Mankind Pharma has received approval from India’s Central Drugs Standard Control Organisation (CDSCO) to begin a Phase I clinical trial of its novel autoimmune therapy MKP11093, an oral JAK-1 inhibitor designed to treat multiple immune-related disorders.
What the Approval Means
The CDSCO authorisation, granted on 8 September 2025, allows Mankind Pharma to test MKP11093 in healthy volunteers. The study will assess safety, tolerability, and pharmacokinetics, including both single and multiple ascending doses, before advancing to later-stage trials.
The approval underscores India’s growing role in developing advanced therapies and highlights Mankind Pharma’s ambition to expand beyond generics into novel research-driven drugs.
About MKP11093 and Its Mechanism
MKP11093 is an oral selective JAK-1 inhibitor developed at the Mankind Research Centre. By blocking the Janus kinase (JAK)/signal transducer and activator of transcription (STAT) pathway, the molecule aims to reduce the activity of pro-inflammatory cytokines associated with autoimmune diseases.
The candidate drug is being investigated for rheumatoid arthritis, ulcerative colitis, plaque psoriasis, and alopecia. According to Mankind Pharma, the compound is designed to balance strong efficacy with improved safety, addressing limitations observed in earlier JAK inhibitors such as tofacitinib (marketed as Xeljanz) and baricitinib (marketed as Olumiant).
The Phase I Trial Plan
The Phase I trial will enrol healthy volunteers to evaluate:
- Safety and tolerability
- Single ascending dose response
- Multiple ascending dose response
- Pharmacokinetics (drug absorption, distribution, metabolism, and excretion)
Such early trials are critical to establishing a drug’s baseline safety before studies in patients with autoimmune diseases.
Strategic Significance for Mankind Pharma
This development aligns with Mankind Pharma’s broader strategy to build a robust research pipeline. In fiscal year 2024-25, the company allocated ₹264 crore to research and development, a significant increase over previous years.
Another experimental candidate, MKP10241, has already moved into Phase II studies for the treatment of obesity and diabetes. Analysts say the progress of MKP11093 could help position Mankind Pharma as a competitive player in immunology drug innovation, an area traditionally dominated by multinational companies.
Broader Context: JAK Inhibitors in Autoimmune Care
JAK inhibitors have transformed treatment options for immune-mediated diseases but face scrutiny for potential safety concerns, including cardiovascular risks and infection susceptibility. Regulators such as the U.S. Food and Drug Administration (FDA) have imposed strict warnings on earlier drugs in the class.
By pursuing a selective JAK-1 approach, Mankind Pharma aims to minimise these risks while maintaining clinical benefit. Dr. Rajeev Nair, a clinical pharmacologist at All India Institute of Medical Sciences (AIIMS), noted in an interview with The Economic Times that selective inhibitors “may represent the next stage in optimising immunomodulatory therapy if safety is adequately demonstrated.”
Looking Ahead
Enrolment for the Phase I trial is expected to begin in the coming weeks. If successful, the programme will advance to patient studies in India and potentially abroad.
While approval for a Phase I trial marks an important step, experts caution that drug development is a long and uncertain process. Only a small proportion of compounds that enter early human studies ultimately secure regulatory approval and reach patients.
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Conclusion
Mankind Pharma’s green light for the Phase I trial of MKP11093 reflects both the promise and the challenges of developing novel autoimmune treatments. The outcome of the study will determine whether this selective JAK-1 inhibitor can progress into later stages of development and contribute to expanding therapeutic options for patients with chronic immune disorders.
