Clinical Trials

Several clinical trials evaluate the safety, efficacy, and physiological impact of acotiamide hydrochloride in healthy participants and patient populations with functional dyspepsia, postprandial distress syndrome, pediatric conditions, or Helicobacter pylori infection. Ranging from Phase III to Phase IV, these studies assess gastric motility and comparative prokinetic efficacy, with recruitment statuses including both completed research and trials not yet recruiting. This research is supported by pharmaceutical sponsors such as Zeria Pharmaceutical and Getz Pharma, alongside academic centers including Sir Ganga Ram Hospital, Aga Khan University, and Universitaire Ziekenhuizen KU Leuven.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07174297 NOT_YET_RECRUITING
Postprandial Distress Syndrome
Getz Pharma
 2025-10-30 PHASE3
NCT07449689 NOT_YET_RECRUITING
Functioanl Dyspepsia; Post Prandial Distress Syndrome
Aga Khan University
 2026-04 PHASE4
NCT04526119 COMPLETED
Functional Dyspepsia
Zeria Pharmaceutical
 2021-02-22 PHASE3
NCT04697641 COMPLETED
Dyspepsia; Helicobacter Pylori Infection
Sir Ganga Ram Hospital
 2017-09-01
NCT03402984 COMPLETED
Healthy
Universitaire Ziekenhuizen KU Leuven
 2017-04-01

(data from https://clinicaltrials.gov, updated on 2025-09-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Acotiamide hydrochloride acts as a selective acetylcholinesterase inhibitor that prevents the breakdown of synaptic acetylcholine in the gastrointestinal enteric nervous system, thereby enhancing local cholinergic neurotransmission and stimulating smooth muscle activity. This prokinetic stimulation of gastric motility and accommodation directly underlies its clinical utility in improving symptoms of functional dyspepsia and postprandial distress syndrome evaluated in clinical trials.

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.