The active ingredient of VG-01 used in the toothpaste have a very low cost per tube. Moreover, we have established a close and fluid relationship with the active ingredients suppliers for the purpose of facilitating the industrial production of VG-01 in all possible aspects. We have finished a clinical trial so we are in the third stage. Within this stage, we have carried out a first-in-human trial.
Besides, the steps to validate a medication according to the AEMPS can be summarized in:
|1. Basic Research Stage|| Completed.|
Vitalgaia has already passed this stage, since the discovery is significantly and its in vitro efficacy fully proven.
|2. Preclinical research||Vitalgaia has tested the product and its stability in gels and creams, obtaining a suitable formulation for its administration. It has been passed directly to clinical trials since both products have been consumed by humans for years, so they were completely safe.|
|3. Clinical research||Vitalgaia has carried out a study on 23 patients diagnosed with oropharyngeal mucositis due to Candida albicans and other species, secondary to treatment with chemotherapy and, therefore, immunosuppressed. The results demonstrated the efficacy of VG-01 in this type of extremely complex patients and there were no moderate or severe adverse reactions. Therefore, we are already in a position to start a phase 3 study or the sample treated in phase 2 can be expanded, if requested by the corresponding Agency.|
|4. Marketing Authorization||In process.|
Marketing authorization is granted on the basis of scientific criteria on the quality, safety and efficacy of the drug in question, as well as the need to identify treatments for populations with special needs, orphaned by therapies or with therapies of this level of complexity that impede real access to therapeutic innovation. These criteria allow evaluating the relationship between the benefits and risks of the drug for the diseases and situations for which it is approved. In case of requiring additional information contact us, please.