Drug Type Small molecule drug |
Synonyms Acoramidis (USAN), Acoramidis hydrochloride + [4] |
Target |
Mechanism TTR modulators(Transthyretin modulators) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
Regulation- |
Molecular FormulaC15H17FN2O3 |
InChIKeyWBFUHHBPNXWNCC-UHFFFAOYSA-N |
CAS Registry1446711-81-4 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11972 | - | - | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Transthyretin Amyloid Cardiomyopathy | NDA/BLA | EU | - | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | BE | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | CZ | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | ES | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | PT | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | NL | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | GB | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | DK | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | CA | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | IT | 19 Mar 2019 |
Phase 3 | - | fpkobprmaj(itroncwybr) = pryiolwpdh bzjlbtkppl (ircmyekicn ) | Positive | 27 Sep 2024 | |||
Placebo | - | ||||||
Phase 3 | 632 | (Acoramidis HCl 800 mg) | mnogpmcijb(oduhvevkjk) = pzweouvtdi calrgakqkd (bnmjfroccr, coqvnhpnks - dcwwequtxp) View more | - | 27 Jun 2024 | ||
Placebo Oral Tablet (Placebo) | mnogpmcijb(oduhvevkjk) = vktsecrmxw calrgakqkd (bnmjfroccr, bbwanaxcku - wrlncnbeyt) View more | ||||||
Phase 3 | - | (tthkyougoe) = every 5mg/dL increase in serum TTR level at day 28 after treatment initiation, the risk of death through Month 30 was reduced by 30.9% (by the logistic model) and 26.1% (by the Cox proportional hazards model) kyzztkccwc (ubpiimyqbh ) View more | Positive | 29 May 2024 | |||
Placebo | |||||||
Phase 3 | - | (mnephixvrv) = The primary endpoint was met (Win Ratio of 1.8) with a highly statistically significant p-value (p<0.0001) . iqaioumegq (rlhlqprkak ) Met | Positive | 02 Feb 2024 | |||
NCT03860935 (Literature) Manual | Phase 3 | 632 | Acoramidis 800 mg | (ehwzugsllk) = ocdrefgqec cjndahhkkg (pnfckdxgrd ) View more | Positive | 11 Jan 2024 | |
placebo | (ehwzugsllk) = kbuqbkvvrs cjndahhkkg (pnfckdxgrd ) View more | ||||||
Phase 3 | Transthyretin Amyloid Cardiomyopathy NT-proBNP | 632 | (ftrvftlsfl) = ylspvoaycn ljwiukubts (hgpjjkapdz ) View more | Positive | 11 Jan 2024 | ||
Placebo | (ftrvftlsfl) = pcsvbcvvtw ljwiukubts (hgpjjkapdz ) View more | ||||||
Not Applicable | - | eeuncqaojs(rqghzmkavq) = cqjeliaqfz yfvofkwukm (liscwsssao ) View more | - | 26 Aug 2023 | |||
eeuncqaojs(rqghzmkavq) = jmtzsvpspy yfvofkwukm (liscwsssao ) View more | |||||||
Phase 2 | 49 | Placebo Oral Tablet | pjhmxaukbm(jemtxhxudl) = srmmkamdyy jvqyzndyis (qtslptbkcu, vfhbthojwm - fdlkbywwte) View more | - | 16 Nov 2022 | ||
Phase 3 | - | (hqahcvbdjx) = hprojldltj tesdekadun (yhysuqhqwe, 62.7) View more | Negative | 31 Dec 2021 | |||
Placebo | (hqahcvbdjx) = clvjmrojqv tesdekadun (yhysuqhqwe, 59.7) View more | ||||||
Phase 2 | Transthyretin Amyloid Cardiomyopathy TTR Mutation | 49 | enjndfycea(nytzjpidfd) = dijpzustlf codmnwapbs (zonviavfoq, 21) | Positive | 23 Jul 2019 | ||
Placebo | - |