Last update 04 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),
RegulationOrphan Drug (US), Fast Track (US)
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Structure

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
US
03 Dec 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hereditary Angioedema Types I and IIPhase 3
US
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
AU
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
DK
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
DE
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
IL
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
IT
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
ES
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
CH
16 Feb 2018
Hereditary Angioedema Types I and IIPhase 3
GB
16 Feb 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ACAAI2024
ManualManual
Not Applicable
466
(patients with C1-inhibitor deficiency)
inrxgrjvxt(pajyhxhcvn) = dqtmsrjxps unbfzqscsv (aowtgwuuhv )
Positive
24 Oct 2024
ACAAI2024
ManualManual
Not Applicable
353
(HAE-nl-C1-INH)
xuwodkhiix(rbcncfpill) = uvdpqhxymd epmoyfxemb (yurcfsbcah )
Positive
24 Oct 2024
ACAAI2024
ManualManual
Not Applicable
257
ulaedzdexw(hvznhhxkim) = mtipzkhzxp irqbgmwpqz (zxsebksvaz )
Positive
24 Oct 2024
ulaedzdexw(hvznhhxkim) = xzezmkzovv irqbgmwpqz (zxsebksvaz )
Not Applicable
260
ORLADEYO® (berotralstat)
uvgxmcmcdk(bvsztnuepu) = ytekkjfgyp awenmeinxz (zfqskqstwz )
Positive
09 May 2024
ORLADEYO® (berotralstat)
(long-term prophylaxis)
uvgxmcmcdk(bvsztnuepu) = erzghmnvmk awenmeinxz (zfqskqstwz )
Not Applicable
Hereditary Angioedema Type III
First line
C1-inhibitor deficiency
-
(HAE-C1INH)
jjyxtaqual(zoorscgyue) = azzbkuloub ehbhiukedg (wwibtqgjaw, 0.33 - 3.33)
Positive
23 Feb 2024
(HAE-nl-C1INH)
jjyxtaqual(zoorscgyue) = zilgebkrmi ehbhiukedg (wwibtqgjaw, 1.33 - >3.33)
Not Applicable
HAE Type I/II
335
rutqkenuvb(dkuljnnryy) = yhgpsazbsb aelpylssrq (sxxbvecooc )
Positive
23 Feb 2024
rutqkenuvb(dkuljnnryy) = vormgipsrg aelpylssrq (sxxbvecooc )
Not Applicable
64
rljriasfbp(umxbnsciks) = 15.6% jaurwzlova (cbgvljwind )
Positive
23 Feb 2024
Not Applicable
47
(Monthly follow-up and therapeutic monitoring by community pharmacists)
ebacfvcnzv(ppcbnkzjbe) = yelttlmwdi cofqgmpasq (rsaefmrtbj )
Positive
23 Feb 2024
Not Applicable
-
Attenuated Androgens
lufqqkzdia(sfydmlpnph) = arlajoymww kagnmkvfac (hsjztsghlu )
-
23 Feb 2024
Not Applicable
-
rnnxczepav(pcppkhekls) = gdyizhwjsb rkivbylgwe (shegupbalt )
-
23 Feb 2024
Subcutaneous C1-inhibitor (C1-INH)
rnnxczepav(pcppkhekls) = bhayrlrsbl rkivbylgwe (shegupbalt )
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