Octenidine Dihydrochloride Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials evaluate octenidine dihydrochloride across dental, dermatological, and infection-control applications, targeting conditions including periodontitis, apical periodontitis, central venous catheter-associated bacterial infections, plaque formation, and preoperative skin preparation. Spanning Phase 2 through Phase 4 alongside non-phased investigations, these active, recruiting, completed, and withdrawn studies are sponsored by both academic entities and commercial organizations. Together, these trials establish the antimicrobial versatility of octenidine dihydrochloride in topical antisepsis and oral health.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06522438	RECRUITING	Periodontitis; Wound Heal; Periodontal Pocket; Periodontal Inflammation; Periodontal Attachment Loss	Queen Mary University of London	2025-06-03
NCT07725913	RECRUITING	Periodontal Disease	University of Bologna	2026-02-01
NCT06946719	ACTIVE_NOT_RECRUITING	Pulp Exposure, Dental	Aydin Adnan Menderes University	2024-06-01
NCT07173725	COMPLETED	Apical Periodontitis; Postoperative Pain	Bezmialem Vakif University	2023-03-08
NCT04985526	UNKNOWN	Polymorphic Light Eruption	Medical University of Graz	2021-05-07
NCT03322124	COMPLETED	Inhibition of Plaque Formation (by Gingivitis-Index ≤1.5)	Schülke & Mayr GmbH	2018-01-22	PHASE3
NCT03378401	COMPLETED	Inhibition of Plaque Formation (by Gingivitis-Index ≤1.5)	Schülke & Mayr GmbH	2018-01-11	PHASE3
NCT03229759	COMPLETED	Preoperative Skin Preparation	Becton, Dickinson and Company	2017-06-21	PHASE2
NCT03140254	COMPLETED	Preoperative Skin Preparation	C. R. Bard	2016-09	PHASE2
NCT02697162	WITHDRAWN	Neurogenic Bladder; Catheter-Related Infections	Children's Hospital Zagreb	2016-06	PHASE2; PHASE3
NCT02169167	COMPLETED	Diabetes Mellitus; Diabetes Complications; Diabetic Neuropathies; Wound Infection	Janne J. Jokinen	2014-06
NCT02138552	COMPLETED	Gingivitis	Schülke & Mayr GmbH	2013-10	PHASE2
NCT00515151	COMPLETED	Catheterization, Central Venous; Catheter-Associated Infections; Bacterial Infections; Bacteremia	University Hospital Freiburg	2002-05	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-02-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Octenidine dihydrochloride functions as a cationic surfactant that binds electrostatically to negatively charged cell wall and membrane components of gram-positive and gram-negative bacteria, disrupting lipid bilayer integrity and causing intracellular leakage. This membrane lysis produces rapid bactericidal action, providing clinical efficacy in reducing microbial colonization during preoperative skin preparation, catheter disinfection, and the treatment of periodontal infections.

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>).