Ionomycin Clinical Trials

Size	Price	Qty
1mg	USD 270
5mg	USD 790

Clinical Trials

Several clinical trials evaluate ionomycin across reproductive and immunological contexts, including female and male infertility, intracytoplasmic sperm injection, azoospermia, hypersensitivity, and asthma. Spanning Phase 2, Phase 4, and unassigned protocols, these studies are sponsored by academic medical centers, specialized fertility clinics, and entities such as Novartis Pharmaceuticals and the Academic Medical Center in Amsterdam. Featuring completed, unknown, and not yet recruiting statuses, these evaluations underscore clinical interest in calcium ionophore-mediated cellular responses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07570342	NOT_YET_RECRUITING	ICSI; Testicular Sperm Extraction in Azoospermic Patients; Male Infertility; PGT-A	ART Fertility Clinics LLC	2026-04-30
NCT06106412	UNKNOWN	Infertility, Female	Instituto Valenciano de Infertilidad, IVI VALENCIA	2024-01-01
NCT03678610	COMPLETED	Infertility	Ibn Sina Hospital	2018-09-25
NCT02686827	Completed	Hypersensitivity	Laurian Jongejan\|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	2015-10	Phase 2
NCT00657891	Completed	Asthma	Creighton University\|Novartis Pharmaceuticals	2007-03	Phase 4

(data from https://clinicaltrials.gov, updated on 2026-05-11)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ionomycin acts as a selective calcium ionophore that binds divalent calcium ions and transports them across cell membranes, rapidly elevating intracellular calcium levels to activate downstream signaling pathways such as protein kinase C. This calcium influx drives key physiological responses including apoptosis and oocyte activation, providing the mechanistic rationale for its clinical investigation in reproductive interventions like intracytoplasmic sperm injection for infertility, as well as hypersensitivity and asthma.

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>).