Synokem Pharmaceutical Gets CDSCO Panel Nod To Study Anti-rheumatoid drug Iguratimod
New Delhi: Suggesting to specify the eGFR (Modification of Diet in Renal Disease Formula) or chronic kidney disease (CKD) stage in the exclusion criteria, the Subject Expert Committee SEC functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to Synokem Pharmaceuticals to conduct a Phase IV clinical trial of iguratimod tablets 25 mg.
However, in addition to the above, the committee opined the firm that serum NT-proBNP be included as a screening tool for significant cardiovascular disease.
This came after the firm presented Phase IV Clinical Trial Protocol No. CT22-005, Version No. 01, dated 03.12.2022, before the committee.
Iguratimod (IGU) is a disease-modifying anti-rheumatic drug (DMARD) that treats rheumatoid arthritis (RA) and other autoimmune diseases. It's also used to treat ankylosing spondylitis, interstitial lung disease, and other rheumatic diseases.
Iguratimod inhibits citrulline protein expression in neutrophils of patients with rheumatoid arthritis at an appropriate concentration, similar to MTX and dexamethasone; the inhibitory effect is mediated by the down-regulation of peptidylarginine deiminase.
At the recent SEC meeting for analgesics and rheumatology held on February 25, 2025, the expert panel reviewed Phase IV Clinical Trial Protocol No. CT22-005, version No. 01, dated 03.12.2022.
After detailed deliberation, the committee recommended conducting a Phase IV clinical trial as per the protocol presented by the firm with the following changes:
- Firm need to specify the eGFR (MDRD formula) or CKD stage in the exclusion criteria, serum NT-proBNP to be included as screening tool for significant cardiovascular disease.
Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO.
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