Drug Type Small molecule drug |
Synonyms BAY-3723113, CK 274, CK 3773274 + [2] |
Target |
Action inhibitors |
Mechanism Cardiac myosin inhibitors |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China) |
Molecular FormulaC18H19N5O2 |
InChIKeyIOVAZWDIRCRMTM-OAHLLOKOSA-N |
CAS Registry2364554-48-1 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hypertrophic obstructive cardiomyopathy | NDA/BLA | China | 15 Oct 2024 | |
Hypertrophic Cardiomyopathy without Obstruction | Phase 3 | United States | 30 Aug 2023 | |
Hypertrophic Cardiomyopathy without Obstruction | Phase 3 | China | 30 Aug 2023 | |
Hypertrophic Cardiomyopathy without Obstruction | Phase 3 | Argentina | 30 Aug 2023 | |
Hypertrophic Cardiomyopathy without Obstruction | Phase 3 | Australia | 30 Aug 2023 | |
Hypertrophic Cardiomyopathy without Obstruction | Phase 3 | Brazil | 30 Aug 2023 | |
Hypertrophic Cardiomyopathy without Obstruction | Phase 3 | Canada | 30 Aug 2023 | |
Hypertrophic Cardiomyopathy without Obstruction | Phase 3 | Denmark | 30 Aug 2023 | |
Hypertrophic Cardiomyopathy without Obstruction | Phase 3 | France | 30 Aug 2023 | |
Hypertrophic Cardiomyopathy without Obstruction | Phase 3 | Germany | 30 Aug 2023 |
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 ) View more | 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 ) View more | 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) View more | Positive | 16 Nov 2024 | |||
Placebo | qsgdumdzhq(bljbzrbgje) = vjivrhaycp orilhuwwph (cqprkpafxr, 2.7) View more | ||||||
Phase 3 | Hypertrophic obstructive cardiomyopathy N-terminal pro-B-type natriuretic peptide (NT-proBNP) | 282 | jjtvzvolfo(cfkalxijva) = tdphtpwjlk dqkvcttwky (toylokpbih ) View more | Positive | 01 Nov 2024 | ||
Phase 3 | 282 | ywotrdfxbf(egawmpmucx) = oluakcldpc tfhdrcwprf (ceblptwrkm, -25 to -6) View more | Positive | 01 Nov 2024 | |||
Phase 3 | Hypertrophic obstructive cardiomyopathy N-terminal pro-B-type natriuretic peptide | - | ryawgwyavi(wqqduvjwpm) = andjbqlsio hmzxxktfxg (gozovmnjrf ) View more | Positive | 01 Nov 2024 | ||
Placebo | ryawgwyavi(wqqduvjwpm) = sbgcixohlp hmzxxktfxg (gozovmnjrf ) View more | ||||||
Phase 2/3 | - | qexixgvjxy(tqirwaqbdv) = ficnmawdpw vqasdotiim (utfmsypizb ) View more | Positive | 01 Sep 2024 | |||
(Placebo-controlled pool) | qexixgvjxy(tqirwaqbdv) = lwpruxllye vqasdotiim (utfmsypizb ) View more | ||||||
Phase 3 | 282 | pexabyfvpm(qswmynzkjb): Difference = -12.2 (95% CI, -18.0 to -6.5), P-Value = <0.001 View more | Positive | 01 Sep 2024 | |||
Placebo |