Ambroxol Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Several clinical trials are currently evaluating ambroxol across neurodegenerative and neuropathic conditions, including Parkinson's disease, Lewy body disease, Gaucher disease with GBA gene mutations, and diabetic peripheral neuropathy. Spanning Phase 1/2 through Phase 3 as well as observational designs, these studies are sponsored by academic and medical institutions such as University College London, Lawson Health Research Institute, Ain Shams University, Shaare Zedek Medical Center, and Italian neurological research centers. Across these active and planned studies, recruitment statuses range from not yet recruiting and active not recruiting to actively recruiting patient cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04405596	Not yet recruiting	Lewy Body Disease	Lawson Health Research Institute	2025-01	Phase 1\|Phase 2
NCT05778617	Not yet recruiting	Parkinson Disease	University College London	2023-09	Phase 3
NCT05558878	Not yet recruiting	Diabetic Neuropathy Peripheral	Ain Shams University	2022-10-01	Not Applicable
NCT05287503	Active not recruiting	Parkinson Disease\|GBA Gene Mutation	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta\|IRCCS National Neurological Institute C. Mondino Foundation\|University of Campania Luigi Vanvitelli	2022-02-15	Phase 2
NCT04388969	Recruiting	Gaucher Disease\|Parkinson Disease\|GBA Gene Mutation	Shaare Zedek Medical Center	2020-05-06	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ambroxol functions as a potent inhibitor of neuronal sodium (Na+) channels, directly binding to the channel complex to block sodium influx and suppress aberrant cellular depolarization. This blockade attenuates pathological neuronal hyperexcitability and downstream neuroinflammatory responses, providing a strong rationale for its therapeutic application in clinical conditions such as Parkinson's disease, Lewy body dementia, and diabetic peripheral neuropathy.

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>).