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Drug

Tafamidis

Approved · EMA
ClassTransthyretin stabiliserEmerging researchLate-stage development
Also known as Vyndamax, Vyndaqel, 2-(3,5-Dichlorophenyl)benzoxazole-6-carboxylic acid, 6-BENZOXAZOLECARBOXYLIC ACID, 2-(3,5-DICHLOROPHENYL)-+1 more

Vyndamax, Vyndaqel, 2-(3,5-Dichlorophenyl)benzoxazole-6-carboxylic acid, 6-BENZOXAZOLECARBOXYLIC ACID, 2-(3,5-DICHLOROPHENYL)-, Tafamidisum.

RxNorm1545063ChEMBLCHEMBL2103837ATCN07XX08UNII8FG9H9D31J
1
Research papers
2
Active clinical trials
Transthyretin
Primary target
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A PHASE 1, OPEN-LABEL, RANDOMIZED, THREE-TREATMENT, THREE-PERIOD, CROSSOVER, SINGLE DOSE, PIVOTAL BIOEQUIVALENCE STUDY TO COMPARE TAFAMIDIS FREE ACID ORALLY DISINTEGRATING TABLET AND COMMERCIAL TAFAMIDIS FREE ACID CAPSULE ADMINISTERED UNDER FASTED CONDITIONS IN HEALTHY ADULT PARTICIPANTS

Clinical trial2026-08-03Primary completion · ClinicalTrials.gov

CHMP positive opinion: Tafamidis Accord (EMA)

Regulatory2026-07-20EMA

An Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Tafamidis in Patients With Transthyretin-mediated Amyloidosis Post Orthotopic Heart Transplantation

Clinical trial2026-06-04Results expected Q2 2027 · ClinicalTrials.gov

A PHASE 1, OPEN-LABEL, RANDOMIZED, CROSSOVER, SINGLE DOSE, PIVOTAL BIOEQUIVALENCE STUDY TO COMPARE TAFAMIDIS FREE ACID TABLET AND COMMERCIAL TAFAMIDIS FREE ACID CAPSULE ADMINISTERED UNDER FED CONDITIONS IN HEALTHY ADULT PARTICIPANTS

Clinical trial2026-06-02Terminated · ClinicalTrials.gov

A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)

Clinical trial2025-02-03Results posted · ClinicalTrials.gov

A Study to Characterize the Safety and Efficacy of Tafamidis Once Daily in the Treatment of Transthyretin Amyloid Cardiomyopathy in Chinese Participants

Clinical trial2024-12-18Results posted · ClinicalTrials.gov

Effect of Tafamidis on Cardiac Function in Patients With Transthyretin Amyloid Cardiomyopathy: A Post Hoc Analysis of the ATTR-ACT Randomized Clinical Trial.

Research2024-01-01JAMA cardiology

OPEN-LABEL SAFETY AND EFFICACY EVALUATION OF FX-1006A IN SUBJECTS WITH TRANSTHYRETIN (TTR) AMYLOIDOSIS

Clinical trial2021-07-29Results posted · ClinicalTrials.gov

Open-Label Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy

Clinical trial2021-01-05Results posted · ClinicalTrials.gov

A PHASE 1, OPEN LABEL, TWO-PERIOD, TWO-TREATMENT, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF A MULTIPLE ORAL DOSE OF TAFAMIDIS ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS

Clinical trial2020-08-10Completed · ClinicalTrials.gov

A MULTICENTER, INTERNATIONAL, PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826) 20 MG OR 80 MG IN COMPARISON TO PLACEBO IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (TTR-CM)

Clinical trial2019-04-24Results posted · ClinicalTrials.gov

Approval: Vyndaqel (EMA)

Regulatory2011-11-16EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tafamidis
Aliases & brands
VyndamaxVyndaqel2-(3,5-Dichlorophenyl)benzoxazole-6-carboxylic acid6-BENZOXAZOLECARBOXYLIC ACID, 2-(3,5-DICHLOROPHENYL)-Tafamidisum
RxNorm CUI
1545063
ChEMBL ID
CHEMBL2103837
ATC codes
N07XX08
UNII
8FG9H9D31J
Primary mechanism
Transthyretin stabiliser
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Transthyretin
TTR · P02766
STABILISERTransthyretin stabiliser

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2011-11-16
Latest approval
2011-11-16
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2026-07-20CHMP positive opinion
CHMP positive opinion: Tafamidis Accord (EMA)

Indication: Treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Evidence ↗
2011-11-16Approval
Approval: Vyndaqel (EMA)

Indication: Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

20 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
20
registered trials across all phases
LATEST COMPLETION 2023
2
Active studies
7
Late-stage (III+)
17
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 20
Phase 113Phase 35Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Tafamidis in Patients With Transthyretin-mediated Amyloidosis Post Orthotopic Heart Transplantation

Active, not recruitingPH IVUniversity of Texas Southwestern Medical Centern=252027

A Study to Characterize the Safety and Efficacy of Tafamidis Once Daily in the Treatment of Transthyretin Amyloid Cardiomyopathy in Chinese Participants

CompletedPH IVPfizern=532023

A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)

CompletedPH IIIKey trialPfizern=1,7332023

OPEN-LABEL SAFETY AND EFFICACY EVALUATION OF FX-1006A IN SUBJECTS WITH TRANSTHYRETIN (TTR) AMYLOIDOSIS

CompletedPH IIIPfizern=932020

Open-Label Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy

CompletedPH IIIPfizern=312019

Recent completions

Trials that read out recently, adding to the completed evidence base.

A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)

CompletedPH IIIKey trialPfizern=1,7332023

A Study to Characterize the Safety and Efficacy of Tafamidis Once Daily in the Treatment of Transthyretin Amyloid Cardiomyopathy in Chinese Participants

CompletedPH IVPfizern=532023

A PHASE 1, OPEN LABEL, TWO-PERIOD, TWO-TREATMENT, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF A MULTIPLE ORAL DOSE OF TAFAMIDIS ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS

CompletedPH IPfizern=122020

OPEN-LABEL SAFETY AND EFFICACY EVALUATION OF FX-1006A IN SUBJECTS WITH TRANSTHYRETIN (TTR) AMYLOIDOSIS

CompletedPH IIIPfizern=932020

Open-Label Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy

CompletedPH IIIPfizern=312019

A PHASE 1, OPEN-LABEL, RANDOMIZED, THREE-PERIOD, THREE-SEQUENCE, SINGLE-DOSE, CROSSOVER STUDY IN FASTED HEALTHY SUBJECTS, TO ASSESS THE SAFETY, PHARMACOKINETICS AND ORAL BIOAVAILABILITY OF TAFAMIDIS FREE ACID WET-MILLED SUSPENSION DOSES, RELATIVE TO 4 X 20 MG COMMERCIAL TAFAMIDIS MEGLUMINE CAPSULES

CompletedPH IPfizern=92019

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes4
Amyloidosis1Cardiomyopathies1Heart Failure1Ventricular Dysfunction, Left1
Journals, researchers & institutions
Top journals
  • JAMA cardiology1
Leading researchers
  • Boman K1
  • Elliott P1
  • Fernandes F1
  • Fine N1
  • Garcia-Pavia P1
  • Gundapaneni B1
  • Klein AL1
  • Maurer MS1
Leading institutions
free-text, unnormalised
  • Cleveland Clinic1
  • Columbia University College of Physicians and Surgeons1
  • Heart Institute1
  • Hospital Universitario Puerta de Hierro Majadahonda1
  • Libin Cardiovascular Institute of Alberta1
  • Medstar Health Research Institute1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.