Gramicidin Clinical Trials

Size	Price	Qty
25mg	USD 127
100mg	USD 317

Clinical Trials

A Phase 3 clinical trial sponsored by Chulalongkorn University evaluates the therapeutic application of gramicidin, specifically assessing the need for antibiotic administration in patients diagnosed with hordeolum following incision and curettage. The recruitment status for this late-stage investigation is currently unknown. Overall, clinical evaluation of gramicidin concentrates on localized ophthalmic bacterial conditions, reflecting its utility in managing acute ocular adnexal infections within a controlled post-procedural setting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00534391	UNKNOWN	Hordeolum	Chulalongkorn University	2007-09	PHASE3

(data from https://clinicaltrials.gov, updated on 2010-11-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gramicidin inserts into the lipid bilayer of gram-positive bacterial cell walls to form cation-conducting transmembrane pores, dissipating essential electrochemical gradients and causing rapid loss of cellular ion homeostasis. This disruption of membrane integrity inhibits bacterial proliferation and induces cell lysis, providing localized antimicrobial efficacy relevant to the clinical management of bacterial ophthalmic conditions such as hordeolum.

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>).