Anemia in Chronic Kidney Disease Pipeline Insight 2025: HIF-PH Inhibitors, Novel ESAs, and Oral Agents Reshape the Treatment Paradigm | DelveInsight

DelveInsight's "Anemia in Chronic Kidney Disease (CKD) - Pipeline Insight, 2025" explores the dynamic therapeutic landscape targeting one of the most burdensome comorbidities in CKD. Affecting millions of dialysis and non-dialysis patients worldwide, CKD-related anemia is primarily driven by insufficient erythropoietin production and iron dysregulation. Traditional erythropoiesis-stimulating agents (ESAs), though widely used, are limited by administration route, cardiovascular risks, and inconsistent efficacy in inflammatory states.

The 2025 pipeline marks a major turning point with the rise of oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors, such as daprodustat (GSK) and vadadustat (Akebia Therapeutics), offering a non-injectable, hepcidin-modulating approach to stimulate endogenous erythropoietin production. Roxadustat, already approved in some geographies, continues to expand into broader patient subsets through ongoing Phase III and post-marketing trials.

Additionally, fibroblast growth factor 23 (FGF23) antagonists, iron-based agents like ferric maltol, and novel long-acting ESAs are making headway in patients with ESA hyporesponsiveness or inflammation-driven anemia. Companies are also exploring anti-hepcidin monoclonal antibodies, aiming to address functional iron deficiency without IV iron burden.

Digital endpoints, patient-reported fatigue scores, and real-world evidence from dialysis registries are increasingly being integrated into regulatory pathways. The FDA and EMA are showing greater flexibility toward oral, inflammation-adaptive therapies in light of unmet needs among non-dialysis CKD populations. With a wave of precision anemia therapies and expanded delivery platforms, the CKD anemia market is undergoing long-overdue transformation poised to enhance quality of life, reduce transfusion rates, and improve cardiovascular outcomes.

Interested in learning more about the current treatment landscape and the key drivers shaping the anemia in chronic kidney disease pipeline? Click here: https://www.delveinsight.com/report-store/anemia-in-chronic-kidney-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Anemia In Chronic Kidney Disease Pipeline Report
• DelveInsight's anemia in chronic kidney disease pipeline analysis depicts a strong space with 10+ active players working to develop 10+ pipeline drugs for anemia in chronic kidney disease treatment.
• The leading anemia in chronic kidney disease companies include Jiangsu HengRui Medicine, Shenyang Sunshine Pharmaceutical, Biocad, Xenetic Biosciences, Chiasma, Liminal BioSciences, Acceleron Pharma, Celgene Corporation, and others are evaluating their lead assets to improve the anemia in chronic kidney disease treatment landscape.
• Key anemia in chronic kidney disease pipeline therapies in various stages of development include DDO-3055, SSS17, BCD-131, BCD-066, Erythropoietin polysialic, CHIP 2, PBI 1402, Sotatercept, and others.
• In March 2025, the FDA expanded the approval of Furoscix to include the treatment of edema in patients with chronic kidney disease, including nephrotic syndrome.
• In March 2025, scPharmaceuticals received FDA approval for a supplemental new drug application (sNDA) for Furoscix (furosemide injection). This approval expands the drug's use to treat edema in patients with chronic kidney disease (CKD), marking a significant advancement in scPharmaceuticals' portfolio for cardiorenal conditions.
• In March 2025, the FDA approved an expanded indication for furosemide injection (Furoscix; scPharmaceuticals, Inc.) to treat edema in adult patients with chronic kidney disease (CKD), including nephrotic syndrome. The expanded treatment is expected to be available by April 2025. This approval follows the FDA's acceptance of the supplemental new drug application in July 2024.
• In January 2025, the FDA approved a new indication for semaglutide to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, according to Novo Nordisk.
• In November 2024, Unicycive Therapeutics (Nasdaq: UNCY) announced that the FDA has accepted its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), with a PDUFA target action date set for June 28, 2025. If approved, OLC has the potential to significantly enhance the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients undergoing dialysis.

Request a sample and discover the recent breakthroughs happening in the anemia in chronic kidney disease pipeline landscape at https://www.delveinsight.com/report-store/anemia-in-chronic-kidney-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Anemia In Chronic Kidney Disease Overview
Anemia is a common and significant complication of chronic kidney disease, primarily caused by reduced erythropoietin production in the kidneys, which leads to decreased red blood cell (RBC) formation. Other contributing factors include iron deficiency, inflammation, and blood loss during dialysis. Anemia in CKD can worsen cardiovascular health, increase hospitalization risk, and reduce overall quality of life.

Management typically involves iron supplementation, erythropoiesis-stimulating agents (ESAs), and newer therapies such as hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), which stimulate endogenous erythropoietin production. Early diagnosis and tailored treatment are essential for improving outcomes in patients with CKD-related anemia.

Find out more about anemia in chronic kidney disease medication at https://www.delveinsight.com/report-store/anemia-in-chronic-kidney-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Anemia In Chronic Kidney Disease Treatment Analysis: Drug Profile
BCD-066: Biocad
BCD-066 is an erythropoietin-based therapy currently in Phase III equivalence studies, aimed at evaluating its efficacy and safety compared to Aranesp® for treating anemia in end-stage chronic kidney disease (CKD) patients undergoing dialysis. Erythropoietin therapies remain the standard approach for managing CKD-related anemia.

SSS17: Shenyang Sunshine Pharmaceutical
SSS17 is an oral, small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PH), in Phase I development for anemia associated with chronic kidney disease. By inhibiting HIF-PH, SSS17 enhances the stability of HIF-α, thereby stimulating endogenous erythropoietin (EPO) production to promote red blood cell formation.

Learn more about the novel and emerging anemia in chronic kidney disease pipeline therapies at https://www.delveinsight.com/report-store/anemia-in-chronic-kidney-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Anemia In Chronic Kidney Disease Therapeutic Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the Anemia In Chronic Kidney Disease Pipeline Report
• Coverage: Global
• Key Anemia In Chronic Kidney Disease Companies: Jiangsu HengRui Medicine, Shenyang Sunshine Pharmaceutical, Biocad, Xenetic Biosciences, Chiasma, Liminal BioSciences, Acceleron Pharma, Celgene Corporation, and others.
• Key Anemia In Chronic Kidney Disease Pipeline Therapies: DDO-3055, SSS17, BCD-131, BCD-066, Erythropoietin polysialic, CHIP 2, PBI 1402, Sotatercept, and others.

To dive deep into rich insights for drugs used for anemia in chronic kidney disease treatment, visit: https://www.delveinsight.com/report-store/anemia-in-chronic-kidney-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Anemia In Chronic Kidney Disease Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Anemia In Chronic Kidney Disease Pipeline Therapeutics
6. Anemia In Chronic Kidney Disease Pipeline: Late-Stage Products (Phase III)
7. Anemia In Chronic Kidney Disease Pipeline: Mid-Stage Products (Phase II)
8. Anemia In Chronic Kidney Disease Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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jvimal@delveinsight.com
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This release was published on openPR.