Zydus’ Desidustat Gets Expert Panel Nod for Phase-III Trial in Cancer-Related Anemia
New Delhi: The Subject Expert Committee (SEC) on Haematology has recommended for grant of permission to conduct a Phase-III clinical trial for Desidustat Tablets 120 mg, developed by Zydus Lifesciences Ltd, aimed at evaluating its efficacy in treating chemotherapy-induced anemia among patients with solid tumors.
At its meeting held on April 8, 2025, the Expert Committee functional under the Central Drugs Standard Control Organisation (CDSCO) reviewed the clinical trial proposal and protocol submitted by the company. As per the minutes:
“The firm presented the proposal for grant of permission to conduct Phase-III clinical trial of Desidustat Tablets 120 mg along with Phase-III clinical trial protocol (protocol ref No. DESI.23.002, ver 01 dated 23/01/2025) before the committee.”
Zydus informed the committee that Desidustat tablets in 25mg, 50mg, and 100mg strengths have already been approved in India for the treatment of anemia in adult patients with Chronic Kidney Disease (CKD). The new study aims to assess the higher strength (120 mg) in a different patient population.
“After detailed deliberation,
“The committee recommended for grant of permission to conduct Phase-III clinical trial of Desidustat Tablets 120 mg for treatment of chemotherapy induced anemia in patients with solid tumor malignancy as per Protocol presented and submit the report to CDSCO for further necessary action.”
The move signals a possible therapeutic expansion for Desidustat beyond CKD-related anemia, as the company explores new indications in oncology.