Clinical Trials

Terbinafine has been evaluated across numerous Phase 1 through Phase 3 clinical trials, primarily targeting superficial fungal diseases—including onychomycosis, dermatophyte infections, and oral candidiasis—as well as indications such as chronic hepatitis B and recurrent prostate cancer. Sponsored by academic medical centers, military hospitals, and biopharmaceutical companies, these investigations comprise completed comparative studies against itraconazole alongside active and recruiting trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07738328 NOT_YET_RECRUITING
Acute Kidney Injury; Cardiac Surgical Procedures
Guangdong Provincial People's Hospital
 2026-09-01 PHASE2
NCT07738328 NOT_YET_RECRUITING
Acute Kidney Injury; Cardiac Surgical Procedures
Guangdong Provincial People's Hospital
 2026-09-01 PHASE2
NCT07365423 RECRUITING
Recurrent Prostate Cancer
Swiss Cancer Institute
 2026-04-24 PHASE2
NCT07365423 RECRUITING
Recurrent Prostate Cancer
Swiss Cancer Institute
 2026-04-24 PHASE2
NCT07382427 NOT_YET_RECRUITING
Onychomycosis of Toenail
Onyx Axiom
 2026-03 PHASE2
NCT07382427 NOT_YET_RECRUITING
Onychomycosis of Toenail
Onyx Axiom
 2026-03 PHASE2
NCT05667246 ENROLLING_BY_INVITATION
Terbinafine Adverse Reaction
Weill Medical College of Cornell University
 2024-07-25
NCT05667246 ENROLLING_BY_INVITATION
Terbinafine Adverse Reaction
Weill Medical College of Cornell University
 2024-07-25
NCT07152327 NOT_YET_RECRUITING
Otomycosis; Fungal Ear Infection
Assiut University
 2025-10-01
NCT07152327 NOT_YET_RECRUITING
Otomycosis; Fungal Ear Infection
Assiut University
 2025-10-01
NCT07242703 NOT_YET_RECRUITING
Fungal Resistance
Cairo University
 2025-12-01
NCT07242703 NOT_YET_RECRUITING
Fungal Resistance
Cairo University
 2025-12-01
NCT07068256 COMPLETED
Tinea Capitis
Muhammad Aamir Latif
 2025-04-01
NCT07068256 COMPLETED
Tinea Capitis
Muhammad Aamir Latif
 2025-04-01
NCT06295328 RECRUITING
Chronic Hepatitis b
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2022-04-13 PHASE1; PHASE2
NCT06295328 RECRUITING
Chronic Hepatitis b
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2022-04-13 PHASE1; PHASE2
NCT06400056 UNKNOWN
Fungal Resistance
Assiut University
 2024-05 PHASE1
NCT06400056 UNKNOWN
Fungal Resistance
Assiut University
 2024-05 PHASE1
NCT05135910 UNKNOWN
Onychomycosis of Toenail
Hallux, Inc.
 2022-01-13 PHASE2
NCT05135910 UNKNOWN
Onychomycosis of Toenail
Hallux, Inc.
 2022-01-13 PHASE2
NCT05049525 TERMINATED
Crohn's Disease; Inflammatory Bowel Diseases
Montreal Heart Institute
 2022-02-22 PHASE2
NCT05049525 TERMINATED
Crohn's Disease; Inflammatory Bowel Diseases
Montreal Heart Institute
 2022-02-22 PHASE2
NCT05119712 WITHDRAWN
Ankylosing Spondylitis; Axial Spondyloarthritis; Psoriatic Spondylitis; Spondylitis Secondary to Inflammatory Bowel Disease; Axial Spondyloarthopathy
Oregon Health and Science University
 2021-03-09 EARLY_PHASE1
NCT05119712 WITHDRAWN
Ankylosing Spondylitis; Axial Spondyloarthritis; Psoriatic Spondylitis; Spondylitis Secondary to Inflammatory Bowel Disease; Axial Spondyloarthopathy
Oregon Health and Science University
 2021-03-09 EARLY_PHASE1
NCT05881980 UNKNOWN
Tinea Corporis; Tinea Cruris; Tinea Faciei; Dermatophytoses
Dhaka Medical College
 2023-05 PHASE2; PHASE3
NCT05881980 UNKNOWN
Tinea Corporis; Tinea Cruris; Tinea Faciei; Dermatophytoses
Dhaka Medical College
 2023-05 PHASE2; PHASE3
NCT05578950 COMPLETED
Onychomycosis
Combined Military Hospital Abbottabad
 2022-03-01 PHASE1
NCT05578950 COMPLETED
Onychomycosis
Combined Military Hospital Abbottabad
 2022-03-01 PHASE1
NCT05128916 UNKNOWN
Platelet Rich Plasma
Sohag University
 2021-12-01 PHASE3
NCT05128916 UNKNOWN
Platelet Rich Plasma
Sohag University
 2021-12-01 PHASE3
NCT06295328 Recruiting
Chronic Hepatitis b
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2022-04-13 Phase 1|Phase 2
NCT04880980 COMPLETED
Dermatophyte Infection; Terbinafine Adverse Reaction; Itraconazole Adverse Reaction
Pak Emirates Military Hospital
 2021-03-15 PHASE3
NCT04880980 COMPLETED
Dermatophyte Infection; Terbinafine Adverse Reaction; Itraconazole Adverse Reaction
Pak Emirates Military Hospital
 2021-03-15 PHASE3
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
NCT02606032 COMPLETED
Ulcerative Colitis
Hamilton Health Sciences Corporation
 2016-05 PHASE2
NCT02606032 COMPLETED
Ulcerative Colitis
Hamilton Health Sciences Corporation
 2016-05 PHASE2
NCT02019446 UNKNOWN
Diabetes Mellitus, Type 2; Onychomycosis
BCDiabetes.Ca
 2018-07
NCT02019446 UNKNOWN
Diabetes Mellitus, Type 2; Onychomycosis
BCDiabetes.Ca
 2018-07
NCT03999437 UNKNOWN
Tinea Pedis
United Laboratories
 2019-01-02 PHASE2
NCT03999437 UNKNOWN
Tinea Pedis
United Laboratories
 2019-01-02 PHASE2
NCT03094468 WITHDRAWN
Onychomycosis of Toenail
Polichem S.A.
 2017-05 PHASE3
NCT03094468 WITHDRAWN
Onychomycosis of Toenail
Polichem S.A.
 2017-05 PHASE3
NCT03171584 UNKNOWN
Antifungal Drugs in Onychomycosis
Assiut University
 2017-07-01 PHASE3
NCT03171584 UNKNOWN
Antifungal Drugs in Onychomycosis
Assiut University
 2017-07-01 PHASE3
NCT03471455 UNKNOWN
Tinea
Post Graduate Institute of Medical Education and Research, Chandigarh
 2018-04 PHASE2
NCT03471455 UNKNOWN
Tinea
Post Graduate Institute of Medical Education and Research, Chandigarh
 2018-04 PHASE2
NCT03135912 COMPLETED
Tinea Pedis
South End Skin Care
 2017-01-03 PHASE2
NCT03135912 COMPLETED
Tinea Pedis
South End Skin Care
 2017-01-03 PHASE2
NCT01920178 TERMINATED
Onychomycosis of Toenails
Cambridge Health Alliance
 2013-04
NCT01920178 TERMINATED
Onychomycosis of Toenails
Cambridge Health Alliance
 2013-04
NCT01851590 COMPLETED
Onychomycosis
Helsinki University Central Hospital
 2013-10 PHASE4
NCT01851590 COMPLETED
Onychomycosis
Helsinki University Central Hospital
 2013-10 PHASE4
NCT01615913 UNKNOWN
Onychomycosis
Taiwan Biotech Co., Ltd.
 2012-04 PHASE1
NCT01615913 UNKNOWN
Onychomycosis
Taiwan Biotech Co., Ltd.
 2012-04 PHASE1
NCT01484145 COMPLETED
Onychomycosis
Nitric BioTherapeutics, Inc
 2011-12 PHASE2
NCT01484145 COMPLETED
Onychomycosis
Nitric BioTherapeutics, Inc
 2011-12 PHASE2
NCT01433107 COMPLETED
Tinea Pedis
Novartis
 2011-08 PHASE3
NCT01433107 COMPLETED
Tinea Pedis
Novartis
 2011-08 PHASE3
NCT01484145 Completed
Onychomycosis
Nitric BioTherapeutics Inc
 2011-12 Phase 2
NCT01080079 COMPLETED
Onychomycosis
Nitric BioTherapeutics, Inc
 2010-05 PHASE2
NCT01080079 COMPLETED
Onychomycosis
Nitric BioTherapeutics, Inc
 2010-05 PHASE2
NCT01772212 COMPLETED
Mycoses
GlaxoSmithKline
 2011-02-24 PHASE1
NCT01772212 COMPLETED
Mycoses
GlaxoSmithKline
 2011-02-24 PHASE1
NCT00768768 COMPLETED
Onychomycosis
Transport Pharmaceuticals
 2008-10 PHASE1
NCT00459537 COMPLETED
Onychomycosis
Novartis
 2007-03 PHASE3
NCT00768768 COMPLETED
Onychomycosis
Transport Pharmaceuticals
 2008-10 PHASE1
NCT00459537 COMPLETED
Onychomycosis
Novartis
 2007-03 PHASE3
NCT00491764 COMPLETED
Onychomycosis
Merck Sharp & Dohme LLC
 2007-06 PHASE2
NCT00491764 COMPLETED
Onychomycosis
Merck Sharp & Dohme LLC
 2007-06 PHASE2
NCT00443898 COMPLETED
Onychomycosis
Novartis Pharmaceuticals
 2006-12 PHASE3
NCT00443820 COMPLETED
Onychomycosis
Novartis Pharmaceuticals
 2006-12 PHASE3
NCT00443898 COMPLETED
Onychomycosis
Novartis Pharmaceuticals
 2006-12 PHASE3
NCT00443820 COMPLETED
Onychomycosis
Novartis Pharmaceuticals
 2006-12 PHASE3
NCT00117767 COMPLETED
Tinea Capitis
Novartis Pharmaceuticals
 2004-06 PHASE3
NCT00117767 COMPLETED
Tinea Capitis
Novartis Pharmaceuticals
 2004-06 PHASE3
NCT00691184 COMPLETED
Onychomycosis/Onycholysis and Tinea Pedis
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
 2005-02 PHASE1
NCT00691184 COMPLETED
Onychomycosis/Onycholysis and Tinea Pedis
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
 2005-02 PHASE1
NCT00602342 COMPLETED
Onychomycosis
Roxane Laboratories
 2004-03
NCT00602251 COMPLETED
Onychomycosis
Roxane Laboratories
 2004-03
NCT00602342 COMPLETED
Onychomycosis
Roxane Laboratories
 2004-03
NCT00602251 COMPLETED
Onychomycosis
Roxane Laboratories
 2004-03
NCT00648713 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2004-02 PHASE1
NCT00648713 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2004-02 PHASE1
NCT00647647 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2004-02 PHASE1
NCT00647647 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2004-02 PHASE1
NCT01286701 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2002-01 PHASE1
NCT01286688 COMPLETED
Fasting
Dr. Reddy's Laboratories Limited
 2002-01 PHASE1
NCT01286701 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2002-01 PHASE1
NCT01286688 COMPLETED
Fasting
Dr. Reddy's Laboratories Limited
 2002-01 PHASE1
NCT00833586 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-01 PHASE1
NCT00833586 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-01 PHASE1
NCT00833664 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-01 PHASE1
NCT00833664 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-01 PHASE1
NCT00117754 COMPLETED
Tinea Capitis
Novartis
 2004-07 PHASE3
NCT00002394 COMPLETED
Candidiasis, Oral; HIV Infections
Novartis
NCT00253305 COMPLETED
Onychomycosis
MediQuest Therapeutics
 2005-09 PHASE2
NCT00117754 COMPLETED
Tinea Capitis
Novartis
 2004-07 PHASE3
NCT00002394 COMPLETED
Candidiasis, Oral; HIV Infections
Novartis
NCT00253305 COMPLETED
Onychomycosis
MediQuest Therapeutics
 2005-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-31)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Terbinafine selectively inhibits fungal squalene epoxidase, which blocks ergosterol biosynthesis and causes intracellular accumulation of toxic squalene, ultimately disrupting fungal cell membrane integrity and inducing cell death. This potent fungicidal activity provides the mechanistic foundation for its clinical efficacy in treating onychomycosis, dermatophyte infections, and other fungal conditions evaluated across clinical trials.

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>).

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Note: Technical data last updated: Sep 1, 2026.