Project status

At present, we have obtained the permission (No.843 dated December 7, 2016) of regulatory authorities of the Russian Federation and have started clinical trials (CT) on healthy volunteers. Until December 2017, it is planned to complete the 1st phase of CT, prepare a protocol for the 2nd phase of CT, and submit a prepared dossier for permission to conduct the 2nd phase of CT according to therapy indications within 30 days after knee or hip replacement surgery. Until May 2018, it is planned to obtain permission to conduct the 2nd phase of CT. From June 2018 - start of the 2nd phase of CT, which, as now follows from the preliminary program for the 2nd phase of CT, can last 12-15 months.

Since the current project participants do not have their own resources for the 3rd phase of CT, there are various options for further promotion of the project. For example, as one of options - it is supposed that the project will be divided according to the territorial character of patents and licenses will be sold to those interested in development of the project in certain countries, and received funds will provide participation in further international studies, registration of the drug in the case of successful completion of 3rd phase of CT and entry of the drug into the market of the Russian Federation. In this case, it should be expected that the conduct of the 3rd phase according to therapy indications within 30 days after knee or hip replacement surgery, as well as the procedure for drug registration in the Russian Federation, will take from 18 to 24 months and end in the first half of 2021.

Later, at the post-registration stage, it is planned to expand indications of the drug for prevention and prophylaxis of deep vein thromboembolism, stroke and embolism in patients with nonvalvular atrial fibrillation.

 Description of existing patents and applications

• Patent or patent application for the invention “Urethanes, ureas, amides and related Xa factor inhibitors”

• Patent Application EAPO 201600486 dated June 15, 2016 “Pharmaceutical compositions comprising the N-(5-chloropyridin-2-yl)-2-({4-[ethanoydoyl(methyl)amino]benzoyl}amino)-5-methylbenzamide anticoagulant".
• Patents and patent applications: in 16 countries on the basis of PCT/ RU2011 / 000129 dated March 2, 2011. The intellectual property protection strategy was copied from Xarelto (Bayer)