosmetic ingredient rather than a drug, so it does not require FDA approval, and its evidence is rated Low.
- Cosmetic & topical Skin & aging
Acetyl-Tetrapeptide-5
Eyeseryl
Acetyl tetrapeptide-5, sold in skincare as Eyeseryl, is a synthetic four-amino acid peptide used in eye creams to soften the look of under-eye bags and puffiness. It is thought to work in two ways, by easing the fluid buildup that makes the under-eye area look swollen and by limiting the glycation that stiffens collagen, though its published evidence comes almost entirely from the manufacturer. It is a cosmetic ingredient rather than a drug, so it does not require FDA approval, and its evidence is rated Low.
- FDA-approved Skin & aging
Afamelanotide
Afamelanotide is a synthetic, longer-lasting analog of alpha-melanocyte-stimulating hormone (α-MSH) that activates the MC1R receptor on pigment cells to boost the skin's own protective eumelanin. The FDA approved it in 2019 as Scenesse, a subcutaneous implant for adults with erythropoietic protoporphyria (EPP), a rare light-sensitivity disorder. In the pivotal 2015 placebo-controlled trials, U.S. patients (94) logged a median 69.4 pain-free hours in direct sunlight versus 40.8 on placebo (P = 0.04). EU patients (74) logged 6.0 versus 0.8 hours (P = 0.005).
- FDA-approved Skin & aging
Bacitracin
Bacitracin is a cyclic polypeptide antibiotic produced by Bacillus bacteria that kills gram-positive bacteria by blocking the construction of their cell wall. It is best known as an over-the-counter topical ointment for preventing infection in minor cuts, scrapes, and burns, often combined with neomycin and polymyxin B in "triple antibiotic" products. It is widely available over the counter, but it is also a common cause of allergic skin reactions, and its injectable form was withdrawn over kidney-toxicity concerns.
- Cosmetic & topical Skin & aging
Carnosine
Carnosine is a naturally occurring dipeptide, made of the amino acids beta-alanine and histidine, used in skincare as an antioxidant ingredient. Laboratory and ex-vivo skin studies suggest it can neutralize reactive oxygen species and limit glycation, a process in which sugars stiffen skin proteins, which is the rationale for using it in products aimed at the appearance of aging skin. As of 2026, the evidence for topical carnosine is largely from lab and ex-vivo studies rather than large human appearance trials.