ASG Receives U.S. FDA IND Approval to Initiate Phase 1 Clinical Trial of the Lead Drug Beta1 for Male Erectile Dysfunction

TAIPEI, Dec. 17, 2025 /PRNewswire/ -- Asia Scientific Global Inc. (ASG), a leader in the research and development of novel inhaled drugs, today announced that its lead product, Beta1, has received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA). Beta1 is currently the only inhaled investigational therapy for male erectile dysfunction to have received such approval and prepared to enter clinical trial. The FDA's clearance underscores ASG's capabilities in drug development and manufacturing technologies. ASG plans to initiate a Phase 1 clinical trial in Taiwan in the first half of 2026.

ASG stated that Beta1 utilizes ASG's core aPPC (Aero-Particles Process Control) technology to optimize the formulation design and an inhaled delivery platform, improving both onset time of action and safety. Receiving FDA IND clearance positions Beta1 as a potential next-generation therapeutic option for erectile dysfunction. The Company noted that, compared with oral formulations, inhaled investigational drugs face particular challenges in clinical trials, including managing variability in blood, drug levels caused by differences in inhaled doses between participants, and maintaining dosage stability. The upcoming clinical study will be conducted in partnership with internationally accredited medical institutions and specialized clinical teams in Taiwan. The trial will focus on assessing the safety, dose tolerability, and early efficacy of the investigational drug, and will be performed in strict accordance with international standards and regulatory guidelines to maximize trial quality and outcomes.

This event marks a key milestone in ASG's new drug development efforts. It not only affirms the Company's R&D capabilities but also significantly enhances its visibility in the global market. According to ASG, as the first inhaled therapy for male erectile dysfunction enters clinical trial, Beta1 holds a uniquely competitive position. With the commencement of clinical trial, ASG is confident to expand its drug pipeline. Looking ahead, the Company will continue to invest in research and clinical resources while pursuing suitable licensing opportunities and strategic partnerships.

About Beta1

Beta1, a novel dry powder inhalable treatment of male erectile dysfunction, has to date shown better-than-expected results in pre-clinical studies and has now been cleared to conduct Phase 1 clinical trial. For existing pharmaceutical therapies, it typically takes at least 40 minutes to two hours to reach the maximum plasma concentration. Drawing on its core aPPC  technology, ASG has accelerated the development timeline for its novel drugs. With an optimized formulation and inhaled delivery, Beta1 can achieve drug absorption within 10 minutes. Paired with ASG's customized portable and modern device, Beta1 offers greater convenience and provides a treatment option that has the potential to be more effective, safer, and easier to administer, aiming to benefit a larger number of patients. According to data from international market research firm The Brainy Insights, the global erectile dysfunction drug market is projected to reach US$7.1 billion by 2032, driven by sustained demand with a compound annual growth rate of 9%.

About Asia Scientific Global Inc.

ASG is dedicated to the research and development of novel inhaled drugs, with a vision of "Making the world a better place, one breath at a time." The Company focuses on providing patients worldwide with faster, safer, more effective and convenient medical solutions. An expert in the 505(b)(2) pathway, ASG's core advantage lies in its proprietary aPPC (Aero-Particles Process Control) technology, which translates to high-barriers to entry and innovative medical device development capabilities. With R&D laboratory established in Taiwan, and additional business units strategically positioned in Mainland China, Southeast Asia, and North America, ASG is well placed to take advantage of new product development and commercialization opportunities worldwide.

SOURCE ASG-Asia Scientific Global