Approval Probability
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Adjusted LOA
ML Risk
SCH 56592 · 1 trial · 1 indication
Complete cure is defined as negative mycology (negative culture and KOH \[potassium hydroxide\]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).
| Arm | Type | Description |
|---|---|---|
| Posaconazole 100 mg QD for 24 weeks. | EXPERIMENTAL | Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. |
| Posaconazole 200 mg QD for 24 weeks. | EXPERIMENTAL | Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. |
| Posaconazole 400 mg QD for 24 weeks. | EXPERIMENTAL | Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. |
| Posaconazole 400 mg QD for 12 weeks. | EXPERIMENTAL | Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. |
| Terbinafine | ACTIVE_COMPARATOR | Terbinafine 250 mg QD for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| SCH 56592 | DRUG | Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. |
| Terbinafine | DRUG | Terbinafine 250 mg QD for 12 weeks. |
| Placebo | DRUG | Placebo for 24 weeks. |
Inclusion Criteria: * The subject must meet ALL the criteria listed below for entry: * Subject must be between 18 and 75 years of age inclusive, of either sex, and of any race; * Subject must have distal subungual infection that affects approximately 25% to 75% of at least one great toenail, b...
SCH 56592, also known as posaconazole, is an investigational small molecule being studied for the treatment of onychomycosis, a fungal infection of the toenails. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 2 clinical development.
SCH 56592 is an antifungal agent that works by inhibiting the synthesis of ergosterol, a key component of fungal cell membranes. By disrupting this process, it helps to eliminate the fungal infection causing onychomycosis. This mechanism is typical of azole antifungals.
SCH 56592 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 2 clinical trials for the treatment of onychomycosis.
SCH 56592 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 study evaluating its efficacy and safety in patients with toenail onychomycosis has been completed.
SCH 56592 has been studied in one completed Phase 2 clinical trial, identified as NCT00491764. This randomized, placebo-controlled study enrolled 218 participants and evaluated the efficacy and safety of four posaconazole regimens compared to placebo and terbinafine in the treatment of toenail onychomycosis.
Yes, SCH 56592 is also known as posaconazole. In clinical trials, it is referred to by both names. The Phase 2 study NCT00491764 specifically evaluates posaconazole regimens for the treatment of toenail onychomycosis.