Laquinimod Clinical Trials

Clinical Trials

Multiple clinical trials are evaluating laquinimod across diverse therapeutic domains, including relapsing-remitting multiple sclerosis, uveitis, Alzheimer's disease, ocular inflammation, and pharmacokinetic evaluation. These investigations encompass Phase 1 and Phase 3 studies alongside non-applicable phase classifications, with recruitment statuses spanning recruiting, completed, and withdrawn. Sponsored by pharmaceutical companies and academic institutions, these studies highlight the clinical exploration of this compound for autoimmune and neuroinflammatory conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06161415	Recruiting	Inflammation\|Uveitis	Quan Dong Nguyen\|Global Ophthalmic Research Center (GORC)\|Stanford University	2024-04	Phase 1
NCT05187403	Completed	Eye Diseases	Active Biotech AB	2021-12-09	Phase 1
NCT02772523	Completed	Alzheimer''s Disease	Barcelonabeta Brain Research Center Pasqual Maragall Foundation	2016-05	Not Applicable
NCT02085863	Completed	Pharmacokinetics\|Pharmacodynamics	Teva Branded Pharmaceutical Products R&D Inc.	2014-02	Phase 1
NCT01975298	Withdrawn	Relapsing Remitting Multiple Sclerosis	Teva Branded Pharmaceutical Products R&D Inc.	2014-01	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Laquinimod functions as a potent immunomodulator targeting pathways including the aryl hydrocarbon receptor to suppress leukocyte infiltration, alter cytokine balances toward anti-inflammatory T helper 2/3 profiles, and inhibit tissue inflammation driven by CD4+ T cells and macrophages. By dampening aberrant immune activation and neuroinflammation, laquinimod exerts protective disease-modifying effects relevant to clinical trial indications such as relapsing-remitting multiple sclerosis and ocular inflammatory disorders like uveitis.

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>).