MSN Lab gets CDSCO panel nod for Phase IV CT of Tofacitinib Tablets 10 mg

Tofacitinib is a Janus kinase (JAK) inhibitor used to treat rheumatic conditions, such as rheumatoid arthritis and ankylosing spondylitis, and ulcerative colitis.

Rheumatoid arthritis is an autoimmune disease characterized by a dysregulation of pro-inflammatory cytokines, including IL7, IL15, IL21, IL6, IFN-alpha, and IFN-beta. Cytokines signalling results in tissue inflammation and joint damage by stimulating the recruitment and activation of immune cells via the Janus kinase signalling pathway.

Tofacitinib is a partial and reversible janus kinase (JAK) inihibitor that will prevent the body from responding to cytokine signals. By inhibiting JAKs, tofacitinib prevents the phosphorylation and activation of STATs. The JAK-STAT signalling pathway is involved in the transcription of cells involved in hematopoiesis and immune cell function. Tofacitinib works therapeutically by inhibiting the JAK-STAT pathway to decrease the inflammatory response.

At the recent SEC meeting for Analgesic and Rheumatology, the expert panel reviewed the proposal presented by MSN Laboratories for the grant of permission to conduct a Phase IV Clinical Trial Protocol vide protocol No. 011/TFCB/MSN/2025, Version 1.0 dated 23.04.2025.

After detailed deliberation, the committee recommended approval to conduct the Phase-IV study as per the protocol presented by the firm.