Mankind Pharma gets CDSCO nod to begin Ph 1 trials of novel autoimmune drug candidate MKP11093

September 08, 2025 | Monday | News

MKP11093 disrupts the JAK/STAT signaling pathway and reduces the activity of several pro-inflammatory cytokines

image credit- shutterstock

image credit- shutterstock

Mankind Pharma 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. This makes it a unique treatment candidate with the potential to deliver better outcomes in autoimmune diseases.

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.

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