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BCX7353

DRUG6 trials

Sponsors

BioCryst Pharmaceuticals

Conditions

HAEHereditary AngioedemaHereditary Angioedema (HAE)Prophylaxis

Phase 1

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
CompletedNCT02448264
BioCryst PharmaceuticalsHereditary Angioedema
Start: 2015-05-31End: 2015-12-31Updated: 2016-01-13
A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions
CompletedNCT03136237
BioCryst PharmaceuticalsHereditary Angioedema
Start: 2017-02-17End: 2017-08-15Updated: 2017-10-26
A Relative Bioavailability Study of Two Formulations of BCX7353
CompletedNCT03202784
BioCryst PharmaceuticalsHereditary Angioedema
Start: 2017-02-27End: 2017-09-30Updated: 2020-01-27

Phase 2

Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
CompletedNCT02870972
BioCryst PharmaceuticalsHereditary Angioedema (HAE)
Start: 2016-08-31End: 2017-08-31Updated: 2021-03-23
Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema
CompletedNCT03240133
BioCryst PharmaceuticalsHereditary Angioedema (HAE)
Start: 2017-07-31End: 2019-01-29Updated: 2021-04-01
A Long Term Safety Study of BCX7353 in Hereditary Angioedema
CompletedNCT03472040
BioCryst PharmaceuticalsHAE, Hereditary Angioedema, Prophylaxis
Start: 2018-02-16End: 2022-04-27Updated: 2023-06-18

Related Papers

Long-term safety and efficacy of once-daily berotralstat in patients with hereditary angioedema: APeX-S final results.
2025-06-071 citations
Hereditary angioedema outcomes in US patients switched from injectable long-term prophylactic medication to oral berotralstat.
2023-11-244 citations
Assessment of HAE prophylaxis transition from androgen therapy to berotralstat: A subset analysis of the APeX-S trial.
2023-11-064 citations
A review of berotralstat for the treatment of hereditary angioedema.
2022-11-294 citations
Shared decision-making in the management of hereditary angioedema: An analysis of patient and physician perspectives
Allergy and Asthma Proceedings2022-07-1311 citations
Berotralstat (BCX7353) is a novel oral prophylactic treatment for hereditary angioedema: Review of phase II and III studies
Allergy and Asthma Proceedings2021-06-1520 citations
Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study
Clinical and Translational Allergy2021-06-0148 citations
Lanadelumab for the Prophylactic Treatment of Hereditary Angioedema with C1 Inhibitor Deficiency: A Review of Preclinical and Phase I Studies.
2019-02-0116 citations
Oral Plasma Kallikrein Inhibitor for Prophylaxis in Hereditary Angioedema
New England Journal of Medicine2018-07-25111 citations