Venus Remedies has received DCGI permission to conduct phase III clinical trials on a novel injectable aminoglycoside. The molecule was in-licensed from Chinese innovator company by Venus who has the exclusive marketing rights for this product in India. The molecule is a latest generation aminoglycoside in injectable form. The company expects to complete the studies in next 9 months time.

The drug is indicated for lower respiratory tract infections likely bronchitis, COPD, pneumonia, skin and skin structure infections, sexually transmitted diseases, urinary tract infections, digestive tract infections and surgical infections caused by various pathogens. Intellectual property rights for this product have already been protected. Innovator company in China has the worldwide patent for this product. The product has a huge potential as the current estimated market size in India is approximately Rs 600 crore and growing at a rate of 8 per cent.

The team of Venus Medicine Research Centre has been working on this novel aminoglycoside from the past two years. The study will be conducted on a minimum of 300 patients and will be an open labelled, randomized, multi-centric comparative study to evaluate the safety and efficacy of this drug with other aminoglycoside like Amikacin sulphate injection. Studies will be conducted under the supervision of Venus Clinical Research Services as per GCP guidelines issued by ICMR.

Aminoglycoside induced toxicities have been a cause of concern since long and this product is reported to be potentially very less nephrotoxic, ototoxic and neurotoxic as compared to other aminoglycosides. Reports of published clinical studies on humans have suggested that this product is more effective than any of the known aminoglycoside.