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Last update 25 Mar 2025
Pegol-Sihematide
Last update 25 Mar 2025
Overview
Basic Info
Drug Type Synthetic peptide |
Synonyms pegmolesatide, Pegol Sihematide, Peihuaxi hippocampal peptide(Jiangsu Hansoh Pharmaceutical) + [5] |
Target |
Action agonists, stimulants |
Mechanism EPO receptor agonists(Erythropoietin receptor agonists), Erythropoiesis stimulants(Erythropoiesis stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date China (30 Jun 2023), |
RegulationSpecial Review Project (China) |
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Structure/Sequence
Sequence Code 16643475
Source: *****
Related
14
Clinical Trials associated with Pegol-SihematideChiCTR2400093814
Optimized and standard Pegmolesatide regimens utilization: investigation of efficacy and safety for anemia in CKD
NCT03903809
A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter, Non-Inferiority Study to Evaluate the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Non-Dialysis-Dependent Chronic Kidney Disease
CTR20190234
培化西海马肽注射液治疗慢性肾脏病非透析患者贫血的有效性和安全性多中心随机开放阳性对照非劣效性Ⅲ期研究
[Translation] A multicenter, randomized, open-label, positively controlled, non-inferiority phase III study on the efficacy and safety of Peihuaxihaima peptide injection in the treatment of anemia in non-dialysis patients with chronic kidney disease
100 Clinical Results associated with Pegol-Sihematide
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100 Translational Medicine associated with Pegol-Sihematide
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100 Patents (Medical) associated with Pegol-Sihematide
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6
Literatures (Medical) associated with Pegol-Sihematide01 Feb 2025Kidney Medicine
EPO-Mimetic Peptide Pegmolesatide Therapy for Pure Red Cell Aplasia in a Patient with Non-dialysis-dependent Type 1 Diabetic Nephropathy: A Case Report
Article
Author: Wang, Juan ; Chen, Qiong ; Liu, Xuan ; Yang, Man ; Fan, Qiu-Ling
Pure red cell aplasia (PRCA) is a rare complication of erythropoietin (EPO) therapy, characterized by a severe deficiency in red blood cell production. There is no guideline on the treatment for PRCA because there have been too few cases to perform prospective cohort studies. The main treatments for PRCA include immediate cessation of EPO, restrictive transfusion, and immunosuppressive therapies. A 35-year-old male patient with type 1 diabetic nephropathy was diagnosed with PRCA. Enarodustat and roxadustat were administered successively after discontinuation of EPO, but anemia did not improve, and the patient was maintained with weekly blood transfusions. Subsequently, the EPO-mimetic peptide pegmolesatide was administered, and the patient's hemoglobin started to increase after 1 week and increased from 50 g/L to 92 g/L over approximately 3 months. Based on these findings, we speculate that pegmolesatide can provide a safe, effective, and convenient therapeutic strategy for PRCA in Chinese patients with chronic kidney disease.
01 Nov 2023EClinicalMedicine
Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial
Article
Author: Li, Shaomei ; Jiang, Hongli ; Liu, Bicheng ; Zhang, Shiying ; Xu, Chengyun ; Zhou, Hua ; Ren, Yueqin ; Luo, Qun ; Zhao, Zhanzheng ; Li, Chuan ; Lu, Guoyuan ; Qiu, Hongyu ; Pan, Chao ; He, Wei ; Zhang, Weili ; Luo, Ping ; Xu, Chunping ; Chen, Menghua ; Sun, Mindan ; Du, Shutong ; Lv, Lu ; Wang, Xiaoling ; He, Liangliang ; Chen, Qinkai ; Li, Guisen ; Yan, Tiekun ; Chen, Jianghua ; Yang, Xiao ; Zhang, Ping ; Wang, Xiaoxia ; Tang, Shuifu ; Zheng, Hongguang ; Xie, Deqiong ; Sun, Bengui ; Huang, Xiangyang ; Yang, Aicheng ; Zhou, Linghui ; Qin, Shuguang ; Guo, Minghao ; Wang, Cheng ; Jiang, Yan ; Xia, Yu'ou ; Wu, Qiong ; Li, Jing ; Zhong, Aimin ; Liu, Hong ; Wang, Qin
Background:
Pegmolesatide, a synthetic peptide-based erythropoietin (EPO) receptor agonist, is being evaluated as an alternative to epoetin alfa for treating anemia of chronic kidney disease (CKD) in Chinese dialysis patients. There is a critical need for a long-acting, cost-effective erythropoiesis-stimulating agent that does not produce EPO antibodies.
Methods:
A randomized, open-label, active-comparator, non-inferiority phase three trial was conducted at 43 dialysis centers in China between May 17th, 2019, and March 28th, 2022. Eligible patients aged 18-70 years were randomly assigned (2:1) to receive pegmolesatide once every four weeks or epoetin alfa one to three times per week, with doses adjusted to maintain a hemoglobin level between 10.0 and 12.0 g/dL. The primary efficacy endpoint was the mean change in hemoglobin level from baseline to the efficacy evaluation period in the per-protocol set (PPS) population. Non-inferiority of pegmolesatide to epoetin alfa was established if the lower limit of the two-sided 95% confidence interval for the between-group difference was ≥ -1.0 g/dL. Safety assessment included adverse events and potential anaphylaxis reactions. This trial is registered at ClinicalTrials.gov, NCT03902691.
Findings:
Three hundreds and seventy-two patients were randomly assigned to the pegmolesatide group (248 patients) or the epoetin alfa group (124 patients). A total of 347 patients (233 in the pegmolesatide group and 114 in the epoetin alfa group) were included in the PPS population. In the PPS, the mean change (standard deviation, SD) in hemoglobin level from baseline to the efficacy evaluation period was 0.07 (0.92) g/dL in the pegmolesatide group and -0.22 (0.97) g/dL in the epoetin alfa group. The between-group difference was 0.29 g/dL (95% confidence interval: 0.11-0.47), verifying non-inferiority of pegmolesatide to epoetin alfa. Adverse events occurred in 231 (94%) participants in the pegmolesatide group and in 110 (89%) in the epoetin alfa group. Hypertension was the most common treatment-related adverse event. No fatal cases of anaphylaxis or hypotension were reported.
Interpretation:
Monthly subcutaneously injection of pegmolesatide was as effective and safe as conventional epoetin alfa administrated one to three times a week in treating anemia in Chinese dialysis patients.
Funding:
The study was supported by Hansoh Medical Development Group.
01 Sep 2016Toxicology and applied pharmacologyQ3 · MEDICINE
Chronic preclinical safety evaluation of EPO-018B, a pegylated peptidic erythropoiesis-stimulating agent in monkeys and rats
Q3 · MEDICINE
Article
Author: Zhu, Hai ; Gu, Xiao-Lei ; Lu, Guo-Cai ; Li, Jian-Zhong ; Chen, Yong-Chun ; Gong, Xue-Lian ; Xia, Zhen-Na
EPO-018B, a synthetic peptide-based erythropoiesis stimulating agent (ESA), is mainly designed for treatment of anemia caused by chronic renal failure and chemotherapy against cancer. It overcomes the deficiencies of currently approved ESA, including the frequent administration of temperature-sensitive recombinant protein and anti-EPO antibody-mediated pure red cell aplasia (PRCA). This study was designed to evaluate the potential chronic toxicity of EPO-018B. Subcutaneous administration doses were designed as 0, 0.2, 1 and 10mg/kg for six months for 160 rats (20/gender/group) and 0, 0.3, 3 and 20mg/kg for nine months for 32 monkeys (4/gender/group) once every three weeks. The vehicles received the same volume of physiological saline injection. All animals survived to the scheduled necropsies after six weeks (for rats) and fourteen weeks (for monkeys) recovery period, except for the two high-dose female rats and two high-dose male monkeys, which were considered related to the increased RBCs, chronic blood hyperviscosity and chronic cardiac injury. EPO-018B is supposed to be subcutaneously injected once every month and the intended human therapeutic dose is 0.025mg/kg. The study findings at 0.2mg/kg for rats and 0.3mg/kg for monkeys were considered to be the study NOAEL (the no observed adverse effect level), which were more than ten times the intended human therapeutic dose. Higher doses caused adverse effects related to the liver toxicity, cardiotoxicity, appearance of neutralizing antibodies of EPO-018B and the decrease of serum glucose and cholesterol. Most treatment-induced effects were reversible or revealed ongoing recovery upon the discontinuation of treatment. The sequelae occurred in rats and monkeys were considered secondary to exaggerated pharmacology and would less likely occur in the intended patient population. As to the differences between human beings and animals, the safety of EPO-018B need to be further confirmed in the future clinical studies.
1
News (Medical) associated with Pegol-Sihematide05 Jan 2021
Small molecular drugAcquisitionCollaborate
100 Deals associated with Pegol-Sihematide
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R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Anemia in chronic kidney disease | China | 30 Jun 2023 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Kidney Diseases | Phase 3 | China | 22 May 2019 | |
| Anemia of renal disease | Phase 3 | China | 15 May 2019 | |
| Chronic Kidney Diseases | Phase 3 | China | 15 May 2019 | |
| chronic renal failure anemia | Phase 3 | China | 15 May 2019 | |
| Kidney Failure, Chronic | Phase 2 | China | 01 Jun 2014 | |
| myelodysplastic anemia | Phase 1 | China | 20 Jun 2014 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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NCT03903809 (Literature) Manual  | Phase 3 | 175 | lypbtcmcqo(eytlndwket) = zhfyxgvwzw vtjobzpnmn (ptysucacwd ) View more | Non-inferior | 06 Feb 2025 | ||
Epoetin alfa | lypbtcmcqo(eytlndwket) = tfenwpvcad vtjobzpnmn (ptysucacwd ) View more | ||||||
NCT03903809 (Literature) Manual | Phase 3 | 173 | lmlriuqwgl(rvghzhkyku) = fmwpefxint wycwwmiqoe (aetobqsuyr ) | Similar | 05 Dec 2024 | ||
lmlriuqwgl(rvghzhkyku) = tkqnzviefu wycwwmiqoe (aetobqsuyr ) | |||||||
NCT03902691 (Literature) Manual | Phase 3 | 372 | ksimmsjpph(kkbalnofsm) = deqykkulxk yhjlwavctg (jnffbrflkx, 0.92) View more | Non-inferior | 28 Oct 2023 | ||
ksimmsjpph(kkbalnofsm) = mlsoywzdxq yhjlwavctg (jnffbrflkx, 0.97) View more | |||||||
Not Applicable | 372 | ztcokqbujt(vxniyzlddk) = 1.6% who received Pegmolesatide and 3.2% who received the Epoetin alfa zmbkuzmxik (ihurmxhsdh ) View more | Positive | 01 Feb 2022 |
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