Clinical Trials

Multiple clinical trials across Phase I, II, and III evaluate the safety and efficacy of Reparixin for inflammatory, oncological, and transplantation-related conditions, including myelofibrosis, acute respiratory distress syndrome, breast cancer, severe pneumonia, and ischemia-reperfusion injury. Sponsored by pharmaceutical entities such as Dompé Farmaceutici S.p.A. alongside academic institutions including the Icahn School of Medicine at Mount Sinai, these studies report varying statuses, ranging from recruiting and completed to terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05835466 RECRUITING
Myelofibrosis (PMF); Post Essential Thrombocythemia Myelofibrosis (ET-MF); Post Polycythemia Vera Related Myelofibrosis (PV-MF)
Icahn School of Medicine at Mount Sinai
 2023-07-24 PHASE2
NCT05496868 COMPLETED
Acute Respiratory Distress Syndrome, Adult
Dompé Farmaceutici S.p.A
 2022-12-06 PHASE2
NCT05254990 TERMINATED
Infectious Pneumonia; Severe COVID-19
Dompé Farmaceutici S.p.A
 2022-04-27 PHASE3
NCT05835466 Recruiting
Myelofibrosis (PMF)|Post Essential Thrombocythemia Myelofibrosis (ET-MF)|Post Polycythemia Vera Related Myelofibrosis (PV-MF)
Icahn School of Medicine at Mount Sinai|Dompé Farmaceutici S.p.A
 2023-06-27 Phase 2
NCT05212701 WITHDRAWN
Fatigue; Locally Advanced or Metastatic Breast Cancer
Dompé Farmaceutici S.p.A
 2022-04-19 PHASE2
NCT05496868 Recruiting
Acute Respiratory Distress Syndrome Adult
Dompé Farmaceutici S.p.A
 2023-02-07 Phase 2
NCT04878055 COMPLETED
Pneumonia, Viral
Dompé Farmaceutici S.p.A
 2021-02-14 PHASE3
NCT04794803 TERMINATED
Severe Pneumonia
Dompé Farmaceutici S.p.A
 2020-05-05 PHASE2; PHASE3
NCT02370238 COMPLETED
Metastatic Breast Cancer
Dompé Farmaceutici S.p.A
 2015-07-29 PHASE2
NCT01967888 COMPLETED
Pancreatectomy for Chronic Pancreatitis
Dompé Farmaceutici S.p.A
 2014-02 PHASE2; PHASE3
NCT03031470 TERMINATED
Ischemia-reperfusion Injury in Liver Transplant; Early Allograft Dysfunction
Dompé Farmaceutici S.p.A
 2015-03-10 PHASE2
NCT01817959 COMPLETED
Islet Transplantation in Diabetes Mellitus Type 1
Dompé Farmaceutici S.p.A
 2012-10 PHASE3
NCT01861054 TERMINATED
Breast Cancer
Dompé Farmaceutici S.p.A
 2013-02 PHASE2
NCT02001974 COMPLETED
Metastatic Breast Cancer
Dompé Farmaceutici S.p.A
 2012-02-27 PHASE1
NCT01220856 COMPLETED
Pancreatic Islet Transplantation in Type 1 Diabetes Mellitus
Dompé Farmaceutici S.p.A
 2010-07-28 PHASE2
NCT01861054 Terminated
Breast Cancer
Dompé Farmaceutici S.p.A
 2013-02 Phase 2
NCT00248040 COMPLETED
Ischemia-Reperfusion Injury; Kidney Diseases
Dompé Farmaceutici S.p.A
 2005-10 PHASE2
NCT00224406 COMPLETED
Ischemia-Reperfusion Injury; Lung Transplantation
Dompé Farmaceutici S.p.A
 2005-05-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Reparixin acts as a potent and specific inhibitor of C-X-C chemokine receptor 1 (CXCR1) with an IC50 of 1 nM, thereby blocking CXCL8-mediated receptor activation and downstream intracellular signaling pathways. This inhibition suppresses polymorphonuclear leukocyte migration and chemotaxis, providing therapeutic potential to mitigate excessive neutrophil-driven inflammation and tissue damage in clinical conditions such as acute respiratory distress syndrome, ischemia-reperfusion injury, and myelofibrosis.

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.