In December 2017, IPHARMA received four approvals from the Ministry of health of the Russian Federation to conduct clinical trials. And, according to the results of 2017 (15 approvals), entered the TOP-3 CROs.

- BE study of Aberon (abiraterone acetate)

- Phase I study of the medicinal product BI-MAB-03 (Trastuzumab)

- Phase III study of the medicinal product OKITASK® (ketoprofen lysine salt)

- Phase I study of the medicinal product Vesustim®

Aberon (abiraterone acetate) is an antitumor hormonal agent developed by JV Pharmland LLC.

The purpose of the Aberon clinical study is to assess bioequivalence of Aberon [T] in comparison to Zitiga® after single fasting dose in healthy male volunteers.

Therapeutic area: oncology.

BI-MAB-03 (Trastuzumab) is developed by BioIntegrator LLC as a lyophilizate for the preparation of infusion solution.

The purpose of the BI-MAB-03 clinical study is to assess the safety, tolerability, pharmacokinetics and immunogenicity of the biosimilardrug BI-MAB-03 compared to the original drug Herceptin® in healthy volunteers.

Therapeutic area: oncology.

OKITASK® is a propanoic acid in the form of a salt with L-lysine developed by Dompé farmaceutici s.p.a.

The purpose of the OKITASK® clinical study is to assess the efficacy and tolerability after single dose of ketoprofen lysine salt granules versus placebo in male and female subjects with acute pain syndrome after removal of molar teeth.

Therapeutic area: dentistry.

Vesustim® is an extract from the bladder of calves developed by SIA Peptides LLC.

The purpose of the Vesustim® clinical study is to assess safety and tolerability of single and following multiple escalating doses of the Vezustim® drug after a single and subsequent multiple intramuscular injection.

Therapeutic area: urology.


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