Delving into the Latest Updates on Herombopag Olamine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Hengqu, Hetrombopag, Hetrombopag olamine

+ [7]

Target

TPO receptor

Mechanism

TPO receptor agonists(Thrombopoietin receptor agonists)

Therapeutic Areas

Immune System DiseasesHemic and Lymphatic DiseasesOther Diseases+ [3]

Active Indication

Anemia, AplasticChronic thrombocytopeniaPurpura, Thrombocytopenic, Idiopathic+ [7]

Inactive Indication

Chronic idiopathic thrombocytopenic purpuraNon-Small Cell Lung CancerSecond Primary Neoplasms

Originator Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Inactive Organization

Atridia Pty Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (16 Jun 2021),

Anemia, AplasticChronic thrombocytopeniaPurpura, Thrombocytopenic, Idiopathic

RegulationConditional marketing approval (CN), Special Review Project (CN), Orphan Drug (US), Priority Review (CN)

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Structure

Molecular FormulaC25H22N4O5

InChIKeyBDGGFTDRPHKXFC-QYQHSDTDSA-N

CAS Registry2600513-51-5

This study includes Part A and Part B. Part A is a dose-finding study for subjects with chronic liver disease-related thrombocytopenia scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Herombopag compared to placebo in patients with chronic liver disease-related thrombocytopenia undergoing elective invasive surgery.

Start Date31 Jul 2024

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

CTR20242559 / RecruitingPhase 3

海曲泊帕乙醇胺片治疗拟择期侵袭性手术慢性肝病患者血小板减少症的有效性和安全性——多中心、随机双盲、安慰剂对照III期临床研究

[Translation] Efficacy and safety of hetrombopag ethanolamine tablets in the treatment of thrombocytopenia in patients with chronic liver disease undergoing elective invasive surgery: a multicenter, randomized, double-blind, placebo-controlled phase III clinical study

Part A：分析海曲泊帕在拟择期侵袭性手术慢性肝病患者血小板减少症人群中的药代动力学（PK）/药效动力学（PD）特征，完善群体药代药效动力学（PopPK/PD）模型，探索该适应症剂量。 Part B：与安慰剂比较，评价海曲泊帕治疗拟择期侵袭性手术慢性肝病患者血小板减少症患者中给药的有效性。

[Translation]

Part A: Analyze the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of Hetrombopag in patients with thrombocytopenia due to chronic liver disease who are scheduled for elective invasive surgery, improve the population pharmacokinetic/pharmacodynamic (PopPK/PD) model, and explore the dosage for this indication. Part B: Compare with placebo, evaluate the effectiveness of Hetrombopag in the treatment of patients with thrombocytopenia due to chronic liver disease who are scheduled for elective invasive surgery.

Start Date26 Jul 2024

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Herombopag Olamine

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100 Translational Medicine associated with Herombopag Olamine

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100 Patents (Medical) associated with Herombopag Olamine

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40

Literatures (Medical) associated with Herombopag Olamine

01 Nov 2024·Annals of Hematology

The effect of hetrombopag combined with conventional treatment on immune function and quality of life in patients with severe aplastic anemia

Article

Author: Wang, Shu-Wen ; Wang, Gu-Yun ; Liu, Dan ; Huang, Ying ; Tang, Rui-Mei ; Chen, Wen-Ting

This study aimed to investigate the effect of hetrombopag combined with conventional treatment on immune function in patients with severe aplastic anemia (SAA). Patients were categorized into the control group (n = 50, receiving conventional treatment only) and experimental group (n = 50, receiving hetrombopag combined with conventional treatment). Before treatment and at weeks 18, 24, and 52 after treatment, the two groups were compared in routine blood test indicators, natural killer (NK) cell activity, and peripheral blood inflammatory factor levels. The overall remission rate and incidence of adverse events were also compared between the two groups. Outpatient or telephone follow-up was performed before treatment and at weeks 18, 24, and 52 after treatment to observe patients' immune function, treatment outcome, quality of life, and adverse events. Hemoglobin (Hb), and platelet count (PLT) (P < 0.05), and a rise in NK cell activity (P < 0.05). Interleukin (IL-10) levels were significantly higher, while IL-6 levels were significantly lower in the experimental group compared to the control group (P < 0.05). After receiving the treatment, all scores of SF-36 domains in both groups were higher than before treatment, particularly with higher scores in the experimental group (P < 0.05). Hetrombopag combined with conventional treatment improved the immune function and hematopoiesis of patients with SAA.

01 Oct 2024·Annals of Hematology

Adding hetrombopag to cyclosporine a improved response of patients with newly diagnosed transfusion-dependent non-severe aplastic anemia

Article

Author: Yang, Chen ; Han, Bing ; Chen, Miao ; Jiang, Zeyu ; Hu, Qinglin ; Shen, Shupei

01 Jul 2024·Annals of Hematology

Switching from eltrombopag to hetrombopag in patients with primary immune thrombocytopenia: a post-hoc analysis of a multicenter, randomized phase III trial

Article

Author: Mei, Heng ; Jin, Jie ; Li, Yan ; Luo, Jianmin ; Niu, Ting ; Gao, Guangxun ; Xia, Ruixiang ; Liu, Li ; Bai, Yuansong ; Wu, Depei ; Yang, Renchi ; Shen, Xuliang ; Huang, Ruibin ; Yao, Yazhou ; Feng, Ying ; Jiang, Zhongxing ; Zeng, Yun ; Hou, Ming ; Wang, Yi ; Hu, Yu ; Zhou, Hu ; Zhou, Xin ; Yang, Linhua ; Hu, Jianda ; Liu, Xiaofan ; Cheng, Peng

AbstractWhile studies have explored the feasibility of switching between various thrombopoietin receptor agonists in treating immune thrombocytopenia (ITP), data on the switching from eltrombopag to hetrombopag remains scarce. This post-hoc analysis of a phase III hetrombopag trial aimed to assess the outcomes of ITP patients who switched from eltrombopag to hetrombopag. In the original phase III trial, patients initially randomized to the placebo group were switched to eltrombopag. Those who completed this 14-week eltrombopag were eligible to switch to a 24-week hetrombopag. Treatment response, defined as a platelet count of ≥ 50 × 109/L, and safety were evaluated before and after the switch. Sixty-three patients who completed the 14-week eltrombopag and switched to hetrombopag were included in this post-hoc analysis. Response rates before and after the switch were 66.7% and 88.9%, respectively. Among those with pre-switching platelet counts below 30 × 109/L, eight out of 12 patients (66.7%) responded, while eight out of nine patients (88.9%) with pre-switching platelet counts between 30 × 109/L and 50 × 109/L responded post-switching. Treatment-related adverse events were observed in 50.8% of patients during eltrombopag treatment and 38.1% during hetrombopag treatment. No severe adverse events were noted during hetrombopag treatment. Switching from eltrombopag to hetrombopag in ITP management appears to be effective and well-tolerated. Notably, hetrombopag yielded high response rates, even among patients who had previously shown limited response to eltrombopag. However, these observations need to be confirmed in future trials.

100 Deals associated with Herombopag Olamine

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	B02BX	DB16184

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia, Aplastic	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Jun 2021
Chronic thrombocytopenia	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Jun 2021
Purpura, Thrombocytopenic, Idiopathic	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Jun 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic liver disease	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	31 Jul 2024
Chronic thrombocytopenia	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	23 Jan 2023
Purpura, Thrombocytopenic, Idiopathic	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	23 Jan 2023
Neoplasms	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	15 Apr 2022
Thrombocytopenia	Phase 3	AU	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Jan 2022
Thrombocytopenia	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Jan 2022
Thrombocytopenia	Phase 3	US	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Jan 2022
Solid tumor	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	06 Nov 2019
Refractory Severe Aplastic Anemia	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	05 Mar 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Hematopoietic stem cell transplantation	-	Hetrombopag	nfrvpvoruj(dxfbarvlgz) = one patient experienced HAPG-related liver damage oevsvptwqb (nxjwsxorqr ) View more	-	08 Dec 2024
ASH2024	Not Applicable	Hematopoietic stem cell transplantation	-	rhTPO		-	08 Dec 2024
ASH2024	Not Applicable	Anemia, Aplastic	-	Hetrombopag + IST	tljynimffi(lipphykvad) = cisnmurobw vpyjbpdnzx (mnuafuthah, 21.2 - 35.1) View more	-	07 Dec 2024
ASH2024	Not Applicable	Anemia, Aplastic	-	Placebo + IST	tljynimffi(lipphykvad) = rzlwejsysg vpyjbpdnzx (mnuafuthah, 6.2 - 21.3) View more	-	07 Dec 2024
ChiCTR2200057846 (ESMO2024) Manual	Phase 2	Solid tumor \| Thrombocytopenia	28	Hetrombopag	(armhgqlhem) = ulfgdyfwxm eoqhilsksy (hrlwkhksbh ) View more	Positive	15 Sep 2024
EHA2024 Manual	Not Applicable	Thrombocytopenia	18	Hetrombopag	(gbyaqtpons) = None seifxgnwrq (ktvpohcgdo ) View more	Positive	14 May 2024
NCT05160857 (EHA2024) Manual	Not Applicable	Thrombocytopenia	23	Hetrombopag	(mejntehtat) = lzuiysmoyh opifcjkkrz (emxchpfzev ) View more	Positive	14 May 2024
EHA2024 Manual	Not Applicable	Thrombocytopenia	22	Hetrombopag 5mg	hmswvdscog(nkdulnnhzh) = iohotwcfhm zkdgxfpofk (lwypwqmetj ) View more	Positive	14 May 2024
EHA2024 Manual	Not Applicable	Thrombocytopenia	22	Placebo	hmswvdscog(nkdulnnhzh) = mkkegihtyc zkdgxfpofk (lwypwqmetj ) View more	Positive	14 May 2024
NCT06099925 (EHA2024) Manual	Phase 2	Thrombocytopenia	20	Hetrombopag 5mg	wbvgsquogu(msyvunaffr) = npxydcamjl cnylhkxonu (kdmawrbviy, 0.1812 - 0.5671) View more	Positive	14 May 2024
EHA2024 Manual	Not Applicable	Anemia, Aplastic	21	Hetrombopag	(lnjybjosre) = qmpzgcgywn byuoauievg (lgbailpbso ) View more	Positive	14 May 2024
EHA2024 Manual	Not Applicable	Anemia, Aplastic	21	Hetrombopag (TD-NSAA, treatment with hetrombopag and CsA)	(lnjybjosre) = wnobshrovs byuoauievg (lgbailpbso ) View more	Positive	14 May 2024
EHA2024 Manual	Phase 3	Thrombocytopenia Consolidation	32	Hetrombopag	iwpjpwkwqf(lwxicxvwah) = pypyoucmlt ciypjpywmd (cbgjfxlnbm, 5.83 - 7.73) View more	Positive	14 May 2024
ASH2023	Not Applicable	Thrombocytopenia \| Multiple Myeloma \| Lymphoma	60	Hetrombopag	vsvuqoaqng(atnvnnmxsq) = mkeukdwlnp zdgzyksljf (hfcqfvxrwd ) View more	-	11 Dec 2023