A fundamentally new infertility drug made in Russia will be launched by 2021

Print 19 December 2017
GMP News

A fundamentally new infertility medication was developed in Obninsk. It is expected to be launched in 2021. The trade name is yet unknown.

Currently, the drug is presented to scientific community under a tentative name of PAM-8. The acronym “PAM” stands for the Park of Active Molecules located in Obninsk and engaged in the development and promotion of promising medicinal products. PAM-8 is at the stage of clinical trials.

This is a non-hormonal drug. It is based on a molecule that stimulates the formation of stem female and male germ cells.

“It will help women with impaired follicular reserve, who have reduced number of eggs in the body,” said Ekaterina Bondarenko, a researcher at the Park of Active Molecules and Candidate of Biological Sciences. “But, it is primarily designed for men. The drug increases the sperm motility and has a positive effect on its viability.”

The medication demonstrated high efficacy and produced an interesting side effect in the form of increased libido in some men. The phase II of trials was successfully completed this year. The final phase III of trials will be conducted in 2018, when the action of the drug will be tested on hundreds of patients in 20 clinics.

The negotiations on manufacturing the drug are currently underway with Russian pharmaceutical companies. A substance, which is already registered with the Ministry of Health, is used as a base for the drug and manufactured by Medbiopharm in Obninsk.

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