Akums Gets CDSCO Panel Nod to Study Cilnidipine, Telmisartan FDC film-coated tablet

This came after the drug major Akum Pharmaceutical presented the Phase IV clinical trial protocol of cardiovascular FDC drug Cilnidipine plus Telmisartan film-coated tablet in accordance with the condition mentioned in permission in Form CT-23 dated 06.01.2023.

Cilnidipine belongs to a class of medicines called calcium channel blockers which are primarily taken for the treatment of hypertension (high blood pressure) and angina (chest pain).

Cilnidipine is a recently developed CCB and possesses both L- and N-type calcium channel-blocking activity. Since N-type calcium is distributed along the nerve and in the brain, cilnidipine is anticipated to exert specific action on nerve activity, such as inhibition of the sympathetic nervous system.

Telmisartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so blood can flow more easily.

Telmisartan is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly.

At the recent SEC meeting for Cardiovascular and Renal held on 21st September 2023, the expert panel reviewed the Phase IV clinical trial protocol of the cardiovascular FDC drug Cilnidipine plus Telmisartan film-coated tablet.

After detailed deliberation, the committee recommended for conduct of the Phase IV clinical trial.

In accordance with the above, the expert panel suggested that the firm should submit the Phase IV clinical trial report to CDSCO for further review by the committee.

Also Read:Zydus gets CDSCO permission to begin PCSK9 inhibitor Phase I clinical study