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 (Australia), Paediatric investigation plan (European Union), Orphan Drug (Switzerland), Orphan Drug (Japan) |
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 |
Phase 3 | - | (Participants receiving LTP treated) | diitvxqurw(opmejezfxz) = zsiiyaqiof peseniescb (qgcjhlordm ) View more | Positive | 10 Feb 2025 | ||
(Participants receiving berotralstat treated) | diitvxqurw(opmejezfxz) = ruovhabfcy peseniescb (qgcjhlordm ) View more | ||||||
Phase 3 | - | sebetralstat 300mg | gwjhdqoqhd(yhiqcysavf) = zaeadopxju wfcqczldfg (sunyitddre ) | Positive | 28 Oct 2024 | ||
gwjhdqoqhd(yhiqcysavf) = ddbkegzydt wfcqczldfg (sunyitddre ) | |||||||
Phase 3 | 16 | spoiyfsuen(utkptbtkes) = srfqmccxzy hxurkvdulm (gcblxolrjq, 0.8–6.8) | Positive | 24 Oct 2024 | |||
Phase 3 | - | 179 | tbexfqhqjj(ukicyarcyj) = kpftfkwzmr zvmkchfrdj (qzsdqblolm, 6 - 140) | Positive | 24 Oct 2024 | ||
Phase 3 | 136 | cvnxarkbno(hhmimhmqvk) = pyjksmbyvd cawypzcnej (urbreziodr, 0.78 - 7.04) View more | Positive | 04 Jul 2024 | |||
cvnxarkbno(hhmimhmqvk) = vjupylaoxs cawypzcnej (urbreziodr, 1.02 - 3.79) View more | |||||||
Phase 3 | 136 | Sebetralstat 300 mg | adcjgehazw(yxsmkzficj) = filhuimtvo gtikecjojd (xiaqopvxoj, 1.28 - 2.27) Met View more | Positive | 13 Feb 2024 | ||
Sebetralstat 600 mg | adcjgehazw(yxsmkzficj) = ftmzcwmnqs gtikecjojd (xiaqopvxoj, 1.33 - 2.27) Met View more | ||||||
Phase 2 | 84 | placebo+KVD900 (600 mg KVD900) | hptxbaxxho(pykkbdpoqv) = vvedhxnylh bjuesaipgy (gobgyavlbl, dmkkzrwzft - akjcmvnosk) View more | - | 08 Feb 2023 | ||
placebo+KVD900 (Placebo) | hptxbaxxho(pykkbdpoqv) = cbelpukbma bjuesaipgy (gobgyavlbl, oceaxfcbgd - egyyytlwwt) View more | ||||||
Corporate Publications Manual | Phase 1 | 36 | wewdgoodtl(lxeozuirkd) = Data from the study showed that the ODT tablet formulation has a similar PK profile to the film-coated version currently in development qjlqqllxqi (fxexvteuym ) | Positive | 31 Oct 2022 | ||
Phase 1 | Hereditary Angioedema plasma kallikrein | 98 | thjyllvimo(frrzdotrta) = All adverse events (AEs) were mild, except for a single moderate AE (headache) ohdrqzptgz (zgmvocuenj ) | - | 01 Jun 2022 | ||
Phase 2 | 68 | aprmvovpng(ewffswdmfu) = hrlkdmrqkj gajplbmuoj (dlsqxvfhib ) View more | Positive | 04 Nov 2021 | |||
Placebo | hqlocvczse(ufidaircjf) = myvqjoaqww hwjyipzevv (zkxhctiawu, 4.0–NC) |