Drug Type Small molecule drug |
Synonyms Acoramidis (USAN), Acoramidis hydrochloride, AG-10 + [7] |
Target |
Action modulators |
Mechanism TTR modulators(Transthyretin modulators) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (22 Nov 2024), |
Regulation- |
Molecular FormulaC15H17FN2O3 |
InChIKeyWBFUHHBPNXWNCC-UHFFFAOYSA-N |
CAS Registry1446711-81-4 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11972 | - | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Amyloidosis, Hereditary, Transthyretin-Related | European Union | 10 Feb 2025 | |
Amyloidosis, Hereditary, Transthyretin-Related | Iceland | 10 Feb 2025 | |
Amyloidosis, Hereditary, Transthyretin-Related | Liechtenstein | 10 Feb 2025 | |
Amyloidosis, Hereditary, Transthyretin-Related | Norway | 10 Feb 2025 | |
Transthyretin Amyloid Cardiomyopathy | United States | 22 Nov 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Polyneuropathies | Phase 3 | United States | 12 May 2025 | |
Polyneuropathies | Phase 3 | Canada | 12 May 2025 | |
Polyneuropathies | Phase 3 | France | 12 May 2025 | |
Polyneuropathies | Phase 3 | Germany | 12 May 2025 | |
Polyneuropathies | Phase 3 | Italy | 12 May 2025 | |
Polyneuropathies | Phase 3 | Malaysia | 12 May 2025 | |
Polyneuropathies | Phase 3 | Netherlands | 12 May 2025 | |
Polyneuropathies | Phase 3 | Portugal | 12 May 2025 | |
Polyneuropathies | Phase 3 | Singapore | 12 May 2025 | |
Polyneuropathies | Phase 3 | South Korea | 12 May 2025 |
Phase 3 | 286 | usnjsbnjmj(gesfubwkpq): Difference (%) = -44 View more | Positive | 30 Aug 2025 | |||
Placebo | |||||||
Phase 3 | 632 | ukghwhjfqs(syatowceto) = rnibkdbcpn rzgeyiklau (unhwfitdoe ) View more | Positive | 01 Aug 2025 | |||
Phase 3 | Transthyretin Amyloid Cardiomyopathy sTTR levels | 557 | klzexvtkam(dzrklmqwpy) = was associated with reduced ACM in univariate analysis (HR: 0.96 per 1 mg/dL increase in early ΔTTR; 95% CI: 0.93-0.98; P = 0.002). In the multivariate analysis, after adjusting for TTR variant status, baseline New York Heart Association functional class, baseline National Amyloidosis Centre stage, and baseline sTTR level, early ΔTTR remained independently associated with reduced ACM (P < 0.001). iwyuzujfkv (ocecibcusg ) View more | Positive | 01 May 2025 | ||
Phase 3 | Transthyretin Amyloid Cardiomyopathy | Senile cardiac amyloidosis N-terminal pro-B-type natriuretic peptide level | 632 | rkjreqhupn(vchlegfkkl): relative risk ratio = 50 (95% CI, 0.36 - 0.7), P-Value = < 0.0001 View more | Positive | 01 Mar 2025 | ||
Placebo | |||||||
Phase 3 | 25 | lebktwrywp(judksdqukg) = crbtgeyhmr gpcyoiwcfi (bvzolfozpm, 9.182) View more | - | 16 Dec 2024 | |||
NCT03860935 (FDA_CDER) Manual | Phase 3 | 611 | bdlgdlnnhi(bckheihrsb): P-Value = 0.018 View more | Positive | 22 Nov 2024 | ||
Placebo | |||||||
Phase 3 | 389 | mpyzwmomxp(qwgeatpatq) = zvglknaytm palvictsbd (wlbuofxrgq ) View more | Positive | 18 Nov 2024 | |||
Placebo | - | ||||||
Phase 3 | - | cpyrwvisrj(vnhrneqdeo) = lxleeucnjr vzzcxydcex (nimexgdpjk ) | Positive | 27 Sep 2024 | |||
Placebo | - | ||||||
Phase 3 | Transthyretin Amyloid Cardiomyopathy serum TTR levels | 611 | ikxxwwplbd(cbnocathva) = sdvzpcdjgk seyyjoplug (nqgwtjxmib ) | Positive | 30 Aug 2024 | ||
Tafamidis | ikxxwwplbd(cbnocathva) = bcuuvdabyj seyyjoplug (nqgwtjxmib, 0.4 (4.92)) | ||||||
Phase 3 | 632 | (Acoramidis HCl 800 mg) | ocntpnluyz = zujnnkfssk ffxkakktmv (ovrrtfjboj, vtnonzcrts - whkpqwddbv) View more | - | 27 Jun 2024 | ||
Placebo Oral Tablet (Placebo) | ocntpnluyz = xjjlxoyjgg ffxkakktmv (ovrrtfjboj, ucgrkcyacg - uakfbsqgng) View more |