Clinical Trials

Several clinical trials evaluate diverse conditions, including intraventricular hemorrhage of prematurity, functional dyspepsia with sleep disturbances, and X-linked hypophosphatemia across Phase 1, Phase 3, and unclassified designs. Currently ranging from recruiting to completed recruitment statuses, these studies are supported by academic, government, and industry entities, including Johns Hopkins University, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Second Affiliated Hospital of Xi'an Jiaotong University, and Kyowa Kirin.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05617833 Recruiting
Intraventricular Hemorrhage of Prematurity
Johns Hopkins University|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2024-04-15 Phase 1
NCT05827575 Recruiting
Functional Dyspepsia|Sleep Disturbances
Second Affiliated Hospital of Xi''an Jiaotong University
 2022-03-30 Not Applicable
NCT02537431 Completed
X-linked Hypophosphatemia
Kyowa Kirin Inc.|Kyowa Kirin Co. Ltd.
 2015-12-23 Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Melittin selectively activates low molecular weight phospholipase A2 (PLA2) without increasing the activity of high molecular weight PLA2 isoforms, thereby stimulating membrane phospholipid hydrolysis and promoting downstream lipid mediator release. This alteration of cellular lipid dynamics modulates membrane-associated signaling networks, providing potential mechanistic relevance to clinical conditions such as intraventricular hemorrhage of prematurity, functional dyspepsia, and X-linked hypophosphatemia.

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.