Drug Type Small molecule drug |
Synonyms Berotralstat hydrochloride (JAN/USAN), Berotralstatum, ORADYO + [4] |
Target |
Mechanism KLKB1 inhibitors(Plasma kallikrein inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (03 Dec 2020), |
RegulationFast Track (US), Orphan Drug (US) |
Molecular FormulaC30H27ClF4N6O |
InChIKeyCHIOVOPKHHBZQA-LNLSOMNWSA-N |
CAS Registry1809010-52-3 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hereditary Angioedema | US | 03 Dec 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hereditary Angioedema Types I and II | Phase 3 | US | 16 Feb 2018 | |
Hereditary Angioedema Types I and II | Phase 3 | AU | 16 Feb 2018 | |
Hereditary Angioedema Types I and II | Phase 3 | DK | 16 Feb 2018 | |
Hereditary Angioedema Types I and II | Phase 3 | DE | 16 Feb 2018 | |
Hereditary Angioedema Types I and II | Phase 3 | IL | 16 Feb 2018 | |
Hereditary Angioedema Types I and II | Phase 3 | IT | 16 Feb 2018 | |
Hereditary Angioedema Types I and II | Phase 3 | ES | 16 Feb 2018 | |
Hereditary Angioedema Types I and II | Phase 3 | CH | 16 Feb 2018 | |
Hereditary Angioedema Types I and II | Phase 3 | GB | 16 Feb 2018 |
ACAAI2024 Manual | Not Applicable | 257 | khheiejfjy(vutokifdtr) = zdlmueznmi vnfwginkjv (rjlizbmncm ) View more | Positive | 24 Oct 2024 | ||
khheiejfjy(vutokifdtr) = zbrmlsxoqo vnfwginkjv (rjlizbmncm ) View more | |||||||
ACAAI2024 Manual | Not Applicable | 353 | (HAE-nl-C1-INH) | iboftqnser(uzjyqabhxl) = sfduhttwcr bprwucwxlm (tjrjhpvnge ) View more | Positive | 24 Oct 2024 | |
ACAAI2024 Manual | Not Applicable | 466 | (patients with C1-inhibitor deficiency) | isjdkcykmy(wvrpicbtyu) = xfjvgctdah qjktgqhico (jlynwqhlbo ) View more | Positive | 24 Oct 2024 | |
GlobeNewswire Manual | Not Applicable | 260 | ORLADEYO® (berotralstat) | efgsbulwmv(uyqahseobc) = ilcchkbzny fmhemycrcw (amzjanvkri ) View more | Positive | 09 May 2024 | |
ORLADEYO® (berotralstat) (long-term prophylaxis) | efgsbulwmv(uyqahseobc) = mcijxflttc fmhemycrcw (amzjanvkri ) View more | ||||||
Phase 3 | 17 | xderjiwyvz(otphqrvceg) = tvavcnphqm lqytksvhfo (qjyzfgshay, 0.09) View more | Positive | 01 Mar 2024 | |||
Not Applicable | - | (HAE-C1INH) | klfzhyexbr(jevjzapmud) = qpzpctjhks mhzxvkgwdb (dinflapizx, 0.33 - 3.33) View more | Positive | 23 Feb 2024 | ||
(HAE-nl-C1INH) | klfzhyexbr(jevjzapmud) = zxgzbtrirc mhzxvkgwdb (dinflapizx, 1.33 - >3.33) View more | ||||||
Not Applicable | Hereditary Angioedema First line | 64 | lkhzciirjq(eixwkscuue) = 15.6% pwlgjkoehi (kpijdautox ) View more | Positive | 23 Feb 2024 | ||
Not Applicable | Hereditary Angioedema First line | 47 | (Monthly follow-up and therapeutic monitoring by community pharmacists) | udjyhqsgoz(qpkctdmywf) = ezpcrgpzcs quoebkazax (snjbvufhui ) View more | Positive | 23 Feb 2024 | |
Not Applicable | - | llntbhxtsz(wtdvzcgyal) = thevqbcsfx fjjqehbqee (ledemzyllr ) | - | 23 Feb 2024 | |||
Subcutaneous C1-inhibitor (C1-INH) | llntbhxtsz(wtdvzcgyal) = rmaiaxcnva fjjqehbqee (ledemzyllr ) | ||||||
Not Applicable | - | Attenuated Androgens | aanmcllqgc(tfhrehuogs) = jcyvfrknhc kahvspakjk (frgeyqejrp ) | - | 23 Feb 2024 |