Telacebec Clinical Trials

Size	Price	Qty
5mg	USD 259
25mg	USD 759

Clinical Trials

Multiple Phase II clinical trials, sponsored by organizations such as Qurient Co. Ltd. and Barwon Health, evaluate Telacebec's therapeutic efficacy, safety, and pharmacokinetics. These studies investigate conditions including drug-sensitive pulmonary tuberculosis in treatment-naïve, sputum smear-positive patients (completed), COVID-19 virus infection (terminated), and Buruli ulcer (currently recruiting). Overall, these efforts reflect an ongoing evaluation of Telacebec's clinical profile against mycobacterial infections and viral pathogens.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06481163	RECRUITING	Buruli Ulcer	Barwon Health	2024-07-09	PHASE2
NCT04847583	TERMINATED	COVID-19 Virus Infection	Qurient Co., Ltd.	2021-07-29	PHASE2
NCT03563599	COMPLETED	Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB	Qurient Co., Ltd.	2018-07-23	PHASE2
NCT03563599	Completed	Treatment-naïve Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB	Qurient Co. Ltd.	2018-07-23	Phase 2

(data from https://clinicaltrials.gov, updated on 2026-06-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Telacebec selectively binds to and inhibits the mycobacterial cytochrome bc1 complex, thereby blocking the electron transport chain and disrupting cellular energy production and adenosine triphosphate synthesis in target pathogens. This depletion of cellular energy inhibits pathogen survival, providing therapeutic rationale for its clinical evaluation in treating pulmonary tuberculosis and Buruli ulcer.

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>).