Product Description
Terbinafine is an antifungal medication that works through the inhibition of squalene epoxidase. It has activity against most dermatophytes, and it has approval for use as an oral therapy for the treatment of onychomycosis. Although most side effects are mild and self-limited, such as headache and gastrointestinal symptoms, taste disturbances (dysgeusia) can range from mild to severe, resulting in weight loss, and have rarely been reported permanent. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK545218/)
Mechanisms of Action: MCHR Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Novartis
Company Location: Europe
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count: 1
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Onychomycosis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2019-002098-68 |
2019-002098-68 | P2 |
Active, not recruiting |
Onychomycosis |
2023-09-04 |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/05/2025 |
News Article |
Moberg Pharma and Karo Healthcare enter into an exclusive license agreement for MOB-015/Terclara in Europe, expanding access and growth potential |
|
10/20/2025 |
News Article |
FungaBeam LLLT Device Disrupts $3.2B Nail Fungus Market with 85% Cost Savings as Americans Waste $500M Annually on Ineffective Treatments |
|
03/26/2025 |
News Article |
Public Advisory - Health Canada warns about unauthorized health products that may pose serious health risks |
|
02/03/2025 |
News Article |
Terclara (MOB-015) is now being launched in Norway |