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orladeyo

Generic: berotralstat·Brand: ORLADEYO, Orladeyo

orladeyo: developed by 1 company · 2 clinical trials tracked · 2 FDA decisions.

orladeyo evidence translation

What we can confirm

2 FDA records · 2 tracked trials

What it means

Source-backed records connect orladeyo to BCRX; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could orladeyo → BCRX affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Hereditary Angioedema

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
BIOCRYST PHARMACEUTICALS INC (BCRX)
Hereditary Angioedema
Approved
BIOCRYST PHARMACEUTICALS INC (BCRX)
Hereditary Angioedema
Approved
Clinical Trials (2)

A Phase 3 Study to Evaluate the Safety and Pharmacokinetics of Berotralstat Prophylaxis in Children With Hereditary Angioedema Who Are 2 to < 12 Years of Age

NCT05453968·Phase 3·BCRX
Active, not recruiting

Primary endpoint: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of Berotralstat

Interventionalopen29 enrolledStarted 2022-10Completion 2027-0215 sites · Austria, Canada, France, Germany…BioCryst Pharmaceuticals

An Open-label Study to Provide Berotralstat Access to Subjects With Type 1 and 2 Hereditary Angioedema Who Were Previously Enrolled in Berotralstat Studies

NCT04933721·Phase 3·BCRX
Enrolling by invitation

Primary endpoint: Number and proportion of subjects with a treatment-related TEAE

Interventionalopen139 targetStarted 2021-07Completion 2031-0816 sites · Canada, Czechia, France, Germany…BioCryst Pharmaceuticals
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE ORLADEYO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years of age and older. ORLADEYO is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years and older. ( 1 ) Limitations of Use : ORLADEYO should not be used for treatment of acute HAE attacks. ( 1 ) Limitations of Use : The safety and effectiveness of ORLADEY(BCRX)FDA ↗
NDA219776Type 3 - New Dosage FormOrphan DrugPriorityOralPellets
Approval1 INDICATIONS AND USAGE ORLADEYO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years of age and older. ORLADEYO is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years and older. ( 1 ) Limitations of Use : ORLADEYO should not be used for treatment of acute HAE attacks. ( 1 ) Limitations of Use : The safety and effectiveness of ORLADEY(BCRX)FDA ↗
NDA214094Type 1 - New Molecular EntityOrphan DrugStandardOralCapsule

Frequently asked questions

Who is developing orladeyo?

orladeyo is being developed by BIOCRYST PHARMACEUTICALS INC.

How many clinical trials involve orladeyo?

BioSniper tracks 2 clinical trials involving orladeyo.

What is orladeyo's latest FDA decision?

The most recent tracked FDA decision for orladeyo is Approval for 1 INDICATIONS AND USAGE ORLADEYO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years of age and older. ORLADEYO is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years and older. ( 1 ) Limitations of Use : ORLADEYO should not be used for treatment of acute HAE attacks. ( 1 ) Limitations of Use : The safety and effectiveness of ORLADEY, dated December 11, 2025.