Track icatibant in Peptimes™
Icatibant is a synthetic peptide of 10 amino acids, five of them non-proteinogenic, and a bradykinin B2 receptor antagonist. It is the active ingredient in FDA-approved prescription injections. (Source: DailyMed label.)
Is icatibant FDA-approved?
Yes, as specific products: Firazyr and generic icatibant injections are FDA-approved for the use in their labels, and they're prescription only.
Icatibant
Also: icatibant acetate, HOE 140, JE 049
- Status label in the Peptimes Library
- FDA Approved
- Routes in Peptimes
- Subcutaneous
- Updated
- 1 Nov 2026
US regulatory status
FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.
Firazyr (icatibant) injection
Subcutaneous
Treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Source: DailyMed label, checked 1 Nov 2026
Generic icatibant injection, from several manufacturers (one sold as Sajazir), with Firazyr as the reference product
Subcutaneous
As stated on each product's label (approved through abbreviated new drug applications, ANDAs).
Source: Drugs@FDA, checked 1 Nov 2026
Investigational
No, for the products and uses above.
Source: Drugs@FDA, checked 1 Nov 2026
What studies have looked at
Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.
- In humans
A placebo-controlled phase 3 trial (FAST-3) in 88 adults with skin or abdominal attacks of hereditary angioedema: median time to at least a 50% drop in symptom severity was 2.0 hours with icatibant and 19.8 hours with placebo. Adverse events were 41% vs 52%, with no serious ones.
Source: PMID 22123383, checked 1 Nov 2026
How to track it in Peptimes
Add icatibant in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the Firazyr and generic entries above give the detail.
- Logging: the amount you took and how you feel.
- Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
- Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.
Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell icatibant or any other compound.
More sources
- FDA, Drugs@FDA, NDA 022150 (Firazyr), checked 1 Nov 2026: product, route and marketing status. Generic icatibant injections are listed under their own ANDAs.
- National Library of Medicine, DailyMed, Sajazir (icatibant) injection label, checked 1 Nov 2026: section 1, the same use as Firazyr’s.
- FDA, Global Substance Registration System, Icatibant, checked 1 Nov 2026: its formula, C59H89N19O13S. The acetate salt has its own record.
Related pages
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