Shares of Shilpa Medicare rose 6.40% on BSE on Monday, and were trading at Rs 741.90 at 12 noon, on company's announcement of successfully completion of phase-3 clinical studies of its novel product SMLNUD07 - Nor Ursodeoxycholic Acid (NorUDCA) tablets for treatment of patients suffering from Nonalcoholic Fatty Liver Disease (NAFLD).The multicentric, placebo controlled double blinded study trial was conducted on a total 165 nonalcoholic fatty liver disease (NAFLD) patients across India.

Shilpa Medicare股价周一因疯牛病上涨6.40%，中午12点收于741.90卢比，该公司宣布成功完成其新产品SMLNUD07-去甲熊去氧胆酸（NorUDCA）片剂的3期临床研究，用于治疗非酒精性脂肪肝（NAFLD）患者。这项多中心，安慰剂对照的双盲研究试验在印度共对165名非酒精性脂肪肝病（NAFLD）患者进行。

There were no serious adverse events reported in this phase 3 study and the treatment was well tolerated at the dose of 1500 mg per day for the duration of 24 weeks.The trial resulted in significant, at least one stage, decrease in liver fibrosis. Additionally, there was a significant reduction in fat accumulation in the liver.

在这项3期研究中没有报告严重的不良事件，并且在24周内每天1500毫克的剂量下治疗耐受性良好。该试验导致肝纤维化显着（至少一个阶段）减少。此外，肝脏中的脂肪积累显着减少。

Also a significant normalization of Alanine Aminotransferase (ALT) was conclusively demonstrated in this study.'These results indicate that NorUDCA could become a new standard of care with significant improvements in restoring liver function in NAFLD patients,' Shilpa Medicare said in a statement to stock exchanges.Shilpa Medicare Ltd plans to submit these phase 3 clinical trial findings at the earliest to the CDSCO, India for seeking marketing authorization in India.NorUDCA is likely to be a first-in-class treatment option for NAFLD in India and has significant advantages over UDCA like enhanced choleretic effect, resistance to amidation, anti-inflammatory properties and reduction in fibrosis.“We are very pleased with the successful Phase III trials outcome for this unique product addressing the unmet need of patients suffering from NAFLD with a potential first line of treatment,' said Vishnukant Bhutada, managing director Shilpa Medicare.NAFLD is the most common.

这项研究也最终证明了丙氨酸氨基转移酶（ALT）的显着正常化。”Shilpa Medicare在向证券交易所发表的声明中表示，这些结果表明，NorUDCA可能成为一种新的护理标准，可以显着改善NAFLD患者的肝功能。Shilpa Medicare Ltd计划最早将这些3期临床试验结果提交给印度CDSCO，以寻求在印度的营销授权。NorUDCA可能是印度NAFLD的一流治疗选择，并且与UDCA相比具有显着优势，如增强的利胆作用，抗酰胺化，抗炎特性和减少纤维化。Shilpa Medicare董事总经理Vishnukant Bhutada说：“我们对这种独特产品的成功III期临床试验结果感到非常高兴，这种产品可以解决NAFLD患者的未满足需求，并提供潜在的一线治疗。”NAFLD是最常见的。