Delving into the Latest Updates on HMPL-004(Hutchison MediPharma Ltd.) with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

Mechanism

IL-1β modulators(Interleukin-1 beta modulators), IL-6 receptor family antagonists, NF-κB inhibitors(Nuclear factor NF-kappa-B complex inhibitors)

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Therapeutic Areas

Digestive System DisordersImmune System DiseasesSkin and Musculoskeletal Diseases

Active Indication-

Inactive Indication

Colitis, UlcerativeCrohn DiseaseSystemic Lupus Erythematosus

Originator Organization

Hutchison MediPharma Ltd.

Active Organization-

Inactive Organization

Nutrition Science Partners Ltd.

Hutchison MediPharma Ltd.

HUTCHMED (China) Ltd.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. Subjects are required to be in clinical remission or clinical response to enter the year long maintenance phase. This study will help evaluate if HMPL-004 is effective in subjects maintaining clinical remission following successful induction therapy achieving clinical remission or clinical response.

Start Date01 Jun 2013

Sponsor / Collaborator

Hutchison MediPharma Ltd.

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NCT01805791 / TerminatedPhase 3

A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis

A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication.
The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine treatment failures). Efficacy will be measured by a comparison of the proportion of patients in each treatment group attaining clinical remission at Week 8 as compared to placebo.

Start Date01 Mar 2013

Sponsor / Collaborator

Hutchison MediPharma Ltd.

EUCTR2007-005166-12-DE / Not yet recruitingNot Applicable

A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine

Start Date29 Jul 2008

Sponsor / Collaborator-

100 Clinical Results associated with HMPL-004(Hutchison MediPharma Ltd.)

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100 Translational Medicine associated with HMPL-004(Hutchison MediPharma Ltd.)

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100 Patents (Medical) associated with HMPL-004(Hutchison MediPharma Ltd.)

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10

Literatures (Medical) associated with HMPL-004(Hutchison MediPharma Ltd.)

01 Jan 2023·Frontiers in pharmacology

Perspectives of international multi-center clinical trials on traditional Chinese herbal medicine.

Review

Author: Chen, Nanjie ; Wang, Chuanchi ; Bai, Dong ; Zhang, Junhua ; Hu, Jingqing ; Wu, Shan

With the introduction of various subjects, such as clinical epidemiology and evidence-based medicine, the qualities and levels of Traditional Chinese Herbal Medicine (TCHM) in China improved substantially, and the processes of internationalization of Traditional Chinese Medicine (TCM) are further accelerated. Since, a variety of drug products in China have been approved for marketing in other countries, and approximately 10 products have submitted the IND application to FDA of United States, of which various Chinese herbal preparations such as compound Danshen dripping pills, Xingling granules, and HMPL-004 have been approved to be investigated in phase III clinical trials. In general, multi-center studies of TCHM are increasing with years, but most of the studies are performed in some certain country, and the actual international multi-center clinical trials are very rare. Number of SCI literatures on multi-center clinical trials of TCHM that published in the recent decade also showed increasing tendency with years, despite the evident reduction in the past 2 years due to the influence of COVID-19 pandemic. Of the multi-center clinical trials of TCHM that performed by mainland China and other oversees regions, except for Taiwan, China, nearly 70% were focused on classic Chinese medicinal formulae and Chinese patent medicine, while the other 30% were on dietary supplements and plant extracts. Facing the future, the "human experience" has attracted close attentions from researchers throughout the world. Effectively utilizing the historic "human experience" is an important method to vitalize potential of original scientific and technological resources of TCHM. Performing multi-center clinical trials with high qualities is still an essential method for TCHM in accessing the mainstream medicine market. In addition, it is also required to further improve the evaluation techniques and methods that not only meet the international standards but also meet the characteristics of TCHM. Furthermore, we should also focus on the TCHM specific clinical values and scientific reports.

01 Jun 2017·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development].

Article

Author: Zhu, You-Ping

This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union（EU）, and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients. Special attention is paid to the technical details of three authorized EU herbal medicinal products (Veregen, Sativex and Episalvan) in comparison with Andrographis paniculata extract HMPL-004 that failed the phase Ⅲ clinical trial for ulcerative colitis. The paper further emphasizes the importance of enriching active fractions of herbal extracts and taking regulatory and quality considerations into account in early stage of botanical drug development.

01 Feb 2016·Expert Opinion on Investigational DrugsQ2 · MEDICINE

Anti-TNF-α therapies for the treatment of Crohn’s disease: the past, present and future

Q2 · MEDICINE

Review

Author: Berns, Marc ; Hommes, Daniel W

INTRODUCTIONAnti-TNF-α therapy is a novel approach that has transformed the way moderate-to-severe Crohn's disease (CD) is treated and has significantly improved clinical outcomes of patients with enhanced remission induction and maintenance efficacies. As a result, anti-TNF-α agents have become the primary cost driver in the treatment of CD, as the frequency of hospitalizations and surgical interventions have been drastically reduced.AREAS COVEREDIn the review, the authors cover current anti-TNF-α treatments for CD including efficacy, mechanisms of action, pharmacokinetics and safety. In addition, the authors discuss future anti-TNF-α agents currently in the development pipeline including biosimilars, golimumab, oral AVX-470, TNF-α-kinoid vaccine, and non-biologic HMPL-004.EXPERT OPINIONWhile new therapeutics are in the pipeline like anti-integrin and anti-interleukin therapeutics, anti-TNF-α therapy remains at the forefront of CD treatment due to its long-term efficacy and safety profiles. The next horizon for new anti-TNF-α agents is biosimilars, which offer comparable safety and effectiveness to the originator molecules. Biosimilars promise to expand accessibility to anti-TNF-α therapy while significantly reducing the cost burden to patients and healthcare systems.

100 Deals associated with HMPL-004(Hutchison MediPharma Ltd.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 3	US	Hutchison MediPharma Ltd.	01 Mar 2013
Crohn Disease	Phase 3	-	Hutchison MediPharma Ltd.	01 Apr 2006
Systemic Lupus Erythematosus	Phase 3	-	Hutchison MediPharma Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00659802 (CTgov)	Phase 2	Colitis, Ulcerative	224	Placebo	qaywtqaoyt(wqqliopwab) = xazwwlopyc mexbgogcmm (zxqwwnvnxu, nrhhvdhkqw - mwcepplxqu) View more	-	22 Jul 2020
NCT01882764 (NATRUL-4, CTgov)	Phase 3	Colitis, Ulcerative	66	HMPL-004 (HMPL-004 1800 mg/Day)	avtfgliuhs(cureqbyuoq) = npbieovxfu rvmaobmexe (fwobauaanl, qtppptufsg - kqkhtcivxq) View more	-	13 Jan 2020
				Placebo (Placebo)	avtfgliuhs(cureqbyuoq) = irdwwkujvd rvmaobmexe (fwobauaanl, iifabtwmwa - ayvbnapqql) View more
NCT01805791 (CTgov)	Phase 3	Colitis, Ulcerative	201	HMPL-004 2400 mg/day (HMPL-004 2400 mg/Day)	ukgvghzdmt(zokqlxpqpa) = obroctxrnm djlfziqybh (pllygotwit, yanwnbdizr - djqorvjetr) View more	-	02 Jan 2020
				HMPL-004 1800 mg/day (HMPL-004 1800 mg/Day)	ukgvghzdmt(zokqlxpqpa) = ysuawrlsbh djlfziqybh (pllygotwit, pnxhmjwggf - lliolglxvi) View more
NCT00655733 (CTgov)	Phase 2	Crohn Disease	101	HMPL-004 (HMPL-004)	xdxzrjmjly(zgstzbufwi) = favonaxocc qqzvxnvxft (xdvazxacbd, bikerdkqkk - uegnbjsubh) View more	-	03 Dec 2012
				Placebo (Placebo)	xdxzrjmjly(zgstzbufwi) = zyiijlruqe qqzvxnvxft (xdvazxacbd, knrccoawtr - hztrzomtml) View more