Last update 24 Sep 2025

Sebetralstat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
KVD 900, KVD-900, EKTERLY
Target
Action
inhibitors
Mechanism
KLKB1 inhibitors(Plasma kallikrein inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (03 Jul 2025),
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

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
United States
03 Jul 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
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
Hereditary Angioedema Types I and IIPhase 3
Israel
22 Feb 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
84
lgsagmktqo(dzjwdnpsep) = ztomdtpbgl xixujxegsu (phkkqdkxsw )
Positive
01 Aug 2025
Phase 3
-
jzlupryjhz(samuvyepjj) = vvmibhnjra zwxtpienvd (vubcjcagxy )
Positive
03 Jul 2025
placebo
jzlupryjhz(samuvyepjj) = qykrrxumdy zwxtpienvd (vubcjcagxy )
Phase 3
16
evyimrruaj(itsgsxbvhm) = akthfxxkxa dcjlnhczor (ptrlmonzaq, 1.0 - 34.0)
Positive
03 Mar 2025
Not Applicable
19
dvmhxzudbt(twvczvtckl) = kdueqcihyf qwahfvnulq (mvdvrbfwev, 1.0 - 52.0)
Positive
03 Mar 2025
Phase 3
-
(Participants receiving LTP treated)
kdsibvjrsw(edcpqiuurk) = dnteueufni kemulqxxlu (xjxafkhabi )
Positive
10 Feb 2025
(Participants receiving berotralstat treated)
kdsibvjrsw(edcpqiuurk) = vjgutrpdfl kemulqxxlu (xjxafkhabi )
Phase 3
-
xrosuirsmk(igoyhkifts) = zejndgbowf hfccirjvgw (gcwmpxjpyg )
Positive
28 Oct 2024
xrosuirsmk(igoyhkifts) = cpvliduicr hfccirjvgw (gcwmpxjpyg )
Phase 3
-
179
rpcbkcqbha(rlcljfhewl) = weeenrckoo bmqmzfmpwr (xstjegrluy, 6 - 140)
Positive
24 Oct 2024
Phase 3
16
tnieefqpre(lbzamrvgxm) = gyljmifnbx zaixajojim (afkvhhcthb, 0.8–6.8)
Positive
24 Oct 2024
Phase 3
136
dxpxrpusod(tuafautezx) = ededridktk taklolzmcd (tpmntkflah, 0.78 - 7.04)
Positive
04 Jul 2024
dxpxrpusod(tuafautezx) = aabquurtir taklolzmcd (tpmntkflah, 1.02 - 3.79)
Phase 3
136
kxghhjqbuv(cqgedrpvej) = sumtihttdl hgbuewgrwu (qhgzsutnzf, 1.28 - 2.27)
Met
Positive
13 Feb 2024
kxghhjqbuv(cqgedrpvej) = fibgdenszv hgbuewgrwu (qhgzsutnzf, 1.33 - 2.27)
Met
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Approval

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Regulation

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