Pimecrolimus Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Multiple clinical trials have evaluated the therapeutic utility of pimecrolimus across dermatological conditions, primarily comprising Phase 1 and Phase 2 investigations focused on safety, systemic absorption, and efficacy in atopic dermatitis, EGFR antagonist-induced rash, prurigo nodularis, and Netherton syndrome. Research efforts have been sponsored by pharmaceutical companies such as Novartis Pharmaceuticals and Evelo Biosciences Inc., alongside academic institutions including West Virginia University, University Hospital Muenster, and the Children's Hospital of Philadelphia. Recorded statuses for these studies encompass both completed and terminated evaluations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05439941	Terminated	Atopic Dermatitis	Evelo Biosciences Inc.	2022-06-06	Phase 2
NCT01692626	Terminated	Rash	West Virginia University	2012-02	Phase 2
NCT00507832	Completed	Prurigo Nodularis	University Hospital Muenster\|Novartis Pharmaceuticals	2007-04	Phase 2
NCT00208026	Completed	Netherton Syndrome	Children''s Hospital of Philadelphia\|Novartis Pharmaceuticals	2005-09	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pimecrolimus selectively binds to the cytosolic immunophilin macrophilin-12 (FKBP-12) to form a complex that inhibits calcineurin phosphatase activity, thereby blocking the dephosphorylation and nuclear translocation of nuclear factor of activated T-cells and suppressing inflammatory cytokine transcription. This targeted inhibition of T-cell activation and mast cell mediator release suppresses cutaneous immune responses, mediating anti-inflammatory effects in clinical trial conditions such as atopic dermatitis, prurigo nodularis, and inflammatory rashes.

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>).