Synokem Pharmaceutical Gets CDSCO Panel Nod To study Tofacitinib Extended Release Tablets

New Delhi: Synokem Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase IV clinical trial of Tofacitinib Extended Release Tablets 11 mg.

However, this approval is subject to the condition that the firm include serum NT-pro BNP in the screening tool for participant recruitment to rule out 'significant cardiovascular disease'.

Furthermore, the expert panel stated that a serum lipid profile shall be performed on the last follow-up visit.

This came after Synokem Pharmaceutical presented active postmarketing surveillance (PMS) study protocol No. CT22-004, version No.01 dated 25.11.2022 before the committee.

Tofacitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system. Tofacitinib is used alone or together with other medicines (e.g., DMARDs) to treat moderate to severely active rheumatoid arthritis, active psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and polyarticular course juvenile idiopathic arthritis (pcJIA) in patients who have taken other medicines.

At the recent SEC meeting for analgesics and rheumatology held on February 25, 2025, the expert panel reviewed the active PMS study protocol No. CT22-004, version No.01 dated 25.11.2022.

After detailed deliberation, the committee recommended conducting a Phase IV Clinical Trial as per protocol presented by the firm with the following changes:

1) To include serum NT-pro BNP in the screening tool for participant recruitment to rule out 'significant cardiovascular disease'.

2) Serum lipid profile shall be performed on the last follow up visit.

Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO.

Also Read:Synokem Pharmaceutical Gets CDSCO Panel Nod To Study Anti-rheumatoid drug Iguratimod