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Terbinafine

Generic Name
Terbinafine
Brand Names
Lamisil, Silka Cream
Drug Type
Small Molecule
Chemical Formula
C21H25N
CAS Number
91161-71-6
Unique Ingredient Identifier
G7RIW8S0XP
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
Related News

Moberg Pharma's MOB-015 Fails Primary Endpoint in North American Phase 3 Onychomycosis Trial

• Moberg Pharma's MOB-015 did not meet the primary endpoint in its North American Phase 3 trial for onychomycosis using an 8-week daily dosing regimen followed by weekly maintenance. • The study's results indicated that the reduced dosage regimen was insufficient, reinforcing the need for a longer daily treatment, as approved in the EU, for effective topical treatment. • Bayer Consumer Health will halt the launch of MOB-015 due to strategic reasons, leading Moberg Pharma to regain full rights for MOB-015 in the EU and reassess its US strategy. • Moberg Pharma will shift its focus to the European market, aiming for a stronger presence and commercial role, while also exploring potential partnerships for further development.

Cipher Pharmaceuticals Faces Temporary Setback with Nail Fungus Treatment Data

• Cipher Pharmaceuticals' partner, Moberg Pharma, reported weaker-than-expected clinical cure data from a North American Phase 3 study of MOB-015 for nail fungus. • Despite the setback, analysts maintain a positive outlook, citing strong mycological cure data from previous Phase 3 studies and existing European approvals. • The analyst anticipates Health Canada approval based on EMA approval precedent, projecting peak Canadian sales of US$17.4M by 2030. • The analyst believes the stock weakness is temporary and expects a recovery, maintaining a "Buy" rating with a target price of $17.00.

Moberg Pharma's MOB-015 Phase 3 Trial Shows Lower Than Expected Clinical Cure Rate

• Moberg Pharma reports that a subset of patients in their North American Phase 3 study of MOB-015 achieved clinical cure for nail fungus at a rate lower than anticipated. • Cipher Pharmaceuticals, which holds Canadian marketing rights to MOB-015, acknowledges the update from Moberg Pharma regarding the clinical trial results. • Cipher Pharmaceuticals emphasizes that the outcome of the MOB-015 trial does not currently impact the company's sales and earnings profile. • Cipher Pharmaceuticals remains focused on the integration of the Natroba™ business and other potential growth opportunities.

Moberg Pharma's MOB-015 Phase 3 Trial Faces Uncertainty After Subgroup Analysis

• Moberg Pharma reports lower than expected clinical cure rates in a subset of patients from its ongoing North American Phase 3 trial of MOB-015 for onychomycosis. • The Phase 3 study, conducted across 33 centers in the US and Canada with 384 patients, is crucial for potential US registration and commercialization of MOB-015. • The company emphasizes data integrity and awaits topline results before speculating on the future potential of MOB-015, a topical terbinafine formulation. • Moberg Pharma will host a conference call to discuss the implications of these findings with its CEO, CMO, and CSO.
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