Lefamulin acetate (Xenleta) Clinical Trials

Size	Price	Qty
5mg	USD 359
25mg	USD 970

Clinical Trials

Multiple clinical trials evaluate the pharmacokinetics, safety, and therapeutic efficacy of lefamulin acetate across Phase 1 and Phase 1/2 studies targeting healthy volunteers, cystic fibrosis, and Mycoplasma genitalium infection. Sponsored by industry entities like Nabriva Therapeutics AG in collaboration with academic and research partners such as the University of Washington and Quotient Clinical, these studies reflect varying completion statuses. While several clinical trials evaluating mass balance, bioavailability, and pharmacokinetics were completed, a clinical trial focusing on resistant Mycoplasma genitalium infections was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05225805	COMPLETED	Cystic Fibrosis	Nabriva Therapeutics AG	2022-03-01	PHASE1
NCT05111002	Terminated	Mycoplasma Genitalium Infection	University of Washington\|Nabriva Therapeutics AG	2022-04-22	Phase 1\|Phase 2
NCT05225805	Completed	Cystic Fibrosis	Nabriva Therapeutics AG	2022-03-01	Phase 1
NCT03131141	Completed	Healthy	Nabriva Therapeutics AG\|Quotient Clinical	2017-01-08	Phase 1
NCT02557789	Completed	Healthy	Nabriva Therapeutics AG	2015-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-06-17)

Check the Lefamulin acetate (Xenleta) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lefamulin acetate is a pleuromutilin antibiotic that specifically binds to the peptidyl transferase center of the bacterial 50S ribosomal subunit, thereby inhibiting transfer RNA positioning and preventing peptide transfer during bacterial protein synthesis. This targeted disruption of translation arrests essential bacterial cellular processes, providing therapeutic efficacy against respiratory and urogenital pathogens studied in community-acquired bacterial pneumonia and Mycoplasma genitalium 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>).