PBTZ169 Clinical Trials

Size	Price	Qty
5mg	USD 157

Clinical Trials

Several clinical trials spanning Phase I and Phase II have evaluated PBTZ169 for pulmonary and general tuberculosis, supported by sponsors including the Bill & Melinda Gates Foundation, Innovative Medicines for Tuberculosis, Nearmedic Plus LLC, and OCT LLC. Completed Phase I trials established the drug's safety, pharmacokinetics, and ex-vivo antitubercular profile across formulations, whereas a Phase II trial investigating early bactericidal activity was terminated. Together, these studies provide essential clinical data regarding the safety and therapeutic potential of PBTZ169 for mycobacterial infections.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03776500	Completed	Tuberculosis Pulmonary	Innovative Medicines for Tuberculosis\|Bill and Melinda Gates Foundation	2019-02-21	Phase 1
NCT03423030	Completed	Tuberculosis\|Tuberculosis Pulmonary	Innovative Medicines for Tuberculosis\|Bill and Melinda Gates Foundation	2017-12-05	Phase 1
NCT03334734	Terminated	Tuberculosis	Nearmedic Plus LLC\|OCT LLC	2016-12-16	Phase 2

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

Check the PBTZ169 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PBTZ169 functions as an irreversible inhibitor of DprE1, blocking the enzymatic synthesis of essential cell wall components and disrupting mycobacterial membrane integrity. This disruption leads to cell lysis and bacterial cell death, providing the biological rationale for its clinical development against pulmonary tuberculosis.

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>).