AstraZeneca gets CDSCO panel Nod To study antihypertensive drug Baxdrostat
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III Clinical study of antihypertensive drug, Baxdrostat Tablets 1mg/ 2mg/Placebo.
However, this approval is subject to the condition that at least 50% of trial sites should be govt. sites and at least 50% of subjects shall be enrolled from govt. sites.
In addition, the expert panel suggested that investigators in the study should be cardiologists only. Furthermore, it is stated that the co-medication and other treatments including follow should be borne by the sponsor.
This came after the firm presented Phase III Clinical Study Protocol No. D6970C00002.
Baxdrostat is a selective aldosterone synthase inhibitor that significantly lowers blood pressure in patients with resistant hypertension. Baxdrostat targets aldosterone synthase, encoded by the CYP11B2 gene. Importantly, the drug has a low affinity for the enzyme responsible for cortisol synthesis, which is also encoded by the CYP11B1 gene.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.