Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
terbinafine hydrogen chloride · 1 trial · 1 indication
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
| Arm | Type | Description |
|---|---|---|
| Terbinafine | EXPERIMENTAL | 10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry. |
| Amorolfine | ACTIVE_COMPARATOR | 5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails. |
| Name | Type | Description |
|---|---|---|
| terbinafine hydrogen chloride | DRUG | 10 % terbinafine hydrogen chloride (HCL) |
| amorolfine nail lacquer | DRUG | 5 % amorolfine nail lacquer |
Inclusion Criteria: * Male and females 12 - 75 years of age * Fungal toenail infection of one or both of the large (great) toenails * The nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed) * The target toenail area must have at lea...
Terbinafine hydrogen chloride is an investigational small molecule being studied for the treatment of onychomycosis, a fungal infection of the toenails. It is being developed as a topical 10% formulation for patients with mild to moderate toenail onychomycosis.
Terbinafine hydrogen chloride is an antifungal agent that works by inhibiting the enzyme squalene epoxidase, which is essential for ergosterol synthesis in fungal cell membranes. This disruption leads to fungal cell death. The drug is being evaluated for its efficacy and safety in treating toenail onychomycosis.
Terbinafine hydrogen chloride is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of onychomycosis.
Terbinafine hydrogen chloride is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for the treatment of onychomycosis.
Terbinafine hydrogen chloride has been studied in one completed Phase 3 clinical trial, identified as NCT00459537. This trial evaluated the efficacy, safety, and tolerability of topical 10% terbinafine hydrogen chloride compared to 5% amorolfine nail lacquer in patients with mild to moderate toenail onychomycosis. The trial enrolled 1,029 participants across multiple countries.
Terbinafine hydrogen chloride is a salt form of terbinafine, an antifungal medication. The hydrogen chloride salt is being developed as a topical formulation for onychomycosis. While related, the salt form may have different properties compared to other formulations of terbinafine.