Mankind Pharma wins CDSCO nod to start Phase 1 trials of Autoimmune drug candidate
Mumbai: Mankind Pharma Ltd., a pharmaceutical company, has announced that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to initiate a Phase 1 clinical trial of MKP11093, a novel, orally administered Janus kinase-1 (JAK-1) inhibitor.
The molecule is being developed for the treatment of multiple autoimmune disorders, including rheumatoid arthritis, ulcerative colitis, plaque psoriasis, and alopecia.
Developed at the Mankind Research Centre, MKP11093 has shown strong results in preclinical studies with a promising safety and selectivity profile. 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.
Speaking on the development, Arjun Juneja, Chief Operating Officer, Mankind Pharma, said, “At Mankind Research Centre, we are advancing a pipeline of innovative therapies across high-burden therapeutic areas where significant unmet needs exist. The development of MKP11093 is a major milestone in this effort, representing our endeavour to deliver a best-in-class JAK inhibitor that maximises therapeutic potential while addressing the safety concerns associated with conventional approaches. 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.”
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. 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. Another candidate from its pipeline, MKP10241, has successfully completed Phase 1 studies and is currently in Phase 2 development for obesity and diabetes.
