Pentetic Acid Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A completed Phase 3 clinical trial sponsored by a public government institution, the National Heart, Lung, and Blood Institute (NHLBI), investigated therapeutic strategies for pediatric sickle cell anemia. The study evaluated a treatment regimen designed to mitigate clinical complications and disease progression in infants and young children with this hematologic disease. Outcomes from this trial provide valuable insights into the management of pediatric blood disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00006400	Completed	Hematologic Diseases\|Anemia Sickle Cell	National Heart Lung and Blood Institute (NHLBI)	2000-08	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pentetic acid is an aminopolycarboxylic acid chelating agent that binds polyvalent metallic ions with high affinity, forming stable, water-soluble coordination complexes that isolate metal ions from downstream biochemical reactions and oxidative pathways. By sequestering heavy metals and excess iron cations, it reduces metal-mediated cellular toxicity and oxidative stress, which is clinically relevant in managing iron overload and related hematologic complications in diseases such as sickle cell anemia.

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>).