TAH3311, a first-of-its-type anticoagulant agent administered orally as a water-free dissolving film, has successfully completed its major clinical trial. The completion was announced in a press release from TAHO Pharmaceuticals Ltd., the manufacturer of the agent.
To produce TAH3311, TAHO Pharmaceuticals applied its experience in developing its proprietary transepithelial delivery system, a set of advanced transmucosal and transdermal methods for pharmacotherapy delivery. The recently concluded study compared TAH3311 with tablet-form apixaban in a cohort of 60 healthy volunteer participants within the bioequivalence regulatory framework.
“The completion of this pivotal study is a significant step forward in TAHO’s mission to bring innovative Transepithelial Delivery System (TDS) drug delivery solutions to patients worldwide,” commented TAHO Pharmaceuticals Chairman and Chief Executive Officer Howard Lee, PhD.
The TAH3311 study was conducted by TAHO Pharmaceuticals in close coordination with both the FDA and the European Medicines Agency, and the agent is under clinical development within the 505(b)(2) regulatory pathway. The company is currently planning regulatory submissions in both the US and Europe and working to accelerate a global commercial launch of the agent.
“As the first ODF [oral dissolving film] formulation in the anticoagulant space, TAH3311 has the potential to transform how these life-saving therapies are delivered, especially for patients who face difficulties with traditional tablet forms,” Dr. Lee remarked.
Reference
TAHO Pharmaceuticals completes pivotal trial of TAH3311, the first oral dissolving film anticoagulant. News release. PR Newswire. January 21, 2025. Accessed January 28, 2025.
© 2025 Mashup Media, LLC, a Formedics Property. All Rights Reserved.