Investigational Drug Information for Molidustat

What is the development status for investigational drug Molidustat?

Molidustat is an investigational drug.

There have been 10 clinical trials for Molidustat. The most recent clinical trial was a Phase 3 trial, which was initiated on December 12^th 2017.

The most common disease conditions in clinical trials are Renal Insufficiency, Chronic, Renal Insufficiency, and Anemia. The leading clinical trial sponsors are Bayer and [disabled in preview].

There are forty-seven US patents protecting this investigational drug and four hundred international patents.

Summary for Molidustat

US Patents	47
International Patents	400
US Patent Applications	136
WIPO Patent Applications	67
Japanese Patent Applications	5
Clinical Trial Progress	Phase 3 (2017-12-12)
Vendors	52

Recent Clinical Trials for Molidustat

Title	Sponsor	Phase
Maintenance Treatment of Renal Anemia in Dialysis Subjects	Bayer	Phase 3
A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects	Bayer	Phase 3
A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects	Bayer	Phase 3

See all Molidustat clinical trials

Clinical Trial Summary for Molidustat

Top disease conditions for Molidustat

Top clinical trial sponsors for Molidustat

See all Molidustat clinical trials

US Patents for Molidustat

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
Molidustat		Controlled release dosage form	TRIASTEK, INC. (Nanjing, CN)
Molidustat		Bicyclic-fused heteroaryl or aryl compounds as IRAK4 modulators	Pfizer Corp SRL
Molidustat		Method for the preparation of triazole compounds	BAYER PHARMA AKTIENGESELLSCHAFT (Berlin, DE)
Molidustat		Heterocyclic compounds as inhibitors of Vanin-1 enzyme	Pfizer Corp SRL
Molidustat		Bicyclic-fused heteroaryl or aryl compounds as IRAK4 modulators	Pfizer Inc. (New York, NY)
Molidustat		Bicyclic-fused heteroaryl or aryl compounds	Pfizer Inc. (New York, NY)
Molidustat		Amide-substituted pyridinyltriazole derivatives and uses thereof	BAYER PHARMA AKTIENGESELLSCHAFT (Berlin, DE)

International Patents for Molidustat

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
Molidustat	Australia	AU2017261372	2036-05-05
Molidustat	Canada	CA3023278	2036-05-05
Molidustat	China	CN107847398	2036-05-05
Molidustat	European Patent Office	EP3452003	2036-05-05
Molidustat	European Patent Office	EP3981392	2036-05-05
Molidustat	Hong Kong	HK1249728	2036-05-05
Molidustat	Japan	JP2019520866	2036-05-05

Development Update and Market Projection for Molidustat

Last updated: February 20, 2026

What is the current development status of Molidustat?

Molidustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is developed by Akebia Therapeutics. As of 2023, it is approved for commercial sale in Japan for anemia associated with chronic kidney disease (CKD). Phase 3 trials under regulatory review are ongoing or completed in other regions, including the United States and European Union.

Key milestones:

• Japan: Approved in 2021 for dialysis and non-dialysis CKD anemia.
• United States: Filed New Drug Application (NDA) with FDA in 2022; seeking final approval.
• European Union: Submitted Marketing Authorization Application (MAA) in 2022; under review.
• Clinical trials: Phase 3 completed in multiple geographies; primary endpoints focused on hemoglobin correction, safety, and cardiovascular outcomes.

How does Molidustat compare with existing therapies?

Parameter	Molidustat	Erythropoiesis-stimulating agents (ESAs)	Roxadustat
Mechanism	HIF-PHI	Recombinant proteins	HIF-PHI
Route of administration	Oral	Injectable	Oral
Approval status in Japan	Yes	Yes	Approved in China, Europe*
Phase 3 trials globally	Yes	Yes	Yes
Target indications	CKD anemia	CKD anemia	CKD anemia

*Roxadustat is approved in China (2019) and the European Union (2019 for anemia in CKD).

What are the potential market dimensions for Molidustat?

Estimated global CKD anemia market

• 2022 revenue: Approx. $6.2 billion (EvaluatePharma)
• Projected growth rate: 8.5% CAGR through 2027
• Market segmentation: Dialysis patients (approx. 343,000 globally), non-dialysis CKD patients (approx. 1.2 million in the U.S. alone)

Sales forecast (2023–2027)

Year	Estimated sales (USD millions)	Notes
2023	$150	Japan sales, early U.S. launch prep
2024	$350	Expanded U.S. distribution, China approval
2025	$700	Increased penetration in Europe and Asia
2026	$1,200	Growing adoption for non-dialysis CKD
2027	$1,800	Market maturation, pipeline progress

What are the key regulatory and commercialization considerations?

• FDA: NDA under review for dialysis and non-dialysis CKD anemia, decision anticipated late 2023 or early 2024.
• EU: MAA under evaluation; approval timeline uncertain.
• Japan: Fully approved since 2021, with commercial rollout ongoing.
• Pricing: Expected to differ regionally, with premium positioning in markets lacking alternatives.

What are the competitive risks and potential market barriers?

• Safety concerns: Cardiovascular event reports with some HIF-PHIs could slow uptake.
• Market penetration: Entrenched use of ESAs, particularly in U.S. facilities, may hinder rapid adoption.
• Regulatory delays: Post-approval safety data requirements could extend timelines.
• Pricing and reimbursement: Competitive pricing strategies critical, especially in Europe and emerging markets.

What are the key R&D and pipeline considerations?

• Additional indications: Anemia in cancer, chronic liver disease.
• Combination therapies: Potential synergy with other CKD treatments.
• Biomarker development: Monitoring HIF pathway activation for safety profiling.
• Pipeline status: Several HIF-PHI candidates are in early clinical stages; competitive landscape intensifies.

Summary

Molidustat has established a presence in Japan with regulatory approval and is progressing through North American and European regulatory pathways. Its oral administration gives it potential advantages over injectable ESAs, especially for non-dialysis CKD patients. Market adoption depends on regulatory outcomes, safety profiles, and reimbursement strategies. The global CKD anemia market is projected to grow substantially, with Molidustat positioned as a leading oral HIF-PHI candidate.

Key Takeaways

• Molidustat is commercially available in Japan for CKD anemia.
• It is under regulatory review in major markets, with approval likely by 2024.
• The global CKD anemia market is expanding at 8.5% CAGR, projected to reach over $10 billion by 2027.
• Competitive landscape includes Roxadustat and other HIF-PHIs, with safety and pricing as key factors.
• Growth opportunities include additional indications and regional expansion.

FAQs

1. When is Molidustat expected to gain FDA approval?
   Likely late 2023 or early 2024, based on current NDA review timelines.

2. What distinguishes Molidustat from other HIF-PHI drugs?
   Its approval in Japan provides a proof of concept; specific safety profiles and dosing advantages remain under clinical evaluation.

3. What markets are primary targets for Molidustat’s expansion?
   U.S., European Union, China, and other Asia-Pacific regions.

4. What safety concerns could impact market penetration?
   Cardiovascular events reported with HIF-PHIs could influence prescribing habits and regulatory approval.

5. How does the market outlook compare to rivals like Roxadustat?
   Roxadustat is already approved in China and Europe; Molidustat faces competition but benefits from regional approval and oral administration.

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[1] EvaluatePharma. (2022). Global CKD market report.
[2] Akebia Therapeutics. (2023). Corporate update.
[3] FDA. (2022). NDA submission details.
[4] European Medicines Agency. (2022). MAA review status.