Biopharmaceutical company Vanda Pharmaceuticals Inc (Nasdaq:VNDA) announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application to assess VTR-297 intended for the treatment of onychomycosis, a fungal infection of the nail.
VTR-297 is a small molecule histone deacetylase (HDAC) inhibitor with activity against dermatophytes and fungi, originally isolated from the yeast species Streptomyces hygroscopicus as an antifungal antibiotic, first described in 1976.
Mihael H Polymeropoulos, MD, Vanda's president, CEO and chairman of the board, said: "The initiation of clinical studies with VTR-297 in the treatment of onychomycosis is an important milestone in studying and developing potential new therapies for this common disorder."
Pierre Fabre Pharmaceuticals reports FDA acceptance and Priority Review of Tabelecleucel BLA
Bavarian Nordic's chikungunya vaccine receives validation from EMA for accelerated review
Atara Biotherapeutics gains FDA Priority Review for tabelecleucel
Hyperfine secures FDA clearance for faster brain imaging software
Silo Pharma agrees Alzheimer's drug licence
Kyverna's KYV-101 granted FDA Regenerative Medicine Advanced Therapy designation
Camurus reports positive Phase 3 ACROINNOVA 2 results
Acurx Pharmaceuticals presents positive Ibezapolstat Phase 2 clinical trial results for CDI