Enarodustat API is a synthetic small-molecule pharmaceutical ingredient belonging to the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor class. It is also known by the development code JTZ-951 and is marketed in Japan under the brand name Enaroy. Enarodustat was approved in Japan for the treatment of renal anemia associated with chronic kidney disease (CKD).
Enarodustat works by inhibiting HIF-prolyl hydroxylase enzymes, helping stabilize hypoxia-inducible factor (HIF) signaling. This promotes the body's physiological response to reduced oxygen availability and supports erythropoietic processes involved in red blood cell production.
Enarodustat is chemically identified as N-[7-Hydroxy-5-(2-phenylethyl)[1,2,4]triazolo[1,5-a]pyridin-8-carbonyl]glycine. It has the molecular formula C₁₇H₁₆N₄O₄ and molecular weight 340.33 g/mol. Its CAS number is 1262132-81-9.
Swapnroop Drugs and Pharmaceuticals provides Enarodustat API for qualified pharmaceutical manufacturing, formulation development, research and pharmaceutical sourcing requirements.
Enarodustat is a specialized API relevant to renal anemia, chronic kidney disease, HIF-PH inhibitor research and pharmaceutical formulation development.
Enarodustat selectively inhibits hypoxia-inducible factor prolyl hydroxylase (HIF-PH). HIF-PH normally contributes to the degradation of HIF under oxygenated conditions. Inhibition of HIF-PH allows HIF signaling to remain active, stimulating pathways involved in erythropoietin production and erythropoiesis.
Enarodustat is associated with:
A peer-reviewed analytical publication describes enarodustat as an orally bioavailable, selective HIF-PH inhibitor that was approved in Japan for anemia in patients with CKD.
Enarodustat is a chemically synthesized small-molecule API and can be evaluated using conventional pharmaceutical analytical techniques such as HPLC, LC-MS, NMR, IR, residual-solvent analysis, water determination and related-substance testing, as applicable to the approved specification.
Do not use generic impurity or assay limits on the website unless they are supported by your actual approved specification or COA. I could verify the identity and regulatory information for Enarodustat, but I could not verify a public pharmacopoeial monograph providing the complete numerical limits for every CMS field.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |