Clinical Trials

Multiple clinical trials across Phase I and Phase II development stages have evaluated SQ109 for pulmonary tuberculosis, drug-susceptible tuberculosis, multi-drug resistant tuberculosis, and Helicobacter pylori infection. Sponsored by industry entities, government organizations, and international academic research consortiums, these investigations assessed safety, tolerability, pharmacokinetics, and early bactericidal activity. While several studies reached completed status, specific exploratory trials were withdrawn, highlighting ongoing interest in SQ109 as an antimicrobial therapeutic candidate.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01252108 Withdrawn
Helicobacter Pylori Infection
Sequella Inc.
 2012-03 Phase 2
NCT01358162 Completed
Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2010-11 Phase 1
NCT01218217 Completed
Tuberculosis Pulmonary
Michael Hoelscher|Sequella Inc.|European and Developing Countries Clinical Trials Partnership (EDCTP)|German Federal Ministry of Education and Research|Quintiles Inc.|CMed Technologies Inc.|PathCare|Parexel|Ludwig-Maximilians - University of Munich
 2010-11 Phase 2
NCT00866190 Completed
TB Multi-drug Resistant
National Institute of Allergy and Infectious Diseases (NIAID)
 2009-04 Phase 1
NCT01585636 Completed
Tuberculosis
Sequella Inc.|Quintiles Inc.
 2006-09 Phase 1
NCT01874314 Withdrawn
Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 Phase 1

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

Check the SQ109 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SQ109 selectively targets and inhibits mycobacterial membrane protein large 3 (MmpL3), thereby disrupting the translocation of trehalose monomycolate and blocking essential cell wall biosynthesis. This inhibition compromises bacterial structural integrity and leads to cell death, providing direct therapeutic relevance for treating pulmonary and multi-drug resistant tuberculosis infections evaluated in clinical trials.

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>).

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Note: Technical data last updated: Sep 1, 2026.