Clinical Trials

A Phase 3 clinical trial sponsored by the University of Zurich has completed recruitment to evaluate the therapeutic potential of genipin in patients with superficial digital flexor tendonitis. The study assessed the clinical and ultrasonographic effects of local intratendinous genipin injections, utilizing the compound as a natural cross-linking agent to improve tendon structure and repair. Overall, the clinical evaluation landscape for genipin focuses on orthopedic regenerative applications and tissue reinforcement.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05755750 COMPLETED
Superficial Digital Flexor Tendonitis
University of Zurich
 2016-06-28 PHASE3

(data from https://clinicaltrials.gov, updated on 2023-03-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Genipin reacts covalently with primary amino groups on biological macromolecules, forming stable intra- and intermolecular cross-links within collagen and extracellular matrix proteins. This structural cross-linking increases matrix rigidity and prevents proteolytic degradation, thereby enhancing mechanical integrity and promoting tissue repair in clinical conditions such as superficial digital flexor tendonitis.

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.