Last update 08 May 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
01 May 2025
PolyneuropathiesPhase 3
Bulgaria
01 May 2025
PolyneuropathiesPhase 3
Italy
01 May 2025
PolyneuropathiesPhase 3
Netherlands
01 May 2025
PolyneuropathiesPhase 3
Spain
01 May 2025
Transthyretin-related (ATTR) familial amyloid polyneuropathyPhase 3
United States
21 Oct 2020
Senile cardiac amyloidosisPhase 3
United States
19 Mar 2019
Senile cardiac amyloidosisPhase 3
Australia
19 Mar 2019
Senile cardiac amyloidosisPhase 3
Belgium
19 Mar 2019
Senile cardiac amyloidosisPhase 3
Brazil
19 Mar 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Transthyretin Amyloid Cardiomyopathy | Senile cardiac amyloidosis
N-terminal pro-B-type natriuretic peptide level
632
Acoramidis hydrochloride 800 mg twice daily
yigfvrhwwk(rrvfdgkqbw): relative risk ratio = 50 (95% CI, 0.36 - 0.7), P-Value = < 0.0001
Positive
01 Mar 2025
Placebo
Phase 3
25
viarrqztyo(jeofhhxckp) = vfcxgspnas khhipscqcp (kpxzmanbwp, 9.182)
-
16 Dec 2024
Phase 3
611
ATTRUBY 712 mg
ngszcbswto(jfbzfosdcw): P-Value = 0.018
Positive
22 Nov 2024
Placebo
Phase 3
389
xlfijxtgaf(tdqpvjnmbb) = rpjvasmldf kksniuaadr (ndgtctdeyg )
Positive
18 Nov 2024
Placebo
-
Phase 3
-
epmnwsotub(sfbfzkanph) = ucvsytbkho dfmxbaknai (ktniojtlue )
Positive
27 Sep 2024
Placebo
-
Phase 3
611
mtsyzevlte(pweibxeotn) = ofraiwfwda llnpstqvgl (eyrgeyyhwv )
Positive
30 Aug 2024
Tafamidis
mtsyzevlte(pweibxeotn) = gijjdlwnkt llnpstqvgl (eyrgeyyhwv, 0.4 (4.92))
Phase 3
632
(Acoramidis HCl 800 mg)
vwzexzuwcn = cnwtlbvpmq xtfoftzswo (bgwqifzwhx, uvashukwaa - plfkxitxni)
-
27 Jun 2024
Placebo Oral Tablet
(Placebo)
vwzexzuwcn = qqznhuztej xtfoftzswo (bgwqifzwhx, vbhyvjhuoi - amowgzkvgk)
Phase 3
-
zjmxtnktji(opnsspbgmp) = 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) dxsnyvkpao (ivudyywjvc )
Positive
29 May 2024
Placebo
Not Applicable
-
kihvczaswp(eajjjcsldb) = A statistically significant (p<0.0001) and clinically meaningful treatment benefit on KCCQ-OS was observed with acoramidis versus placebo gfmgpbsaqj (ilaboyhyjl )
-
13 May 2024
Placebo
Not Applicable
-
qsvthxtnwd(jzattnmwdc) = shiavoyoio uwoloeupcm (ikliiypmzi, 0.07 - 0.18)
-
13 May 2024
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