Zydus receives approval for Phase III trial of Desidustat
Zydus Lifesciences Limited has secured approval for a Phase III clinical trial of Desidustat for sickle cell disease in partnership with ICMR. The 203-day study involving 164 patients follows a successful Phase II trial that met its primary endpoints. Desidustat also holds Orphan Drug Designation from the US FDA for sickle cell disease and beta-thalassemia.
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Zydus Lifesciences Limited has received regulatory approval to initiate a Phase III clinical trial of Desidustat for the treatment of sickle cell disease. Conducted in collaboration with the Indian Council of Medical Research (ICMR), the 203-day study will evaluate the efficacy and safety of Desidustat oral tablets in treating anaemia. The trial will enrol 164 patients diagnosed with the disease, addressing a significant public health concern in India where nearly 20 million people live with the condition.
Phase II Trial Achieves Primary Objectives
The progression to Phase III follows the successful completion of a Phase II proof-of-concept (PoC) trial, which met its primary endpoint. The double blind, randomised, placebo controlled, parallel, multi-centre study demonstrated that Desidustat was well tolerated up to a 150 mg dose, with minimal adverse events reported. The trial showed a promising trend toward improvement in haemoglobin (Hb) levels and higher responder rates compared to placebo.
Key Highlights of Desidustat's Development
The following table outlines the key details surrounding Desidustat's clinical and regulatory status:
| Parameter | Details |
|---|---|
| Drug Name | Desidustat |
| Indication | Sickle Cell Disease |
| Trial Phase Approved | Phase III |
| Collaboration Partner | Indian Council of Medical Research (ICMR) |
| Phase II Status | Primary objectives achieved |
| US FDA Designation | Orphan Drug Status |
Orphan Drug Status from US FDA
Desidustat has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (US FDA) for treating sickle cell disease (SCD) and beta-thalassemia. This designation reflects the unmet medical need in these areas and the potential significance of Desidustat as a therapeutic option. Dr. Rajiv Bahl, Secretary, Department of Health Research & Director General, ICMR, highlighted the collaboration as a significant leap forward for patients with limited options beyond hydroxyurea.
Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd., emphasized the company's commitment to advancing novel innovations to improve the quality of life for patients living with sickle cell disease.
What are the projected timelines for the completion of the Phase III trial and potential market launch?
How will the cost of Desidustat compare to existing treatments like hydroxyurea, and will it be accessible to the majority of patients in India?
Could the success of Desidustat in sickle cell disease pave the way for its approval in beta-thalassemia, given its Orphan Drug Status?
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