Clinical Trials

To date, a clinical trial is on record investigating generic racecadotril formulations in healthy volunteers. Sponsored by the pharmaceutical sponsor Pharma Nueva, this Phase 1 bioequivalence study is currently reported as not yet recruiting. Consequently, the clinical landscape for racecadotril remains focused on early-phase testing to support drug development and regulatory approval.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06297174 Not yet recruiting
Healthy Vollunteer
Pharma Nueva
 2024-08-26 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Racecadotril acts as a peripherally acting enkephalinase inhibitor that prevents the enzymatic breakdown of endogenous enkephalins, thereby reducing excessive water and electrolyte secretion into the intestinal lumen without affecting gastrointestinal motility. This antisecretory mechanism provides the physiological basis for evaluating racecadotril formulations in Phase 1 clinical studies involving healthy volunteers to demonstrate bioequivalence for the management of acute diarrhea.

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.