NEOHEP ® A new hepatoprotector drug
1. Basic data
1.1. A synthetic hepatoprotector of a new class of violuric acid derivatives – NeoHep®.
1.2. Created is a new chemical compound which shows pronounced hepatoprotector activity. It prevents death and destruction of hepatic cells subject to exposure to chemical and toxic action.
1.3. The chemical compound named NeoHep® is innovatively structured and has no direct analogues in terms of its range of activity.
2. Fields of application and estimate of the potential market for NeoHep®
2.1. Treatment of the whole range of hepatitides:
- Viral hepatitides (caused by viruses A, B, C, D, Е, G)
- Drug-induced hepatitides
- Alcohol-induced cirrhosises
- Autoimmune hepatic lesions
2.2. NeoHep ® can be made in various dosage forms: tablet-form, infusion solution.
3. Disadvantages of analogues and advantages of the newly developed drug
3.1. No direct analogues of this drug are known to the authors. Available in the pharmaceutical market are hepatoprotectors (Carsil, Essentiale, ursodesoxycholic acid derivatives), however the majority of them are phytogenous and show no proved level of efficiency.
4. Degree of development completeness
4.1. The drug has successfully passed preclinical tests in Russia.
4.2. The efficiency is estimated on laboratory animals and cell cultures (hepatic lesions caused by CCL4 and dichloroethane on mice, rats, dogs). The estimation of efficiency of the drug was carried out in terms of change of the level of ALT, AST, bilirubin, ceruloplasmin, lactate dehydrogenase, cytochrome р450 and b5, IFN-α, in terms of change of the histological picture of the liver, according to the international standards..
4.3. The range and level of biological activity is determined.
4.4. A technology for producing the substance under semi-industrial and industrial conditions is developed.
4.5. A high-yield one-phase synthesis of the active pharmaceutical substance and ready-to-use dosage form (capsules and infusion solution) is arranged.
4.6. NeoHep ® is cost-effective.
5. Protection of the intellectual property
5.1. The patent in the Russian Federation is obtained
5.2. The international patent application (PCT) is filed
5.3. The trade mark is protected