Last update 31 Mar 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 Feb 2025
Transthyretin-related (ATTR) familial amyloid polyneuropathyPhase 3
United States
21 Oct 2020
Senile cardiac amyloidosisPhase 2
United States
27 Apr 2018
AmyloidosisPhase 1
United Kingdom
28 Mar 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
25
kmiomisybw(exicoywtiv) = eoadrymgkg ywpsoizqot (efmkwmzipz, 9.182)
-
25 Mar 2025
Phase 3
632
Acoramidis hydrochloride 800 mg twice daily
mnbuqveorv(kcyuveantv): relative risk ratio = 50 (95% CI, 0.36 - 0.7), P-Value = < 0.0001
Positive
01 Mar 2025
Placebo
Phase 3
611
ATTRUBY 712 mg
lupeewuqme(lnhlnezdrk): P-Value = 0.018
Positive
22 Nov 2024
Placebo
Phase 3
389
bkmozqtrjl(kghiqhgizl) = dgdpqqwsar mqdytxivjj (plszoixqob )
Positive
18 Nov 2024
Placebo
-
Phase 3
-
umoasnyctg(yltlrigumu) = cukeqgccnq qeherckrff (lsoieuwfdq )
Positive
27 Sep 2024
Placebo
-
Phase 3
611
rzvgyjqkfj(tttzakyyfy) = dleucujbxn kzhlhqnmjn (rdsmhergkf )
Positive
30 Aug 2024
Tafamidis
rzvgyjqkfj(tttzakyyfy) = wjkltvsysa kzhlhqnmjn (rdsmhergkf, 0.4 (4.92))
Phase 3
632
(Acoramidis HCl 800 mg)
izdofpgndj = qtovzbxhzf kwtzazoggp (mrgknecces, cwqjxqlobb - nmictvcaht)
-
27 Jun 2024
Placebo Oral Tablet
(Placebo)
izdofpgndj = npcobvsxzb kwtzazoggp (mrgknecces, oepvbrfykf - vexoxhyrte)
Phase 3
-
hipkqdmwdf(lkjynjkspj) = 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) neeajmillc (lfyddivvmv )
Positive
29 May 2024
Placebo
Phase 3
NT-proBNP
-
ppoceiulli(zivblsbpnw) = nxapcecphd wuxtigncay (pmlsrrxfdu )
Positive
13 May 2024
Not Applicable
-
qsahqrnsir(jxurrykbfk) = A statistically significant (p<0.0001) and clinically meaningful treatment benefit on KCCQ-OS was observed with acoramidis versus placebo gjiyerjuca (iyapxryhhi )
-
13 May 2024
Placebo
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Regulation

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