Clinical Trials

Multiple clinical trials evaluate the therapeutic application of iron sucrose for conditions such as iron deficiency anemia—particularly during pregnancy or following major surgery—and postpartum hemorrhage. Sponsored by academic medical centers including Ain Shams University, University Hospital Bordeaux, and Peking Union Medical College Hospital, these Phase III, Phase IV, and unspecified-phase investigations currently range in recruitment status from not yet recruiting and actively recruiting to unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05921968 Not yet recruiting
Iron Deficiency Anemia
Ain Shams University
 2023-07-30 Phase 4
NCT04304625 Recruiting
Postpartum Hemorrhage
University Hospital Bordeaux
 2020-08-07 Phase 3
NCT03917394 Unknown status
Anemia Iron Deficiency
Peking Union Medical College Hospital
 2019-04-24 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Following intravenous administration, iron sucrose releases elemental iron into reticuloendothelial macrophages, where it binds circulating transferrin and replenishes depleted intracellular ferritin stores. This restoration of iron availability facilitates heme synthesis and stimulates erythropoiesis, ultimately raising circulating hemoglobin levels to resolve iron deficiency anemia and manage perioperative or postpartum blood loss.

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>).

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Note: Technical data last updated: Sep 1, 2026.