Delving into the Latest Updates on Taltirelin Hydrate with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Taltirelin, Taltirelin hydrate (JP17)

+ [2]

Target

TRHR

Mechanism

TRHR agonists(Thyrotropin releasing hormone receptor agonists)

Therapeutic Areas

Nervous System DiseasesCongenital DisordersOther Diseases

Active Indication

Spinocerebellar DegenerationsCentral Nervous System Diseases

Inactive Indication-

Originator Organization

Mitsubishi Tanabe Pharma Corp.

Active Organization

Mitsubishi Tanabe Pharma Corp.Tanabe Seiyaku Co., Ltd. /Pet Medicine Operations/

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (26 Oct 2009),

Spinocerebellar Degenerations

RegulationOrphan Drug (JP)

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Structure

Molecular FormulaC17H31N7O9

InChIKeyHRCJDWMUKPHPHR-NTFWNTCYSA-N

CAS Registry201677-75-0

View All Structures (2)

Primary objective: Evaluate the bioequivalence of the test formulation and the reference formulation in Chinese healthy adult subjects in the fasting/fed state. Secondary objective: Evaluate the safety of the test formulation and the reference formulation in Chinese healthy adult subjects in the fasting/fed state.

Start Date01 Nov 2023

Sponsor / Collaborator

Jiangsu Durui Pharmaceutical Co. Ltd.

CTR20232774 / CompletedNot Applicable

他替瑞林片随机、开放、两制剂、两周期、双交叉在健康人体餐后条件下生物等效性试验

[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of talatirelin tablets in healthy volunteers under postprandial conditions

主要目的：评价在餐后给药条件下，受试制剂他替瑞林片（四川科伦药业股份有限公司生产）5mg和参比制剂他替瑞林片（商品名：Ceredist®，田辺三菱製薬株式会社生产）5mg在中国健康受试者中的生物等效性。次要目的：评价中国健康成人受试者餐后口服试验药物他替瑞林片的安全性。

[Translation]

Main purpose: To evaluate the test preparation Tatirelin Tablets (manufactured by Sichuan Kelun Pharmaceutical Co., Ltd.) 5 mg and the reference preparation Tatirelin Tablets (trade name: Ceredist®, Mitsubishi Tabei) under postprandial administration conditions. Bioequivalence of 5 mg (manufactured by Seiko Co., Ltd.) in Chinese healthy subjects. Secondary objective: To evaluate the safety of oral administration of the experimental drug tartirelin tablets to healthy adult subjects in China after meals.

Start Date04 Sep 2023

Sponsor / Collaborator

Chengdu Jianze Pharmaceutical Technology Co., Ltd.

CTR20232775 / CompletedNot Applicable

他替瑞林片随机、开放、两制剂、两周期、双交叉在健康人体空腹条件下生物等效性试验

[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of talatirelin tablets in healthy volunteers under fasting conditions

主要目的：评价在空腹给药条件下，受试制剂他替瑞林片（四川科伦药业股份有限公司生产）5mg和参比制剂他替瑞林片（商品名：Ceredist®，田辺三菱製薬株式会社生产）5mg在中国健康受试者中的生物等效性。次要目的：评价中国健康成人受试者空腹口服试验药物他替瑞林片的安全性。

[Translation]

Main purpose: To evaluate the efficacy of the test preparation Tatirelin Tablets (manufactured by Sichuan Kelun Pharmaceutical Co., Ltd.) 5 mg and the reference preparation Tatirelin Tablets (trade name: Ceredist®, manufactured by Mitsubishi Tabae) under fasting administration conditions. Bioequivalence of 5 mg (produced by 薬有限公司) in Chinese healthy subjects. Secondary objective: To evaluate the safety of oral administration of the investigational drug tartirelin tablets to healthy Chinese adult subjects on an empty stomach.

Start Date23 Jul 2023

Sponsor / Collaborator

Chengdu Jianze Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Taltirelin Hydrate

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100 Translational Medicine associated with Taltirelin Hydrate

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100 Patents (Medical) associated with Taltirelin Hydrate

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82

Literatures (Medical) associated with Taltirelin Hydrate

20 Sep 2024·Cureus

Multiple System Atrophy Masquerading as Drug-Resistant Orthostatic Hypotension

Article

Author: Maruyama, Hirofumi ; Yamaoka, Manami ; Neshige, Shuichiro ; Sasaki, Kenta

A 54-year-old male presented with a two-year history of recurrent syncope. Although he was treated with droxidopa and amezinium metilsulfate, his syncope was drug-resistant. Blood tests, cardiac evaluation and brain computed tomography (CT) were unremarkable. As his Schellong test was positive, orthostatic hypotension and syncope were the tentative diagnoses. Upon evaluating the patient neurologically while carefully avoiding syncope induction, mild cerebellar ataxia was observed. However, a brain magnetic resonance imaging (MRI) scan revealed a possible "cross sign" in the pons. Subsequent dopamine transporter single-photon emission computed tomography (DAT-SPECT) showed reduced uptake in the basal ganglia. Based on these findings, a clinical diagnosis of probable multiple system atrophy of the cerebellar type (MSA-C) was made, and treatment with taltirelin hydrate was initiated. This case underscores the importance of considering multiple system atrophy (MSA) in patients with persistent orthostatic hypotension and syncope, even before more obvious neurodegenerative symptoms emerge.

01 Apr 2024·Nature Immunology

A method for predicting drugs that can boost the efficacy of immune checkpoint blockade

Article

Author: Chen, Chuang ; Miao, Ya-Ru ; Pan, Wen ; Bie, Nana ; Gan, Lu ; Gao, Yan ; Xia, Yun ; Yang, Mei ; Guo, An-Yuan ; Liu, Hanqing ; Li, Xin

Combination therapy is a promising therapeutic strategy to enhance the efficacy of immune checkpoint blockade (ICB); however, predicting drugs for effective combination is challenging. Here we developed a general data-driven method called CM-Drug for screening compounds that can boost ICB treatment efficacy based on core and minor gene sets identified between responsive and nonresponsive samples in ICB therapy. The CM-Drug method was validated using melanoma and lung cancer mouse models, with combined therapeutic efficacy demonstrated in eight of nine predicted compounds. Among these compounds, taltirelin had the strongest synergistic effect. Mechanistic analysis and experimental verification demonstrated that taltirelin can stimulate CD8⁺ T cells and is mediated by the induction of thyroid-stimulating hormone. This study provides an effective and general method for predicting and evaluating drugs for combination therapy and identifies candidate compounds for future ICB combination therapy.

01 Dec 2023·Biomedicine & Pharmacotherapy

Regulation of phosphosignaling pathways involved in transcription of cell cycle target genes by TRH receptor activation in GH1 cells

Article

Author: Novotny, Jiri ; Drastichova, Zdenka ; Trubacova, Radka

Thyrotropin-releasing hormone (TRH) is known to activate several cellular signaling pathway, but the activation of the TRH receptor (TRH-R) has not been reported to regulate gene transcription. The aim of this study was to identify phosphosignaling pathways and phosphoprotein complexes associated with gene transcription in GH1 pituitary cells treated with TRH or its analog, taltirelin (TAL), using label-free bottom-up mass spectrometry-based proteomics. Our detailed analysis provided insight into the mechanism through which TRH-R activation may regulate the transcription of genes related to the cell cycle and proliferation. It involves control of the signaling pathways for β-catenin/Tcf, Notch/RBPJ, p53/p21/Rbl2/E2F, Myc, and YY1/Rb1/E2F through phosphorylation and dephosphorylation of their key components. In many instances, the phosphorylation patterns of differentially phosphorylated phosphoproteins in TRH- or TAL-treated cells were identical or displayed a similar trend in phosphorylation. However, some phosphoproteins, especially components of the Wnt/β-catenin/Tcf and YY1/Rb1/E2F pathways, exhibited different phosphorylation patterns in TRH- and TAL-treated cells. This supports the notion that TRH and TAL may act, at least in part, as biased agonists. Additionally, the deficiency of β-arrestin2 resulted in a reduced number of alterations in phosphorylation, highlighting the critical role of β-arrestin2 in the signal transduction from TRH-R in the plasma membrane to transcription factors in the nucleus.

100 Deals associated with Taltirelin Hydrate

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