Mankind Pharma Gets CDSCO Nod for First-in-Human Trial of Novel JAK-1 Inhibitor

Mankind Pharma Gets CDSCO Nod for First-in-Human Trial of Novel JAK-1 Inhibitor

By, Admin 9 September 2025

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.

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