Carbamoylcholine chloride (Carbachol) Clinical Trials

Size	Price	Qty
25mg	USD 97
100mg	USD 247

Clinical Trials

Carbamoylcholine chloride (Carbachol) has been evaluated across several clinical trials in ophthalmology and neurology, targeting indications such as presbyopia, cataracts, choroid disease, epinephrine toxicity, and headache mechanisms. Encompassing Phase 2, Phase 3, and unassigned mechanistic studies, these protocols include both completed and actively recruiting trials. Research sponsorship spans diverse stakeholders, ranging from academic and clinical institutions to biopharmaceutical companies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06948357	RECRUITING	Presbyopia	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	2025-03-24	PHASE2
NCT05135286	COMPLETED	Presbyopia	Visus Therapeutics	2022-03-15	PHASE3
NCT05270863	COMPLETED	Presbyopia	Visus Therapeutics	2022-03-30	PHASE3
NCT04774237	COMPLETED	Presbyopia	Visus Therapeutics	2021-03-24	PHASE2
NCT05225597	COMPLETED	Epinephrine Toxicity; Cataract; Carbachol Adverse Reaction; Choroid Disease	Ordu University	2021-01-01
NCT00564408	COMPLETED	Headache	Danish Headache Center	2007-08

(data from https://clinicaltrials.gov, updated on 2025-04-29)

Check the Carbamoylcholine chloride (Carbachol) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Carbamoylcholine chloride binds to and activates both muscarinic and nicotinic acetylcholine receptors, stimulating G-protein-coupled signaling cascades that elevate intracellular calcium levels to induce sustained contraction of the iris sphincter muscle. This pharmacologically induced miosis enhances depth of focus and reduces intraocular pressure, establishing the therapeutic mechanism for its clinical application in presbyopia and cataract procedures.

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>).