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Tafamidis Meglumine Soft Capsules
Tafamidis stabilizes transthyretin (TTR) protein tetramers, preventing their dissociation and misfolding into amyloid fibrils.
Tafamidis stabilizes transthyretin (TTR) protein tetramers, preventing their dissociation and misfolding into amyloid fibrils. Used for Transthyretin amyloidosis (ATTR amyloidosis), including hereditary ATTR (hATTR) with polyneuropathy, Wild-type transthyretin amyloidosis (wtATTR).
At a glance
| Generic name | Tafamidis Meglumine Soft Capsules |
|---|---|
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Drug class | Transthyretin stabilizer |
| Target | Transthyretin (TTR) |
| Modality | Small molecule |
| Therapeutic area | Rare disease / Neurology / Cardiology |
| Phase | FDA-approved |
Mechanism of action
Tafamidis binds to transthyretin and increases its kinetic stability, preventing the formation of amyloid deposits that cause tissue damage. By stabilizing the native tetrameric form of TTR, it slows or halts the progression of transthyretin amyloidosis, a progressive neurodegenerative and/or cardiomyopathic disease.
Approved indications
- Transthyretin amyloidosis (ATTR amyloidosis), including hereditary ATTR (hATTR) with polyneuropathy
- Wild-type transthyretin amyloidosis (wtATTR)
Common side effects
- Diarrhea
- Abdominal pain
- Nausea
- Peripheral edema
- Fatigue
Key clinical trials
- To Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients With Transthyretin Amyloid Polyneuropathy (PHASE4)
- Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy (PHASE3)
- A Study to Determine the Bioequivalence of Two Doses of Tafamidis (PHASE1)
- Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy (PHASE3)
- Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy (PHASE3)
- Phase I Safety, Pharmacokinetics and Bioavailability Study Comparing Rate and Extent of Absorption of Two Different Forms of Tafamidis (PF-6291826) (PHASE1)
- A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood (PHASE1)
- A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood (PHASE1)
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
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