Drugs / Terbinafine
Terbinafine
also known as
Lamisil · Terbinafine hydrochloride · MOB015B · TDT067 · AP4500 · Terbinafine HCl · Terbinafine hydrochloride (HCl) · terbinafine hydrogen chloride (HCl)
Small molecule targets SQLE via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | LAMISIL | — | 1997-01-21 – 1999-07-26 | fda.gov ↗ |
| Approved | US (FDA) | LAMISIL | — | 1992-12-30 | fda.gov ↗ |
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06400056 | May 2024 → Apr 2025 | fungal infectious disease | Assiut University | Unknown | No outcome recorded |
| Phase 1 | NCT03244280 | Dec 2017 → Apr 2018 | tinea unguium | Moberg Pharma AB | Completed | No outcome recorded |
| Phase 1 | NCT06369675 | Oct → Nov 2017 | — | Moberg Pharma AB | Completed | No outcome recorded |
| Phase 1 | NCT01615913 | Apr 2012 → Jun 2013 | tinea unguium | Taiwan Biotech Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT00647647 | Feb → Mar 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00648713 | Feb → Mar 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT07365423 | Apr 2026 → Feb 2028 expected | prostate carcinoma | Swiss Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07382427 | Mar 2026 → Jan 2028 expected | fungal infection of the toenail | Onyx Axiom | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05135910 | Jan 2022 → Sep 2024 | fungal infection of the toenail | Hallux, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT04188574 | Mar 2021 → Dec 2022 | tinea unguium | Blueberry Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03999437 | Jan → Dec 2019 | tinea pedis | United Laboratories | Unknown | No outcome recorded |
| Phase 2 | NCT01484145 | Dec 2011 → Mar 2012 | tinea unguium | Nitric BioTherapeutics, Inc | Completed | No outcome recorded |
| Phase 2 | NCT02366884 | Jul 2011 → Dec 2022 | neoplasm | Dr. Frank Arguello Cancer Clinic | Unknown | No outcome recorded |
| Phase 2 | NCT01400594 | Jul 2011 → Jan 2013 | tinea unguium | Hisamitsu Pharmaceutical Co., Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01790165 | Dec 2009 → Jan 2010 | tinea unguium | Celtic Pharma Development Services | Completed | No outcome recorded |
| Phase 2 | NCT00253305 | Sep 2005 → ? | tinea unguium | MediQuest Therapeutics | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05881980 | May → Oct 2023 | dermatophytosis of groin and perianal area, tinea corporis | Dhaka Medical College | Unknown | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT05279846 | May 2022 → Jan 2025 | tinea unguium | Moberg Pharma AB | Unknown | No outcome recorded |
| Phase 3 | NCT03171584 | Jul 2017 → Jun 2019 | — | Assiut University | Unknown | No outcome recorded |
| Phase 3 | NCT02859519 | Oct 2016 → Nov 2019 | tinea unguium | Moberg Pharma AB | Completed | No outcome recorded |
| Phase 3 | NCT01433107 | Aug 2011 → Feb 2012 | tinea pedis | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT01145807 | Apr 2010 → Feb 2012 | tinea unguium | Celtic Pharma Development Services | Unknown | No outcome recorded |
| Phase 3 | NCT00459537 | Mar 2007 → Jan 2009 | tinea unguium | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00443898 | Dec 2006 → Jun 2008 | tinea unguium | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00443820 | Dec 2006 → Jun 2008 | tinea unguium | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00117754 | Jul 2004 → Apr 2006 | dermatophytosis of scalp or beard | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00117767 | Jun 2004 → Mar 2006 | dermatophytosis of scalp or beard | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07152327 | Oct 2025 → Oct 2026 expected | otomycosis | Assiut University | Not yet recruiting | No outcome recorded |
| — | NCT07068256 | Apr → Sep 2025 | dermatophytosis of scalp or beard | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT07816510 | Mar → Aug 2021 | dermatophytosis | Chittagong Medical College | Completed | No outcome recorded |
| — | NCT00002394 | — | HIV infectious disease, oral candidiasis | Novartis | Completed | No outcome recorded |
| Comparator or background therapy19 trials | ||||||
| Phase 0 | NCT05119712 Comparator | Mar 2021 → Oct 2023 | ankylosing spondylitis | Oregon Health and Science University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05578950 Comparator | Mar → Aug 2022 | tinea unguium | Combined Military Hospital Abbottabad | Completed | No outcome recorded |
| Phase 1 | NCT00691184 Comparator | Feb → Jun 2005 | tinea infection | NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) | Completed | No outcome recorded |
| Phase 1 | NCT00833586 Comparator | Jan 2002 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00833664 Comparator | Jan 2002 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1/2 | NCT06295328 Comparator | Apr 2022 → Apr 2025 overdue | chronic hepatitis B virus infection | Academic Medical Center - University of Amsterdam | Recruiting | No outcome recorded |
| Phase 2 | NCT05049525 Comparator | Feb 2022 → Feb 2024 | Crohn disease | Montreal Heart Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03471455 Comparator | Apr 2018 → Jan 2019 | tinea infection | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 2 | NCT03135912 Comparator | Jan → Aug 2017 | tinea pedis | South End Skin Care | Completed | No outcome recorded |
| Phase 2 | NCT02606032 Comparator | May 2016 → Jan 2021 | ulcerative colitis | Hamilton Health Sciences Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01080079 Comparator | May 2010 → Nov 2011 | tinea unguium | Nitric BioTherapeutics, Inc | Completed | No outcome recorded |
| Phase 2 | NCT01013909 Comparator | Dec 2009 → May 2010 | tinea pedis | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00491764 Comparator | Jun 2007 → Dec 2008 | tinea unguium | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT05128916 Comparator | Dec 2021 → Jun 2022 | — | Sohag University | Unknown | No outcome recorded |
| Phase 3 | NCT04880980 Comparator | Mar 2021 → Mar 2022 | dermatophytosis, poisoning | Pak Emirates Military Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01851590 Comparator | Oct 2013 → Oct 2014 | tinea unguium | Helsinki University Central Hospital | Completed | No outcome recorded |
| — | NCT07869706 Background | Oct 2026 → Oct 2027 expected | tinea unguium | Assiut University | Not yet recruiting | No outcome recorded |
| — | NCT07242703 Comparator | Dec 2025 → Apr 2026 overdue | fungal infectious disease | Cairo University | Not yet recruiting | No outcome recorded |
| — | NCT02019446 Comparator | Jul 2018 → Dec 2020 | tinea unguium, type 2 diabetes mellitus | BCDiabetes.Ca | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2007-07-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Terbinafine Hcl Tablets tevapharm.com ↗
the U.S. Food and Drug Administration (FDA) has granted final approval |
| 2006-08-07 | Perrigo Company | Regulatory Perrigo Company to Market Terbinafine Hydrochloride Tablets perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that its partner, InvaGen Pharmaceuticals, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) on its ANDA for Terbinafine Hydrochloride Tablets, 250 mg (base). |
| 2003-12-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval of Terbinafine HCL Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the company's ANDA for Terbinafine Hydrochloride Tablets, 250 mg. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2007-07-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Terbinafine Hcl Tablets tevapharm.com ↗ |
| 2006-08-07 | Perrigo Company | Perrigo Company to Market Terbinafine Hydrochloride Tablets perrigo.com ↗ |
| 2006-01-26 | Daiichi Sankyo | Sankyo Releases Lamisil AT® in New Female-Friendly Pink Packaging daiichisankyo.com ↗ |
| 2003-12-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval of Terbinafine HCL Tablets tevapharm.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 50 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TERBINAFINE | “Terbinafine is a well-established synthetic allylamine anti-fungal developed by Sandoz (now Novartis) and commercially available worldwide for more than 25 years in different...” NCT04188574 ↗47“In this study, we assess the safety, tolerability, systemic exposure, and pharmacokinetic characteristics of topical terbinafine hydrochloride 10% solution (MOB015B) in adults...” PMID 39158295 ↗ Aug 2024 “MOB015B is a newly developed topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine.” NCT05279846 ↗ “MOB015B is a newly developed topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine.” NCT06369675 ↗ “Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo” NCT01013909 ↗ “Itraconazole, Amphotericin B liposomal, Fluconazole, Terbinafine, Voriconazole” NCT02366884 ↗ “MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution” NCT02859519 ↗ “Terbinafine hydrochloride patch” NCT01400594 ↗ |
| Known as | AP4500 | “A Phase 2, Randomized, Single-blind, Active- and Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of 2.4% Terbinafine Hydrochloride Topical Solution...” NCT07382427 ↗ |
| Known as | Lamisil | “in octobr 2007 The FDA has approved terbinafine oral granules (Lamisil), which can be sprinkled on food, for tinia capitis in children four years and older” NCT06400056 ↗5“with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals)” NCT00833586 ↗ “Lamisil® Tablets 250 mg” NCT00648713 ↗ |
| Known as | MOB015B | “In this study, we assess the safety, tolerability, systemic exposure, and pharmacokinetic characteristics of topical terbinafine hydrochloride 10% solution (MOB015B) in adults...” PMID 39158295 ↗ Aug 20241“MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution” NCT02859519 ↗ |
| Known as | TDT067 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01790165 ↗ |
| Known as | Terbinafine HCl | “10% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.” NCT00691184 ↗ |
| Known as | Terbinafine hydrochloride | “A Phase 2, Randomized, Single-blind, Active- and Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of 2.4% Terbinafine Hydrochloride Topical Solution...” NCT07382427 ↗5“In this study, we assess the safety, tolerability, systemic exposure, and pharmacokinetic characteristics of topical terbinafine hydrochloride 10% solution (MOB015B) in adults...” PMID 39158295 ↗ Aug 2024 “Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent.” NCT00117754 ↗ “Terbinafine tablets 250 mg (as terbinafine hydrochloride), antifungal agent.” NCT05049525 ↗ “Terbinafine hydrochloride is an antifungal drug from the allylamine class.” NCT07152327 ↗ “Terbinafine Hydrochloride Tablets 250 mg” NCT00648713 ↗ |
| Known as | Terbinafine hydrochloride (HCl) | “MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution” NCT02859519 ↗ |
| Known as | terbinafine hydrogen chloride (HCl) | “In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl) nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream” NCT00691184 ↗ |
| Action | Inhibit | “Terbinafine's anti-fungal mechanism of action is by inhibition of squalene epoxidase” NCT04188574 ↗ |
| Modality | Small molecule | “Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent.” NCT00117754 ↗ |
| Route | Topical | “This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus.” NCT00443820 ↗ |
| Target | SQLE | “inhibits squalene epoxidase (SQLE)” NCT07365423 ↗ |