Overview
Terbinafine hydrochloride (Lamisil) is a synthetic allylamine antifungal. It is highly lipophilic in nature and tends to accumulate in skin, nails, and fatty tissues. Like other allylamines, terbinafine inhibits ergosterol synthesis by inhibiting the fungal squalene monooxygenase (also called squalene epoxidase), an enzyme that is part of the fungal cell wall synthesis pathway. Terbinafine hydrochloride was granted FDA approval on 30 December 1992.
Background
Terbinafine hydrochloride (Lamisil) is a synthetic allylamine antifungal. It is highly lipophilic in nature and tends to accumulate in skin, nails, and fatty tissues. Like other allylamines, terbinafine inhibits ergosterol synthesis by inhibiting the fungal squalene monooxygenase (also called squalene epoxidase), an enzyme that is part of the fungal cell wall synthesis pathway. Terbinafine hydrochloride was granted FDA approval on 30 December 1992.
Indication
Terbinafine hydrochloride is indicated to treat fungal skin and nail infections caused by Trichophyton species, Microsporum canis, Epidermophyton floccosum, and Tinea species. Terbinafine hydrochloride also treats yeast infections of the skin caused by Candida species and Malassezia furfur.
Associated Conditions
- Onychomycosis
- Pityriasis versicolor
- Sporotrichosis
- Tinea Capitis
- Tinea Corporis
- Tinea Cruris
- Tinea Pedis
- Cutaneous candidiasis
- Severe Tinea Corporis
- Severe Tinea Cruris
- Severe Tinea Pedis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/02 | N/A | Recruiting | Shandong University | ||
2024/05/06 | Phase 1 | Not yet recruiting | |||
2024/03/06 | Phase 1 | Recruiting | |||
2023/05/31 | Phase 2 | Not yet recruiting | |||
2022/10/13 | Phase 1 | Completed | Combined Military Hospital Abbottabad | ||
2022/08/01 | N/A | Active, not recruiting | University of Rome Tor Vergata | ||
2021/11/22 | Phase 3 | UNKNOWN | |||
2021/11/15 | Early Phase 1 | Withdrawn | |||
2021/05/11 | Phase 3 | Completed | Pak Emirates Military Hospital | ||
2019/06/26 | Phase 2 | UNKNOWN | United Laboratories |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| direct rx | 72189-243 | ORAL | 250 mg in 1 1 | 7/23/2021 | |
| Chartwell RX, LLC | 62135-572 | ORAL | 250 mg in 1 1 | 10/6/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-209 | ORAL | 250 1 in 1 1 | 2/15/2015 | |
| Cipla USA Inc. | 69097-731 | ORAL | 250 mg in 1 1 | 1/5/2021 | |
| REMEDYREPACK INC. | 70518-3919 | ORAL | 250 mg in 1 1 | 12/13/2023 | |
| Aurobindo Pharma Limited | 65862-079 | ORAL | 250 mg in 1 1 | 2/22/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-893 | ORAL | 250 mg in 1 1 | 12/15/2017 | |
| NuCare Pharmaceuticals,Inc. | 68071-4712 | ORAL | 250 mg in 1 1 | 2/17/2021 | |
| REMEDYREPACK INC. | 70518-1191 | ORAL | 250 mg in 1 1 | 2/17/2022 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-906 | ORAL | 250 mg in 1 1 | 7/7/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FINAB CREAM 1% W/W | SIN16896P | CREAM | 1% w/w | 11/7/2023 | |
| SOLVEASY TINEA SPRAY 1% w/w | SIN15295P | SPRAY | 1% w/w | 7/7/2017 | |
| LAMISIL TABLET 250 mg | SIN06932P | TABLET, FILM COATED | 250 mg | 4/13/1992 | |
| SOLVEASY TINEA CREAM 1% w/w | SIN15296P | CREAM | 1.000% w/w | 7/7/2017 | |
| DERMAFIN CREAM 10MG/G | SIN15413P | CREAM | 10mg/g | 1/29/2018 | |
| FUNGIFEX TABLET 250MG | SIN16925P | TABLET | 250.00mg | 1/5/2024 | |
| LAMISIL DERMGEL 1% | GSK Consumer Healthcare SARL, NOVARTIS PHARMA PRODUKTIONS GMBH | SIN10617P | GEL | 1% | 1/8/1999 |
| LAMISIL CREAM 1% | GSK Consumer Healthcare SARL, NOVARTIS PHARMA PRODUKTIONS GMBH | SIN07623P | CREAM | 1% w/w | 1/26/1994 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Terbinafine Hydrochloride Tablets | 国药准字H20223591 | 化学药品 | 片剂 | 8/10/2022 | |
| Terbinafine Hydrochloride Tablets | 国药准字H10970218 | 化学药品 | 片剂 | 4/9/2024 | |
| Terbinafine Hydrochloride Tablets | 国药准字H20094133 | 化学药品 | 片剂 | 2/6/2024 | |
| Terbinafine Hydrochloride Tablets | 国药准字H20163016 | 化学药品 | 片剂 | 11/23/2020 | |
| Terbinafine Hydrochloride Tablets | 国药准字H19980206 | 化学药品 | 片剂 | 5/22/2020 | |
| Terbinafine Hydrochloride Tablets | 国药准字H20083377 | 化学药品 | 片剂 | 4/17/2023 | |
| Terbinafine Hydrochloride Tablets | 国药准字H20103319 | 化学药品 | 片剂 | 5/19/2020 | |
| Terbinafine Hydrochloride Tablets | 国药准字H20093125 | 化学药品 | 片剂 | 6/21/2023 | |
| Terbinafine Hydrochloride Tablets | 国药准字H20184160 | 化学药品 | 片剂 | 7/5/2023 | |
| Terbinafine Hydrochloride Tablets | 国药准字H20083816 | 化学药品 | 片剂 | 11/7/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ERBINOL CREAM 1% W/W | N/A | health alliance international co ltd | N/A | N/A | 9/27/2019 |
| TERFINE CREAM 10MG/G | N/A | N/A | N/A | 12/19/2008 | |
| KOLMARSIL TOPICAL CREAM 10MG/G | N/A | N/A | N/A | 4/25/2025 | |
| TERNASIL GEL 10MG/G | N/A | julius chen & company (hk) limited | N/A | N/A | 10/31/2019 |
| BF-TERBINAFINE CREAM 1% W/W | N/A | N/A | N/A | 11/15/2024 | |
| LAMISIL SPRAY 1% | N/A | N/A | N/A | 10/7/1998 | |
| LAMISIL DERMGEL 1% | N/A | N/A | N/A | 1/21/2000 | |
| LAMISIL CRM 1% | N/A | N/A | N/A | 3/1/1999 |