Roxadustat

Regulatory record

European Medicines Agency. Evrenzo (roxadustat), European public assessment report page. Product number EMEA/H/C/004871.

Evrenzo received a European Commission marketing authorization valid throughout the EU on 18 August 2021, after a CHMP opinion adopted on 24 June 2021, with latest renewal on 30 March 2026. The EU indication is treatment of adult patients with symptomatic anemia associated with chronic kidney disease. The marketing authorization holder is Astellas Pharma Europe B.V.

Participants / model

Adults with symptomatic anemia associated with chronic kidney disease

Treatment

Evrenzo film-coated tablets, oral

Follow-up

Authorization on 18 August 2021; latest renewal on 30 March 2026

Study design

EMA regulatory record

Funding

not stated in the source

The EU indication is anemia of chronic kidney disease. It does not include athletic performance.

Regulatory record

Dhillon S. Drugs. 2019;79(5):563-572. PMID 30805897.

Roxadustat received its first global approval in China for anemia in dialysis-dependent CKD, the first approval for this drug class; the 2019 review describing that approval notes long-term cardiovascular outcome studies were then underway. The sponsor's 2021 release states that roxadustat is approved in China, Japan, Chile and South Korea for the treatment of anemia of CKD in adult patients on dialysis and not on dialysis.

Participants / model

Adults with CKD-associated anemia

Treatment

Oral roxadustat

Follow-up

Approval record to 2021

Study design

Review of the approval record

Funding

not stated in the source

The Japan, Chile and South Korea statement is the sponsor's, not a regulator document read for this page.

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA API search run on 9 October 2026 for roxadustat by active ingredient, substance name, brand name and generic name, and a DailyMed search the same day.

The Drugs@FDA search for roxadustat by active ingredient, substance name, brand name and generic name returned no matching application, and a DailyMed search returned no roxadustat labels. This supports the dated, US-scoped statement that no FDA-approved roxadustat product was located. It is not a worldwide status claim.

Participants / model

FDA application and label databases, not a clinical population

Treatment

Exact name and ingredient searches

Follow-up

Searches run on 9 October 2026

Study design

Dated US approval-record search

Funding

not stated in the source

A search result shows what the databases returned on that date. No post-2021 US regulatory action was located.

Regulatory record

FibroGen, Inc. Press release announcing receipt of a complete response letter from the FDA for the roxadustat new drug application, 11 August 2021, filed as an exhibit in the SEC archive.

FibroGen announced on 11 August 2021 that it received a complete response letter from the FDA for the roxadustat new drug application for anemia of chronic kidney disease. The release states that the letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested additional clinical study of roxadustat be conducted prior to resubmission. The release does not name the affected populations or the FDA reasoning.

Participants / model

Not a clinical population

Treatment

Oral roxadustat

Follow-up

Announcement dated 11 August 2021

Study design

Company filing exhibit in the SEC archive (sponsor's own account)

Funding

not stated in the source

This is the sponsor's account. The FDA complete response letter itself is not public.

Chemical identity record

National Center for Biotechnology Information. PubChem Compound Summary for CID 11256664, roxadustat.

Roxadustat: PubChem CID 11256664, C19H16N2O5, 352.3 g/mol, CAS 808118-40-3. Synonyms include FG-4592, ASP1517 and Evrenzo.

Participants / model

Chemical identity, not a clinical population

Treatment

Defined molecule

Follow-up

Not applicable

Study design

NLM chemical record

Funding

not stated in the source

Identity record only; it says nothing about efficacy or safety.

Randomized controlled trial

Fishbane S et al. J Am Soc Nephrol. 2021;32(3):737-755. PMID 33568383.

Mean hemoglobin change from baseline over weeks 28 to 52 was 1.75 g/dl (95% CI 1.68 to 1.81) versus 0.40 g/dl (0.33 to 0.47), p less than 0.001, and roxadustat reduced red cell transfusion risk by 63% (hazard ratio 0.37, 95% CI 0.30 to 0.44). Urinary tract infection (12.8% versus 8.0%) and pneumonia (11.9% versus 9.4%) were more common on roxadustat.

Participants / model

2,781 adults with non-dialysis-dependent CKD stages 3 to 5 and hemoglobin below 10.0 g/dl

Treatment

Oral roxadustat thrice weekly versus placebo

Follow-up

Hemoglobin change assessed over weeks 28 to 52

Study design

Randomized placebo-controlled trial

Funding

not stated in the source

Endpoints were hemoglobin change, transfusion and adverse events in kidney patients with anemia.

Randomized controlled trial

Fishbane S et al. J Am Soc Nephrol. 2022;33(4):850-866. PMID 35361724.

Mean hemoglobin change over weeks 28 to 52 was 0.77 g/dl (95% CI 0.69 to 0.85) versus 0.68 g/dl (0.60 to 0.76), meeting the noninferiority margin. At least one adverse event occurred in 85.0% versus 84.5%, and at least one serious adverse event in 57.6% versus 57.5%.

Participants / model

2,133 adults with dialysis-dependent CKD and anemia

Treatment

Oral roxadustat three times weekly versus parenteral epoetin alfa

Follow-up

Hemoglobin change assessed over weeks 28 to 52

Study design

Randomized open-label active-comparator trial

Funding

not stated in the source

Endpoints were hemoglobin change and adverse events in dialysis patients.

PubMed search record

PubMed search run on 9 October 2026: (roxadustat OR FG-4592) AND (healthy[tiab] OR athletes[tiab] OR volunteers[tiab]) AND (exercise[tiab] OR performance[tiab] OR VO2[tiab] OR endurance[tiab] OR time trial[tiab]). 6 records returned.

The search returned 6 records: four doping-detection or analytical papers, one bioanalytical method paper and one trial protocol. That protocol, ROXACardioMeta in 24 healthy volunteers aged 18 to 40, has total cholesterol as its primary hypothesis, lists exercise capacity only as a secondary outcome, and reports no results. No completed trial measuring endurance performance in healthy people or athletes was located. The endurance claim rests on mechanism, on anemia-correction trials in kidney patients, and on the mouse study.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Search run on 9 October 2026

Study design

Literature search

Funding

not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

Randomized controlled trial

Fishbane S et al. J Am Soc Nephrol. 2021;32(3):737-755. PMID 33568383.

Mean hemoglobin change from baseline over weeks 28 to 52 was 1.75 g/dl (95% CI 1.68 to 1.81) versus 0.40 g/dl (0.33 to 0.47), p less than 0.001, and roxadustat reduced red cell transfusion risk by 63% (hazard ratio 0.37, 95% CI 0.30 to 0.44). Urinary tract infection (12.8% versus 8.0%) and pneumonia (11.9% versus 9.4%) were more common on roxadustat.

Participants / model

2,781 adults with non-dialysis-dependent CKD stages 3 to 5 and hemoglobin below 10.0 g/dl

Treatment

Oral roxadustat thrice weekly versus placebo

Follow-up

Hemoglobin change assessed over weeks 28 to 52

Study design

Randomized placebo-controlled trial

Funding

not stated in the source

Endpoints were hemoglobin change, transfusion and adverse events in kidney patients with anemia.

Animal study

Takemura K et al. Physiol Rep. 2025;13(13):e70464. PMID 40659571.

Blood hemoglobin rose, muscle HIF-downstream gene expression increased, and treadmill running time to exhaustion improved compared with vehicle, with comparable body weight and skeletal muscle mass. Hemodilution by phlebotomy with saline infusion removed the effect, indicating it depended on the hemoglobin increase. The authors describe the finding as a blood doping abuse risk.

Participants / model

Male C57BL/6J mice

Treatment

Oral gavage roxadustat 30 mg/kg three times per week

Follow-up

5 weeks

Study design

Original animal study

Funding

not stated in the source

This is a mouse result; no completed human performance study was located.

Animal study

Takemura K et al. Physiol Rep. 2025;13(13):e70464. PMID 40659571.

Blood hemoglobin rose, muscle HIF-downstream gene expression increased, and treadmill running time to exhaustion improved compared with vehicle, with comparable body weight and skeletal muscle mass. Hemodilution by phlebotomy with saline infusion removed the effect, indicating it depended on the hemoglobin increase. The authors describe the finding as a blood doping abuse risk.

Participants / model

Male C57BL/6J mice

Treatment

Oral gavage roxadustat 30 mg/kg three times per week

Follow-up

5 weeks

Study design

Original animal study

Funding

not stated in the source

This is a mouse result; no completed human performance study was located.

Regulatory record

World Anti-Doping Agency. Prohibited List, class S2 (peptide hormones, growth factors, related substances and mimetics), subsection S2.1.2. The list edition year is not stated in the page text read.

Roxadustat (FG-4592) is named on the WADA Prohibited List under S2.1.2, hypoxia-inducible factor activating agents, inside class S2, which is prohibited at all times, in and out of competition. All substances in S2 are non-specified substances. Other agents listed in the same subsection include daprodustat, molidustat, vadadustat, IOX2, cobalt and xenon. Use by an athlete subject to the Code is an anti-doping rule violation.

Participants / model

Athletes under the World Anti-Doping Code

Treatment

Any route

Follow-up

Current list as read on 9 October 2026

Study design

Official anti-doping record

Funding

not stated in the source

The list edition year was not stated in the retrieved text, so no list year is given on the page.

Human study

Buisson C et al. J Pharm Biomed Anal. 2016;121:181-187. PMID 26808067.

An anti-doping laboratory reported the first identified case of an athlete using FG-4592, detected and confirmed in urine by LC-MS/MS, and states that WADA has listed HIF stabilizers and FG-4592 as prohibited since 2011. Erythropoietin and Athlete Biological Passport hematological parameters showed no profound alterations, and the abnormal blood profile score reached but did not exceed the adaptive model upper limit just after the period of use. A separate validation study implemented roxadustat and its main metabolites in routine doping controls with detection limits of 0.05 to 1 ng/mL in urine and 1 to 5 ng/mL in plasma.

Participants / model

One athlete in a doping control case; method validation samples

Treatment

Oral roxadustat, measured in urine and plasma

Follow-up

not stated in the source

Study design

Original anti-doping analytical studies

Funding

not stated in the source

The 2011 listing date is the case report's statement, not a WADA document read for this page. Endpoints were direct detection of use and indirect blood markers.

Official label

European Medicines Agency. Evrenzo (roxadustat) film-coated tablets, EPAR product information. Product number EMEA/H/C/004871.

The product information describes roxadustat as a hypoxia-inducible factor prolyl hydroxylase inhibitor that raises plasma endogenous erythropoietin, regulates iron transporter proteins and lowers hepcidin, improving iron availability and increasing hemoglobin and red cell mass. Mean effective half-life is approximately 15 hours in patients with CKD, Cmax is usually reached 2 hours post dose in the fasted state, plasma protein binding is approximately 99%, and apparent volume of distribution at steady state is 24 L. A thorough QT study in healthy subjects showed no QTc prolongation but a placebo-corrected heart rate increase of up to 9 to 10 bpm at a single 2.75 mg/kg dose and 15 to 18 bpm at 5 mg/kg. A misuse warning states that misuse may lead to an excessive increase in packed cell volume, which may be associated with life-threatening complications of the cardiovascular system. Other warnings cover cardiovascular and mortality risk, thrombotic vascular events including deep vein thrombosis, pulmonary embolism and cerebral infarction (most events serious, fatal cerebral infarction reported), seizures, serious infections, sepsis including fatal events, and secondary hypothyroidism. It is contraindicated in the third trimester of pregnancy and during breastfeeding, and women of childbearing potential must use highly effective contraception. Across 3,542 non-dialysis and 3,353 dialysis patients who received at least one dose, adverse reactions at 10% or above were hypertension (13.9%), vascular access thrombosis (12.8%), diarrhea (11.8%), peripheral edema (11.7%), hyperkalemia (10.9%) and nausea (10.2%). The most frequent serious adverse reactions were sepsis (3.4%), hyperkalemia (2.5%), hypertension (1.4%) and deep vein thrombosis (1.2%). In patients not on dialysis, seizures occurred in 1.1% on roxadustat versus 0.2% on placebo, sepsis in 2.1% versus 0.4%, and deep vein thrombosis in 1.0% versus 0.2%. A meta-analysis of adjudicated cardiovascular events from the phase 3 program in 8,984 patients appears in the label.

Participants / model

Adults with CKD-associated anemia; healthy subjects in the QT study

Treatment

Evrenzo oral tablets

Follow-up

Current EU product information

Study design

Official EU product information

Funding

not stated in the source

The page gives no label dosing or duration-of-use details. The EU document is not an FDA label.

Official label

European Medicines Agency. Evrenzo (roxadustat) film-coated tablets, EPAR product information. Product number EMEA/H/C/004871.

The product information describes roxadustat as a hypoxia-inducible factor prolyl hydroxylase inhibitor that raises plasma endogenous erythropoietin, regulates iron transporter proteins and lowers hepcidin, improving iron availability and increasing hemoglobin and red cell mass. Mean effective half-life is approximately 15 hours in patients with CKD, Cmax is usually reached 2 hours post dose in the fasted state, plasma protein binding is approximately 99%, and apparent volume of distribution at steady state is 24 L. A thorough QT study in healthy subjects showed no QTc prolongation but a placebo-corrected heart rate increase of up to 9 to 10 bpm at a single 2.75 mg/kg dose and 15 to 18 bpm at 5 mg/kg. A misuse warning states that misuse may lead to an excessive increase in packed cell volume, which may be associated with life-threatening complications of the cardiovascular system. Other warnings cover cardiovascular and mortality risk, thrombotic vascular events including deep vein thrombosis, pulmonary embolism and cerebral infarction (most events serious, fatal cerebral infarction reported), seizures, serious infections, sepsis including fatal events, and secondary hypothyroidism. It is contraindicated in the third trimester of pregnancy and during breastfeeding, and women of childbearing potential must use highly effective contraception. Across 3,542 non-dialysis and 3,353 dialysis patients who received at least one dose, adverse reactions at 10% or above were hypertension (13.9%), vascular access thrombosis (12.8%), diarrhea (11.8%), peripheral edema (11.7%), hyperkalemia (10.9%) and nausea (10.2%). The most frequent serious adverse reactions were sepsis (3.4%), hyperkalemia (2.5%), hypertension (1.4%) and deep vein thrombosis (1.2%). In patients not on dialysis, seizures occurred in 1.1% on roxadustat versus 0.2% on placebo, sepsis in 2.1% versus 0.4%, and deep vein thrombosis in 1.0% versus 0.2%. A meta-analysis of adjudicated cardiovascular events from the phase 3 program in 8,984 patients appears in the label.

Participants / model

Adults with CKD-associated anemia; healthy subjects in the QT study

Treatment

Evrenzo oral tablets

Follow-up

Current EU product information

Study design

Official EU product information

Funding

not stated in the source

The page gives no label dosing or duration-of-use details. The EU document is not an FDA label.

Official label

European Medicines Agency. Evrenzo (roxadustat) film-coated tablets, EPAR product information. Product number EMEA/H/C/004871.

The product information describes roxadustat as a hypoxia-inducible factor prolyl hydroxylase inhibitor that raises plasma endogenous erythropoietin, regulates iron transporter proteins and lowers hepcidin, improving iron availability and increasing hemoglobin and red cell mass. Mean effective half-life is approximately 15 hours in patients with CKD, Cmax is usually reached 2 hours post dose in the fasted state, plasma protein binding is approximately 99%, and apparent volume of distribution at steady state is 24 L. A thorough QT study in healthy subjects showed no QTc prolongation but a placebo-corrected heart rate increase of up to 9 to 10 bpm at a single 2.75 mg/kg dose and 15 to 18 bpm at 5 mg/kg. A misuse warning states that misuse may lead to an excessive increase in packed cell volume, which may be associated with life-threatening complications of the cardiovascular system. Other warnings cover cardiovascular and mortality risk, thrombotic vascular events including deep vein thrombosis, pulmonary embolism and cerebral infarction (most events serious, fatal cerebral infarction reported), seizures, serious infections, sepsis including fatal events, and secondary hypothyroidism. It is contraindicated in the third trimester of pregnancy and during breastfeeding, and women of childbearing potential must use highly effective contraception. Across 3,542 non-dialysis and 3,353 dialysis patients who received at least one dose, adverse reactions at 10% or above were hypertension (13.9%), vascular access thrombosis (12.8%), diarrhea (11.8%), peripheral edema (11.7%), hyperkalemia (10.9%) and nausea (10.2%). The most frequent serious adverse reactions were sepsis (3.4%), hyperkalemia (2.5%), hypertension (1.4%) and deep vein thrombosis (1.2%). In patients not on dialysis, seizures occurred in 1.1% on roxadustat versus 0.2% on placebo, sepsis in 2.1% versus 0.4%, and deep vein thrombosis in 1.0% versus 0.2%. A meta-analysis of adjudicated cardiovascular events from the phase 3 program in 8,984 patients appears in the label.

Participants / model

Adults with CKD-associated anemia; healthy subjects in the QT study

Treatment

Evrenzo oral tablets

Follow-up

Current EU product information

Study design

Official EU product information

Funding

not stated in the source

The page gives no label dosing or duration-of-use details. The EU document is not an FDA label.

Regulatory record

FibroGen, Inc. Press release on roxadustat cardiovascular safety analyses, 6 April 2021, filed as an exhibit in the SEC archive.

The sponsor disclosed that the primary cardiovascular safety analyses it had reported at the American Society of Nephrology conference in November 2019 included post-hoc changes to the stratification factors, and that analyses with the pre-specified stratification factors result in higher hazard ratios. The release states that for MACE+ in dialysis and for MACE and MACE+ in incident dialysis the 95% confidence intervals include 1.0, so the company cannot conclude that roxadustat reduces the risk of, or is superior to, those endpoints compared with epoetin alfa. The company maintained that roxadustat remained comparable to placebo in non-dialysis patients and to epoetin alfa in dialysis patients on MACE.

Participants / model

Patients in the US phase 3 cardiovascular safety analyses

Treatment

Oral roxadustat versus placebo or epoetin alfa

Follow-up

Disclosure dated 6 April 2021

Study design

Company filing exhibit in the SEC archive (sponsor's own account)

Funding

not stated in the source

This is the sponsor's own account of its analyses, not an independent assessment.

Regulatory record

European Medicines Agency. Evrenzo (roxadustat), European public assessment report page. Product number EMEA/H/C/004871.

Evrenzo received a European Commission marketing authorization valid throughout the EU on 18 August 2021, after a CHMP opinion adopted on 24 June 2021, with latest renewal on 30 March 2026. The EU indication is treatment of adult patients with symptomatic anemia associated with chronic kidney disease. The marketing authorization holder is Astellas Pharma Europe B.V.

Participants / model

Adults with symptomatic anemia associated with chronic kidney disease

Treatment

Evrenzo film-coated tablets, oral

Follow-up

Authorization on 18 August 2021; latest renewal on 30 March 2026

Study design

EMA regulatory record

Funding

not stated in the source

The EU indication is anemia of chronic kidney disease. It does not include athletic performance.

Randomized controlled trial

Fishbane S et al. J Am Soc Nephrol. 2021;32(3):737-755. PMID 33568383.

Mean hemoglobin change from baseline over weeks 28 to 52 was 1.75 g/dl (95% CI 1.68 to 1.81) versus 0.40 g/dl (0.33 to 0.47), p less than 0.001, and roxadustat reduced red cell transfusion risk by 63% (hazard ratio 0.37, 95% CI 0.30 to 0.44). Urinary tract infection (12.8% versus 8.0%) and pneumonia (11.9% versus 9.4%) were more common on roxadustat.

Participants / model

2,781 adults with non-dialysis-dependent CKD stages 3 to 5 and hemoglobin below 10.0 g/dl

Treatment

Oral roxadustat thrice weekly versus placebo

Follow-up

Hemoglobin change assessed over weeks 28 to 52

Study design

Randomized placebo-controlled trial

Funding

not stated in the source

Endpoints were hemoglobin change, transfusion and adverse events in kidney patients with anemia.

Randomized controlled trial

Fishbane S et al. J Am Soc Nephrol. 2022;33(4):850-866. PMID 35361724.

Mean hemoglobin change over weeks 28 to 52 was 0.77 g/dl (95% CI 0.69 to 0.85) versus 0.68 g/dl (0.60 to 0.76), meeting the noninferiority margin. At least one adverse event occurred in 85.0% versus 84.5%, and at least one serious adverse event in 57.6% versus 57.5%.

Participants / model

2,133 adults with dialysis-dependent CKD and anemia

Treatment

Oral roxadustat three times weekly versus parenteral epoetin alfa

Follow-up

Hemoglobin change assessed over weeks 28 to 52

Study design

Randomized open-label active-comparator trial

Funding

not stated in the source

Endpoints were hemoglobin change and adverse events in dialysis patients.

Official label

European Medicines Agency. Evrenzo (roxadustat) film-coated tablets, EPAR product information. Product number EMEA/H/C/004871.

The product information describes roxadustat as a hypoxia-inducible factor prolyl hydroxylase inhibitor that raises plasma endogenous erythropoietin, regulates iron transporter proteins and lowers hepcidin, improving iron availability and increasing hemoglobin and red cell mass. Mean effective half-life is approximately 15 hours in patients with CKD, Cmax is usually reached 2 hours post dose in the fasted state, plasma protein binding is approximately 99%, and apparent volume of distribution at steady state is 24 L. A thorough QT study in healthy subjects showed no QTc prolongation but a placebo-corrected heart rate increase of up to 9 to 10 bpm at a single 2.75 mg/kg dose and 15 to 18 bpm at 5 mg/kg. A misuse warning states that misuse may lead to an excessive increase in packed cell volume, which may be associated with life-threatening complications of the cardiovascular system. Other warnings cover cardiovascular and mortality risk, thrombotic vascular events including deep vein thrombosis, pulmonary embolism and cerebral infarction (most events serious, fatal cerebral infarction reported), seizures, serious infections, sepsis including fatal events, and secondary hypothyroidism. It is contraindicated in the third trimester of pregnancy and during breastfeeding, and women of childbearing potential must use highly effective contraception. Across 3,542 non-dialysis and 3,353 dialysis patients who received at least one dose, adverse reactions at 10% or above were hypertension (13.9%), vascular access thrombosis (12.8%), diarrhea (11.8%), peripheral edema (11.7%), hyperkalemia (10.9%) and nausea (10.2%). The most frequent serious adverse reactions were sepsis (3.4%), hyperkalemia (2.5%), hypertension (1.4%) and deep vein thrombosis (1.2%). In patients not on dialysis, seizures occurred in 1.1% on roxadustat versus 0.2% on placebo, sepsis in 2.1% versus 0.4%, and deep vein thrombosis in 1.0% versus 0.2%. A meta-analysis of adjudicated cardiovascular events from the phase 3 program in 8,984 patients appears in the label.

Participants / model

Adults with CKD-associated anemia; healthy subjects in the QT study

Treatment

Evrenzo oral tablets

Follow-up

Current EU product information

Study design

Official EU product information

Funding

not stated in the source

The page gives no label dosing or duration-of-use details. The EU document is not an FDA label.

PubMed search record

PubMed search run on 9 October 2026: (roxadustat OR FG-4592) AND (healthy[tiab] OR athletes[tiab] OR volunteers[tiab]) AND (exercise[tiab] OR performance[tiab] OR VO2[tiab] OR endurance[tiab] OR time trial[tiab]). 6 records returned.

The search returned 6 records: four doping-detection or analytical papers, one bioanalytical method paper and one trial protocol. That protocol, ROXACardioMeta in 24 healthy volunteers aged 18 to 40, has total cholesterol as its primary hypothesis, lists exercise capacity only as a secondary outcome, and reports no results. No completed trial measuring endurance performance in healthy people or athletes was located. The endurance claim rests on mechanism, on anemia-correction trials in kidney patients, and on the mouse study.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Search run on 9 October 2026

Study design

Literature search

Funding

not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

Regulatory record

World Anti-Doping Agency. Prohibited List, class S2 (peptide hormones, growth factors, related substances and mimetics), subsection S2.1.2. The list edition year is not stated in the page text read.

Roxadustat (FG-4592) is named on the WADA Prohibited List under S2.1.2, hypoxia-inducible factor activating agents, inside class S2, which is prohibited at all times, in and out of competition. All substances in S2 are non-specified substances. Other agents listed in the same subsection include daprodustat, molidustat, vadadustat, IOX2, cobalt and xenon. Use by an athlete subject to the Code is an anti-doping rule violation.

Participants / model

Athletes under the World Anti-Doping Code

Treatment

Any route

Follow-up

Current list as read on 9 October 2026

Study design

Official anti-doping record

Funding

not stated in the source

The list edition year was not stated in the retrieved text, so no list year is given on the page.

Regulatory record

FibroGen, Inc. Press release announcing receipt of a complete response letter from the FDA for the roxadustat new drug application, 11 August 2021, filed as an exhibit in the SEC archive.

FibroGen announced on 11 August 2021 that it received a complete response letter from the FDA for the roxadustat new drug application for anemia of chronic kidney disease. The release states that the letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested additional clinical study of roxadustat be conducted prior to resubmission. The release does not name the affected populations or the FDA reasoning.

Participants / model

Not a clinical population

Treatment

Oral roxadustat

Follow-up

Announcement dated 11 August 2021

Study design

Company filing exhibit in the SEC archive (sponsor's own account)

Funding

not stated in the source

This is the sponsor's account. The FDA complete response letter itself is not public.

Regulatory record

European Medicines Agency. Evrenzo (roxadustat), European public assessment report page. Product number EMEA/H/C/004871.

Evrenzo received a European Commission marketing authorization valid throughout the EU on 18 August 2021, after a CHMP opinion adopted on 24 June 2021, with latest renewal on 30 March 2026. The EU indication is treatment of adult patients with symptomatic anemia associated with chronic kidney disease. The marketing authorization holder is Astellas Pharma Europe B.V.

Participants / model

Adults with symptomatic anemia associated with chronic kidney disease

Treatment

Evrenzo film-coated tablets, oral

Follow-up

Authorization on 18 August 2021; latest renewal on 30 March 2026

Study design

EMA regulatory record

Funding

not stated in the source

The EU indication is anemia of chronic kidney disease. It does not include athletic performance.

Official label

European Medicines Agency. Evrenzo (roxadustat) film-coated tablets, EPAR product information. Product number EMEA/H/C/004871.

The product information describes roxadustat as a hypoxia-inducible factor prolyl hydroxylase inhibitor that raises plasma endogenous erythropoietin, regulates iron transporter proteins and lowers hepcidin, improving iron availability and increasing hemoglobin and red cell mass. Mean effective half-life is approximately 15 hours in patients with CKD, Cmax is usually reached 2 hours post dose in the fasted state, plasma protein binding is approximately 99%, and apparent volume of distribution at steady state is 24 L. A thorough QT study in healthy subjects showed no QTc prolongation but a placebo-corrected heart rate increase of up to 9 to 10 bpm at a single 2.75 mg/kg dose and 15 to 18 bpm at 5 mg/kg. A misuse warning states that misuse may lead to an excessive increase in packed cell volume, which may be associated with life-threatening complications of the cardiovascular system. Other warnings cover cardiovascular and mortality risk, thrombotic vascular events including deep vein thrombosis, pulmonary embolism and cerebral infarction (most events serious, fatal cerebral infarction reported), seizures, serious infections, sepsis including fatal events, and secondary hypothyroidism. It is contraindicated in the third trimester of pregnancy and during breastfeeding, and women of childbearing potential must use highly effective contraception. Across 3,542 non-dialysis and 3,353 dialysis patients who received at least one dose, adverse reactions at 10% or above were hypertension (13.9%), vascular access thrombosis (12.8%), diarrhea (11.8%), peripheral edema (11.7%), hyperkalemia (10.9%) and nausea (10.2%). The most frequent serious adverse reactions were sepsis (3.4%), hyperkalemia (2.5%), hypertension (1.4%) and deep vein thrombosis (1.2%). In patients not on dialysis, seizures occurred in 1.1% on roxadustat versus 0.2% on placebo, sepsis in 2.1% versus 0.4%, and deep vein thrombosis in 1.0% versus 0.2%. A meta-analysis of adjudicated cardiovascular events from the phase 3 program in 8,984 patients appears in the label.

Participants / model

Adults with CKD-associated anemia; healthy subjects in the QT study

Treatment

Evrenzo oral tablets

Follow-up

Current EU product information

Study design

Official EU product information

Funding

not stated in the source

The page gives no label dosing or duration-of-use details. The EU document is not an FDA label.

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA API search run on 9 October 2026 for roxadustat by active ingredient, substance name, brand name and generic name, and a DailyMed search the same day.

The Drugs@FDA search for roxadustat by active ingredient, substance name, brand name and generic name returned no matching application, and a DailyMed search returned no roxadustat labels. This supports the dated, US-scoped statement that no FDA-approved roxadustat product was located. It is not a worldwide status claim.

Participants / model

FDA application and label databases, not a clinical population

Treatment

Exact name and ingredient searches

Follow-up

Searches run on 9 October 2026

Study design

Dated US approval-record search

Funding

not stated in the source

A search result shows what the databases returned on that date. No post-2021 US regulatory action was located.

Regulatory record

FibroGen, Inc. Press release announcing receipt of a complete response letter from the FDA for the roxadustat new drug application, 11 August 2021, filed as an exhibit in the SEC archive.

FibroGen announced on 11 August 2021 that it received a complete response letter from the FDA for the roxadustat new drug application for anemia of chronic kidney disease. The release states that the letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested additional clinical study of roxadustat be conducted prior to resubmission. The release does not name the affected populations or the FDA reasoning.

Participants / model

Not a clinical population

Treatment

Oral roxadustat

Follow-up

Announcement dated 11 August 2021

Study design

Company filing exhibit in the SEC archive (sponsor's own account)

Funding

not stated in the source

This is the sponsor's account. The FDA complete response letter itself is not public.

Regulatory record

FibroGen, Inc. Press release on roxadustat cardiovascular safety analyses, 6 April 2021, filed as an exhibit in the SEC archive.

The sponsor disclosed that the primary cardiovascular safety analyses it had reported at the American Society of Nephrology conference in November 2019 included post-hoc changes to the stratification factors, and that analyses with the pre-specified stratification factors result in higher hazard ratios. The release states that for MACE+ in dialysis and for MACE and MACE+ in incident dialysis the 95% confidence intervals include 1.0, so the company cannot conclude that roxadustat reduces the risk of, or is superior to, those endpoints compared with epoetin alfa. The company maintained that roxadustat remained comparable to placebo in non-dialysis patients and to epoetin alfa in dialysis patients on MACE.

Participants / model

Patients in the US phase 3 cardiovascular safety analyses

Treatment

Oral roxadustat versus placebo or epoetin alfa

Follow-up

Disclosure dated 6 April 2021

Study design

Company filing exhibit in the SEC archive (sponsor's own account)

Funding

not stated in the source

This is the sponsor's own account of its analyses, not an independent assessment.

Regulatory record

Dhillon S. Drugs. 2019;79(5):563-572. PMID 30805897.

Roxadustat received its first global approval in China for anemia in dialysis-dependent CKD, the first approval for this drug class; the 2019 review describing that approval notes long-term cardiovascular outcome studies were then underway. The sponsor's 2021 release states that roxadustat is approved in China, Japan, Chile and South Korea for the treatment of anemia of CKD in adult patients on dialysis and not on dialysis.

Participants / model

Adults with CKD-associated anemia

Treatment

Oral roxadustat

Follow-up

Approval record to 2021

Study design

Review of the approval record

Funding

not stated in the source

The Japan, Chile and South Korea statement is the sponsor's, not a regulator document read for this page.

Randomized controlled trial

Fishbane S et al. J Am Soc Nephrol. 2021;32(3):737-755. PMID 33568383.

Mean hemoglobin change from baseline over weeks 28 to 52 was 1.75 g/dl (95% CI 1.68 to 1.81) versus 0.40 g/dl (0.33 to 0.47), p less than 0.001, and roxadustat reduced red cell transfusion risk by 63% (hazard ratio 0.37, 95% CI 0.30 to 0.44). Urinary tract infection (12.8% versus 8.0%) and pneumonia (11.9% versus 9.4%) were more common on roxadustat.

Participants / model

2,781 adults with non-dialysis-dependent CKD stages 3 to 5 and hemoglobin below 10.0 g/dl

Treatment

Oral roxadustat thrice weekly versus placebo

Follow-up

Hemoglobin change assessed over weeks 28 to 52

Study design

Randomized placebo-controlled trial

Funding

not stated in the source

Endpoints were hemoglobin change, transfusion and adverse events in kidney patients with anemia.

Randomized controlled trial

Fishbane S et al. J Am Soc Nephrol. 2022;33(4):850-866. PMID 35361724.

Mean hemoglobin change over weeks 28 to 52 was 0.77 g/dl (95% CI 0.69 to 0.85) versus 0.68 g/dl (0.60 to 0.76), meeting the noninferiority margin. At least one adverse event occurred in 85.0% versus 84.5%, and at least one serious adverse event in 57.6% versus 57.5%.

Participants / model

2,133 adults with dialysis-dependent CKD and anemia

Treatment

Oral roxadustat three times weekly versus parenteral epoetin alfa

Follow-up

Hemoglobin change assessed over weeks 28 to 52

Study design

Randomized open-label active-comparator trial

Funding

not stated in the source

Endpoints were hemoglobin change and adverse events in dialysis patients.

Regulatory record

World Anti-Doping Agency. Prohibited List, class S2 (peptide hormones, growth factors, related substances and mimetics), subsection S2.1.2. The list edition year is not stated in the page text read.

Roxadustat (FG-4592) is named on the WADA Prohibited List under S2.1.2, hypoxia-inducible factor activating agents, inside class S2, which is prohibited at all times, in and out of competition. All substances in S2 are non-specified substances. Other agents listed in the same subsection include daprodustat, molidustat, vadadustat, IOX2, cobalt and xenon. Use by an athlete subject to the Code is an anti-doping rule violation.

Participants / model

Athletes under the World Anti-Doping Code

Treatment

Any route

Follow-up

Current list as read on 9 October 2026

Study design

Official anti-doping record

Funding

not stated in the source

The list edition year was not stated in the retrieved text, so no list year is given on the page.

Human study

Buisson C et al. J Pharm Biomed Anal. 2016;121:181-187. PMID 26808067.

An anti-doping laboratory reported the first identified case of an athlete using FG-4592, detected and confirmed in urine by LC-MS/MS, and states that WADA has listed HIF stabilizers and FG-4592 as prohibited since 2011. Erythropoietin and Athlete Biological Passport hematological parameters showed no profound alterations, and the abnormal blood profile score reached but did not exceed the adaptive model upper limit just after the period of use. A separate validation study implemented roxadustat and its main metabolites in routine doping controls with detection limits of 0.05 to 1 ng/mL in urine and 1 to 5 ng/mL in plasma.

Participants / model

One athlete in a doping control case; method validation samples

Treatment

Oral roxadustat, measured in urine and plasma

Follow-up

not stated in the source

Study design

Original anti-doping analytical studies

Funding

not stated in the source

The 2011 listing date is the case report's statement, not a WADA document read for this page. Endpoints were direct detection of use and indirect blood markers.

Animal study

Takemura K et al. Physiol Rep. 2025;13(13):e70464. PMID 40659571.

Blood hemoglobin rose, muscle HIF-downstream gene expression increased, and treadmill running time to exhaustion improved compared with vehicle, with comparable body weight and skeletal muscle mass. Hemodilution by phlebotomy with saline infusion removed the effect, indicating it depended on the hemoglobin increase. The authors describe the finding as a blood doping abuse risk.

Participants / model

Male C57BL/6J mice

Treatment

Oral gavage roxadustat 30 mg/kg three times per week

Follow-up

5 weeks

Study design

Original animal study

Funding

not stated in the source

This is a mouse result; no completed human performance study was located.

PubMed search record

PubMed search run on 9 October 2026: (roxadustat OR FG-4592) AND (healthy[tiab] OR athletes[tiab] OR volunteers[tiab]) AND (exercise[tiab] OR performance[tiab] OR VO2[tiab] OR endurance[tiab] OR time trial[tiab]). 6 records returned.

The search returned 6 records: four doping-detection or analytical papers, one bioanalytical method paper and one trial protocol. That protocol, ROXACardioMeta in 24 healthy volunteers aged 18 to 40, has total cholesterol as its primary hypothesis, lists exercise capacity only as a secondary outcome, and reports no results. No completed trial measuring endurance performance in healthy people or athletes was located. The endurance claim rests on mechanism, on anemia-correction trials in kidney patients, and on the mouse study.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Search run on 9 October 2026

Study design

Literature search

Funding

not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

Chemical identity record

National Center for Biotechnology Information. PubChem Compound Summary for CID 11256664, roxadustat.

Roxadustat: PubChem CID 11256664, C19H16N2O5, 352.3 g/mol, CAS 808118-40-3. Synonyms include FG-4592, ASP1517 and Evrenzo.

Participants / model

Chemical identity, not a clinical population

Treatment

Defined molecule

Follow-up

Not applicable

Study design

NLM chemical record

Funding

not stated in the source

Identity record only; it says nothing about efficacy or safety.