Shilpa Medicare Concludes phase 1 trial for volume replacement therapy

Shilpa Medicare has effectively finished its phase 1 clinical trial for its leading product, sRbumin, a recombinant human albumin 20% (rHA). Human serum albumin is crucial for different medical interventions, including fluid replacement therapy for injuries, burns, and surgical procedures.

The Raichur company provides APIs, formulations, and biologics, operating facilities that are approved by major regulatory agencies. The company is also acknowledged for offering comprehensive turnkey CDMO solutions to clients worldwide.

The favorable outcomes highlight the potential of rHA as a suitable substitute for plasma-derived human serum albumin, filling a crucial need in worldwide healthcare. The phase 1 clinical trial involved 62 healthy volunteers and was randomized, dose-escalating, and comparative against European-sourced human-derived serum albumin. The objective was to assess the safety, effectiveness, and pharmacokinetics of rHA at varying doses. The company claimed to be the first pharmaceutical company in India to reach this milestone.

We will begin phase-3 studies from this point and at the same time, we will consult various regulatory agencies for their input on our clinical study protocol. Developing this took us over 5 years. It will assist us in qualifying various excipient grade end users. The successful results of the phase I trial serve as a testament to our company's ability to progress a new biological product from animal testing to commercialization, as well as our expertise in developing intricate molecules like Albumin. We are optimistic about the prospect of additional new opportunities, stated Vishnukanth Bhutada, CMD of Shilpa Medicare.