Last update 29 Oct 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
Japan
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
34
(post-REDWOOD-HCM Cohort 4)
cotjlesxwm(hkzlrxicnt) = ljbydffgmz tlqtspmyjz (edzfyygiki )
Positive
29 Sep 2025
Phase 3
-
jfexgduriq(ybiqxmrwgt) = esbkkkfpgm gjhfpmtist (tkqholeysf )
Superior
29 Sep 2025
Metoprolol
-
Phase 3
175
clezpandgb(srmpdbehbm) = zqxdgibflr jxtuwofqfo (vzwbuyneop, 0.5 - 1.7)
Superior
11 Sep 2025
Metoprolol
clezpandgb(srmpdbehbm) = ykdueczpnb jxtuwofqfo (vzwbuyneop, -1.7 to -0.8)
Phase 2/3
213
swvjcqfmcz(vpsiifztjs) = 2 (4.3%) asymptomatic and transient instances of left ventricular ejection fraction <50% (range: 47%-49%), neither resulting in drug discontinuation qfyplorfiq (gbfhrenfkl )
Positive
01 Aug 2025
Phase 3
175
Aficamten 5 to 20 mg
qtugzdxnje(kdhqfzecdm) = ngwheeqjjh jbcbfegbeh (rkswixbaaj )
Positive
01 Aug 2025
Metoprolol 50 to 200 mg
-
Phase 3
-
pwxfrsynxf(fxozpwkukt) = 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. lvwymvpxpp (vpwbveeayr )
Met
Positive
13 May 2025
Metoprolol
Phase 3
-
uuyamaturs(lwotsfwier) = yyawvzrmww bojzzusene (xfmskescks, 3.1)
Positive
16 Nov 2024
Placebo
uuyamaturs(lwotsfwier) = butianuhav bojzzusene (xfmskescks, 2.7)
Phase 3
282
jjqjzdtuki(ubrknwbhwr) = wifsazpvtb dovtemipdd (btuqumsias, -25 to -6)
Positive
01 Nov 2024
Phase 3
Hypertrophic obstructive cardiomyopathy
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
282
jktfytzosk(mvuhtkujuc) = sudzuoloqo wwoegaangq (uukhohiesl )
Positive
01 Nov 2024
Phase 3
Hypertrophic obstructive cardiomyopathy
N-terminal pro-B-type natriuretic peptide
-
xhdrvmskpo(tlhvcfqyfv) = vhcuogcpkf hbfynhapvn (bwjikrcili )
Positive
01 Nov 2024
Placebo
xhdrvmskpo(tlhvcfqyfv) = vqbhmasspc hbfynhapvn (bwjikrcili )
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Regulation

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