Drugs / Desidustat
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | anemia due to chronic disorder | 2024-04-23 | “New Drug Application（NDA） of Desidustat Tablets (“Desidustat Tablets” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA).” zyduslife.com ↗ |
| Filed | Other | — | anemia due to chronic disorder | 2021-11-23 | “today announced that it has submitted the New Drug Application (NDA) to the Drug Controller General of India for Desidustat” zyduslife.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04667533 | Nov 2020 → Mar 2022 | anemia due to chronic disorder, chemotherapy-induced toxicity | Zydus Lifesciences Limited | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04463602 | Jul 2020 → Jan 2021 | COVID-19 | Zydus Lifesciences Limited | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05515367 | Apr 2023 → Jun 2025 overdue | anemia due to chronic disorder, chronic kidney disease | Zydus Lifesciences Limited | Recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT04215120 Comparator | Jan 2020 → Sep 2021 | end stage renal failure | Zydus Lifesciences Limited | Completed | No outcome recorded |
| Phase 3 | NCT04012957 Comparator | Jul 2019 → Aug 2021 | anemia, chronic kidney disease | Zydus Lifesciences Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-07-23 | Zydus Lifesciences Limited | Regulatory Zydus receives approval for Phase III trial of Desidustat in patients with Sickle Cell Disease, to be conducted in collaboration with ICMR zyduslife.com ↗
Zydus Lifesciences Limited (Zydus), an innovation-led global lifesciences company, has received permission to conduct a Phase III clinical trial of Desidustat for patients with sickle cell disease. |
| 2026-03-14 | Zydus Lifesciences Limited | Regulatory Zydus’ new drug discovery, ‘Desidustat’ licensed to China Medical System Holdings receives approval from NMPA of China zyduslife.com ↗
Desidustat is now approved by National Medical Products Administration of China (NMPA) for renal anaemia in China. |
| 2026-02-06 | Zydus Lifesciences Limited | Regulatory Zydus receives USFDA Orphan Drug Designation (ODD) for Desidustat for the treatment of Sickle Cell Disease zyduslife.com ↗
Zydus, a leading, discovery-based, global pharmaceutical company today announced that the USFDA has granted Orphan Drug Designation (ODD) to Desidustat, a novel oral HIF-PHI, for the treatment of Sickle Cell Disease (SCD). |
| 2025-11-06 | Zydus Lifesciences Limited | Regulatory Zydus receives USFDA Orphan Drug Designation (ODD) for Desidustat for the treatment of beta-thalassemia zyduslife.com ↗ |
| 2024-04-23 | Zydus Lifesciences Limited | Regulatory New Drug Application of Zydus’ innovative drug Desidustat tablets by China Medical System Holdings Limited accepted in China zyduslife.com ↗ |
| 2022-04-25 | Zydus Lifesciences Limited | Results Zydus announces publication of DREAM-ND and DREAM-D Phase 3 trials of Desidustat in American Journal of Nephrology zyduslife.com ↗
Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), a discovery-driven, global lifesciences company today announced the publication of two manuscripts detailing the DREAM-ND and DREAM-D Phase 3 study results of Desidustat, a novel HIF -PH inhibitor in the prestigious American Journal of Nephrology. |
| 2022-03-07 | Zydus Lifesciences Limited | Regulatory Zydus to launch Oxemia (Desidustat) a breakthrough treatment for Anemia in patients suffering from Chronic Kidney Disease (CKD) zyduslife.com ↗
it has received approval for its New Drug Application (NDA) from the Drug Controller General of India for OxemiaTM (Desidustat) |
| 2021-11-23 | Zydus Lifesciences Limited | Regulatory Zydus develops new treatment for patients suffering from Chronic Kidney Disease (CKD), submits first New Drug Application (NDA) to DCGI zyduslife.com ↗
Zydus Cadila, an innovation -driven, global pharmaceutical company, today announced that it has submitted the New Drug Application (NDA) to the Drug Controller General of India for Desidustat, an oral small molecule hypoxia -inducible factor prolyl hydroxylase (HIF -PH) inhibitor for treatment of anaemia in patients with Chronic Kidney Disease (CKD) who are on Dialysis and Not on Dialysis. |
| 2021-01-25 | Zydus Lifesciences Limited | Results Zydus Desidustat shows efficacy and safety in treating Hypoxia in hospitalized Covid-19 patients in Mexico zyduslife.com ↗
Zydus, a leading discovery based global pharmaceutical company today announced that it has received positive results from Phase 2(b) studies of Desidustat in COVID -19 patients [ClinicalTrials.gov Identifier: NCT04463602] conducted at Mexico. |
| 2020-08-05 | Zydus Lifesciences Limited | Regulatory Zydus Cadila's Q1 Net profit up by 50% zyduslife.com ↗
Showing progress in its research efforts, the Company announced the USFDA approval to initiate clinical trials of Desidustat, its Investigational New Drug targeted at treating anemia in cancer patients, receiving chemotherapy. |
| 2020-07-23 | Zydus Lifesciences Limited | Regulatory Zydus receives approval from USFDA to initiate clinical trials of Desidustat in Cancer Patients receiving Chemotherapy zyduslife.com ↗
Zydus, a leading discovery based , global pharmaceutical company today announced that it has received approval from the USFDA, to initiate clinical trials of Desidustat in Chemotherapy Induced Anemia (CIA). |
| 2020-07-06 | Zydus Lifesciences Limited | Regulatory Zydus receives approval from COFEPRIS, Mexico to study Desidustat in the management of COVID-19 zyduslife.com ↗
Zydus, a leading discovery based global pharmaceutical company today announced that it has received approval from the regulatory authority of Mexico, COFEPRIS, for its one of its lead research candidate Desid ustat to be tested in the management of COVID -19. |
| 2017-11-18 | Zydus Lifesciences Limited | Regulatory Zydus oral anemia developmental candidate, ZYAN1 named as Desidustat by WHO zyduslife.com ↗
Zydus Cadila, an innovation -driven global pharmaceutical company, today announced that the WHO INN committee has granted the name Desidustat to its Phase II anemia candidate, ZYAN1. |
All press releases naming this drug 22 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Desidustat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05515367 ↗ |
| Known as | ZYAN1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650314 ↗ |
| Modality | Small molecule | — CHEMBL4650314 ↗ |
| Route | Oral | “Desidustat oral tablet” NCT04012957 ↗ |