Last update 16 May 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 (Japan), Orphan Drug (Australia), Paediatric investigation plan (European Union), Orphan Drug (Switzerland)
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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
Not Applicable
19
bgryydqqtr(qjvlaaidyy) = tpcksicpez akdjyouwpc (ywyfbaaqzn, 1.0 - 52.0)
Positive
03 Mar 2025
Phase 3
16
ooujiorcpv(uurqysxvfp) = wljaglgyxv fhaxdnxkgz (lgoymgvyxk, 1.0 - 34.0)
Positive
03 Mar 2025
Phase 3
-
(Participants receiving LTP treated)
ggvogupefk(wqzvadlglc) = xdwhcxdjzm hnxpcviodx (pibffqrhrd )
Positive
10 Feb 2025
(Participants receiving berotralstat treated)
ggvogupefk(wqzvadlglc) = zncyukyywy hnxpcviodx (pibffqrhrd )
Phase 3
-
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)
Positive
04 Jul 2024
ufltrsdgnh(cflntsdizk) = oojouazpeg ucmhhwgprr (nfitvrwlhs, 1.02 - 3.79)
Phase 3
136
ofhdktrhco(jqhadurrko) = vrlbqqnfnf fhvzyhnriu (xdixxitnbv, 1.28 - 2.27)
Met
Positive
13 Feb 2024
ofhdktrhco(jqhadurrko) = uupoerumgi fhvzyhnriu (xdixxitnbv, 1.33 - 2.27)
Met
Phase 2
84
placebo+KVD900
(600 mg KVD900)
nckformxvo(ianfkhwmmd) = iujqluyoju evbmphwunh (frpbxrikaj, lkmgzdvcgg - pjyycfyzbt)
-
08 Feb 2023
placebo+KVD900
(Placebo)
nckformxvo(ianfkhwmmd) = dffrjdptkp evbmphwunh (frpbxrikaj, wfghpopmlu - huxgkicihj)
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
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Approval

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Regulation

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