Clinical Trials

A small number of clinical trials have evaluated sulfapyridine, primarily within pharmacokinetic assessments of its parent compound, sulfasalazine. These industry-sponsored studies include a completed Phase 1 trial by Galapagos NV evaluating drug-drug interactions in healthy subjects and a terminated Phase 4 trial by Pfizer examining steady-state pharmacokinetics in pediatric patients with juvenile rheumatoid arthritis. Together, these Phase 1 and Phase 4 protocols represent industry-led evaluations of pharmacokinetic parameters across healthy adult and pediatric populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04720183 Completed
Healthy
Galapagos NV
 2021-01-11 Phase 1
NCT00637780 Terminated
Arthritis Juvenile Rheumatoid
Pfizer
 2010-06 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sulfapyridine competitively binds to dihydropteroate synthase, blocking bacterial dihydropteroate synthesis and disrupting downstream folate metabolism necessary for nucleotide production. This biochemical blockade impairs microbial cell division and growth, providing antibacterial efficacy and underlying its relevance as an active metabolic component of sulfasalazine evaluated in clinical trials for juvenile rheumatoid arthritis.

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.