Last update 17 Dec 2024
Pegol-Sihematide
Last update 17 Dec 2024
Overview
Basic Info
Drug Type Synthetic peptide |
Synonyms pegmolesatide, Pegol Sihematide, Peihuaxi hippocampal peptide(Jiangsu Hansoh Pharmaceutical) + [5] |
Target |
Mechanism EPO receptor agonists(Erythropoietin receptor agonists), Erythropoiesis stimulants(Erythropoiesis stimulants) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (30 Jun 2023), |
RegulationSpecial Review Project (CN) |
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Gene Sequence
Sequence Code 16643475
Source: *****
Related
12
Clinical Trials associated with Pegol-SihematideA 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
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
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 Chronic Kidney Disease on Dialysis
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 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 ; Sun, Mindan ; Du, Shutong ; Chen, Menghua ; 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 May 2017European journal of cancer (Oxford, England : 1990)Q1 · MEDICINE
Health-related quality of life in patients with locally recurrent or metastatic breast cancer treated with etirinotecan pegol versus treatment of physician's choice: Results from the randomised phase III BEACON trial
Q1 · MEDICINE
Article
Author: Moreno-Aspitia, Alvaro ; Zhao, Carol ; O'Shaughnessy, Joyce ; Yardley, Denise A ; Mailliez, Audrey ; Hoch, Ute ; Hannah, Alison L ; Ahn, Jin-Seok ; Im, Seock-Ah ; Cortés, Javier ; Gómez-Pardo, Patricia ; Potter, David A ; Twelves, Chris ; Rugo, Hope S ; Awada, Ahmad ; Perez, Edith A ; Schwartzberg, Lee S ; Tagliaferri, Mary ; Diéras, Véronique
BACKGROUND:
Health-related quality of life (HRQoL) enhances understanding of treatment effects that impact clinical decision-making. Although the primary end-point was not achieved, the BEACON (BrEAst Cancer Outcomes with NKTR-102) trial established etirinotecan pegol, a long-acting topoisomerase-1 (TOP1) inhibitor, as a promising therapeutic for patients with advanced/metastatic breast cancer (MBC) achieving clinically meaningful benefits in median overall survival (OS) for patients with stable brain metastases, with liver metastases or ≥ 2 sites of metastatic disease compared to treatment of physician's choice (TPC). Reported herein are the findings from the preplanned secondary end-point of HRQoL.
PATIENTS AND METHODS:
HRQoL, assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) (version 3.0) supplemented by the breast cancer-specific Quality of Life Questionnaire (QLQ-BR23), was evaluated post randomisation in 733 of 852 patients with either anthracycline-, taxane- and capecitabine-pretreated locally recurrent or MBC randomised to etirinotecan pegol (n = 378; 145 mg/m2 every 3 weeks (q3wk)) or single-agent TPC (n = 355). Patients completed assessments at screening, every 8 weeks (q8wk) during treatment, and end-of-treatment. Changes from baseline were analysed, and the proportions of patients achieving differences (≥5 points) in HRQoL scores were compared.
RESULTS:
Differences were seen favouring etirinotecan pegol up to 32 weeks for global health status (GHS) and physical functioning scales (P < 0.02); numerical improvement was reported in other functional scales. The findings from HRQoL symptom scales were consistent with adverse event profiles; etirinotecan pegol was associated with worsening gastrointestinal symptoms whereas TPC was associated with worsened dyspnoea and other systemic side-effects. Analysis of GHS and physical functioning at disease progression showed a decline in HRQoL in both treatment arms, with a mean change from baseline of -9.4 and -10.8 points, respectively.
CONCLUSION:
There was evidence of benefit associated with etirinotecan pegol compared with current standard of care agents in multiple HRQoL measurements, including global health status and physical functioning, despite worse gastrointestinal symptoms (e.g. diarrhoea). Patients in both arms had a decline in HRQoL at disease progression.
STUDY NUMBER:
NCT01492101.
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 ; Li, Jian-Zhong ; Lu, Guo-Cai ; 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 | CN | 30 Jun 2023 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Anemia of renal disease | Phase 3 | CN | 15 May 2019 | |
| chronic renal failure anemia | Phase 3 | CN | 15 May 2019 | |
| myelodysplastic anemia | Phase 1 | CN | 20 Jun 2014 | |
| Myelodysplastic Syndromes | Phase 1 | CN | 01 Jun 2014 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Not Applicable | 372 | nyiwmvctlv(qsoeksldbm) = 1.6% who received Pegmolesatide and 3.2% who received the Epoetin alfa paupboflkv (infanxhxex ) View more | Positive | 01 Feb 2022 |
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