Zydus gets Phase III trial approval for Desidustat in Sickle Cell Disease
ZYDUSLIFE · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Zydus Lifesciences received approval to conduct a Phase III clinical trial of its drug Desidustat for Sickle Cell Disease, in collaboration with ICMR. The earlier Phase II trial successfully met its primary endpoint with favourable safety. The Phase III will be a 203-day study enrolling 164 patients. US FDA has granted Orphan Drug Designation for Desidustat for SCD and beta-thalassemia. Desidustat is already approved in India for CKD anemia and in China from March 2026.
Positive for pipeline. Phase III progress and US FDA orphan drug status strengthen long-term potential, though commercial revenue from SCD is still years away.