Ambroxol HCl Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate ambroxol hydrochloride as a potential disease-modifying agent across neurodegenerative and metabolic disorders, including Parkinson's disease, Lewy body dementia, diabetic peripheral neuropathy, and Gaucher disease, with a focus on GBA mutation carriers. Spanning Phase 1/2, Phase 2, and Phase 3 evaluations alongside observational registries, these studies encompass planned, recruiting, and active non-recruiting statuses. Led by academic medical centers such as University College London, Lawson Health Research Institute, and Shaare Zedek Medical Center, these initiatives continue to advance clinical research for these targeted indications.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ambroxol hydrochloride functions as a potent voltage-gated sodium channel inhibitor, effectively blocking tetrodotoxin-resistant and tetrodotoxin-sensitive sodium currents to reduce intracellular ion influx and stabilize neuronal membrane potential. This inhibition attenuates cellular hyperexcitability and downstream neuroinflammatory signaling pathways, providing a rationale for its clinical evaluation in diabetic peripheral neuropathy and neurodegenerative disorders such as Parkinson's disease and Lewy body dementia.

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>).