Roxadustat is the first oral HIF-PHI for CKD anaemia and was first approved in China before any other major market. Here is what international patients with CKD anaemia should know.
Roxadustat (Evrenzo, Aerctra) is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor (HIF-PHI). It treats anaemia in chronic kidney disease (CKD) — both dialysis-dependent and non-dialysis — by stimulating endogenous erythropoietin production. Unlike darbepoetin or epoetin alfa, it is taken orally, three times per week.
The Drug
Roxadustat (Evrenzo, Aerctra) is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor (HIF-PHI). It treats anaemia in chronic kidney disease (CKD) — both dialysis-dependent and non-dialysis — by stimulating endogenous erythropoietin production. Unlike darbepoetin or epoetin alfa, it is taken orally, three times per week.
The drug was approved first in China in 2018 — well ahead of approvals in Japan, the EU, and other major markets. The US FDA path has been complicated; FDA has not granted approval, and the drug remains unavailable through US channels for most CKD anaemia indications.
Why International Patients Travel for It
Patients with CKD anaemia who do not have access to roxadustat in their home country face limited oral options. Injectable ESAs (epoetin alfa, darbepoetin) are effective but require frequent injections and are expensive. Roxadustat is:
- Oral (no injections)
- Substantially cheaper at Chinese hospital pharmacies (USD 80–140/month vs USD 500–1,200/month equivalents in Western markets)
- Effective in both ESA-naive and ESA-resistant patients in pivotal trials
The Workup Before Prescription
Class A nephrology departments (Peking University First, Huashan, Renji) run a structured workup before initiating roxadustat:
- Confirmation of anaemia aetiology (rule out iron deficiency, B12, folate, thalassaemia, GI bleeding, malignancy)
- Iron studies (ferritin, TSAT) — iron deficiency must be addressed first
- Renal function staging (eGFR, urine albumin/creatinine ratio)
- Cardiovascular risk assessment
- Baseline ECG, BP control review
Workup block: USD 200–340 at a Class A international department.
Outcomes Data
Pivotal Chinese Phase III trials (FGCL-4592-808 and others) demonstrated meaningful haemoglobin response and improvement in iron utilisation in both dialysis-dependent and non-dialysis CKD populations. Subsequent Japanese and European trials replicated these findings. Long-term follow-up data continues to accumulate.
Practical Logistics
Initial prescription requires in-person evaluation at a Class A nephrology department. Subsequent refills can typically be coordinated via telehealth with the prescribing physician. A 3-month supply is the common dispense interval. Long-distance shipment of refills via licensed channels is feasible in many cases — confirm with the coordinator at evaluation.
Who Is This For?
This is appropriate for adults with confirmed CKD anaemia (with or without dialysis), particularly those who:
- Are not responding adequately to current ESA therapy
- Want oral therapy rather than injectable
- Have access barriers to ESAs in their home country
- Find current monthly cost burdensome
See our roxadustat page for partner-hospital details and pricing.
Sources: NMPA approval registry; FGCL-4592-808 trial results published in NEJM; PMDA roxadustat approval; partner-hospital nephrology pricing 2026.