VYNDAMAX (tafamidis)
Vyndamax treats adults with a specific heart condition known as transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM), which can be either the hereditary or wild-type form. This medication helps patients by reducing the risk of cardiovascular-related hospitalizations and death. It is used to manage the underlying amyloidosis that affects the heart muscle in these individuals.
How VYNDAMAX Works
This medication works by selectively binding to the transthyretin (TTR) protein at its thyroxine binding sites. By doing so, it stabilizes the TTR tetramer and slows its breakdown into individual monomers. This stabilization targets the primary step in the process that leads to amyloid formation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-05-03
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- CAPSULE
VYNDAMAX Approval History
What VYNDAMAX Treats
1 indicationsVYNDAMAX is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Transthyretin Amyloid Cardiomyopathy
VYNDAMAX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VYNDAMAX
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02791230 results posted | B3461045 2016-000868-42 | Ph 3 | completed | Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy |
| NCT04814186 results posted | B3461077 | Ph 4 | completed | A Study to Assess the Safety and Efficacy Of Tafamidis In Chinese Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) |
| NCT00925002 results posted | FX1A-303 B3461023, 2009-011535-12 | Ph 3 | completed | Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis |
| NCT00935012 results posted | FX1B-303 B3461026 | Ph 3 | completed | Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy |
| NCT04253353 | B3461075 | Ph 1 | completed | A Drug-Drug Interaction Study To Estimate The Effect Of Tafamidis On Rosuvastatin Pharmacokinetics |
| NCT01994889 ATTR-ACT results posted | B3461028 2012-002465-35, ATTR-ACT | Ph 3 | completed | Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy |
| NCT03662191 | B3461059 2017-004935-35, BA STUDY | Ph 1 | completed | Phase I Safety, Pharmacokinetics and Bioavailability Study Comparing Rate and Extent of Absorption of Two Different Forms of Tafamidis (PF-6291826) |
| NCT03266705 | B3461056 2017-002572-15 | Ph 1 | completed | A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood |
| NCT03280173 | B3461054 2017-002769-23 | Ph 1 | completed | A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood |
| NCT02746926 | B3461053 | Ph 1 | completed | A Study Comparing Amounts of Tafamidis (PF-06291826) in the Blood Without Food in Healthy Volunteers |
| NCT02697864 | B3461051 2016-000295-16 | Ph 1 | completed | A Study Comparing Amounts of Tafamidis In The Blood Without Food |
| NCT02534740 | B3461052 2015-002315-15 | Ph 1 | completed | A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food |
| NCT01435655 results posted | B3461010 | Ph 3 | completed | The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin |
| NCT02406560 | B3461050 2015-000706-19 | Ph 1 | completed | A Study Comparing The Amounts of Tafamidis In The Blood With Or Without Food |
| NCT02217813 | B3461044 2014-003271-35 | Ph 1 | completed | A Bioequivalence Study Comparing Two Different Tafamidis Formulations |
| NCT02189330 | B3461030 | Ph 1 | completed | A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples |
| NCT01655511 | B3461040 B3461040 | Ph 1 | completed | Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers |
| NCT07587697 | B3461128 | Ph 1 | not yet recruiting | A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fasting Conditions |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VYNDAMAX FDA Label Details
Indications & Usage
FDA Label (PDF)VYNDAMAX is indicated for the treatment of Transthyretin Amyloid Cardiomyopathy.
VYNDAMAX Patents & Exclusivity
Patents (3 active)
Exclusivity
Pro Intelligence Preview
Deep insights for VYNDAMAX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 3 active patents
Trial Analysis
- • 29 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment