Clinical Trials

Multiple clinical trials evaluate the safety, pharmacokinetics, and clinical application of ladarixin across Phase 1 and Phase 2 development. Sponsored by pharmaceutical industry sponsor Dompé Farmaceutici S.p.A and academic partner NYU Langone Health, these studies focus on new-onset or recent-onset type 1 diabetes mellitus, advanced KRAS G12C-mutant non-small cell lung cancer, and safety evaluations in healthy volunteers. Trial recruitment statuses vary across the portfolio, encompassing completed, actively recruiting, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05815173 RECRUITING
Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
NYU Langone Health
 2023-08-01 PHASE1
NCT05815186 WITHDRAWN
Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
NYU Langone Health
 2024-04 PHASE2
NCT04628481 TERMINATED
Recent Onset type1 Diabetes
Dompé Farmaceutici S.p.A
 2021-01-12 PHASE2
NCT05368402 TERMINATED
Type 1 Diabetes
Dompé Farmaceutici S.p.A
 2022-09-14 PHASE2
NCT05035368 WITHDRAWN
Type I Diabetes
Dompé Farmaceutici S.p.A
 2021-09-30 PHASE2
NCT04899271 TERMINATED
New-onset Type 1 Diabetes
Dompé Farmaceutici S.p.A
 2020-12-14 PHASE2
NCT04854642 COMPLETED
no Condition
Dompé Farmaceutici S.p.A
 2020-10-20 PHASE1
NCT02814838 COMPLETED
Diabetes Mellitus, Insulin-Dependent
Dompé Farmaceutici S.p.A
 2016-08 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-12-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ladarixin functions as an orally active, allosteric, non-competitive dual antagonist that selectively binds chemokine receptor 1 (CXCR1) and chemokine receptor 2 (CXCR2), thereby blocking downstream signal transduction and impairing neutrophil migration and activation. By suppressing acute and chronic neutrophilic inflammation, this targeted inhibition seeks to protect pancreatic beta-cell function in type 1 diabetes and disrupt pro-tumor inflammatory signaling in advanced KRAS G12C-mutant non-small cell lung cancer.

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.