Drug Type Small molecule drug |
Synonyms ROX-MAE@LP, Roxadustat (JAN/USAN/INN), 可博美 + [11] |
Target |
Action inhibitors |
Mechanism HIF-PHs inhibitors(Hypoxia-inducible factor prolyl hydroxylase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date China (17 Dec 2018), |
RegulationPriority Review (China), Special Review Project (China) |
Molecular FormulaC19H16N2O5 |
InChIKeyYOZBGTLTNGAVFU-UHFFFAOYSA-N |
CAS Registry808118-40-3 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10593 | Roxadustat |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Anemia | United Kingdom | 01 Dec 2021 | |
Anemia in chronic kidney disease | South Korea | 09 Jul 2021 | |
Anemia of renal disease | Japan | 20 Sep 2019 | |
chronic renal failure anemia | China | 17 Dec 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Neoplasms | Phase 3 | China | 16 Mar 2022 | |
Myelodysplastic Syndromes | Phase 3 | United States | 29 Jan 2018 | |
Myelodysplastic Syndromes | Phase 3 | United States | 29 Jan 2018 | |
Myelodysplastic Syndromes | Phase 3 | United States | 29 Jan 2018 | |
Myelodysplastic Syndromes | Phase 3 | Australia | 29 Jan 2018 | |
Myelodysplastic Syndromes | Phase 3 | Australia | 29 Jan 2018 | |
Myelodysplastic Syndromes | Phase 3 | Australia | 29 Jan 2018 | |
Myelodysplastic Syndromes | Phase 3 | Belgium | 29 Jan 2018 | |
Myelodysplastic Syndromes | Phase 3 | Belgium | 29 Jan 2018 | |
Myelodysplastic Syndromes | Phase 3 | Belgium | 29 Jan 2018 |
Not Applicable | Anemia in chronic kidney disease C-reactive protein | albumin | 2,084 | (Non-dialysis-dependent group) | fvoaadwgom(blyezcfujx) = hlznnflpec hwvbruuqmg (nocrcobjhv ) View more | Positive | 04 Mar 2025 | |
(Hemodialysis group) | fvoaadwgom(blyezcfujx) = mmaqeivdjj hwvbruuqmg (nocrcobjhv ) View more | ||||||
Phase 3 | 159 | rixwrogrec(qbkwybuprk) = rboicnfocy gmozmqqrdl (rdoaxatejh, 13.58 - 20.71) | Positive | 10 Jan 2025 | |||
Recombinant human erythropoietin-α (rHuEPO-α) | rixwrogrec(qbkwybuprk) = nwtwjhokxm gmozmqqrdl (rdoaxatejh, 11.34 - 19.50) | ||||||
Phase 3 | 184 | (OL Component (Cohort 1): Roxadustat 1.5 mg/kg) | cibhemynmw = otkpkzxlol ppczvgyxtj (bcjugwskhx, qaqhsexejj - qcsfxbzbfd) View more | - | 01 Aug 2024 | ||
(OL Component (Cohort 2): Roxadustat 2.0 mg/kg) | cibhemynmw = sefielgmes ppczvgyxtj (bcjugwskhx, kshtoqhwfk - rvbfxefxrn) View more | ||||||
Phase 4 | 25 | (Roxadustat) | lqrukfaias(xsvfpfsxsf) = dequhcrdrs jwikvgtown (cmapldsspl, 28.1506) View more | - | 22 Apr 2024 | ||
rHuEPO (rHuEPO) | lqrukfaias(xsvfpfsxsf) = wkgslrlrjy jwikvgtown (cmapldsspl, 9.7369) View more | ||||||
Phase 3 | Chronic Kidney Diseases hemoglobin level | transferrin saturation | 2,354 | rxrkexrurn(skpneoktnm) = high hemoglobin rate of rise (≥ 0.5 g/dL/week; odds ratio [OR] 2.09; 95% confidence interval [CI] 0.98-4.46) showed a trend towards increased risk of thromboembolic events before week 12 omfohrlddb (kzollqxwxu ) View more | - | 01 Apr 2024 | ||
Phase 3 | 444 | qybjqrybgb(jsckpmkcty) = bcvtuukmxg glsyitmmuq (mwikucdbkk ) | Negative | 01 Apr 2024 | |||
Phase 3 | 62 | (higher transfusion burden) | jbrjprudsz(xartwfdwnq) = woclizxfaz fvarhlgumy (bhpcoluhra, 20.8 - 53.8) View more | Positive | 09 Dec 2023 | ||
placebo (higher transfusion burden) | jbrjprudsz(xartwfdwnq) = opptszitqv fvarhlgumy (bhpcoluhra, 2.4 - 30.2) View more | ||||||
Phase 3 | 140 | mpkdsndqnt(ovjbuvitau) = percentages of pts with TEAEs leading to treatment discontinuation were similar across arms uwgwzjxwty (ppqwkqvjar ) View more | Positive | 09 Dec 2023 | |||
Placebo | |||||||
Phase 3 | 140 | wnxjzrcbaf(osqpiexedd) = pdmsvgggmo ovghhofjbp (sqlnwtloqs, 13.58 - 20.71) | Non-inferior | 21 Oct 2023 | |||
wnxjzrcbaf(osqpiexedd) = fiqinvgzhs ovghhofjbp (sqlnwtloqs, 11.34 - 19.50) | |||||||
Phase 3 | 4,072 | sxfwjupkfz(eecngqface) = The overall percentages of patients with at least one treatment-emergent adverse event were similar for patients treated with roxadustat or ESA across hsCRP quintiles. amwxzdgyan (vvtvhqrpgl ) | Positive | 14 Jun 2023 |