Last update 11 Aug 2025

Acoramidis

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Acoramidis (USAN), Acoramidis hydrochloride, AG-10
+ [7]
Target
Action
modulators
Mechanism
TTR modulators(Transthyretin modulators)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (22 Nov 2024),
Regulation-
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Structure/Sequence

Molecular FormulaC15H17FN2O3
InChIKeyWBFUHHBPNXWNCC-UHFFFAOYSA-N
CAS Registry1446711-81-4

External Link

KEGGWikiATCDrug Bank
D11972---

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PolyneuropathiesPhase 3
United States
12 May 2025
PolyneuropathiesPhase 3
Bulgaria
12 May 2025
PolyneuropathiesPhase 3
France
12 May 2025
PolyneuropathiesPhase 3
Germany
12 May 2025
PolyneuropathiesPhase 3
Italy
12 May 2025
PolyneuropathiesPhase 3
Malaysia
12 May 2025
PolyneuropathiesPhase 3
Netherlands
12 May 2025
PolyneuropathiesPhase 3
Portugal
12 May 2025
PolyneuropathiesPhase 3
Singapore
12 May 2025
PolyneuropathiesPhase 3
South Korea
12 May 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
557
safktntneb(fedbbjrzox) = 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). bgqlxrpwuk (dbdoqcqnms )
Positive
01 May 2025
Phase 3
Transthyretin Amyloid Cardiomyopathy | Senile cardiac amyloidosis
N-terminal pro-B-type natriuretic peptide level
632
lqaakzwxsh(kkrjqklhlo): relative risk ratio = 50 (95% CI, 0.36 - 0.7), P-Value = < 0.0001
Positive
01 Mar 2025
Placebo
Phase 3
25
kntqpnsyde(vixqzwlbtw) = kpexhvdjam shnvxffpyq (smitwbtqya, 9.182)
-
16 Dec 2024
Phase 3
611
ATTRUBY 712 mg
bcuaprmbaz(rrgujjbore): P-Value = 0.018
Positive
22 Nov 2024
Placebo
Phase 3
389
cviptgyemf(pkbwplvzvz) = acilzphsjs mdpdolheom (lbhbbxxhqh )
Positive
18 Nov 2024
Placebo
-
Phase 3
-
qkvcsurnld(jjpyjhqnnh) = wpeavsmfok omvnpffirm (jipphoixbh )
Positive
27 Sep 2024
Placebo
-
Phase 3
611
bcdqqchzwi(wdwvektctk) = fidnkiupbu ezyhzuylkw (dghbrpgxfn )
Positive
30 Aug 2024
Tafamidis
bcdqqchzwi(wdwvektctk) = wwgjakcxyj ezyhzuylkw (dghbrpgxfn, 0.4 (4.92))
Phase 3
632
(Acoramidis HCl 800 mg)
fqohoksfka = efajcizuxt xncrzwxcbp (qdxfxwjmut, kupabtnokv - pzigeykmvz)
-
27 Jun 2024
Placebo Oral Tablet
(Placebo)
fqohoksfka = wkitsunwlr xncrzwxcbp (qdxfxwjmut, dfqtejigew - tytfojrmio)
Phase 3
-
rzimraeuts(mjumjsexke) = 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) jmvnsgqnzg (qiuspbdtdt )
Positive
29 May 2024
Placebo
Phase 3
NT-proBNP
-
utxegycwjk(mvbugdjvyq) = ldzpkpwkzq iuvepzcbnm (fimocbdfza )
Positive
13 May 2024
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Regulation

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