Clinical Trials

Several completed Phase 1 and Phase 3 clinical trials sponsored by Astellas Pharma Inc. have evaluated ramosetron hydrochloride (YM060). A Phase 3 study assessed the compound in female patients with diarrhea-predominant irritable bowel syndrome. Additionally, Phase 1 bioequivalence studies in healthy participants evaluated plasma concentrations comparing orally-disintegrating versus conventional tablet formulations administered with or without water.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01870895 Completed
Diarrhea-predominant Irritable Bowel Syndrome
Astellas Pharma Inc
 2013-02 Phase 3
NCT01394653 Completed
Healthy|Plasma Concentration of YM060
Astellas Pharma Inc
 2011-07 Phase 1
NCT01392794 Completed
Healthy|Plasma Concentration of YM060
Astellas Pharma Inc
 2011-04 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ramosetron hydrochloride selectively binds to and antagonizes serotonin 5-HT3 receptors, thereby blocking serotonin-mediated depolarization of enteric neurons and suppressing hyperactive gastrointestinal motility. By dampening abnormal intestinal signaling and visceral hypersensitivity, this pharmacological blockade reduces stool frequency and relieves visceral discomfort in gastrointestinal disorders such as diarrhea-predominant irritable bowel syndrome.

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.