Berotralstat
- Generic Name
- Berotralstat
- Brand Names
- Orladeyo
- Drug Type
- Small Molecule
- Chemical Formula
- C30H26F4N6O
- CAS Number
- 1809010-50-1
- Unique Ingredient Identifier
- XZA0KB1BDQ
- Background
Berotralstat is a selective inhibitor of plasma kallikrein used in the prophylaxis of attacks of hereditary angioedema (HAE). It works by blocking the enzymatic activity of plasma kallikrein in releasing bradykinin, the major biologic peptide that promotes swelling and pain associated with attacks of HAE. Berotralstat is strictly used to prevent, but not tre...
- Indication
Berotralstat is indicated for prophylaxis of attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. It is not used for the treatment of acute HAE attacks.
- Associated Conditions
- Acute attacks of hereditary angioedema
- Associated Therapies
- -
Berotralstat Treatment in Children With Hereditary Angioedema
- Conditions
- Interventions
- First Posted Date
- 2022-07-12
- Last Posted Date
- 2024-10-15
- Lead Sponsor
- BioCryst Pharmaceuticals
- Target Recruit Count
- 29
- Registration Number
- NCT05453968
- Locations
- 🇬🇧
Investigative Site #1, Bristol, United Kingdom
🇪🇸Investigative Site #2, Málaga, Spain
🇫🇷Investigative Site #3, Grenoble, France
Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies
- First Posted Date
- 2021-06-22
- Last Posted Date
- 2024-06-25
- Lead Sponsor
- BioCryst Pharmaceuticals
- Target Recruit Count
- 110
- Registration Number
- NCT04933721
- Locations
- 🇿🇦
Study Center, Cape Town, South Africa
Oral Berotralstat Expanded Access Program
- Conditions
- First Posted Date
- 2020-06-11
- Last Posted Date
- 2020-12-11
- Lead Sponsor
- BioCryst Pharmaceuticals
- Registration Number
- NCT04428632
A Long Term Safety Study of BCX7353 in Hereditary Angioedema
- First Posted Date
- 2018-03-21
- Last Posted Date
- 2023-06-18
- Lead Sponsor
- BioCryst Pharmaceuticals
- Target Recruit Count
- 387
- Registration Number
- NCT03472040
- Locations
- 🇬🇧
Study center, Birmingham, United Kingdom
🇬🇧Study Center, Southampton, United Kingdom
Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema
- First Posted Date
- 2017-08-04
- Last Posted Date
- 2021-04-01
- Lead Sponsor
- BioCryst Pharmaceuticals
- Target Recruit Count
- 58
- Registration Number
- NCT03240133
- Locations
- 🇮🇹
Study center, Padova, Italy
🇬🇧Study Center, Southampton, United Kingdom
A Relative Bioavailability Study of Two Formulations of BCX7353
- First Posted Date
- 2017-06-29
- Last Posted Date
- 2020-01-27
- Lead Sponsor
- BioCryst Pharmaceuticals
- Target Recruit Count
- 24
- Registration Number
- NCT03202784
- Locations
- 🇬🇧
Quotient Clinical, Nottingham, United Kingdom
A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions
- Conditions
- Interventions
- First Posted Date
- 2017-05-02
- Last Posted Date
- 2017-10-26
- Lead Sponsor
- BioCryst Pharmaceuticals
- Target Recruit Count
- 54
- Registration Number
- NCT03136237
- Locations
- 🇬🇧
Covance CRU, Leeds, United Kingdom
Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
- First Posted Date
- 2016-08-18
- Last Posted Date
- 2021-03-23
- Lead Sponsor
- BioCryst Pharmaceuticals
- Target Recruit Count
- 75
- Registration Number
- NCT02870972
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
- Conditions
- Interventions
- First Posted Date
- 2015-05-19
- Last Posted Date
- 2016-01-13
- Lead Sponsor
- BioCryst Pharmaceuticals
- Target Recruit Count
- 122
- Registration Number
- NCT02448264
- Locations
- 🇬🇧
Quotient Clinical, Ruddington, United Kingdom
Drug Development Updates
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