Dicloxacillin Sodium hydrate Clinical Trials

Size	Price	Qty
25mg	USD 199

Clinical Trials

The clinical research profile for Dicloxacillin Sodium hydrate includes a clinical trial focused on dermatological pathology, specifically targeting Psoriasis Vulgaris. Sponsored by Delenex Therapeutics AG, this multi-center Phase 2 study evaluated the safety, tolerability, and therapeutic efficacy of the compound and has reached completed status. No additional trials across other developmental phases or sponsored by other organizations are currently registered.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01936337	Completed	Psoriasis Vulgaris	Delenex Therapeutics AG	2013-08	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dicloxacillin Sodium hydrate selectively binds to penicillin-binding proteins, inhibiting bacterial peptidoglycan cell wall synthesis and triggering bacterial cell lysis. This bactericidal action reduces cutaneous microbial burden and secondary inflammatory signaling, supporting its clinical exploration in Phase 2 trials for psoriasis vulgaris.

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>).