Clinical Trials

Multiple mid- to late-phase clinical trials evaluate sitafloxacin hydrate for bacterial and mycobacterial infections, including acute pyelonephritis, complicated urinary tract infections, pulmonary tuberculosis, and acute exacerbations of bronchiectasis and COPD. Overseen by academic, hospital, and industry sponsors such as Mahidol University, Shenzhen Third People's Hospital, and Daiichi Sankyo, these studies investigate regimens for acute exacerbations and short-course pulmonary tuberculosis. Recruitment statuses across these clinical trials range from completed and recruiting to enrolling by invitation and not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07076225 NOT_YET_RECRUITING
Pulmonary Tuberculosis
Shenzhen Third People's Hospital
 2025-07-25 PHASE3
NCT06905522 RECRUITING
Pulmonary Tuberculosis
Shenzhen Third People's Hospital
 2025-06-18 PHASE3
NCT05454345 UNKNOWN
Tuberculosis, Pulmonary
First Affiliated Hospital of Zhejiang University
 2022-10-01 PHASE3
NCT06809413 ENROLLING_BY_INVITATION
Fluoroquinolone; Mycobacterium
Beijing Chest Hospital
 2025-01-28 PHASE2
NCT05400369 COMPLETED
COPD Exacerbation Acute
Daiichi Sankyo
 2022-08-10 PHASE4
NCT05313750 UNKNOWN
Acute Exacerbation of Bronchiectasis
Shanghai Pulmonary Hospital, Shanghai, China
 2021-06-30 PHASE4
NCT02729116 UNKNOWN
Anti-Infective Agents, Urinary; Escherichia Coli Infections; Klebsiella Infections; Kidney Transplantation; Urinary Tract Infections
Khon Kaen University
 2016-07 PHASE2; PHASE3
NCT02537847 UNKNOWN
Infection Due to Escherichia Coli; Acute Pyelonephritis
Mahidol University
 2012-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-07-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a broad-spectrum fluoroquinolone antibiotic, sitafloxacin targets bacterial type II topoisomerases, inhibiting DNA gyrase and topoisomerase IV to block bacterial DNA replication and transcription. This inhibition induces rapid bacterial double-stranded DNA breaks and bactericidal cell death, providing potent therapeutic efficacy against diverse pathogens responsible for urinary tract infections, acute pyelonephritis, pulmonary tuberculosis, and acute respiratory exacerbations.

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.