Orladeyo (berotralstat) / BioCryst, Royalty  >>  Phase 3
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5 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Orladeyo (berotralstat) / BioCryst
APeX-2, NCT03485911 / 2017-003966-29: Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE

Completed
3
121
Europe, Canada, US, RoW
BCX7353 capsules, Berotralstat, Placebo oral capsule
BioCryst Pharmaceuticals
Hereditary Angioedema, HAE
04/19
04/22
APeX-J, NCT03873116: Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan

Completed
3
19
Japan
BCX7353 capsules, Placebo oral capsule
BioCryst Pharmaceuticals
Hereditary Angioedema, HAE
11/19
07/21
APeX-P, NCT05453968 / 2021-005932-50: Berotralstat Treatment in Children With Hereditary Angioedema

Active, not recruiting
3
29
Europe, Canada, RoW
Berotralstat, BCX7353, Orladeyo®
BioCryst Pharmaceuticals
Hereditary Angioedema, Pediatric
07/25
07/27
APeX-A, NCT04933721 / 2020-004230-37: Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

Active, not recruiting
3
110
Europe, RoW
berotralstat, Orladeyo
BioCryst Pharmaceuticals
Hereditary Angioedema, HAE
08/26
08/26
APeX-S, NCT03472040 / 2017-003281-27: A Long Term Safety Study of BCX7353 in Hereditary Angioedema

Completed
2/3
387
Europe, US, RoW
BCX7353
BioCryst Pharmaceuticals
Hereditary Angioedema, HAE, Prophylaxis
04/22
04/22

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