Zydus Life gets nod for Phase III Sickle Cell trial of Desidustat with ICMR
Zydus Lifesciences received approval for a Phase III clinical trial of Desidustat for sickle cell disease patients, in collaboration with ICMR. The trial will enroll 164 patients and evaluate efficacy and safety. Desidustat previously received Orphan Drug Designation from the US FDA for SCD and beta-thalassemia.
The progression to Phase III trials is a significant step, but the ultimate market impact depends on trial success, regulatory approvals, and market adoption. The Orphan Drug Designation also offers potential benefits. However, it is not a direct revenue-generating event yet.
The approval for a Phase III trial for a novel drug candidate in a significant unmet medical need area like Sickle Cell Disease is a positive development for the company.
Zydus Lifesciences Limited has received approval to conduct a Phase III clinical trial for Desidustat, an oral tablet, in patients with sickle cell disease. This trial, a collaboration with the Indian Council of Medical Research (ICMR), aims to evaluate the efficacy and safety of Desidustat in treating anemia in sickle cell disease patients. The study will be a double-blind, randomized, placebo-controlled, parallel, multicentre trial and will enroll 164 patients. This development follows the successful completion of a Phase II Proof-of-concept (PoC) trial, which met its primary endpoint and demonstrated positive outcomes. Desidustat has previously received Orphan Drug Designation (ODD) from the US FDA for treating sickle cell disease and beta-thalassemia. The drug was approved by the Drug Controller General of India (DCGI) in March 2022 for anemia in chronic kidney disease (CKD) patients and by China's National Medical Products Administration (NMPA) in March 2026 for renal anemia in CKD patients. Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, highlighted the company's commitment to developing novel therapeutic options for sickle cell disease patients, while Dr. Rajiv Bahl from ICMR emphasized the potential of this Indian innovation in addressing a significant health challenge through public-private partnerships.
The Phase II trial indicated that Desidustat was well tolerated with minimal adverse events, showing a promising trend towards improved Hb levels and higher responder rates compared to placebo. The reported treatment-emergent adverse events were mild and comparable across cohorts, with no serious adverse events reported. Desidustat is a hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) that stimulates endogenous erythropoietin (EPO) production.
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