Terbinafine HCl Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate terbinafine across Phase 1 through Phase 3 development, encompassing both completed and actively recruiting studies. Sponsored by academic institutions, military hospital networks, and biotechnology firms, these trials primarily target superficial fungal conditions such as onychomycosis, distal subungual nail infections, and dermatophyte skin infections, alongside antiviral indications like chronic hepatitis B. Specific investigations compare continuous dosing against alternative antifungals or evaluate novel topical and iontophoretic delivery systems.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06295328	Recruiting	Chronic Hepatitis b	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	2022-04-13	Phase 1\|Phase 2
NCT05578950	Completed	Onychomycosis	Combined Military Hospital Abbottabad	2022-03-01	Phase 1
NCT04880980	Completed	Dermatophyte Infection\|Terbinafine Adverse Reaction\|Itraconazole Adverse Reaction	Pak Emirates Military Hospital	2021-03-15	Phase 3
NCT04188574	Completed	Distal Subungual Onychomycosis\|Fungal Infection\|Fungus Nail	Blueberry Therapeutics\|IQVIA Biotech	2021-03-22	Phase 2
NCT01484145	Completed	Onychomycosis	Nitric BioTherapeutics Inc	2011-12	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Terbinafine hydrochloride selectively inhibits squalene epoxidase, an essential enzyme in the fungal membrane synthesis pathway, thereby preventing the conversion of squalene to lanosterol and impairing ergosterol biosynthesis. This targeted biochemical block disrupts fungal cell membrane integrity and permeability, ultimately leading to intracellular squalene accumulation and fungal cell lysis to support therapeutic efficacy against dermatophyte infections and onychomycosis evaluated in clinical studies.

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>).