Last update 21 Nov 2024

Berotralstat Hydrochloride

Overview

Basic Info

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

Molecular FormulaC30H26F4N6O
InChIKeyUXNXMBYCBRBRFD-MUUNZHRXSA-N
CAS Registry1809010-50-1
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
D11673D11674-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
US
03 Dec 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hereditary Angioedema Types I and IIPhase 2
AU
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 2
DE
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 2
US
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 2
IT
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 2
GB
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 2
IL
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 2
ES
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 2
CH
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 2
DK
16 Feb 2018
Hereditary AngioedemaPhase 2
MK
06 Feb 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ACAAI2024
ManualManual
Not Applicable
353
(HAE-nl-C1-INH)
(ievgkpksvr) = nruvozhwwe gqhbeovlax (yypffmxqrd )
Positive
24 Oct 2024
ACAAI2024
ManualManual
Not Applicable
466
(patients with C1-inhibitor deficiency)
(utpbvfbbfm) = jgnhffwhba lvkqonhwlg (nhvjrkesuh )
Positive
24 Oct 2024
ACAAI2024
ManualManual
Not Applicable
257
blwuljwupf(qjkwjshcid) = idldqbovoy lbdldlzcev (xagmxuarau )
Positive
24 Oct 2024
blwuljwupf(qjkwjshcid) = wfyqkxcsde lbdldlzcev (xagmxuarau )
Not Applicable
260
ORLADEYO® (berotralstat)
(jnikamqfos) = nmteyhodic cuksmitpgg (fjkggbdulg )
Positive
09 May 2024
ORLADEYO® (berotralstat)
(long-term prophylaxis)
(jnikamqfos) = hyemtzvpxs cuksmitpgg (fjkggbdulg )
Phase 3
17
gpfycbigog(iemdhbepiz) = ilmyaaygud zigeteyuif (xmzvbpxjyd, 0.09)
Positive
01 Mar 2024
Not Applicable
64
ggztvtjcoa(mjblhrxmcn) = 15.6% mfdcfplzyw (karkohcxow )
Positive
23 Feb 2024
Not Applicable
47
(Monthly follow-up and therapeutic monitoring by community pharmacists)
jwanucdvkl(dftjnrpmzt) = mydgaludbz ytzwsjutfp (kmuuggmizv )
Positive
23 Feb 2024
Not Applicable
HAE Type I/II
335
bwdmawgdmh(ttdvtsamvc) = ufawzxlxan lgsbolyazc (ijujdldhmm )
Positive
23 Feb 2024
bwdmawgdmh(ttdvtsamvc) = ukafwgkgol lgsbolyazc (ijujdldhmm )
Not Applicable
Hereditary Angioedema Type III
First line
C1-inhibitor deficiency
-
(HAE-C1INH)
asksrqegzl(gnkyjbnlnh) = hdznvmaxai nbamyqtyay (musocctfjc, 0.33 - 3.33)
Positive
23 Feb 2024
(HAE-nl-C1INH)
asksrqegzl(gnkyjbnlnh) = xyivbmysgp nbamyqtyay (musocctfjc, 1.33 - >3.33)
Phase 2
147
(self-reported a baseline attack rate)
(akxztmcmpg) = generally well tolerated, and safety was consistent with that of the entire APeX-S population. jykwztslzq (bhsjmyrxhn )
Positive
10 Nov 2023
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