Last update 10 Apr 2025

Sebetralstat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
KVD 900, KVD-900
Target
Action
inhibitors
Mechanism
KLKB1 inhibitors(Plasma kallikrein inhibitors)
Inactive Indication-
Originator 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)
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Structure/Sequence

Molecular FormulaC26H26FN5O4
InChIKeyKGMPDQIYDKKXRD-UHFFFAOYSA-N
CAS Registry1933514-13-6

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hereditary AngioedemaNDA/BLA
United States
18 Jun 2024
Hereditary Angioedema Types I and IIPhase 3
United States
22 Feb 2022
Hereditary Angioedema Types I and IIPhase 3
Japan
22 Feb 2022
Hereditary Angioedema Types I and IIPhase 3
Australia
22 Feb 2022
Hereditary Angioedema Types I and IIPhase 3
Bulgaria
22 Feb 2022
Hereditary Angioedema Types I and IIPhase 3
Canada
22 Feb 2022
Hereditary Angioedema Types I and IIPhase 3
France
22 Feb 2022
Hereditary Angioedema Types I and IIPhase 3
Germany
22 Feb 2022
Hereditary Angioedema Types I and IIPhase 3
Greece
22 Feb 2022
Hereditary Angioedema Types I and IIPhase 3
Hungary
22 Feb 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(Participants receiving LTP treated)
diitvxqurw(opmejezfxz) = zsiiyaqiof peseniescb (qgcjhlordm )
Positive
10 Feb 2025
(Participants receiving berotralstat treated)
diitvxqurw(opmejezfxz) = ruovhabfcy peseniescb (qgcjhlordm )
Phase 3
-
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)
Positive
04 Jul 2024
cvnxarkbno(hhmimhmqvk) = vjupylaoxs cawypzcnej (urbreziodr, 1.02 - 3.79)
Phase 3
136
adcjgehazw(yxsmkzficj) = filhuimtvo gtikecjojd (xiaqopvxoj, 1.28 - 2.27)
Met
Positive
13 Feb 2024
adcjgehazw(yxsmkzficj) = ftmzcwmnqs gtikecjojd (xiaqopvxoj, 1.33 - 2.27)
Met
Phase 2
84
placebo+KVD900
(600 mg KVD900)
hptxbaxxho(pykkbdpoqv) = vvedhxnylh bjuesaipgy (gobgyavlbl, dmkkzrwzft - akjcmvnosk)
-
08 Feb 2023
placebo+KVD900
(Placebo)
hptxbaxxho(pykkbdpoqv) = cbelpukbma bjuesaipgy (gobgyavlbl, oceaxfcbgd - egyyytlwwt)
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 )
Positive
04 Nov 2021
Placebo
hqlocvczse(ufidaircjf) = myvqjoaqww hwjyipzevv (zkxhctiawu, 4.0–NC)
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