Mankind Pharma gets CDSCO nod for Phase 1 trials for novel autoimmune drug

Mankind Pharma has received CDSCO approval to initiate Phase 1 trials of MKP11093, a novel JAK-1 inhibitor for autoimmune disorders, as part of its expanding R&D pipeline

Delhi-based drugmaker Mankind Pharma has received an approval from the Central Drugs Standard Control Organisation (CDSCO) to initiate phase-1 clinical trials of its novel autoimmune drug candidate, the company said on Monday.

 

The molecule, MKP11093, an orally administered Janus Kinase-1 (JAK-1) inhibitor, is being developed for the treatment of multiple autoimmune disorders such as rheumatoid arthritis, ulcerative colitis, plaque psoriasis and alopecia.

 

JAK-1 inhibitors are a type of medication that blocks the JAK-1 enzyme, which is involved in signalling pathways that cause inflammation and immune system overactivity in certain autoimmune and inflammatory conditions.

 

The company added that phase-1 trials are 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 development of MKP11093 is a major milestone representing the company’s endeavour to deliver a best in class JAK inhibitor that maximises therapeutic potential while addressing the safety concerns associated with conventional approaches,” Arjun Juneja, chief operating officer (COO) at Mankind Pharma said.

 

This comes at a time when Mankind has been focusing on creating a pipeline of novel therapies, investing ₹264 crore in research and development (R&D) during FY25. 

 

Apart from autoimmune disorders, the drugmaker has also been looking at metabolic diseases such as oncology, diabetes and obesity.

 

This includes first-in-class novel therapeutics for melanoma and lung cancer, as well as development of molecules that reenergise T cells to maintain anti-tumour activity across solid tumours.

 

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

 

With six R&D centres and a strong portfolio spanning complex generics, biologics, and new chemical entities, the drugmaker is now looking to position itself as a future-ready biopharmaceutical company.

 

“Our R&D strategy is focussed on expanding our innovation pipeline by developing niche complex molecules, investing in specialty research and scaling capabilities to meet global standards,” Mankind Pharma stated in its annual report for 2024-25.