Hemin Clinical Trials

Size	Price	Qty
25mg	USD 147
100mg	USD 247

Clinical Trials

Multiple clinical trials evaluate the therapeutic application of hemin across diverse indications, with a primary focus on acute hepatic, acute intermittent, hereditary coproporphyria, and variegate porphyrias across Phase 1 through Phase 3 studies. Additionally, Phase 1 and Phase 2 trials have investigated hemin in healthy volunteers, post-ERCP acute pancreatitis, and diabetic gastroparesis. Sponsored by academic institutions like the Mayo Clinic and pharmaceutical companies such as Alnylam Pharmaceuticals, these studies encompass completed, active non-recruiting, and terminated recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02922413	TERMINATED	Acute Intermittent Porphyria; Hereditary Coproporphyria; Variegate Porphyria	The University of Texas Medical Branch, Galveston	2015-10-30	PHASE2
NCT01855841	COMPLETED	Post-ERCP Acute Pancreatitis	Erasme University Hospital	2012-04	PHASE2
NCT03338816	Completed	Acute Hepatic Porphyria\|Acute Intermittent Porphyria\|Porphyria Acute Intermittent\|Acute Porphyria\|Hereditary Coproporphyria (HCP)\|Variegate Porphyria (VP)\|ALA Dehydratase Deficient Porphyria (ADP)	Alnylam Pharmaceuticals	2017-11-16	Phase 3
NCT02949830	Completed	Acute Intermittent Porphyria	Alnylam Pharmaceuticals	2016-10	Phase 1\|Phase 2
NCT01206582	COMPLETED	Gastroparesis; Diabetes Mellitus	Mayo Clinic	2010-05	PHASE2
NCT01855841	Completed	Post-ERCP Acute Pancreatitis	Erasme University Hospital	2012-04	Phase 2
NCT00882804	COMPLETED	Healthy Volunteers	Mayo Clinic	2009-02	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-01-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hemin functions as an iron-containing porphyrin and potent inducer of heme oxygenase-1, which acts to replenish cellular heme pools and repress the feedback-inhibited enzyme delta-aminolevulinic acid synthase. This down-regulation prevents the accumulation of neurotoxic porphyrin precursors, offering clinical efficacy in mitigating acute porphyria attacks and attenuation of tissue inflammation in post-ERCP acute pancreatitis.

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>).