Drugs / berotralstat
berotralstat
also known as
BCX7353 · BCX-7353 DIHYDROCHLORIDE · BCX7353.2HCl · Berotralstat dihydrochloride · BEROTRALSTAT HYDROCHLORIDE · Orladeyo
Small molecule targets KLKB1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Orladeyo | — | 2021-04-30 | europa.eu ↗ |
| Approved | US (FDA) | ORLADEYO | — | 2020-12-03 | fda.gov ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03202784 | Feb → Aug 2017 | hereditary angioedema | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03136237 | Feb → Aug 2017 | hereditary angioedema | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02819102 | Mar → Jun 2016 | hereditary angioedema | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02448264 | May → Nov 2015 | hereditary angioedema | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03240133 | Jul 2017 → Jan 2019 | hereditary angioedema | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02870972 | Aug 2016 → Aug 2017 | hereditary angioedema | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03472040 | Feb 2018 → Apr 2022 | hereditary angioedema | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05453968 | Oct 2022 → Sep 2024 overdue | hereditary angioedema | BioCryst Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04933721 | Jul 2021 → Aug 2031 expected | hereditary angioedema | BioCryst Pharmaceuticals | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT03873116 | Dec 2018 → Jul 2021 | hereditary angioedema | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03485911 | Feb 2018 → Apr 2019 | hereditary angioedema | BioCryst Pharmaceuticals | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT04428632 Background | — | hereditary angioedema | BioCryst Pharmaceuticals | Approved for marketing | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | berotralstat | “BACKGROUND: Berotralstat (BCX7353) is an oral, once-daily inhibitor of plasma kallikrein recently approved for prevention of angioedema attacks in adults and adolescents with...” PMID 34161665 ↗ Jun 20214“Berotralstat (BCX7353) is an oral, once-daily, highly selective inhibitor of plasma kallikrein in development for prophylaxis of angioedema attacks in HAE patients.” PMID 33247955 ↗ Dec 2020 |
| Known as | BCX-7353 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5189739 ↗ |
| Known as | BCX7353 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02819102 ↗ |
| Known as | BCX7353.2HCl | ChEMBL registry synonym — accepted as the source's own label CHEMBL5189739 ↗ |
| Known as | Berotralstat dihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL5189739 ↗ |
| Known as | BEROTRALSTAT HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5189739 ↗ |
| Known as | Orladeyo | ChEMBL registry synonym — accepted as the source's own label CHEMBL5189739 ↗ |
| Action | Inhibit | “inhibitor of plasma kallikrein” PMID 30044938 ↗ Jul 20181“Plasma kallikrein inhibitor” CHEMBL5189739 ↗ |
| Modality | Small molecule | “BCX7353 is a potent oral small-molecule inhibitor of plasma kallikrein” PMID 30044938 ↗ Jul 2018 |
| Route | Oral | “BCX7353 capsules administered orally” NCT02448264 ↗ |
| Target | KLKB1 | “Plasma kallikrein inhibitor” CHEMBL5189739 ↗ |