Efficacy and Safety of Pegmolesatide in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI): a Multi-center, Prospective, Open-label, Randomized Parallel Controlled Trial

For patients with renal anemia treated with hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), there is a clinical need of switching to long-acting and safe medications.
Pegmolesatide, a polyethylene glycol (PEG)-conjugated erythropoiesis-stimulating peptide, is a long-acting erythropoiesis-stimulating agent (ESA) with sustained activity. It was approved for marketing by the National Medical Products Administration (NMPA) in June 2023. Phase III clinical trials have demonstrated its efficacy and safety in dialysis patients with renal anemia who were previously treated with recombinant human erythropoietin (rHuEPO). However, there are currently no data regarding the efficacy and safety of switching from HIF-PHIs to pegmolesatide, and there is a lack of standard for the dose conversion.
This study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial, planning to enroll 96 patients.
All enrolled patients will receive 12 weeks of treatment and be followed up for 16 weeks.

Start Date08 Sep 2025

Sponsor / Collaborator

Guangdong General Hospital

NCT07045155

/ RecruitingPhase 4IIT

Pegmolesatide for Anemia Treatment：Investigation Upgrade Therapy in rhuEPO Patients Undergoing Dialysis: A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study（PANGU-stepup）

This study is a prospective, multicenter, parallel-controlled, open-label clinical trial, planned to be conducted across multiple research centers in various provinces and cities in China.
It will enroll 240 dialysis-dependent chronic kidney disease (DD-CKD) patients with anemia who have been receiving rHuEPO treatment for at least 4 weeks, with hemoglobin (Hb) levels of ≥70 g/L and <110 g/L. After enrollment, participants will be randomly assigned in a 1:1:1 ratio to the experimental group, control group, and exploratory group. The study will involve a 24-week treatment and observation period, divided into three phases: a screening period (Day -28 to Day -1), a treatment period (Week 0 to Week 16), and an extension period (Week 17 to Week 24).
The primary objective is to assess the impact of the three treatment regimens on the hemoglobin levels of patients with DD-CKD anemia.

Start Date01 Aug 2025

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

[+1]

CTR20251013

/ RecruitingPhase 4

培莫沙肽注射液在接受过促红细胞生成素治疗的慢性肾脏病透析贫血患者中长期有效性和安全性的IV期临床研究

[Translation] Phase IV clinical study on the long-term efficacy and safety of pemosatin injection in patients with chronic kidney disease and anemia on dialysis who have received erythropoietin treatment

1) 在经治CKD透析贫血患者中评估培莫沙肽治疗的长期安全性和有效性； 2) 在经治CKD透析贫血患者中评估由各种短效ESAs按照说明书获批的剂量方案（包括剂量转换方案和剂量调整方案）转换成培莫沙肽的有效性。

[Translation]

1) To evaluate the long-term safety and efficacy of pemosatin in patients with anaemia on dialysis who have been treated for CKD; 2) To evaluate the efficacy of switching from various short-acting ESAs to pemosatin according to the approved dosage regimen (including dosage conversion regimen and dosage adjustment regimen) in patients with anaemia on dialysis who have been treated for CKD.

Start Date21 May 2025

Sponsor / Collaborator

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Pegol-Sihematide

100 Translational Medicine associated with Pegol-Sihematide

100 Patents (Medical) associated with Pegol-Sihematide

Literatures (Medical) associated with Pegol-Sihematide

01 Sep 2026·Drug Testing and Analysis

Development of an Enzyme‐Linked Immunosorbent Assay for Pegmolesatide in Doping Analysis: An Initial Testing Method

Article

Author: Chen, Jie ; Niu, Chengshuai ; Zhou, Xinmiao

ABSTRACT:

Pegmolesatide is a novel synthetic erythropoietin‐mimetic agent that binds to and activates the erythropoietin receptor (EPOR), thereby stimulating erythropoiesis. Owing to its erythropoiesis‐stimulating activity, it has been included in the latest World Anti‐Doping Agency (WADA) Prohibited List as an erythropoietin receptor agonist (S2.1.1). The current analytical approach for pegmolesatide in doping analysis mainly relies on bottom‐up nano‐liquid chromatography–high‐resolution tandem mass spectrometry (LC‐HRMS) in serum. Although accurate and sensitive, this approach involves extensive sample preparation and time‐consuming LC analysis, which limits its suitability for high‐throughput initial testing procedure (ITP). In this study, an enzyme‐linked immunosorbent assay (ELISA), termed the EPOR–anti‐PEG ELISA, was developed as a screening method for pegmolesatide in urine and serum. The assay employs EPOR as the capture reagent to enrich pegmolesatide, followed by detection of its polyethylene glycol (PEG) moiety using the anti‐PEG monoclonal antibody RM105. Method validation included assessment of selectivity, limit of detection (LOD), dynamic range, reliability, and carryover. Under optimized conditions, the assay showed an LOD of 1 ng/mL in urine, with an adjusted OD 450 screening cutoff of 0.029. In serum, with an adjusted OD 450 screening cutoff of 0.243, the LOD was 2 ng/mL, which was lower than the limit of identification (LOI) of 7 ng/mL determined by LC‐HRMS. Overall, this ELISA provides a streamlined, cost‐effective, and high‐throughput screening approach for pegmolesatide and may serve as a practical complement to the LC‐HRMS method in doping analysis.

01 Jun 2026·Blood Red Cells & Iron

Daprodustat augments red blood cell and γ-globin production in models of sickle cell disease

Article

Author: Chowdhury, Fabliha A ; Crosby, Danielle ; Ishfaq, Muhammad ; Mohideen, Aiden ; Ghosh, Samit ; Yien, Yvette Y ; Taiclet, Stefanie ; Mondal, Paritosh ; Sharma, Malini ; Wood, Katherine C ; Xu, Julia Z ; Straub, Adam C ; Philips, Brian J

Sickle cell disease (SCD) causes erythrocyte sickling and downstream sequelae, including hemolysis, iron mishandling, and subclinical renal dysfunction, thereby reducing erythropoietic drive. These effects result in chronic anemia that drives SCD-related complications. Treatment of severe anemia in SCD with frequent subcutaneous injections of erythropoiesis-stimulating agents is often poorly tolerated by patients, underscoring the need for oral treatments. Here, we provide key insights into how daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that stimulates red cell production, may serve as a targeted treatment for anemia in SCD. In a mouse model of SCD, daprodustat increases red blood cell production, reduces sickling, and improves iron mobilization by suppressing hepatic hepcidin expression, thereby enhancing iron availability for erythropoiesis and ameliorating chronic anemia. In addition to these systemic, non-cell-autonomous effects on iron homeostasis, daprodustat directly induces γ-globin expression and increases the production of fetal hemoglobin-containing erythroid cells (F-cells) derived from CD34+ hematopoietic stem and progenitor cells of patients with SCD, conferring cell-autonomous therapeutic benefits. These findings demonstrate that HIF-PHIs act on multiple therapeutic targets in SCD and represent a promising oral treatment option for chronic anemia in this disease.

01 Dec 2025·INTERNATIONAL IMMUNOPHARMACOLOGY

Pegmolesatide ameliorates indoxyl sulfate-induced cardiomyocyte hypertrophy through modulating the EPOR-CD131-dependent JAK2/STAT3 signaling pathway

Article

Author: Zhang, Xinyu ; Lin, Tingru ; Zhu, Li ; Zuo, Li ; Gan, Liangying ; Li, Sufang

BACKGROUND:

Cardiovascular events remain the leading cause of mortality in chronic kidney disease (CKD). Pegmolesatide(P), a novel long-acting EPO receptor modulator, shows cardiovascular benefits in clinical studies. This study aims to demonstrate Pegmolesatide suppressed the formation of EPOR-CD131 heterodimer and to explore its cardioprotective mechanisms against indoxyl sulfate (IS)-induced cardiomyocyte hypertrophy.

METHODS:

H9c2 cardiomyocytes were assigned to different treatment groups (vehicle, IS, IS+P, P) and RNA sequencing was performed to identify dysregulated signaling pathways. Mechanistic exploration groups supplemented with CD131 agonist ARA290, STAT3 activator Colivelin, or STAT3 inhibitor Stattic for rescue experiments. Analyses included real-time qPCR/Western blot for cardiac hypertrophy markers and EPOR-CD131/JAK2/STAT3 axis components, phalloidin staining for cell size and co-immunoprecipitation (Co-IP) for EPOR-CD131 heterodimerization.

RESULTS:

Pegmolesatide significantly attenuated IS-induced cardiomyocyte hypertrophy, as evidenced by suppressed expression of cardiac hypertrophy markers (ANP, BNP, and β-MHC), reduced cell surface area, and improved cytoskeletal organization(P < 0.05). Mechanistically, Pegmolesatide upregulated EPOR expression while suppressing CD131 expression and activation of the JAK2/STAT3 signaling. Co-IP analysis demonstrated that Pegmolesatide suppressed the formation of EPOR-CD131 heterodimer. Functional rescue experiments showed that the cardioprotective effects of Pegmolesatide were reversed by CD131 agonist ARA290 or STAT3 activator Colivelin. Notably, combined treatment with ARA290 and STAT3 inhibitor Stattic partially restored its anti-hypertrophic activity.

CONCLUSION:

Pegmolesatide exerts protective effects against IS-induced cardiomyocyte hypertrophy by inhibiting the EPOR-CD131/JAK2/STAT3 signaling axis. It may be a promising strategy for CKD-related cardiovascular complications.

News (Medical) associated with Pegol-Sihematide

05 Jan 2021

·www.globenewswire.com

Chronic Kidney Disease (CKD) Pipeline Insight, 2020 Report Featuring 55 Key players & 10 Key Products

Dublin, Dec. 31, 2020 (GLOBE NEWSWIRE) -- The "Chronic Kidney Disease (CKD) - Pipeline Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering. The "Chronic Kidney Disease (CKD) - Pipeline Insight, 2020," report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Chronic Kidney Disease pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Chronic Kidney Disease Emerging Drugs Chapters This segment of the Chronic Kidney Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Chronic Kidney Disease Emerging Drugs AZD5718: AstraZeneca AstraZeneca is conducting a study to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease. The study will be conducted in approximately 118 study centers across 12 countries. The overall study period will be around 28 weeks. Approximately 632 participants comprising of 67% diabetic kidney disease (DKD) and 33% non-DKD participants will be enrolled. DDO-3055: Jiangsu HengRui Medicine Co., Ltd. Jiangsu HengRui Medicine is conducting a randomized, double-blind, dose-escalating, placebo controlled, phase I study to evaluate the safety and pharmacokinetics and pharmacodynamics of DDO-3055 in healthy volunteers and patients with Chronic Kidney Disease. This is a randomized, double-blind, dose-escalating, placebo controlled, Phase I study to evaluate the safety, pharmacokinetics and pharmacodynamics of DDO-3055 in healthy volunteers and patients with chronic kidney disease. 48 healthy volunteers will be enrolled in Part A, and 18 patients with chronic kidney disease will be enrolled in Part B. Chronic Kidney Disease: Therapeutic Assessment This segment of the report provides insights about the different Chronic Kidney Disease drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Chronic Kidney Disease There are approx. 50+ key companies which are developing the therapies for Chronic Kidney Disease. The companies which have their Chronic Kidney Disease drug candidates in the mid to advanced stage, i.e. phase III and Phase II include, AstraZeneca, UnicoCell Biomed, Jiangsu Hansoh Pharmaceutical, Bio Sidus, Keryx Biopharmaceuticals, AMAG Pharmaceuticals, inRegen, AbbVie etc. Phases The report covers around 50+ products under different phases of clinical development like Mid-stage products (Phase II and Phase I/II) Early-stage products (Phase I/II and Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Chronic Kidney Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Subcutaneous Intravenous Oral Intramuscular Molecule Type Products have been categorized under various Molecule types such as Small molecules Proteins and peptides Polymers Diamines Chlorinated hydrocarbons Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Chronic Kidney Disease: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chronic Kidney Disease therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Chronic Kidney Disease drugs. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Chronic Kidney Disease R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Kidney Disease. August 2020: DAPA-CKD trial meets primary endpoint in patients with chronic kidney disease. Dapagliflozin reduces the risk of kidney failure, death from cardiovascular causes or heart failure hospitalisation and all-cause mortality in chronic kidney disease patients with or without type 2 diabetes. That's the main result of the DAPA-CKD trial presented in a Hot Line session today at ESC Congress 2020. Chronic Kidney Disease Report Insights Chronic Kidney Disease Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Chronic Kidney Disease Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: How many companies are developing Chronic Kidney Disease drugs? How many Chronic Kidney Disease drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Kidney Disease? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Chronic Kidney Disease therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Chronic Kidney Disease and their status? What are the key designations that have been granted to the emerging drugs? Key Players AdAlta Ltd Allena Pharmaceuticals Inc apceth Biopharma GmbH Arch Biopartners Inc Astellas Pharma Inc AstraZeneca Plc Bayer AG BiOrion Technologies BV Boehringer Ingelheim GmbH Boryung Pharmaceutical Co Ltd Celgene Corp Certa Therapeutics Pty Ltd Conatus Pharmaceuticals Inc Corvidia Therapeutics Inc DiaMedica Therapeutics Inc Dimerix Bioscience Pty Ltd DiscoveryBiomed Inc DURECT Corp Epigen Biosciences Inc Galectin Therapeutics Inc GenKyoTex SA GNI Group Ltd iBio Inc IC-MedTech Inc Ipsen SA Isarna Therapeutics GmbH KBP BioSciences Co Ltd Kidney Fibrosis Klotho Therapeutics Inc Les Laboratoires Servier SAS ManRos Therapeutics Mironid Ltd NovaTarg Therapeutics Inc Novo Nordisk AS OPKO Health Inc Opsidio LLC Otsuka Holdings Co Ltd Pharmaxis Ltd Q BioMed Inc Redx Pharma Plc Regulus Therapeutics Inc Resverlogix Corp Sanwa Kagaku Kenkyusho Co Ltd Sarfez Pharmaceuticals Inc Scholar Rock Inc Sirnaomics Inc Sphaera Pharma Pte Ltd Symic Biomedical Inc Taisho Pharmaceutical Holdings Co Ltd Theravance Biopharma Inc Unity Biotechnology Inc Vascular Biogenics Ltd Vascular BioSciences VESSL Therapeutics Ltd Vicore Pharma AB Key Products AZD5718 MEDI8367 efepoetin alfa Verinurad Empagliflozin DDO-3055 KBP-5074 Doxercalciferol TRC101 Pegol-Sihematide For more information about this drug pipelines report visit Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research. CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

Small molecular drugAcquisitionCollaborate

100 Deals associated with Pegol-Sihematide

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Anemia in chronic kidney disease	China	Jiangsu Hansoh Pharmaceutical Group Co., Ltd.	30 Jun 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Kidney Failure, Chronic	Phase 3	China	Jiangsu Hansoh Pharmaceutical Group Co., Ltd.	15 May 2019
myelodysplastic anemia	Phase 1	China	Jiangsu Hansoh Pharmaceutical Group Co., Ltd.	20 Jun 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07136792 (ASN2026)	Not Applicable	Anemia of renal disease	24	Roxadustat ≤210 mg stratum; Pegmolesatide 2 mg	umojrmumgj(vhxxsyegrz) = hbavmamkru bhvbaezyfs (yvrbtcujjn, 7.84)	Positive	24 Oct 2026
				Roxadustat ≤210 mg stratum; Pegmolesatide 4 mg	umojrmumgj(vhxxsyegrz) = hvyovhvpyq bhvbaezyfs (yvrbtcujjn, 11.69)
ASN2026	Not Applicable	Anemia	63	Pegmolesatide 4 mg	eahxckiheo(ohptpjadqj) = ykekiggpnq emhmvanxtw (mejcktgnga, 16.8) View more	Positive	23 Oct 2026
				Roxadustat 100-150mg	eahxckiheo(ohptpjadqj) = zfdfahbfrb emhmvanxtw (mejcktgnga, 11.2) View more
NCT03903809 (Literature) Manual	Phase 3	Anemia in chronic kidney disease	175	Pegmolesatide	hrsdmimrac(wlxmtcaimx) = mueehnuqqp zxukpahcdh (gsfsagcgac ) View more	Non-inferior	06 Feb 2025
				Epoetin alfa	hrsdmimrac(wlxmtcaimx) = ksctvghvac zxukpahcdh (gsfsagcgac ) View more
NCT03903809 (ISN WCN2025)	Phase 3	Anemia in chronic kidney disease	175	Pegmolesatide	vswziuvluj(kaapkfnywp): P-Value = 0.0163	Positive	01 Feb 2025
				Epoetin alfa
NCT03903809 (Literature) Manual	Phase 3	Anemia in chronic kidney disease	173	Pegmolesatide	amsgkwqjwx(jgzqsrbzly) = eezanrwgsi mauplekysa (qpuptofhad )	Similar	05 Dec 2024
				Epoetin alfa	amsgkwqjwx(jgzqsrbzly) = ybabxlhilz mauplekysa (qpuptofhad )
NCT03902691 (Literature) Manual	Phase 3	chronic renal failure anemia	372	pegmolesatide	cxljvhfrsb(laoliuibuj) = xckpxhgpyx ebscuwhzse (buvacrrifu, 0.92) View more	Non-inferior	28 Oct 2023
				epoetin alfa	cxljvhfrsb(laoliuibuj) = pqlbtoqmkd ebscuwhzse (buvacrrifu, 0.97) View more
ISN WCN2022	Not Applicable	-	372	Pegmolesatide	uoandlfpme(pnzxrnnlys) = 1.6% who received Pegmolesatide and 3.2% who received the Epoetin alfa ahxnexqjmq (biynpotanz ) View more	Positive	01 Feb 2022

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis