Last reviewed 2026-05-29 · How we verify

Tafamidis 61 milligrams (tafamidis-61-milligrams)

Pfizer Inc. · preclinical active

Tafamidis 61 milligrams (generic name: tafamidis-61-milligrams) is a Tafamidis 61mg as provided in real-world practice drug developed by Pfizer Inc.. It is currently in preclinical development.

Tafamidis 61mg as provided in real-world practice

Tafamidis 61 milligrams is a transthyretin (TTR) stabilizer approved for treating transthyretin amyloidosis, a progressive disease where abnormal protein deposits damage organs. By stabilizing the transthyretin protein, tafamidis prevents it from breaking apart and forming toxic amyloid deposits, thereby slowing disease progression. This mechanism directly addresses the underlying cause of the disease rather than just managing symptoms.

Likelihood of approval

6% vs 5% industry baseline

If approved by FDA: likely 2036–2040

Steps remaining: Phase 1 → Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Low

Why this estimate

Baseline preclinical → approval rate +5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
Big-pharma sponsor +3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2036–2040	—
EMA	EU	2037–2041	+0.7 yr
MHRA	GB	2037–2041	+0.7 yr
Health Canada	CA	2037–2042	+0.9 yr
TGA	AU	2037–2042	+1.2 yr
PMDA	JP	2037–2042	+1.5 yr
NMPA	CN	2038–2043	+2.3 yr
MFDS	KR	2037–2042	+1.4 yr
CDSCO	IN	2037–2043	+1.8 yr
ANVISA	BR	2038–2043	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	tafamidis-61-milligrams
Sponsor	Pfizer Inc.
Drug class	Tafamidis 61mg as provided in real-world practice
Therapeutic area	Cardiovascular
Phase	preclinical

Mechanism of action

Tafamidis works by binding to a protein called transthyretin and making it more stable. In patients with transthyretin amyloidosis, this protein misfolds and breaks apart, creating fragments that clump together and accumulate in various organs like the heart, nerves, and liver. By keeping the protein intact and preventing it from unraveling, tafamidis stops this harmful accumulation from happening in the first place. The body naturally produces transthyretin, which normally carries certain vitamins and hormones through the bloodstream. In amyloidosis patients, genetic mutations or aging cause this protein to become unstable and prone to misfolding. Tafamidis acts like a stabilizing glue that holds the protein together, preventing the cascade of problems that leads to organ damage and disease progression. This approach is powerful because it targets the root cause of the disease rather than treating only the symptoms. By preventing the formation of toxic protein deposits, tafamidis can slow or halt the worsening of nerve damage, heart dysfunction, and other complications that severely impact patients' quality of life and lifespan.

Approved indications

No approved indications tracked.

Pipeline indications

Transthyretin Amyloid Cardiomyopathy — preclinical

Common side effects

No common side effects on file.

Key clinical trials

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

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Tafamidis 61 milligrams CI brief — competitive landscape report
Tafamidis 61 milligrams updates RSS · CI watch RSS
Pfizer Inc. portfolio CI

Frequently asked questions about Tafamidis 61 milligrams

What is Tafamidis 61 milligrams?

Tafamidis 61 milligrams (tafamidis-61-milligrams) is a Tafamidis 61mg as provided in real-world practice drug developed by Pfizer Inc..

How does Tafamidis 61 milligrams work?

Tafamidis 61mg as provided in real-world practice

Who makes Tafamidis 61 milligrams?

Tafamidis 61 milligrams is developed by Pfizer Inc. (see full Pfizer Inc. pipeline at /company/pfizer).

What is the generic name of Tafamidis 61 milligrams?

tafamidis-61-milligrams is the generic (nonproprietary) name of Tafamidis 61 milligrams.

What drug class is Tafamidis 61 milligrams in?

Tafamidis 61 milligrams belongs to the Tafamidis 61mg as provided in real-world practice class. See all Tafamidis 61mg as provided in real-world practice drugs at /class/tafamidis-61mg-as-provided-in-real-world-practice.

What development phase is Tafamidis 61 milligrams in?

Tafamidis 61 milligrams is in preclinical.

Drug class: All Tafamidis 61mg as provided in real-world practice drugs
Manufacturer: Pfizer Inc. — full pipeline
Therapeutic area: All drugs in Cardiovascular

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing