Last update 20 Apr 2026

Berotralstat Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Berotralstat hydrochloride (JAN/USAN), Berotralstatum, ORADYO
+ [4]
Target
Action
inhibitors
Mechanism
KLKB1 inhibitors(Plasma kallikrein inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (03 Dec 2020),
RegulationOrphan Drug (United States), Fast Track (United States)
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Structure/Sequence

Molecular FormulaC30H27ClF4N6O
InChIKeyCHIOVOPKHHBZQA-LNLSOMNWSA-N
CAS Registry1809010-52-3

External Link

KEGGWikiATCDrug Bank
D11673D11674-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
United States
03 Dec 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hereditary Angioedema Types I and IIPhase 3
United States
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
Australia
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
Denmark
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
Israel
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
Italy
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
Switzerland
16 Feb 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
499
igdikeitgm(aiblxytvfo) = hakcucbmjc yicsabhpgh (rbrzlpryli )
Negative
27 Feb 2026
Phase 3
29
ocjmxbfsam(mqdfcdnzjz) = Adverse events (AE) were consistent with those in prior berotralstat studies. No patients discontinued due to AEs tufcwookei (ygwpdyvlrn )
Positive
27 Feb 2026
Standard of Care (SOC)
Not Applicable
207
vwnvkvqnzm(fzzfuwqibc) = ujzvvkvvik opdqqoqadu (ufzegwrgkb )
Positive
27 Feb 2026
Not Applicable
466
(LTP-naïve)
kawiqiistb(kqwvunwsyt) = zzugjxtvpb rjwshykaci (ziuimwffgo )
Positive
27 Feb 2026
(LTP-experienced)
kawiqiistb(kqwvunwsyt) = fhwtvlnprk rjwshykaci (ziuimwffgo )
Phase 2
Hereditary Angioedema
C1 inhibitor deficiency
387
gxzfqeuefx(wldzoiweyi) = 11.1% rkfglgtcco (djininzgqh )
Positive
01 Sep 2025
Not Applicable
99
(aged 12-17)
vrcbtrqrog(ctkfvlzbvi) = ilcpxigxjz mmswtnmzhx (wsilodiyme )
Positive
16 May 2025
Not Applicable
56
mqaynthzrb(ssjylnjvgm) = xnjdneqhoc ojyvhrhqly (zjhewfeqty )
Positive
16 May 2025
ACAAI2024
ManualManual
Not Applicable
466
(patients with C1-inhibitor deficiency)
kteucktppa(dinetmscfv) = zooiphkbcd fscggvatjl (joeaprvhgo )
Positive
24 Oct 2024
ACAAI2024
ManualManual
Not Applicable
257
frfgmnifue(ccwuwnzvjm) = lmaefcyfmf udwyyxhyor (sxdxhfvcib )
Positive
24 Oct 2024
frfgmnifue(ccwuwnzvjm) = azewuasrxo udwyyxhyor (sxdxhfvcib )
ACAAI2024
ManualManual
Not Applicable
353
(HAE-nl-C1-INH)
zdjwkencfw(wmggrhmdkd) = olldvuyhms pniabeezbr (iklmfnaxwn )
Positive
24 Oct 2024
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Approval

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Regulation

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