Drug Type Small molecule drug |
Synonyms Acoramidis (USAN), Acoramidis hydrochloride, AG-10 + [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 | US | 05 Dec 2023 | |
Polyneuropathies | Phase 3 | - | 01 Oct 2024 | |
Transthyretin-related (ATTR) familial amyloid polyneuropathy | Phase 3 | US | 21 Oct 2020 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | US | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | AU | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | BE | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | BR | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | CA | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | CZ | 19 Mar 2019 | |
Amyloidosis, Hereditary, Transthyretin-Related | Phase 3 | DK | 19 Mar 2019 |
Phase 3 | 632 | (Acoramidis HCl 800 mg) | hmhnwveejh(uohlcjwljg) = hlyogdccec aiakrtclmh (oukemmqzye, bgentqvhom - ggbifzvzhl) View more | - | 27 Jun 2024 | ||
Placebo Oral Tablet (Placebo) | hmhnwveejh(uohlcjwljg) = cavmzwxhgd aiakrtclmh (oukemmqzye, smxdokdwfj - cfpzotoyht) View more | ||||||
Phase 3 | - | dsmyqrfaee(rcajirephj) = 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) zevwewhesz (udcuhwxrji ) View more | Positive | 29 May 2024 | |||
Placebo | |||||||
Phase 3 | - | ntbzzkkuth(gpfposdmtr) = The primary endpoint was met (Win Ratio of 1.8) with a highly statistically significant p-value (p<0.0001) . kacpktppkc (whsepsyctw ) Met | Positive | 02 Feb 2024 | |||
NCT03860935 (Literature) Manual | Phase 3 | 632 | Acoramidis 800 mg | ayyiypnwfs(zmkfphphnr) = qjagrzjrhh hfnhfvhkaf (dpklurtjmd ) View more | Positive | 11 Jan 2024 | |
placebo | ayyiypnwfs(zmkfphphnr) = bzoijuqlhu hfnhfvhkaf (dpklurtjmd ) View more | ||||||
Phase 3 | Transthyretin Amyloid Cardiomyopathy NT-proBNP | 632 | ewkywexyij(ffwipfowfv) = hpatbutmtu ijfylxukpz (ubcjfszqvj ) View more | Positive | 11 Jan 2024 | ||
Placebo | ewkywexyij(ffwipfowfv) = cbpsqcstbw ijfylxukpz (ubcjfszqvj ) View more | ||||||
ATTRibute-CM (NEWS) Manual | Phase 3 | - | acoramidis | mdtresofkw(lrdjfktjfk) = mujdmohfgj vpfejdychr (dtrnicyuiw ) View more | Positive | 07 Dec 2023 | |
placebo | - | ||||||
Not Applicable | - | gyauplpbwc(usqwhsvtex) = svnvzqhirl aqxksyushk (imrxkafvxy ) View more | - | 26 Aug 2023 | |||
gyauplpbwc(usqwhsvtex) = jvbuhgtjjp aqxksyushk (imrxkafvxy ) View more | |||||||
Phase 2 | 49 | Placebo Oral Tablet | zybjfmwmgq(filebgvnsp) = tljpgkcegi obokswrctb (uxroikatxe, nkmlpykipl - owzupqrppj) View more | - | 16 Nov 2022 | ||
Phase 3 | - | bpuermiggw(hdykelzslm) = vgsxqmumpt rcyrznipmf (euvgijwdmb, 62.7) View more | Negative | 31 Dec 2021 | |||
Placebo | bpuermiggw(hdykelzslm) = gmrugdqvyk rcyrznipmf (euvgijwdmb, 59.7) View more | ||||||
Phase 2 | Transthyretin Amyloid Cardiomyopathy TTR Mutation | 49 | iolcoqcthd(gjeubmnyqf) = rprpyxvgbu llqcrbrmsr (ygixfdvkub, 21) | Positive | 23 Jul 2019 | ||
Placebo | - |