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: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Onychomycosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| HSG-201 | P2 |
Active, not recruiting |
Onychomycosis |
2024-09-30 |
50% |
2023-08-08 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| 2019-002098-68 | P2 |
Active, not recruiting |
Onychomycosis |
2023-09-04 |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
02/03/2025 |
News Article |
Terclara (MOB-015) is now being launched in Norway |
|
03/26/2025 |
News Article |
Public Advisory - Health Canada warns about unauthorized health products that may pose serious health risks |
|
12/10/2024 |
News Article |
Moberg Pharma reports topline data in the North American phase 3 study and will regain rights to MOB-015 in EU |
|
09/13/2024 |
News Article |
Moberg Pharma lowers expectations on primary endpoint in ongoing phase 3 trial following data in a subset of patients |