Mankind Pharma Ltd., India’s fourth-largest pharmaceutical company, has received approval from the Central Drugs Standard Control Organisation (CDSCO) to begin a Phase 1 clinical trial of MKP11093, an innovative, 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.
Strong Preclinical Performance
Developed at the Mankind Research Centre, MKP11093 demonstrated encouraging results in preclinical studies with a strong safety and selectivity profile. The molecule works by specifically targeting JAK-1, one of the four enzymes in the JAK family (JAK1, JAK2, JAK3, TYK2). By blocking these enzymes, MKP11093 interrupts the JAK/STAT signaling pathway and lowers the activity of several pro-inflammatory cytokines. This targeted approach positions the drug as a promising candidate with the potential to improve outcomes in autoimmune diseases.
Leadership Perspective
Commenting on the milestone, Mr. 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 represents a major step forward in our mission to deliver a best-in-class JAK inhibitor that maximises therapeutic potential while addressing the safety concerns linked to conventional approaches.”
He further highlighted that this achievement reflects Mankind Pharma’s broader innovation agenda, driven by the expertise of over 730 scientists and supported by an expanding R&D ecosystem. By integrating advanced technologies, the company is accelerating drug discovery and development to bring forward differentiated treatments. Importantly, Mankind Pharma remains committed to making these innovations both accessible and affordable for patients in India and across global markets.
Trial Design and Next Steps
As per the press release, the Phase 1 clinical trial of MKP11093 will begin shortly. It will evaluate the drug’s safety, tolerability, and pharmacokinetics in healthy volunteers using single and multiple-ascending dose studies.
Expanding Research Pipeline
Established in 2012, the Mankind Research Centre has been leading several discovery programs targeting autoimmune disorders, metabolic diseases such as diabetes, obesity, and NASH, as well as oncology. Another promising candidate, MKP10241, has already completed Phase 1 trials and is currently in Phase 2 development for obesity and diabetes.