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Mankind Pharma Receives CDSCO Nod for Phase 1 Trial of Autoimmune Drug

Synopsis:


Mankind Pharma gets CDSCO approval to begin Phase 1 trial of MKP11093, targeting autoimmune disorders. The oral JAK-1 inhibitor showed promising preclinical safety and selectivity. Phase 1 will assess safety, tolerability and pharmacokinetics in healthy volunteers.


Source:
Mankind Pharma Press Release (NSE Exchange Fillings) | Published on Sept 09, 2025

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

Mankind Pharma news today

As quoted in the press release from Mankind Pharma (BSE Exchange filings), the company received approval from CDSCO to begin the Phase 1 clinical study of its new molecule, MKP11093. This candidate, developed at the Mankind Research Centre is a JAK-1 inhibitor for the treatment of several autoimmune diseases, including: rheumatoid arthritis, ulcerative colitis, plaque psoriasis, and alopecia. You will note that obtaining this regulatory clearance is a step closer along the drug development pathway.

MANKIND PHARMA LIMITED

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2589.39.90 (0.38 %)

Updated - 09 September 2025
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Key Takeaways

  • CDSCO grants approval to initiate Phase 1 trial of MKP11093.

  • The molecule targets disorders including rheumatoid arthritis, ulcerative colitis, plaque psoriasis, and alopecia.

  • Preclinical studies indicate good safety and selectivity profiles.

  • Phase 1 will test safety, tolerability, and pharmacokinetics in healthy volunteers.

  • Mankind Pharma share price stands at ₹820.50 per share on the BSE as of 8 September 2025 at 15:30 PM IST.

Molecule Profile And Trial Structure

You may be interested to know that MKP11093 acts as an inhibitor of JAK-1, leading to inhibition of the JAK/STAT pathway, which helps impede the activity of inflammatory cytokines. This profile leads to targeted therapy which should lead to potential safety advantages. In phase 1 there are both single-ascending dose and multiple-ascending dose studies in healthy volunteers that will evaluate safety, tolerability and pharmacokinetic properties.

If you follow drug development you will see that human trials are a sign that the molecule cleared preclinical hurdles.

Pipeline Context And Development Ecosystem

You'll want to be aware of this also in the context of the overall research pipeline. Mankind is advancing MKP11093 with other drug candidates. For instance, MKP10241 has completed Phase 1, and is now in Phase 2 trials for obesity and diabetes indications. This fact shows you the depth of Mankind's R&D, balancing autoimmune targets with metabolic disease research.

Snapshot Table: Trial Overview

Aspect

Details

Molecule

MKP11093 (JAK-1 inhibitor)

Target Conditions

Rheumatoid arthritis, ulcerative colitis, plaque psoriasis, alopecia

Trial Phase

Phase 1 – Healthy volunteers

Objectives

Safety, tolerability, pharmacokinetics

Related Pipeline

MKP10241 at Phase 2 for obesity and diabetes

What This Means 

If you follow biomedical advances or pharmaceutical financings, this news indicates Mankind Pharma has made progress with a novel molecule moving through early development. One could consider that the transition from preclinical to human trials could change investor perceptiveness and cause the share price of Mankind Pharma to fluctuate accordingly based upon future safety and efficacy data. Presently, the share price context reflects anticipation which is tempered with the need for trial results.

Broader R&D Outlook

You may think of this approval as part of Mankind Pharma’s investment in innovation. By managing several candidates in a range of therapeutic areas, and navigating the subsequent clinical phases, it can be concluded that the company is building a diversified research profile. To any extent that MKP11093’s journey demonstrates one pole, the company’s R&D approaches demonstrate a far deeper impression of the company’s scientific aspirations and development direction.

Also read: TCS to Build AI-Powered Financial System for Odisha Government

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