Ascendia Pharmaceuticals Develops Novel Nanoemulsion IV Formulation for Clopidogrel That Received IND Approval
Ascendia Pharmaceuticals CEO Jim Huang, PhD, recently announced Ascendia’s patented Emulsol® nanotechnology has been used to develop a novel nanoemulsion IV formulation for clopidogrel that has received Investigational New Drug (IND) approval from the US Food & Drug Administration (FDA). Ascendia, a leading specialty CDMO, developed the formulation in partnership with AcuteBio, LLC.
Ascendia and AcuteBio are establishing an improved treatment method for coronary artery disease (CAD). It is particularly beneficial for stent placements. For example, an oral dose has a 2- to 5-hour onset of action, while IV delivery allows for immediate onset of action, so stents can be inserted to remove blockages in significantly less time. The FDA IND approval validates Ascendia Pharma’s EmulSol technology platform.
“The idea of a clopidogrel IV formulation advancing to a Phase 1 human clinical study is important, as clopidogrel is the recognized gold standard that will lead to better quality of life for patients. Many other reputable pharmaceutical companies have attempted to develop such a formulation but have been unsuccessful. Our achievement is another milestone that hallmarks how Ascendia Pharmaceuticals continues to Make the Impossible Possible by leveraging our nanotechnologies,” said Dr. Huang. “We look forward to assisting AcuteBio advance this delivery method to market.”
EmulSol is one of four proprietary nanotechnology platforms developed by Ascendia. The others are AmorSol®, NanoSol®, and LipidSol®. These nanotechnologies represent tremendous advantages in drug development and have proven track records in overcoming bioavailability, solubility, and stability challenges.
AcuteBio, LLC is a specialty biopharmaceutical company that concentrates on developing novel pharmaceutical products that fulfill unmet market needs. Its current product portfolio and pipeline focus on treatments for acute cardiovascular and dry eye diseases.
Ascendia Pharmaceuticals is a leading specialty CDMO that makes the insoluble soluble through a comprehensive suite of pre-formulation, formulation development, cGMP manufacturing, and ICH stability services for a variety of dosage forms using its proprietary enabling nano-technologies including nanoemulsions, nanoparticles, lipid nanoparticles, and amorphous solid dispersions technology platforms. The company built its foundation of success on its customer-centric culture that cultivates its BEST philosophy (Brilliant technology, Excellent service, Superior quality, and Trust).
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