Timolol Maleate Clinical Trials

Size	Price	Qty
50mg	USD 79
1g	USD 670

Clinical Trials

Several completed clinical trials, encompassing Phase 3 and unassigned phase protocols, evaluate topical timolol maleate across ophthalmic and dermatologic indications. Sponsored by pharmaceutical entities such as Santen Pharmaceutical and government healthcare systems including the VA Office of Research and Development, these studies focus on primary open-angle glaucoma, ocular surface disease, chronic diabetic neuropathic ulcers, and non-healing cutaneous wounds. Together, these investigations highlight the therapeutic utility of timolol formulations in managing intraocular pressure and facilitating tissue repair.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04828057	Completed	Ocular Surface Disease\|Primary Open Angle Glaucoma	Santen Pharmaceutical (Taiwan) Co. LTD	2021-09-01	--
NCT03282981	Completed	Chronic Diabetic Foot Ulcers\|Diabetic Neuropathic Ulcers\|Non Healing Wound	VA Office of Research and Development\|VA Northern California Health Care System	2018-06-14	Phase 3
NCT04903366	Completed	Glaucoma Open-Angle\|Chronic Wounds	VA Northern California Health Care System	2017-11-21	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Timolol maleate functions as a non-selective antagonist that competitively binds to β1- and β2-adrenergic receptors with Ki values of 1.97 nM and 2.0 nM, respectively, thereby inhibiting catecholamine-stimulated adenylate cyclase activity and downstream cyclic AMP signaling. This molecular blockade reduces aqueous humor secretion in ciliary epithelia to lower intraocular pressure in open-angle glaucoma and modulates localized adrenergic signaling to promote tissue repair in chronic diabetic foot ulcers.

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>).