Clinical Trials

A clinical trial evaluates an adelmidrol-containing formulation (Saginil) administered via vaginal cannulas versus placebo for preventing vaginitis in patients with gynecologic cancers undergoing chemotherapy. This combined Phase 2/3 study is sponsored by an academic institution, Università degli Studi dell'Insubria, and its current recruitment status is recorded as unknown. Overall, clinical research on adelmidrol is targeted specifically toward mitigating chemotherapy-induced inflammatory mucosal complications in gynecologic oncology.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01420510 Unknown status
Vaginitis
Università degli Studi dell''Insubria
 2011-09 Phase 2|Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a synthetic analogue of palmitoylethanolamide, adelmidrol modulates mast cell degranulation and downregulates the downstream release of pro-inflammatory cytokines, thereby suppressing hyperactive tissue immune responses. By attenuating localized biochemical inflammatory cascades, adelmidrol prevents mucosal cell injury, providing a strong biological rationale for its therapeutic application in managing mucosal inflammatory conditions such as vaginitis.

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.