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Ascendia Pharmaceuticals Receives IND Approval for Novel Nanoemulsion IV Formulation of Clopidogrel

Wednesday, June 28, 2023

Ascendia Pharmaceuticals CEO, Dr. Jim Huang, Ph.D., has announced a groundbreaking achievement in pharmaceutical research and development. Ascendia's proprietary EmulSol® nanotechnology has been instrumental in the creation of a unique nanoemulsion IV formulation for clopidogrel, which has recently obtained Investigational New Drug (IND) approval from the Food and Drug Administration (FDA). This groundbreaking formulation is the result of a collaborative effort between Ascendia Pharmaceuticals, a leading specialty CDMO, and AcuteBio, LLC.

The primary objective of this partnership is to revolutionize the treatment of coronary artery disease (CAD), with a specific focus on improving the effectiveness of stent placements. Unlike the traditional oral administration of clopidogrel, which typically takes two to five hours to take effect, the nanoemulsion IV formulation enables an immediate onset of action. This significant advancement allows for much shorter timeframes in performing stent insertions, leading to quicker removal of blockages and improved patient outcomes.

The FDA's approval of the IND application is a validation of Ascendia Pharma's EmulSol technology platform, underscoring its efficacy and safety in developing innovative pharmaceutical solutions. This achievement further solidifies Ascendia's position as an industry leader, demonstrating their unwavering commitment to advancing drug delivery methods and enhancing patient care, particularly in critical therapeutic areas like CAD.

According to Dr. Huang, CEO of Ascendia Pharmaceuticals, the advancement of a clopidogrel IV formulation to Phase 1 human clinical study is a significant milestone. He emphasized that clopidogrel is widely recognized as the gold standard and its availability in IV form can greatly enhance the quality of life for patients. While other reputable pharmaceutical companies have previously attempted but failed to develop such a formulation, Ascendia's achievement showcases their commitment to pushing boundaries and making the seemingly impossible possible through their nanotechnology expertise. Dr. Huang expressed eagerness to support AcuteBio in further progressing this innovative delivery method towards commercialization.

Ascendia Pharmaceuticals has successfully developed four proprietary nanotechnology platforms: EmulSol, AmorSol, NanoSol, and LipidSol. These platforms offer substantial advantages in drug development, effectively addressing challenges associated with bioavailability, solubility, and stability. Ascendia's nanotechnologies have a proven track record of overcoming these obstacles, underscoring their potential to revolutionize the pharmaceutical industry.

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