Developers: | PeptidePro (PeptidPro) |
Date of the premiere of the system: | 2022/06/27 |
Branches: | Pharmaceuticals, Medicine, Healthcare |
Main article: Infertility
2022: Entering the market and obtaining state registration
On June 27, 2022, PeptidPRO announced that it would enter the market and receive state registration for three injectable drugs: Vesusten, Fertiwell, Slavinorm. Read more here.
According to the company, Fertiwell is an organ-specific non-hormonal drug for the treatment of various forms of male infertility, which has been proven in clinical trials according to GCP standards.
Fertywell is a prescription medicinal injection preparation consisting of a complex of regulatory peptides with a molecular weight of not more than 10 kDa, isolated from testes. Based on the results of a double-blind, placebo-controlled, multicenter phase III clinical study of Fertiwell for spermatogenesis disorders (CT TST-06-2019), the following were noted:
- Significant statistically significant therapeutic response;
- 3-fold increase in sperm concentration;
- 2-fold increase in the absolute number of progressively mobile sperm with a placebo effect exceeding 3.4 times immediately after the end of the course and 5 times 3 weeks after the end of therapy;
- An increase in the absolute number of morphologically normal sperm forms compared with baseline data by 2.6 times 3 weeks after completion of the course;
- Persistence of effects with respect to spermogram parameters for at least 3 weeks after the end of the course, i.e. prolonged action due to the effect of the peptide cascade;
- Appropriate safety profile (comparable to placebo).