Approved products in the AT-Closed Vial®

From preclinical to commercial approval

Before any new medicine can be made available to patients, it must go through a rigorous process known as product approval. This ensures that the drug is safe, effective, and manufactured to the highest quality standards. The journey typically begins with preclinical studies, followed by three key clinical trial phases: Phase I tests safety in a small group of healthy volunteers, Phase II assesses how well the drug works and determines the optimal dose, and Phase III confirms its effectiveness and monitors side effects in a larger patient population.

Once all trial data is collected, the manufacturer submits it to health authorities for review. These include, but is not limited to, the FDA (United States), EMA (European Union), MHRA (United Kingdom), PMDA (Japan), Health Canada, and the TGA (Australia). If the results meet the required standards, the product receives marketing authorization, meaning it can be commercialized and prescribed to patients. Below, we proudly present the therapies that have reached this important milestone using our AT-Closed Vial® technology.