Hetero Biopharma Gets CDSCO Panel Nod for Phase IV Trial of Denosumab Injection in Cancer Patients
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to Hetero Biopharma Limited to conduct a Phase IV multi-centric, post-marketing clinical trial of Denosumab Injection 120 mg/0.7 ml.
The decision was taken during the SEC meeting held on August 20, 2025, at CDSCO headquarters in New Delhi.
The firm presented its proposal for a Phase IV clinical trial titled “A Phase IV Multi-Centric, Post-Marketing Study Evaluating the Safety, Immunogenicity and Efficacy of the Marketed Formulation of Hetero-Denosumab in patients with Advanced Malignancies involving Bone or Giant Cell Tumour of Bone” (Protocol No. HCR/IV/DENOSOL/01/2025, Version 1.0 dated March 18, 2025).tr6
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.