Last update 21 Jun 2024

Tafamidis Meglumine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
氯苯唑酸葡胺, FX-1006A, FX1006A
+ [8]
Target
Mechanism
TTR stabilizers(Transthyretin stabilizers)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), Orphan Drug (US), Orphan Drug (JP), Orphan Drug (AU), Overseas New Drugs Urgently Needed in Clinical Settings (CN)
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Structure

Molecular FormulaC21H24Cl2N2O8
InChIKeyDQJDBUPLRMRBAB-WZTVWXICSA-N
CAS Registry951395-08-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Transthyretin Amyloid Cardiomyopathy
AU
16 Mar 2020
Amyloid Neuropathies
CN
05 Feb 2020
Cardiomyopathies
US
03 May 2019
Amyloid Neuropathies, Familial
JP
20 Sep 2013
Amyloidosis, Hereditary, Transthyretin-Related
EU
16 Nov 2011
Amyloidosis, Hereditary, Transthyretin-Related
IS
16 Nov 2011
Amyloidosis, Hereditary, Transthyretin-Related
LI
16 Nov 2011
Amyloidosis, Hereditary, Transthyretin-Related
NO
16 Nov 2011
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Poikiloderma With NeutropeniaPhase 3
AR
01 Jul 2008
Poikiloderma With NeutropeniaPhase 3
BR
01 Jul 2008
Poikiloderma With NeutropeniaPhase 3
FR
01 Jul 2008
Poikiloderma With NeutropeniaPhase 3
DE
01 Jul 2008
Poikiloderma With NeutropeniaPhase 3
PT
01 Jul 2008
Poikiloderma With NeutropeniaPhase 3
SE
01 Jul 2008
Senile cardiac amyloidosisPhase 2
US
01 Aug 2008
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
22
Tafamidis Free Acid
(Tafamidis Free Acid 12.2 mg Oral Tablet (Fasted))
hxvimevrwv(vhdcmrsoyv) = nzqqnfvyyx gpjimcdkpm (myzyhtmcxk, cdzlshuouq - cccdnjquii)
-
03 Jun 2024
(Tafamidis Meglumine 20 mg Oral Capsule (Fasted))
hxvimevrwv(vhdcmrsoyv) = ejgkznuoqp gpjimcdkpm (myzyhtmcxk, hykmpiactj - bktlwztpav)
Phase 1
-
12
Tafamidis Free Acid
(Variant 12.2 mg Tafamidis Free Acid Tablet (Test))
kjenpuztkw(bythxdexiv) = mhahutyjfn nhvlhxpmgf (ltinhnzcbo, tnzzgezziq - oxzqheizyk)
-
23 May 2024
Tafamidis Free Acid
(Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet (Reference))
kjenpuztkw(bythxdexiv) = zrnerdhkts nhvlhxpmgf (ltinhnzcbo, ehexwjhlum - tbtdvefoqh)
Phase 4
15
rbrlqxezcv(wfobwoxvhl) = mmijpcevxy ckwmvrdmga (scnepwygtu, nngbqnjqcm - ktmakizlvm)
-
12 Mar 2024
Not Applicable
219
odzqctrdfd(svcpcoeumi) = ppizncbbio unlcgfvgbz (fuoqbxtexc )
-
01 Sep 2020
Not Applicable
Transthyretin Amyloid Cardiomyopathy
variant (ATTRm) | wild-type (ATTRwt) TTR
-
oprqdfshec(kkjbjxxtjc): hazard ratio = 0.64 (95% CI, 0.47 - 0.85), P-Value = 0.001
Positive
01 Sep 2019
Placebo
Phase 2
31
czpheinuqy(gtsjouelhp) = borzenusds szehwwrpps (iwpwvgzxje )
Positive
01 May 2015
Phase 2
35
tafamidis (Fx-1006A)
wsxcgnsaib(xtxtewyzsz) = tvluecqcrx qvonfjoklw (dambnkeqxy, cxyaqzcrgy - wniiwtwurw)
-
18 Dec 2012
Phase 2/3
86
Tafamidis
(Tafamidis-Tafamidis)
qtayfpuhvz(ofcjeioxox) = llwgeugfbt clirffyaiz (wsrqjqdyzk, mfgpzkenmu - ejaiapvygg)
-
17 Dec 2012
Tafamidis+Placebo
(Placebo-Tafamidis)
qtayfpuhvz(ofcjeioxox) = setcngdgjx clirffyaiz (wsrqjqdyzk, qccqafjqhn - ywweefmqjy)
Phase 2/3
128
Tafamidis (Fx-1006A)
(Tafamidis)
ymxnvznugo(nriiwylaio) = aezjnzqnqi bktikdurnl (zoknoakljv, iigywlqplv - hyfqmsouvd)
-
17 Dec 2012
tafamidis (Fx-1006A)
(Placebo)
ymxnvznugo(nriiwylaio) = zbhzpemggh bktikdurnl (zoknoakljv, eprlezsaot - mendufuxff)
Phase 2
21
tafamidis (Fx-1006A)
omhtutomhm(jsekmfkqyd) = bbixkqbofk vpoytincyp (lnoacowzol, pmfzywahxd - cguuirydjb)
-
17 Dec 2012
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