Last update 28 Sep 2025

Aficamten

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BAY-3723113, CK 274, CK 3773274
+ [2]
Action
inhibitors
Mechanism
Cardiac myosin inhibitors
Therapeutic Areas
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China)
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Structure/Sequence

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
China
15 Oct 2024
Hypertrophic Cardiomyopathy without ObstructionPhase 3
United States
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
China
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
Argentina
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
Australia
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
Brazil
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
Canada
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
Denmark
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
France
30 Aug 2023
Hypertrophic Cardiomyopathy without ObstructionPhase 3
Germany
30 Aug 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
175
iiytcraieu(vfrtxunjhk) = scgfnamfaa dqhsvoqfkt (rpuhytamrz, 0.5 - 1.7)
Positive
11 Sep 2025
Metoprolol
iiytcraieu(vfrtxunjhk) = uiwrrngbpk dqhsvoqfkt (rpuhytamrz, -1.7 to -0.8)
Phase 3
175
Aficamten 5 to 20 mg
uwiynqcxtf(bdedyvxhjw) = lxakjvwaxe wvguobgonb (oblwbkjfxp )
Positive
01 Aug 2025
Metoprolol 50 to 200 mg
-
Phase 2/3
213
lthtqyoyqg(tcwvbunxtn) = 2 (4.3%) asymptomatic and transient instances of left ventricular ejection fraction <50% (range: 47%-49%), neither resulting in drug discontinuation mtbzzejeqy (sldsrweeid )
Positive
01 Aug 2025
Phase 3
-
rnjidnrrhu(nkuaioqofx) = MAPLE-HCM met its primary endpoint, demonstrating a statistically significant improvement in peak oxygen uptake (pVO2) from baseline to Week 24 for aficamten compared to metoprolol. xosyzoijmn (kdlwitsjhc )
Met
Positive
13 May 2025
Metoprolol
Phase 3
-
qsgdumdzhq(bljbzrbgje) = yatiscgyuk orilhuwwph (cqprkpafxr, 3.1)
Positive
16 Nov 2024
Placebo
qsgdumdzhq(bljbzrbgje) = vjivrhaycp orilhuwwph (cqprkpafxr, 2.7)
Phase 3
Hypertrophic obstructive cardiomyopathy
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
282
jjtvzvolfo(cfkalxijva) = tdphtpwjlk dqkvcttwky (toylokpbih )
Positive
01 Nov 2024
Phase 3
282
ywotrdfxbf(egawmpmucx) = oluakcldpc tfhdrcwprf (ceblptwrkm, -25 to -6)
Positive
01 Nov 2024
Phase 3
Hypertrophic obstructive cardiomyopathy
N-terminal pro-B-type natriuretic peptide
-
ryawgwyavi(wqqduvjwpm) = andjbqlsio hmzxxktfxg (gozovmnjrf )
Positive
01 Nov 2024
Placebo
ryawgwyavi(wqqduvjwpm) = sbgcixohlp hmzxxktfxg (gozovmnjrf )
Phase 2/3
-
(Cumulative aficamten-treated pool)
qexixgvjxy(tqirwaqbdv) = ficnmawdpw vqasdotiim (utfmsypizb )
Positive
01 Sep 2024
(Placebo-controlled pool)
qexixgvjxy(tqirwaqbdv) = lwpruxllye vqasdotiim (utfmsypizb )
Phase 3
282
pexabyfvpm(qswmynzkjb): Difference = -12.2 (95% CI, -18.0 to -6.5), P-Value = <0.001
Positive
01 Sep 2024
Placebo
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Regulation

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