9 completed, 1 active not recruiting, 1 approved for marketing, 1 enrolling by invitation. 5 Phase 3, 4 Phase 1, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 5 | Completed 3, Active not recruiting 1, Enrolling by invitation 1 |
| Phase 1 | 4 | Completed 4 |
| Phase 2 | 3 | Completed 3 |
Follow berotralstat: new trials by email Literature Review of berotralstat trials Research Report on berotralstat
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Berotralstat Treatment in Children With Hereditary Angioedema Berotralstat - Hereditary Angioedema, Pediatric | Phase 3 | Active not recruiting | BioCryst Pharmaceuticals | 29 | 2022-10-25 | 2026-02-25 |
| Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies berotralstat - Hereditary Angioedema, HAE | Phase 3 | Enrolling by invitation | BioCryst Pharmaceuticals | 139 | 2021-07-23 | 2025-12-23 |
| Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan BCX7353 capsules, Placebo oral capsule - Hereditary Angioedema, HAE | Phase 3 | Completed | BioCryst Pharmaceuticals | 19 | 2018-12-27 | 2024-07-19 |
| A Long Term Safety Study of BCX7353 in Hereditary Angioedema BCX7353 - Hereditary Angioedema, HAE | Phase 2 / Phase 3 | Completed | BioCryst Pharmaceuticals | 387 | 2018-02-16 | 2023-06-18 |
| Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE BCX7353 capsules, Placebo oral capsule - Hereditary Angioedema, HAE | Phase 3 | Completed | BioCryst Pharmaceuticals | 121 | 2018-02-06 | 2023-06-26 |
| Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema BCX7353, Placebo - Hereditary Angioedema (HAE) | Phase 2 | Completed | BioCryst Pharmaceuticals | 58 | 2017-07-31 | 2021-04-01 |
| A Relative Bioavailability Study of Two Formulations of BCX7353 BCX7353 - Hereditary Angioedema | Phase 1 | Completed | BioCryst Pharmaceuticals | 24 | 2017-02-27 | 2020-01-27 |
| A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions BCX7353, Digoxin, BCX7353 + digoxin - Hereditary Angioedema | Phase 1 | Completed | BioCryst Pharmaceuticals | 54 | 2017-02-17 | 2017-10-26 |
| Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema BCX7353, Placebo - Hereditary Angioedema (HAE) | Phase 2 | Completed | BioCryst Pharmaceuticals | 75 | 2016-08-01 | 2021-03-23 |
| An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates BCX7353 and probes - Hereditary Angioedema | Phase 1 | Completed | BioCryst Pharmaceuticals | 20 | 2016-03-01 | 2017-01-31 |
| First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers BCX7353, Placebo to match BCX7353 - Hereditary Angioedema | Phase 1 | Completed | BioCryst Pharmaceuticals | 122 | 2015-05-01 | 2016-01-13 |
| Oral Berotralstat Expanded Access Program Berotralstat - Hereditary Angioedema, HAE | Approved for marketing | BioCryst Pharmaceuticals | 2020-12-11 |
United Kingdom (10) · Germany (6) · Austria (5) · France (5) · North Macedonia (5) · Spain (5) · Canada (4) · Hungary (4) · Italy (4) · Poland (4) · Denmark (3) · Israel (3) · Romania (3) · Switzerland (3) · Australia (2)
Bruce Zuraw, MD (1) · Firas Almazedi, MBChB, Msc, CPI (1) · Henriette Farkas, MD (1) · Hilary Longhurst, MBBS, PhD (1) · Isao Ohsawa (1) · Joanne Collier, MBChB, FFPM, Dip Stats (OU) (1) · Jolanta Bernatoniene, MD (1) · Litza McKenzie, MBChB (1) · Litza McKenzie, MBChB, BScMedSci (1) · Vesna Grivcheva-Panoska, MD, PhD (1)
PMID 36408587, PMID 36326435, PMID 30044938, PMID 33098856, PMID 33247955, PMID 33866032, PMID 34161665, PMID 35820771, PMID 38006972, PMID 38020288, PMID 38445295, PMID 40490218, PMID 40716738