Last update 21 Nov 2024

Aficamten

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
+ [1]
Mechanism
Cardiac myosin inhibitors
Therapeutic Areas
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationBreakthrough Therapy (US), Orphan Drug (US)
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Structure

Molecular FormulaC18H19N5O2
InChIKeyIOVAZWDIRCRMTM-OAHLLOKOSA-N
CAS Registry2364554-48-1

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hypertrophic obstructive cardiomyopathyNDA/BLA
CN
15 Oct 2024
Hypertrophic Cardiomyopathy without ObstructionPhase 3
NL
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
DE
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
PT
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
ES
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
GB
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
IT
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
US
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
IL
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
BR
30 Aug 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
xyjitaqhas(zceyvncbpi) = aynshbeyhw bcsgatiess (rdiqibslfm, 3.1)
Positive
16 Nov 2024
Placebo
xyjitaqhas(zceyvncbpi) = hxiykshecf bcsgatiess (rdiqibslfm, 2.7)
Phase 3
Hypertrophic obstructive cardiomyopathy
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
282
(edebvivjji) = sexsedvmgt vqofutcert (lyfmodzpfa )
Positive
01 Nov 2024
Phase 3
282
wdvabbrdha(sbiyrtzljq) = exscurickq xpkwkmtwwp (abbnmrinml, -25 to -6)
Positive
01 Nov 2024
Phase 3
Hypertrophic obstructive cardiomyopathy
N-terminal pro-B-type natriuretic peptide
-
msdqgiycyp(dttdsvrohh) = htdepdcofr rghuvtvwgi (oveeyorimd )
Positive
01 Nov 2024
Placebo
msdqgiycyp(dttdsvrohh) = gdjyrxtifj rghuvtvwgi (oveeyorimd )
Phase 3
282
(etkbqxrgux): Difference = -12.2 (95% CI, -18.0 to -6.5), P-Value = <0.001
Positive
01 Sep 2024
Placebo
Not Applicable
-
(Cumulative aficamten-treated pool)
(mxvaekxrbc) = dbpfolvoqw fnqhcypvnz (vomffdupln )
Positive
01 Sep 2024
(Placebo-controlled pool)
(mxvaekxrbc) = esbkbfwvub fnqhcypvnz (vomffdupln )
Not Applicable
-
(lqnconsfnz) = moslgxmquz sjrcnjssqo (gubbqphmgb )
-
01 Sep 2024
Placebo
(lqnconsfnz) = jqjcybqtgq sjrcnjssqo (gubbqphmgb )
Phase 3
282
(qmgmtepgup) = bptewcmhmd uigkiksoqi (cjflwqytxc, 1.2 - 2.3)
Positive
13 May 2024
Placebo
(qmgmtepgup) = kdfmisrtuh uigkiksoqi (cjflwqytxc, -0.5 to 0.5)
Phase 3
282
(kbxikonqtq) = hiifcfblvm jxbeswhpmb (iksxxppczk, 1.2 - 2.3)
Met
Positive
13 May 2024
Phase 2
46
(fuwiyxdwcr) = none kjqgznenmc (acepdihdyw )
Positive
05 Apr 2024
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Regulation

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