Polymyxin B sulphate Clinical Trials

Size	Price	Qty
100mg	USD 147
500mg	USD 347

Clinical Trials

Several clinical trials spanning Phase 1 through Phase 4 and unassigned classifications investigate conditions such as eczema, post-traumatic stress disorder, multiple sclerosis, and pediatric heart transplant rejection. These initiatives are supported by academic, public, and pharmaceutical sponsors, including Johns Hopkins University, Unity Health Toronto, the National Heart, Lung, and Blood Institute, EMS, and Bayer. Recruitment statuses across the portfolio range from not yet recruiting to completed investigations evaluating treatments like topical combination therapies for eczema.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06386003	Not yet recruiting	Post Traumatic Stress Disorder\|PTSD\|Chronic PTSD	Unity Health Toronto\|Toronto Metropolitan University\|University of Ottawa	2024-08	Phase 2
NCT06407635	Not yet recruiting	Post Traumatic Stress Disorder	Johns Hopkins University	2024-05	Phase 1
NCT05732779	Not yet recruiting	Heart Transplant Rejection\|Immune Suppression\|Pediatric Heart Transplant\|Medication Nonadherence\|Health Behavior\|Remote Monitoring\|Patient Engagement	University of Florida\|emocha Mobile Health Inc.\|National Heart Lung and Blood Institute (NHLBI)	2024-03-31	Not Applicable
NCT01795872	Completed	Multiple Sclerosis	Bayer	2013-09	Phase 4
NCT01429701	COMPLETED	Eczema	EMS	2012-05	PHASE3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Polymyxin B sulphate is a cationic surfactant antibiotic that binds directly to lipopolysaccharides and phospholipids within the bacterial cell membrane. This electrostatic interaction destabilizes membrane structural integrity and increases permeability, triggering excessive osmotic water uptake that causes rapidly fatal cell lysis in resistant gram-negative pathogens and clinical conditions such as topical dermatological 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>).