Desidustat Tablets Approved in China for Renal Anemia Treatment
China's NMPA approved Desidustat Tablets on March 13, 2026, for treating anemia in non-dialysis CKD patients. Clinical trials showed the oral HIF-PHI was non-inferior to erythropoietin in maintaining hemoglobin levels with improved quality of life.
On 13 March 2026, Desidustat Tablets have been approved for marketing in China by the National Medical Products Administration of the People's Republic of China (NMPA). The Product is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in non-dialysis adult, Chronic Kidney Disease (CKD) patients.
China Medical System Holdings Limited obtained an exclusive license for the Product from Zydus Lifesciences Limited (earlier known as Cadila Healthcare Limited) pursuant to a License Agreement with an effective date of 20 January 2020. Desidustat Tablets have been approved for marketing in India.
As a novel oral HIF-PHI, the Product's mechanism of action promotes erythropoiesis through increasing endogenous erythropoietin, improving iron availability and reducing hepcidin. Its China Phase III clinical trial has demonstrated positive results. The primary endpoint of the haemoglobin (Hb) mean change from baseline to Week 7-9 has indicated that, Desidustat is more effective than placebo in increasing Hb level. Results from the extension study demonstrate that the Product can maintain Hb level within the target range over the long term with acceptable safety. In addition, the Product significantly reduces hepcidin levels and ameliorates iron metabolism disorders.
An open-label, randomized, prospective, non-inferiority trial included 60 dialysis-naïve CKD patients with baseline hemoglobin of ≤9 g/dL and adequate iron stores who were randomized (1:1) to receive either desidustat orally or erythropoietin subcutaneous injection for six months, once every two weeks. Desidustat showed non-inferiority to erythropoietin in increasing and maintaining hemoglobin levels within the target range over six months. The mean hemoglobin increased in the desidustat arm from baseline 7.99±0.73 to the estimated marginal mean (EMM) of 10.01±0.21 (95% CI: 9.59-10.4), while the mean hemoglobin in the erythropoietin arm increased from baseline 7.68±0.84 to the EMM of 9.89±0.21 g/dL (95% CI: 9.46-10.3). The percentage of hemoglobin responders was higher with desidustat (15 (57.69%)) compared to erythropoietin (12 (48%)).
Both treatments showed comparable improvements in hematological parameters and iron profiles. Desidustat had a greater improvement in quality of life score (Chronic Kidney Disease-Anemia Questionnaire (CKD-AQ) compared to erythropoietin at each time interval, reflecting lower symptom burden. From baseline to six months, an increased level of growth differentiation factor-15 (GDF-15) and a decreased level of interleukin 6 (IL-6) were noted in both arms.
It is estimated that there are more than 120 million CKD patients in China. Anaemia is one of the frequent complications of CKD, which exhibits a progressively increasing incidence with disease progression. A survey in China showed that the prevalences of anaemia in patients at CKD stage 1 to 5 were 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively. The target-achieving rate (the Hb level reaching the target value (110~120g / L)) has increased to 51.5% for haemodialysis CKD patients with anaemia, but is still only 8.2% for anaemia patients in non-dialysis CKD. The Product is administrated orally, thus expecting to improve the treatment compliance of patients and to meet the unmet treatment needs in the field of CKD anaemia.
The approval of Desidustat Tablets will further strengthen the Group's overall layout in the field of nephrology, and synergize with the marketed innovative drug Velphoro (Sucroferric Oxyhydroxide Chewable Tablets, indicated for CKD hyperphosphatemia).