Mankind Pharma gets CDSCO nod for Phase 1 clinical trial of new molecule to treat autoimmune disorders

“This achievement underscores our broader innovation agenda at Mankind Pharma, powered by the expertise of over 730 scientists and supported by an expanding R&D ecosystem. By integrating advanced technologies, we are accelerating discovery and development to bring forward differentiated treatments that can make a meaningful impact on patients’ lives – with a strong focus on ensuring that such innovations are accessible and affordable to those who need them most, both in India and globally,” he added.

The Phase 1 trial is expected to begin shortly and will evaluate the safety, tolerability, and pharmacokinetics of MKP11093 in healthy volunteers through single and multiple-ascending dose studies.

The molecule works by targeting JAK-1—one of the key enzymes in the JAK family (JAK1, JAK2, JAK3, TYK2). By blocking these enzymes, MKP11093 disrupts the JAK/STAT signaling pathway and reduces the activity of several pro-inflammatory cytokines.

This makes it a unique treatment candidate with the potential to deliver better outcomes in autoimmune diseases, the company said in a statement.

Established in 2012, the Mankind Research Centre is driving several discovery programs in autoimmune disorders, metabolic diseases such as diabetes, obesity, and NASH, as well as oncology, the statement added.

Another candidate from its pipeline, MKP10241, has successfully completed Phase 1 studies and is currently in Phase 2 development for obesity and diabetes, it added.