Product Description
Tafamidis is an oral medication for treating cardiomyopathy and peripheral neuropathy due to transthyretin amyloidosis (ATTR). It is a transthyretin stabilizer and has been shown to reduce disease progression and mortality significantly. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK574508/)
Mechanisms of Action: TTR Stabilizer
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | Norway | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hong Kong, Italy, Japan, Netherlands, Spain, Sweden, Taiwan, United Kingdom, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Cardiomyopathies|Transthyretin Amyloidosis
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| B3461115 | P1 |
Not yet recruiting |
Healthy Volunteers |
2025-04-03 |
|
| B3461114 | P1 |
Completed |
Healthy Volunteers |
2024-05-27 |
|
| ATTR-CM | P3 |
Completed |
Cardiomyopathies|Transthyretin Amyloidosis |
2023-10-26 |
70% |
| B3461103 | P1 |
Completed |
Healthy Volunteers |
2022-12-18 |