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: None *
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: Onychomycosis | Tinea | Onychomycosis | Tinea
Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Pruritus | Diarrhea | Dyspepsia | Flatulence
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Tinea
Phase 2: Hepatitis B, Chronic|Onychomycosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| HSG-201 | P2 |
Active, not recruiting |
Onychomycosis |
2024-09-30 |
24% |
| ERC-DMC/ECC/2023/81 | P3 |
Not yet recruiting |
Tinea |
2023-10-01 |
|
| 2019-002098-68 | P2 |
Active, not recruiting |
Onychomycosis |
2023-09-04 |
|
| HepBTer Trial | P2 |
Active, not recruiting |
Hepatitis B, Chronic |
2023-04-18 |