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Vyndamax (tafamidis 61mg) (vyndamax-tafamidis-61mg)
Vyndamax (tafamidis 61mg) (generic name: vyndamax-tafamidis-61mg) is a As prescribed in real world practice drug developed by Pfizer Inc.. It is currently in preclinical development.
As prescribed in real world practice
Vyndamax (tafamidis 61mg) is a small molecule that stabilizes transthyretin, a protein associated with Transthyretin Amyloid Cardiomyopathy (ATTR-CM). It is used to treat Transthyretin Amyloid Cardiomyopathy, as indicated by clinical trials.
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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.
| 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 | vyndamax-tafamidis-61mg |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | As prescribed in real world practice |
| Therapeutic area | Cardiovascular |
| Phase | preclinical |
Approved indications
Pipeline indications
- ATTR-CM (Transthyretin Amyloid Cardiomyopathy) — preclinical
Common side effects
Key clinical trials
- Korean Post-marketing Surveillance Vyndamax® Capsules for the Treatment of Transthyretin Amyloid Car (N/A)
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:
- Vyndamax (tafamidis 61mg) CI brief — competitive landscape report
- Vyndamax (tafamidis 61mg) updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Vyndamax (tafamidis 61mg)
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Related
- Drug class: All As prescribed 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