[Translation] A single-center, non-randomized, open-label, active-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous injection of alorellin acetate microspheres in healthy Chinese adult female subjects

主要目的：评价单次皮下注射注射用醋酸丙氨瑞林微球在健康成年女性受试者中的安全性和耐受性。次要目的：评价单次皮下注射注射用醋酸丙氨瑞林微球在健康成年女性受试者中的药代动力学（PK）特征；评价单次皮下注射注射用醋酸丙氨瑞林微球在健康成年女性受试者中的药效动力学（PD）特征；评价注射用醋酸丙氨瑞林微球与注射用醋酸丙氨瑞林在健康女性受试者中的PK差异。

[Translation]

Primary objective: To evaluate the safety and tolerability of a single subcutaneous injection of alorelin acetate microspheres in healthy adult female subjects. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous injection of alorelin acetate microspheres in healthy adult female subjects; To evaluate the pharmacodynamic (PD) characteristics of a single subcutaneous injection of alorelin acetate microspheres in healthy adult female subjects; To evaluate the PK differences between alorelin acetate microspheres and alorelin acetate in healthy female subjects.

Start Date26 Apr 2024

Sponsor / Collaborator

Shanghai Livzon Pharmaceutical Co. Ltd.

CTR20222748 / CompletedPhase 1

评价中国健康成年男性受试者单次皮下注射注射用醋酸丙氨瑞林微球的安全性、耐受性、药代动力学和药效学特征的单中心、随机、双盲、安慰剂对照的I期临床试验

[Translation] A single-center, randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous injection of alorellin acetate microspheres in healthy Chinese adult male subjects

主要目的：评价注射用醋酸丙氨瑞林微球单次皮下注射在健康成年男性受试者中的安全性和耐受性。次要目的：评价注射用醋酸丙氨瑞林微球单次皮下注射在健康成年男性受试者中的药代动力学（PK）特征；评价注射用醋酸丙氨瑞林微球单次皮下注射在健康成年男性受试者中的药效学（PD）特征。

[Translation]

Primary objective: To evaluate the safety and tolerability of a single subcutaneous injection of alorelin acetate microspheres for injection in healthy male adult subjects. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous injection of alorelin acetate microspheres for injection in healthy male adult subjects; to evaluate the pharmacodynamic (PD) characteristics of a single subcutaneous injection of alorelin acetate microspheres for injection in healthy male adult subjects.

Start Date07 Nov 2022

Sponsor / Collaborator

Shanghai Livzon Pharmaceutical Co. Ltd.

CTR20130677 / Not yet recruitingPhase 1

注射用丙氨瑞林缓释微球Ⅰ期临床试验

[Translation] Phase I clinical trial of alanine sustained-release microspheres for injection

研究注射用丙氨瑞林缓释微球的耐受性和药代动力学。

[Translation]

To study the tolerability and pharmacokinetics of aloperelin sustained-release microspheres for injection.

Start Date-

Sponsor / Collaborator

Bengbu Fengyuan Pharmaceutical Technology Dev Co. Ltd.

[+1]

100 Clinical Results associated with Alarelin Acetate

100 Translational Medicine associated with Alarelin Acetate

100 Patents (Medical) associated with Alarelin Acetate

Literatures (Medical) associated with Alarelin Acetate

01 Jan 2024·Iranian Journal of Veterinary Research

Comparing CIDR with progesterone injections and eCG with human recombinant FSH for synchronizing estrous cycle in ewes.

Article

Author: Baninajar, M ; Ganjkhanlou, M ; Alijani, A ; Niasari-Naslaji, A ; Sayyah, N

Background:

It is desirable in estrus synchronization in sheep to avoid intravaginal devices and to shorten the program from 14 to 6 days. Moreover, replacement of eCG with safe, cheap, and efficient gonadotropin is in worldwide demand.

Aims:

This study investigates the possibility of replacing eCG with human recombinant FSH (hrFSH) and CIDR with progesterone injections for estrous synchronization in ewes.

Methods:

Assaf and Lacaune ewes (n=170) were divided into two groups and synchronized with either progesterone injections for 6 days or CIDR for 14 days. Ewes assigned in the injection group, received progesterone (37.5 mg; SC) and GnRH analogue (7.5 µg Alarelin acetate; IM) on day 0 of the experiment. On days 3 and 6, ewes received 25 and 12.5 mg progesterone (SC), respectively. On day 6, ewes in both groups received prostaglandin F₂α (250 µg Cloprostenol; IM), and were divided into two subgroups to receive either hrFSH (75 IU Follitropin alfa; SC) or eCG (400 IU; IM). On day 7, fertile rams were introduced to ewes for 21 days. Data were analyzed using GLM and Glimmix.

Results:

There was no difference in the respective lambing rates, prolificacy, and fecundity between CIDR (71.1, 1.63, and 1.16%) and injections (66.7, 1.55, and 1.03%); between eCG (71.4, 1.60, and 1.14%), and hrFSH (66.3, 1.58, and 1.05%, P>0.05).

Conclusion:

In conclusion, 6-day progesterone injection-based protocol produced similar results to 14-day CIDR program and hrFSH could be an effective alternative for eCG during estrus synchronization in ewes.

01 Jun 2020·BRITISH POULTRY SCIENCE

The direct effects of gonadotropin-releasing hormone on proliferation of granulosa cells and development of follicles in goose.

Article

Author: Xie, Y ; Zhao, X ; Gao, G ; Li, Q ; Zhong, H ; Wang, Q ; Zhang, K

1. The study objectives were to determine the direct effects of gonadotropin-releasing hormone (GnRH) on the proliferation of ovarian granulosa cells (GCs) and the development of follicles in geese (Anser cygnoides) by colorimetry and ethynyl-2'-deoxyuridine (EdU) cell proliferation assays, in which primary GCs were treated with different concentrations of GnRH agonist (alarelin acetate) and an antagonist (cetrorelix acetate). Differently expressed genes (DEGs) were identified by RNA-sequencing and validated by quantitative reverse transcription polymerase chain reaction (RT-qPCR) and Western blotting. 2. The EdU assays showed that the proliferation of GCs was affected by the GnRH agonist and antagonist in a dose-dependent manner. The effect of treatment on cell proliferation was statistically significant at the concentrations of 10^-5 mol/l alarelin and 1 mg/l cetrorelix acetate. A total of 134 DEGs (76 downregulated and 58 upregulated for alarelin treatment) and 226 DEGs (90 downregulated and 136 upregulated for cetrorelix) were identified by RNA-sequencing analysis, respectively. Enrichment analysis indicated that DEGs were enriched in the GO terms of cell-cell signalling and cell junctions. The pathways that regulate the development of follicles were identified, including the biological progress of cAMP accumulation, ovulation cycle and vasculature that are essential to follicular selection. 3. The results suggested that GnRH might directly regulate GC proliferation via autocrine or paracrine pathways related to cell junctions. In particular, it was confirmed that the mRNA and protein expression levels of the oestrogen receptor 2 (ESR2) gene, a negative transcription factor involved in follicular maturation and ovulation, were affected by GnRH agonist or antagonist in GCs. 4. In conclusion, GnRH might play an important role in follicular development by changing the expression of genes that participate in cAMP accumulation, ovulation cycle and cell junctions in ovarian GCs.

01 Sep 2019·Journal of separation scienceQ3 · CHEMISTRY

Liquid chromatography tandem mass spectrometry with triple stage fragmentation for highly selective analysis and pharmacokinetics of alarelin in rat plasma

Q3 · CHEMISTRY

Article

Author: Gu, Jingkai ; Fawcett, John Paul ; Zhang, Zhi ; Yin, Lei ; Xu, Tongtong ; Li, Runzhi ; Liu, Shihao

Abstract:

Alarelin, a gonadotropin‐releasing hormone analogue, is widely used in China for the treatment of endometriosis and uterine leiomyoma. In order to investigate its pharmacokinetic behavior and support the preclinical application of new formulations, we have developed a novel and highly selective bioanalytical method to determine alarelin in rat plasma based on liquid chromatography tandem mass spectrometry with triple stage fragmentation. After sample preparation by protein precipitation followed by reversed phase solid phase extraction, alarelin and triptorelin (internal standard) were chromatographed on an Ascentis® Express C18 column (50 mm × 4.6 mm, 2.7 µm) using gradient elution with 0.1% formic acid in water and acetonitrile at a flow rate of 1 mL/min. Detection was by positive mode electrospray ionization followed by triple stage fragmentation using the transitions at m/z 584.6→249.1→221.0 for alarelin and 656.5→249.1→176.0 for triptorelin, The assay was linear in the concentration range 0.3‐10 ng/mL with excellent precision and accuracy. It was successfully applied to a pharmacokinetic study in rats administered a dose of 13.5 µg/kg alarelin by intramuscular injection. The results show that the triple stage fragmentation strategy allows highly selective analysis of alarelin and has the potential to be widely applied to the bioassay of other peptidic drugs.

News (Medical) associated with Alarelin Acetate

24 Nov 2016

·www.bioportfolio.com

Hybio Pharmaceutical Co., Ltd. 300199 Financial and Strategic SWOT Analysis Review Prices from USD $300

Summary Hybio Pharmaceutical Co., Ltd. Hybio is a biopharmaceutical company that develops polypeptide drugs. The company manufactures and develops peptide finished dosage products and peptide active pharmaceutical ingredients. Its finished dosage products include desmopressin for injection, terlipressin for injection, sodium ozagrel for injection, oxytocin for injection, omeprazole sodium for injection,and others. Hybio provides active pharmaceutical ingredients such as abarelix, calcitonin, copaxone, antide, desmopression, alarelin, bivalirudin, desirudin, elecatonin, fertirelin, ganadorelin, histrelin, leuprorelin, vapreotide and haxapeptide. The company conducts research and development to advance its products. Hybio is headquartered in Shenzhen, China. This comprehensive SWOT profile of Hybio Pharmaceutical Co., Ltd. provides you an indepth strategic analysis of the company's businesses and operations. The profile has been compiled by GlobalData to bring to you a clear and an unbiased view of the company's key strengths and weaknesses and the potential opportunities and threats. The profile helps you formulate strategies that augment your business by enabling you to understand your partners, customers and competitors better. This company report forms part of GlobalData's Profile on Demand' service, covering over 50,000 of the world's leading companies. Once purchased, GlobalData's highly qualified team of company analysts will comprehensively research and author a full financial and strategic analysis of Hybio Pharmaceutical Co., Ltd. including a detailed SWOT analysis, and deliver this direct to you in pdf format within two business days. excluding weekends. The profile contains critical company information including*, x000D x000D Business description A detailed description of the company's operations and business divisions.x000D Corporate strategy Analyst's summarization of the company's business strategy.x000D SWOT Analysis A detailed analysis of the company's strengths, weakness, opportunities and threats.x000D Company history Progression of key events associated with the company.x000D Major products and services A list of major products, services and brands of the company.x000D Key competitors A list of key competitors to the company.x000D Key employees A list of the key executives of the company.x000D Executive biographies A brief summary of the executives' employment history.x000D Key operational heads A list of personnel heading key departments/functions.x000D Important locations and subsidiaries A list and contact details of key locations and subsidiaries of the company.x000D Key manufacturing facilities A list of key manufacturing facilities of the company.x000D Detailed financial ratios for the past five years The latest financial ratios derived from the annual financial statements published by the company with 5 years history.x000D Interim ratios for the last five interim periods The latest financial ratios derived from the quarterly/semiannual financial statements published by the company for 5 interims history.x000D x000D Note*: Some sections may be missing if data is unavailable for the company. Key benefits of buying this profile include,x000D x000D You get detailed information about the company and its operations to identify potential customers and suppliers.x000D The profile analyzes the company's business structure, operations, major products and services, prospects, locations and subsidiaries, key executives and their biographies and key competitors.x000D x000D Understand and respond to your competitors' business structure and strategies, and capitalize on their weaknesses. Stay up to date on the major developments affecting the company.x000D The company's core strengths and weaknesses and areas of development or decline are analyzed and presented in the profile objectively. Recent developments in the company covered in the profile help you track important events. x000D x000D Equip yourself with information that enables you to sharpen your strategies and transform your operations profitably.x000D Opportunities that the company can explore and exploit are sized up and its growth potential assessed in the profile. Competitive and/or technological threats are highlighted.x000D x000D Scout for potential investments and acquisition targets, with detailed insight into the companies' strategic, financial and operational performance.x000D Financial ratio presented for major public companies in the profile include the revenue trends, profitability, growth, margins and returns, liquidity and leverage, financial position and efficiency ratios.x000D x000D Gain key insights into the company for academic or business research.x000D Key elements such as SWOT analysis, corporate strategy and financial ratios and charts are incorporated in the profile to assist your academic or business research needs.

Financial StatementAcquisition

100 Deals associated with Alarelin Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Endometriosis	CN	Ma'anshan Fengyuan Pharmaceutical Co., Ltd.	01 Jan 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 1	CN	Shanghai Livzon Pharmaceutical Co. Ltd.	07 Nov 2022
Estrogen receptor positive breast cancer	IND Approval	CN	Shanghai Livzon Pharmaceutical Co. Ltd.	29 Aug 2023

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