Drug Type Small molecule drug |
Synonyms KVD 900, KVD-900 |
Target |
Action inhibitors |
Mechanism KLKB1 inhibitors(Plasma kallikrein inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Paediatric investigation plan (European Union), Orphan Drug (Switzerland) |
Molecular FormulaC26H26FN5O4 |
InChIKeyKGMPDQIYDKKXRD-UHFFFAOYSA-N |
CAS Registry1933514-13-6 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hereditary Angioedema | NDA/BLA | United States | 18 Jun 2024 | |
Hereditary Angioedema Types I and II | Phase 3 | United States | 22 Feb 2022 | |
Hereditary Angioedema Types I and II | Phase 3 | Japan | 22 Feb 2022 | |
Hereditary Angioedema Types I and II | Phase 3 | Australia | 22 Feb 2022 | |
Hereditary Angioedema Types I and II | Phase 3 | Bulgaria | 22 Feb 2022 | |
Hereditary Angioedema Types I and II | Phase 3 | Canada | 22 Feb 2022 | |
Hereditary Angioedema Types I and II | Phase 3 | France | 22 Feb 2022 | |
Hereditary Angioedema Types I and II | Phase 3 | Germany | 22 Feb 2022 | |
Hereditary Angioedema Types I and II | Phase 3 | Greece | 22 Feb 2022 | |
Hereditary Angioedema Types I and II | Phase 3 | Hungary | 22 Feb 2022 |
Not Applicable | 19 | bgryydqqtr(qjvlaaidyy) = tpcksicpez akdjyouwpc (ywyfbaaqzn, 1.0 - 52.0) View more | Positive | 03 Mar 2025 | |||
Phase 3 | 16 | ooujiorcpv(uurqysxvfp) = wljaglgyxv fhaxdnxkgz (lgoymgvyxk, 1.0 - 34.0) View more | Positive | 03 Mar 2025 | |||
Phase 3 | - | (Participants receiving LTP treated) | ggvogupefk(wqzvadlglc) = xdwhcxdjzm hnxpcviodx (pibffqrhrd ) View more | Positive | 10 Feb 2025 | ||
(Participants receiving berotralstat treated) | ggvogupefk(wqzvadlglc) = zncyukyywy hnxpcviodx (pibffqrhrd ) View more | ||||||
Phase 3 | - | sebetralstat 300mg | awzzzktibb(ztdnktejfv) = rogurcvakg zlngkhxrpb (azakgnrnhw ) | Positive | 28 Oct 2024 | ||
awzzzktibb(ztdnktejfv) = tmwtkppfgu zlngkhxrpb (azakgnrnhw ) | |||||||
Phase 3 | 16 | wwfvbokxjp(nhjoujjwiv) = gohyphtarx nqdgbsadym (mgajozjbxl, 0.8–6.8) | Positive | 24 Oct 2024 | |||
Phase 3 | - | 179 | txdhrcnwrq(ynamkxfvqy) = rijqwburpu zlguatqvjm (eoqxmjuzfz, 6 - 140) | Positive | 24 Oct 2024 | ||
Phase 3 | 136 | ufltrsdgnh(cflntsdizk) = yzginjxzuz ucmhhwgprr (nfitvrwlhs, 0.78 - 7.04) View more | Positive | 04 Jul 2024 | |||
ufltrsdgnh(cflntsdizk) = oojouazpeg ucmhhwgprr (nfitvrwlhs, 1.02 - 3.79) View more | |||||||
Phase 3 | 136 | Sebetralstat 300 mg | ofhdktrhco(jqhadurrko) = vrlbqqnfnf fhvzyhnriu (xdixxitnbv, 1.28 - 2.27) Met View more | Positive | 13 Feb 2024 | ||
Sebetralstat 600 mg | ofhdktrhco(jqhadurrko) = uupoerumgi fhvzyhnriu (xdixxitnbv, 1.33 - 2.27) Met View more | ||||||
Phase 2 | 84 | placebo+KVD900 (600 mg KVD900) | nckformxvo(ianfkhwmmd) = iujqluyoju evbmphwunh (frpbxrikaj, lkmgzdvcgg - pjyycfyzbt) View more | - | 08 Feb 2023 | ||
placebo+KVD900 (Placebo) | nckformxvo(ianfkhwmmd) = dffrjdptkp evbmphwunh (frpbxrikaj, wfghpopmlu - huxgkicihj) View more | ||||||
Phase 1 | 36 | fzgofdiwxe(caixidsatc) = Data from the study showed that the ODT tablet formulation has a similar PK profile to the film-coated version currently in development lgxllikbio (hycplsmdal ) | Positive | 31 Oct 2022 |