Clinical Trials

Multiple Phase 2 clinical trials sponsored by Active Biotech AB have evaluated paquinimod (ABR-215757) as an immunomodulatory agent for autoimmune pathologies. These completed studies investigated safety profiles, disease activity parameters, and biomarker alterations in patients with mild active systemic lupus erythematosus and systemic sclerosis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01487551 COMPLETED
Systemic Sclerosis
Active Biotech AB
 2011-12 PHASE2
NCT00997100 COMPLETED
Systemic Lupus Erythematosus
Active Biotech AB
 2009-08 PHASE2

(data from https://clinicaltrials.gov, updated on 2014-08-27)

Check the Paquinimod (ABR-215757) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Paquinimod selectively binds to the S100A8/S100A9 protein complex, preventing its downstream interaction with proinflammatory receptors including Toll-like receptor 4. This inhibition blocks pro-inflammatory cytokine pathways and leukocyte recruitment, thereby reducing systemic immune activation and tissue inflammation relevant to systemic lupus erythematosus and systemic sclerosis.

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.