Tafamidis meglumine    (DrugBank: Meglumine, Tafamidis)

1 disease
IDDisease name (Link within this page)Number of trials
28Systemic amyloidosis4

28. Systemic amyloidosis    [ 212 clinical trials,   234 drugs,   (DrugBank: 72 drugs),   54 drug target genes,   170 drug target pathways]
Searched query = "Systemic amyloidosis", "AL amyloidosis", "Immunoglobulin light chain amyloidosis", "Amyloid light-chain amyloidosis", "Familial amyloidosis", "Familial amyloid polyneuropathy", "Senile transthyretin amyloidosis", "Senile TTR amyloidosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
4 / 212 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-111678
07/11/201102/11/2011The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M TransthyretinThe Effect Of Transthyretin Stabilization, Safety, Tolerability, Efficacy And Pharmacokinetics Of Orally Administered Tafamidis In Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin: A Phase 3, Open-Label(B3461010) Transthyretin Familial Amyloid PolyneuropathyIntervention name : tafamidis meglumine
INN of the intervention : tafamidis meglumine
Dosage And administration of the intervention : 20 mg QD
Control intervention name : null
Pfizer Japan Inc.NULL2075BOTH10Phase 3NULL
2EUCTR2009-011535-12-PT
(EUCTR)
09/09/200915/07/2009Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin AmyloidosisOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 14.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Tafamidis meglumine
Product Code: Fx-1006A
INN or Proposed INN: tafamidis
Other descriptive name: [d-glucitol, 1-deoxy-1-(methylamino)-,2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)]
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
110France;United States;Portugal;Argentina;Brazil;Germany;Italy;Sweden
3EUCTR2009-011535-12-DE
(EUCTR)
26/08/200918/05/2009In preparationOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 14.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Tafamidis meglumine
Product Code: Fx-1006A
INN or Proposed INN: tafamidis
Other descriptive name: [d-glucitol, 1-deoxy-1-(methylamino)-, 2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)]
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
110Portugal;Germany;Argentina;France;Italy;United States;Sweden;Brazil
4EUCTR2009-011535-12-SE
(EUCTR)
24/06/200910/06/2009To obtain additional long-term, safety and efficacy data for tafamidis in subjects with transthyretin (TTR) familial amyloid polyneuropathy (TTR-FAP) and to continue to provide the Tafamidis to subjects with TTR-FAP who have completed Protocol Fx-006 or Protocol Fx1A-201Open-Label Safety and Efficacy Evaluation of Fx-1006A in Subjects with Transthyretin (TTR) Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 16.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Vyndaqel 20mg soft capsule
Product Name: Tafamidis Meglumine 20mg Soft Gelatin Capsule (Clinical trial image)
Product Code: PF-06291826-83/Fx-1006A
INN or Proposed INN: Tafamidis meglumine
Other descriptive name: tafamidis meglumine 20 mg soft gelatin capsules
Trade Name: Vyndaqel 20mg soft capsule
Product Name: Tafamidis Meglumine 20mg Soft Gelatin Capsule (Commerical image)
Product Code: PF-06291826-83/Fx-1006A
INN or Proposed INN: Tafamidis meglumine
Other descriptive name: tafamidis meglumine 20 mg soft gelatin capsules
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Portugal;France;United States;Argentina;Brazil;Germany;Italy;Sweden