orladeyo
orladeyo: sourced relationships with 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
What to watch
Prepared research question
How could orladeyo → BCRX affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| BIOCRYST PHARMACEUTICALS INC (BCRX) | Approved |
Clinical Trial Registry Records (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
Primary endpoint: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of Berotralstat
An Open-label Study to Provide Berotralstat Access to Subjects With Type 1 and 2 Hereditary Angioedema Who Were Previously Enrolled in Berotralstat Studies
Primary endpoint: Number and proportion of subjects with a treatment-related TEAE
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with orladeyo?
orladeyo has dated SEC/FDA relationship records for 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 ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for treatment of acute HAE attacks. Additional doses or doses of ORLADEYO higher than the prescribed once-daily dose are not recommended due to the potential for QTc interval prolongation [see Warnings and Precautions (5.1) ] ., dated December 11, 2025.