Delafloxacin (ABT-492) Clinical Trials

Size	Price	Qty
5mg	USD 167

Clinical Trials

Multiple clinical trials sponsored by industry sponsor Melinta Therapeutics Inc. have evaluated delafloxacin (ABT-492) for the treatment of respiratory and dermatological bacterial infections, specifically pneumonia and acute skin and subcutaneous tissue infections. These completed Phase 1 and Phase 2 studies assessed the drug's safety, pharmacokinetics, and therapeutic efficacy across both healthy subjects and patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03534622	Completed	Pneumonia	Melinta Therapeutics Inc.	2018-04-30	Phase 1
NCT01283581	Completed	Skin and Subcutaneous Tissue Bacterial Infections	Melinta Therapeutics Inc.	2011-01	Phase 2

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

Check the Delafloxacin (ABT-492) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Delafloxacin is a novel fluoroquinolone antibacterial agent that binds to bacterial DNA gyrase and topoisomerase IV enzymes, inhibiting essential DNA replication and transcription to induce rapid bactericidal cell death. This potent antimicrobial activity provides clinical relevance by suppressing bacterial proliferation in severe infectious diseases, including pneumonia and skin and subcutaneous tissue bacterial 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>).