Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Albaconozole · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Albaconazole 400 mg cohort 1 | EXPERIMENTAL | Albaconazole 400 mg |
| Placebo cohort 1 | PLACEBO_COMPARATOR | Placebo once daily |
| Albaconozole 400 mg cohort 2 | EXPERIMENTAL | Albaconozole 400 mg every 12 hours |
| Placebo cohort 2 | PLACEBO_COMPARATOR | Placebo every 12 hours |
| Albaconozole 400 mg cohort 3 | EXPERIMENTAL | Albaconozole 400 mg every 8 hours |
| Placebo cohort 3 | PLACEBO_COMPARATOR | Placebo every 8 hours |
| Name | Type | Description |
|---|---|---|
| Albaconozole | DRUG | Albaconozole 400 mg oral once daily for 5 days |
| Placebo | DRUG | Placebo oral once daily for 5 days |
Inclusion Criteria: * Male or female subjects age 18 to 45 * A body mass index (BMI) between 18.5 and 30 kg/m2. * Good physical and mental health. * Vital signs .within the acceptable range. * Electrocardiogram (12-lead) after at least 5 minutes in supine position considered as normal or with findi...
Albaconozole is being developed for the treatment of onychomycosis, a fungal infection of the nails. It is an investigational small molecule in Phase 1 clinical development and has not been approved for any indication. GSK plc is the developer.
Albaconozole is being developed by GSK plc, which trades under the ticker GSK. The company is responsible for the clinical program evaluating the drug in onychomycosis.
Albaconozole is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It remains an investigational agent and has not been approved by the FDA for any use.
Albaconozole has been studied in one completed Phase 1 trial, NCT01014962, titled "A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus." The trial enrolled 24 healthy volunteers in the United States and was randomized, double-blind, and placebo-controlled.
No, Albaconozole is not FDA approved. It is an investigational small molecule in Phase 1 development for onychomycosis, and its only listed trial, NCT01014962, has been completed. Approval would require further clinical testing.