Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BB2603-1 · 1 trial · 3 indications
Early Response is defined as clinimetrically assessed clear nail growth (yes/no) and/or negative dermatophyte culture (yes/no).
| Arm | Type | Description |
|---|---|---|
| BB2603-10 | EXPERIMENTAL | Treatment with topical spray twice-daily (BID) BB2603-10: 0.1% terbinafine |
| BB2603-3 | EXPERIMENTAL | Treatment with topical spray twice-daily (BID) BB2603-3: 0.03% terbinafine |
| BB2603-1 | EXPERIMENTAL | Treatment with topical spray twice-daily (BID)BB2603-1: 0.01% terbinafine |
| Vehicle Control | OTHER | 0.3% polyhexanide/ 20% ethanol/ water formulation. |
| Name | Type | Description |
|---|---|---|
| BB2603-1 | DRUG | Treatment with topical spray twice-daily (BID) BB2603-1: 0.01% terbinafine |
| BB2603-3 | DRUG | Treatment with topical spray twice-daily (BID) BB2603-3: 0.03% terbinafine |
| BB2603-10 | DRUG | Treatment with topical spray twice-daily (BID) BB2603-10: 0.1% terbinafine |
| Vehicle | OTHER | Treatment with topical spray twice-daily (BID): 0.3% polyhexanide/ 20% ethanol/ water formulation. |
Inclusion Criteria: 1. Male or female ≥18 (and ≤99) at the time of Informed Consent. 2. Clinically and mycologically (KOH and culture positive for dermatophytes \[microbial infection with fungus belonging to the genus Trichophyton, Microsporum, Epidermophyton\]) confirmed diagnoses of DSO of the ta...
BB2603-1 is an investigational small molecule being developed for the treatment of distal subungual onychomycosis, a fungal infection of the toenail. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
The molecular target of BB2603-1 has not been disclosed. It is a small molecule modality being studied for its antifungal activity in distal subungual onychomycosis, but the specific biological target is not publicly available.
BB2603-1 is being developed by IQVIA Holdings, Inc., a company publicly traded under the ticker symbol IQV. IQVIA is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
BB2603-1 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the drug remains under evaluation.
BB2603-1 has one completed Phase 2 clinical trial registered as NCT04188574. This trial enrolled 111 participants with distal subungual onychomycosis of the toenail and was conducted in Czechia, Germany, and Poland. The study was randomized, double-blind, and controlled.
No alternative names for BB2603-1 have been disclosed. It is identified solely by its code name BB2603-1 in clinical trial registrations and development documentation.