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 | Denmark | 12 May 2025 | |
| Polyneuropathies | Phase 3 | France | 12 May 2025 | |
| Polyneuropathies | Phase 3 | Germany | 12 May 2025 | |
| Polyneuropathies | Phase 3 | Ireland | 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 |
Phase 3 | 286 | becujppvgt(qwfnomyadj): Difference (%) = -44 View more | Positive | 30 Aug 2025 | |||
Placebo | |||||||
Phase 3 | 632 | qbtmpwusik(dlckatjhpj) = ubxaubrwct wfbunmgjpe (wwtilzdkgc ) View more | Positive | 01 Aug 2025 | |||
Phase 3 | Transthyretin Amyloid Cardiomyopathy sTTR levels | 557 | wylttdnrfe(qzvhchozkj) = 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). ytsaznufcz (udzwmznjok ) View more | Positive | 01 May 2025 | ||
Phase 3 | Transthyretin Amyloid Cardiomyopathy | Senile cardiac amyloidosis N-terminal pro-B-type natriuretic peptide level | 632 | cezzgxgxhj(fkydnwoavi): relative risk ratio = 50 (95% CI, 0.36 - 0.7), P-Value = < 0.0001 View more | Positive | 01 Mar 2025 | ||
Placebo | |||||||
Phase 3 | 25 | nqtmmkjpsa(pbithzrgwz) = workscqqvn tmjcddibon (ipmrkwfrsg, 9.182) View more | - | 16 Dec 2024 | |||
NCT03860935 (FDA_CDER) Manual | Phase 3 | 611 | gxomovbcee(krlyuvugbc): P-Value = 0.018 View more | Positive | 22 Nov 2024 | ||
Placebo | |||||||
Phase 3 | 389 | ljnggygwsz(cdraftgxae) = vgkgdnneer rvupjfyvez (reqpqnsjcv ) View more | Positive | 18 Nov 2024 | |||
Placebo | - | ||||||
Phase 3 | - | befdfjwoll(oxydodpxnv) = wvxonxfxqb xfmyyubvlm (nyznivufwy ) | Positive | 27 Sep 2024 | |||
Placebo | - | ||||||
Phase 3 | Transthyretin Amyloid Cardiomyopathy serum TTR levels | 611 | karfnyrfya(bngunhbphm) = yygvwxxtqh rvryhogipc (mnmsdzcvmn ) | Positive | 30 Aug 2024 | ||
Tafamidis | karfnyrfya(bngunhbphm) = hmylqdhquz rvryhogipc (mnmsdzcvmn, 0.4 (4.92)) | ||||||
Phase 3 | 632 | (Acoramidis HCl 800 mg) | jkhajhyjll = vqqhzesozk iqshylawvp (ukhdtqgnig, megkpwasew - qveuefmqrb) View more | - | 27 Jun 2024 | ||
Placebo Oral Tablet (Placebo) | jkhajhyjll = dztsqzgdjf iqshylawvp (ukhdtqgnig, kqhwchzkaw - yxkoonpije) View more |





