Maltol Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials across Phase I, Phase III, and Phase IV evaluate ferric maltol formulations for iron-deficiency anemia in pediatric and adult populations, post-operative anemia following colorectal cancer surgery, and iron deficiency in patients with left-sided heart failure. Led by sponsors ranging from pharmaceutical companies like Shield Therapeutics to healthcare institutions such as The Royal Wolverhampton Hospitals NHS Trust and Hannover Medical School, these studies feature recruitment statuses spanning actively recruiting, completed, terminated, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05177484	Recruiting	Cancer Colon	The Royal Wolverhampton Hospitals NHS Trust\|Norgine	2022-05-30	Phase 3
NCT05126901	Recruiting	Anemia\|Iron-deficiency	Shield Therapeutics	2021-10-04	Phase 3
NCT04626414	Unknown status	Anemia Iron Deficiency	Shield Therapeutics	2020-09-28	Phase 1
NCT03774615	Terminated	Heart Failure Left Sided\|Anemia Iron Deficiency	Hannover Medical School\|Shields Shields and Associates	2019-03-18	Phase 4
NCT03181451	Completed	Iron Deficiency Anaemia in Children\|Iron-Deficiency	Shield Therapeutics\|Medpace Inc.	2017-03-14	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Maltol functions as a high-affinity iron-chelating ligand that forms a stable, lipophilic ferric maltol complex, facilitating mucosal brush-border membrane penetration and efficient iron absorption into enterocytes. By delivering bioavailable iron directly to systemic circulation without inducing localized mucosal inflammation, this pathway promotes hemoglobin synthesis and restores iron homeostasis in clinical conditions such as iron-deficiency anemia, post-surgical recovery, and heart failure.

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>).