PharmaceuticalHIF prolyl-hydroxylase inhibitorOral erythropoiesis stimulant

Molidustat

Also known as BAY 85-3934 · Mobix

Written by enwyReviewed 5 Aug 20262 sources0 comments

Molidustat is an oral HIF prolyl-hydroxylase inhibitor developed for renal anaemia, approved in Japan (Mochida/Bayer, Mobix) but not in the US or EU. It stimulates endogenous erythropoietin and is a doping concern within WADA's prohibited HIF activating agents class.

01 Overview

Molidustat (BAY 85-3934) inhibits HIF prolyl hydroxylases to stabilise HIF-alpha and increase endogenous erythropoietin. Phase II/III studies (the MIYABI programme) supported its approval in Japan for anaemia associated with chronic kidney disease.\n\nIt has less clinical exposure than roxadustat or daprodustat, and no US/EU approval, so its long-term safety is less established. As with the whole HIF-PHI class, it carries thromboembolic and cardiovascular concerns, and its oral erythropoietic action makes it prohibited in sport.

02 Mechanism

Inhibits HIF prolyl-4-hydroxylase, stabilising HIF-alpha and increasing transcription of erythropoietin to raise red cell production.

03 Dosing

Tier	Dose	Route	Notes
CKD anaemia (medical, Japan)	25–200 mg/day	Oral	Once daily, titrated; approved in Japan only

04 Effects

Effect	Magnitude	Evidence
Increased endogenous EPORaises endogenous erythropoietin to correct renal anaemia orally.	Hb raised	Clinical
Improved iron utilisationLike other HIF-PHIs it improves iron handling, supporting erythropoiesis.	Lower hepcidin	Clinical

05 Side effects

Effect	Severity	Frequency	Evidence	Countermeasures
ThromboembolismShares the HIF-PHI thromboembolic risk profile.	Severe	Class risk	Clinical
HypertensionBlood pressure elevation reported.	Moderate	Common	Clinical

06 Legal status

United States

Not FDA-approved

Approved in Japan; WADA-prohibited in sport · as of Jan 2026

07 References

Molidustat for anemia in CKD (MIYABI programme)Nephrology / clinical trials, 2021

WADA Prohibited List — S2 (HIF activating agents)World Anti-Doping Agency

08 Discussion0 comments

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This page is reference information, not medical advice. Doses and protocols are documented as they appear in the clinical literature and in practice — describing them is not a recommendation to use them. Countermeasures listed here are not a substitute for a physician. Legal status varies by jurisdiction and changes.