HA-100 dihydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 217
25mg	USD 649

Clinical Trials

A clinical trial sponsored by the Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico evaluated the therapeutic effects of oral supplementation on sexual and urinary symptoms in women presenting with recurrent urinary tract infections. This completed study, categorized with an unspecified phase status, represents the current extent of clinical evaluation for this molecule, as no additional or actively recruiting studies are presently registered.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06268483	COMPLETED	Urinary Tract Infections, Recurrent	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	2022-03-01

(data from https://clinicaltrials.gov, updated on 2024-02-20)

Check the HA-100 dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

HA-100 dihydrochloride functions as a multi-kinase inhibitor that selectively targets cGMP-dependent protein kinase, cAMP-dependent protein kinase, and protein kinase C, thereby disrupting downstream signal transduction pathways and cellular activation cascades. This inhibition of kinase-mediated signaling regulates smooth muscle contractility and inflammatory cell responses, providing a biochemical basis for mitigating symptoms in patient populations evaluated for recurrent urinary tract infections.

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>).