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Tafamidis

Generic Name: Tafamidis

Brand Names: Vyndamax, Vyndaqel

Drug Type: Small Molecule

Chemical Formula: C_₁₄H_₇Cl_₂NO_₃

CAS Number: 594839-88-0

Unique Ingredient Identifier: 8FG9H9D31J

Overview

Tafamidis and tafamidis meglumine (FX-1006A) are benzoxazole derivatives developed by FoldRX. Tafamidis is structurally similar to diflusinal. Tafamidis was granted an EMA market authorisation on 16 November 2011 and FDA approval on 3 May 2019.

Background

Indication

Tafamidis is indicated to treat cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults.

Associated Conditions

Cardiomyopathy

Clinical Trials

To Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients With Transthyretin Amyloid Polyneuropathy

Phase 4

Not yet recruiting

Posted: 2025/04/23

Sponsor:Qilu Pharmaceutical ...

ID:NCT06940336

A Study to Compare Two Forms of Study Medicine Tafamidis in the Blood in Healthy Adults

Phase 1

Recruiting

Posted: 2024/11/26

Sponsor:Pfizer

ID:NCT06705569

Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy

Active, not recruiting

Posted: 2024/05/01

Sponsor:Pfizer

ID:NCT06393465

A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Active, not recruiting

Posted: 2024/03/20

Sponsor:Pfizer

ID:NCT06321523

A Study to Learn How Different Forms of Study Medicine Tafamidis Are Taken Up Into The Blood in Healthy Adults

Phase 1

Completed

Posted: 2024/02/23

Sponsor:Pfizer

ID:NCT06273839

FDA Approved Products

Vyndaqel

Manufacturer:Pfizer Laboratories Div Pfizer Inc

Route:ORAL

Strength:20 mg in 1 1

Approved: 2023/10/01

NDC:0069-1975

Vyndamax

Manufacturer:Pfizer Laboratories Div Pfizer Inc

Route:ORAL

Strength:61 mg in 1 1

Approved: 2023/10/01

NDC:0069-8730

Singapore Approved Products

VYNDAQEL SOFT GELATIN CAPSULE 20MG

Manufacturer:Catalent Pharma Solutions, AndersonBrecon Inc. (Primary packager)

Form:CAPSULE

Strength:20mg

Online:Yes

Approved: 2020/02/27

Approval:SIN15893P

VYNDAMAX SOFT GELATIN CAPSULE 61MG

Manufacturer:Catalent Pharma Solutions, AndersonBrecon Inc. (Primary packager)

Form:CAPSULE

Strength:61.0 mg

Online:Yes

Approved: 2020/02/27

Approval:SIN15894P

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Drug Development Updates

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