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BCX7353
BCX7353 is a selective inhibitor of plasma kallikrein that reduces bradykinin generation in the contact system pathway.
BCX7353 is a selective inhibitor of plasma kallikrein that reduces bradykinin generation in the contact system pathway. Used for Hereditary angioedema (HAE) with C1-inhibitor deficiency or dysfunction, Angioedema prevention and acute attack management.
At a glance
| Generic name | BCX7353 |
|---|---|
| Sponsor | BioCryst Pharmaceuticals |
| Drug class | Plasma kallikrein inhibitor |
| Target | Plasma kallikrein (Factor XIa substrate) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rare Disease |
| Phase | Phase 2 |
Mechanism of action
BCX7353 inhibits Factor XIIa-driven contact system activation by blocking plasma kallikrein, thereby reducing excessive bradykinin production. This mechanism is intended to prevent the inflammatory and vascular permeability effects associated with bradykinin-mediated angioedema. The drug targets the intrinsic coagulation pathway without affecting thrombin generation or fibrinolysis.
Approved indications
- Hereditary angioedema (HAE) with C1-inhibitor deficiency or dysfunction
- Angioedema prevention and acute attack management
Common side effects
- Headache
- Nasopharyngitis
- Upper respiratory tract infection
Key clinical trials
- Berotralstat Treatment in Children With Hereditary Angioedema (PHASE3)
- Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies (PHASE3)
- Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan (PHASE3)
- Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE (PHASE3)
- A Long Term Safety Study of BCX7353 in Hereditary Angioedema (PHASE2, PHASE3)
- Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema (PHASE2)
- Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema (PHASE2)
- Oral Berotralstat Expanded Access Program
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BCX7353 CI brief — competitive landscape report
- BCX7353 updates RSS · CI watch RSS
- BioCryst Pharmaceuticals portfolio CI