Tafamidis meglumine Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials have evaluated tafamidis meglumine across Phase 1, Phase 3, and Phase 4 studies for indications including transthyretin amyloid polyneuropathy, transthyretin amyloid cardiomyopathy, and evaluations in healthy volunteers. Industry sponsors, notably Pfizer and Qilu Pharmaceutical Co., Ltd., have led these investigations, ranging from early crossover bioequivalence assessments to pivotal efficacy trials. While the majority of these studies are completed, select Phase 4 post-marketing evaluations remain actively recruiting to further evaluate efficacy and safety.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06940336	RECRUITING	Transthyretin Amyloid Polyneuropathy	Qilu Pharmaceutical Co., Ltd.	2025-06-19	PHASE4
NCT02791230	COMPLETED	Transthyretin (TTR) Amyloid Cardiomyopathy	Pfizer	2016-06-13	PHASE3
NCT04828993	COMPLETED	Transthyretin Amyloid Polyneuropathy (ATTR-PN)	Pfizer	2021-04-28	PHASE4
NCT05498701	COMPLETED	Healthy	Pfizer	2022-09-29	PHASE1
NCT04575116	COMPLETED	Healthy	Pfizer	2020-09-17	PHASE1
NCT03662191	COMPLETED	Healthy Volunteers	Pfizer	2018-09-28	PHASE1
NCT03280173	COMPLETED	Healthy	Pfizer	2017-09-29	PHASE1
NCT03266705	COMPLETED	Healthy	Pfizer	2017-09-20	PHASE1
NCT01994889	COMPLETED	Transthyretin (TTR) Amyloid Cardiomyopathy	Pfizer	2013-12-09	PHASE3

(data from https://clinicaltrials.gov, updated on 2025-07-30)

Check the Tafamidis meglumine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tafamidis meglumine selectively binds to the thyroxine-binding sites of transthyretin (TTR), stabilizing its native tetrameric structure and preventing dissociation into monomeric subunits. By inhibiting TTR misfolding and subsequent aggregation into cytotoxic amyloid fibrils, this mechanism prevents tissue damage, demonstrating clinical relevance in the treatment of transthyretin amyloid polyneuropathy and transthyretin amyloid cardiomyopathy.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).