Zydus Lifesciences just received Phase III clearance for Desidustat in sickle cell disease, in collaboration with ICMR. The 203-day multicentre trial will enrol 164 patients.
But to appreciate why this matters, you need to understand the drug itself.
What is Desidustat?
Desidustat is an oral molecule developed and discovered by Zydus, sold in India as Oxemia. It was approved by India's drug regulator (DCGI) in March 2022 to treat anaemia associated with chronic kidney disease (CKD). Since launch, it's treated more than 100,000 CKD patients in India.
What does "oral HIF-PH inhibitor" actually mean? This is the part that makes Desidustat clinically interesting.
HIF stands for Hypoxia-Inducible Factor, a protein your body naturally produces when tissues sense low oxygen (hypoxia).
PH stands for Prolyl Hydroxylase, an enzyme that normally breaks HIF down, keeping it inactive under normal oxygen conditions.
A HIF-PH inhibitor blocks that breakdown enzyme. With PH inhibited, HIF accumulates and signals the body as if it were in a low-oxygen state, even though it isn't.
The downstream effect: the drug stimulates endogenous erythropoietin production and iron utilization, essentially triggering the body's own machinery to make more red blood cells and use iron more efficiently, without injecting synthetic EPO.
This is a fundamentally different mechanism from older anaemia treatments (like injectable erythropoiesis-stimulating agents), and critically, it's an oral tablet, not an injection. That's a major convenience and access advantage, especially in a country like India with large rural and tribal populations who need repeat, long-term therapy.
The Progression: A Textbook Biotech Value Chain
March 2022 - DCGI approval in India for CKD-associated anaemia (as Oxemia)
100,000+ patients treated in India since launch
US FDA Orphan Drug Designation granted for sickle cell disease and beta-thalassemia
March 2026 - Approval by China's NMPA for the same CKD anaemia indication
October 2024 - Phase II trial initiated with ICMR in sickle cell disease
Phase II met its primary endpoint, with a favorable safety and tolerability profile across 50mg, 100mg, and 150mg doses, and infrequent, mild adverse events
July 2026 - Phase III clearance granted; 203-day study to evaluate efficacy and safety of Desidustat oral tablets in 164 sickle cell disease patients, in partnership with ICMR
Why Sickle Cell Disease, and Why Now? Sickle cell disease is a major public health burden in India, especially among tribal populations, where prevalence is significantly higher. By July 2025, India's National Sickle Cell Mission had screened 6.07 crore individuals, identifying 2.15 lakh diagnosed cases. Current options remain limited, largely hydroxyurea, alongside expensive, resource-intensive options like blood transfusions.
An oral, once-daily therapy that boosts natural red-cell and haemoglobin production could be a genuinely accessible option for underserved populations that today face logistical and cost barriers to treatment.