Clinical Trials

A completed Phase 1 clinical trial, jointly sponsored by Astellas Pharma Inc and Ono Pharma USA Inc, evaluated the impact of food co-administration on the pharmacokinetic parameters of an intermittent formulation of minodronic acid (ONO-5920/YM529). Overall, clinical research into minodronic acid focuses on skeletal disorders, specifically targeting conditions including osteoporosis, postmenopausal osteoporosis, and related bone diseases.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00965978 Completed
Osteoporosis|Osteoporosis Postmenopausal|Bone Diseases
Astellas Pharma Inc|Ono Pharma USA Inc
 2009-07 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Minodronic acid selectively antagonizes purinergic P2X2/3 receptors while functioning as a nitrogen-containing bisphosphonate, thereby blocking downstream enzymatic signaling required for osteoclast function and disrupting cell-mediated bone resorption. By suppressing osteoclast viability and pain receptor activation, minodronic acid prevents structural bone degradation and alleviates skeletal pain, underlying its clinical relevance in the management of osteoporosis and postmenopausal bone diseases.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.