Mankind Pharma, 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, its novel, orally administered Janus kinase-1 (JAK-1) inhibitor.
Targeting Autoimmune Disorders
MKP11093 is being developed to treat multiple autoimmune conditions, including:
- Rheumatoid arthritis
- Ulcerative colitis
- Plaque psoriasis
- Alopecia
The candidate, discovered at the Mankind Research Centre, has shown strong preclinical data with promising safety and selectivity. By selectively blocking JAK-1, the molecule disrupts the JAK/STAT signalling pathway, dampening pro-inflammatory cytokine activity.
Executive Commentary
Arjun Juneja, COO, Mankind Pharma:
“MKP11093 represents our endeavour to deliver a best-in-class JAK inhibitor that maximises therapeutic potential while addressing safety concerns of conventional approaches. This milestone reflects our innovation agenda powered by 730+ scientists, advanced technologies, and our commitment to ensuring access and affordability for patients in India and globally.”
Trial Details
- Design: Phase 1 study in healthy volunteers.
- Focus: Safety, tolerability, pharmacokinetics.
- Approach: Single- and multiple-ascending dose studies.
- Next Steps: Trial initiation expected shortly.
Broader R&D Pipeline
Since its establishment in 2012, the Mankind Research Centre has advanced multiple discovery programs in:
- Autoimmune disorders
- Metabolic diseases (diabetes, obesity, NASH)
- Oncology
Another pipeline candidate, MKP10241, has already completed Phase 1 and is in Phase 2 for obesity and diabetes.