Asia Scientific Global has received US Food and Drug Administration Investigational New Drug application clearance for Beta1, marking the first and currently only inhaled investigational therapy for male erectile dysfunction to receive this type of approval and advance to clinical trials. The Taipei-based company plans to initiate phase I trials in Taiwan during the first half of 2026.
Beta1 employs Asia Scientific Global's (ASG) proprietary Aero-Particles Process Control technology combined with dry powder inhalation to achieve drug absorption within 10 minutes, significantly accelerating the onset of action compared with existing oral therapies that require 40 minutes to 2 hours to reach maximum plasma concentration. The company stated that Beta1 has the potential to offer advantages in safety, effectiveness, and ease of administration beyond just faster onset. The investigational treatment uses an optimized formulation delivered through a customized portable device designed for point-of-use administration.
As the first inhaled erectile dysfunction (ED) therapy to enter clinical trials, Beta1 holds a unique competitive position in the ED treatment landscape, according to ASG.
The upcoming phase I trial will assess safety, dose tolerability, and preliminary efficacy in partnership with internationally accredited medical institutions in Taiwan. ASG acknowledged specific methodologic challenges inherent to inhaled drug development, including managing interparticipant variability in blood drug levels caused by differences in inhaled doses and maintaining dosage stability throughout the study period. The trial will be conducted in strict accordance with international standards and regulatory guidelines.
The results of preclinical studies have already exceeded expectations, according to the company; however, specific safety and efficacy metrics weren't disclosed in the announcement.
ASG indicated the Investigational New Drug application clearance represented a key milestone that will support the expansion of its drug pipeline and enable pursuit of licensing opportunities and strategic partnerships.
Market research firm The Brainy Insights projects the global ED pharmaceutical market will reach $7.1 billion by 2032, representing a 9% compound annual growth rate. ASG maintains research and development facilities in Taiwan with additional business operations in mainland China, Southeast Asia, and North America. The company specializes in the 505(b)(2) regulatory pathway and emphasizes innovative medical device development as core competitive advantages.
Source: PRNewswire
