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Berotralstat · Orladeyo, BCX-7353

Small molecule · Inhibitor of Plasma kallikrein (KLKB1) · developed by Biocryst

Approved FDA, Dec 2020
BCRX Developer
3 Registered trials

What is Berotralstat?

Berotralstat is an oral plasma kallikrein inhibitor that binds plasma kallikrein and blocks its proteolytic activity, reducing excess bradykinin generation.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Orladeyo, BCX-7353
Drug type
Small molecule
Targets
Plasma kallikrein (KLKB1)
Mechanism
Inhibitor of Plasma kallikrein (KLKB1)
Pathways
Kallikrein-kinin system, Bradykinin generation
Therapy area
Immunology
Developer
Biocryst (BCRX)
FDA status
Approved as Orladeyo (December 3, 2020), NDA214094 · FDA label
UNII
XZA0KB1BDQ

✅ FDA-approved uses

From the indications section of the FDA label (version of Aug 20, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT05453968 Phase 3 Hereditary Angioedema Active not recruiting BCRX
NCT03873116 Phase 3 Hereditary Angioedema, HAE Completed BCRX
NCT03472040 Phase 2/3 Hereditary Angioedema Completed BCRX

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

PediatricHAEHereditary AngioedemaHereditary Angioedema, HAEProphylaxis

Other drugs acting on KLKB1

More from Biocryst

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the BCRX page.

Follow BCRX, the company behind Berotralstat

See BCRX's upcoming FDA decisions, trial readouts, cash runway and dilution risk, updated every day from SEC, FDA and ClinicalTrials.gov filings.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.