盐酸阿拉莫林(Anamorelin Hydrochloride) - 药物靶点：GHSR_在研适应症：恶病质，厌食症，非小细胞肺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Anamorelin HCl、Anamorelin hydrochloride (JAN/USAN)、anamorelin

+ [10]

靶点

GHSR

作用机制

GHSR激动剂(促生长激素释放激素受体激动剂)

治疗领域

肿瘤呼吸系统疾病其他疾病+ [2]

在研适应症

恶病质厌食症非小细胞肺癌+ [8]

非在研适应症-

原研机构

Ono Pharmaceutical Co., Ltd.

在研机构

Helsinn Healthcare SA

National Cancer Institute

Ono Pharmaceutical Co., Ltd.

非在研机构

Helsinn Therapeutics (U.S.), Inc.

最高研发阶段批准上市

首次获批日期

日本 (2021-01-22),

恶病质

最高研发阶段(中国)无进展

特殊审评特殊审批 (中国)

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结构

分子式C31H42N6O3

InChIKeyVQPFSIRUEPQQPP-MXBOTTGLSA-N

CAS号249921-19-5

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关联

35

项与盐酸阿拉莫林相关的临床试验

JPRN-jRCTs031230446 / Recruiting临床2期

Prospective, open-label, interventional study to explore the efficacy of the ghrelin agonist anamorelin in patients with cachexia associated with chronic obstructive pulmonary disease

开始日期2023-11-13

申办/合作机构-

JPRN-jRCTs041230012 / Recruiting临床2期

A Phase II Study to Investigate the Efficacy and Safety of Oral intake of Anamorelin in Patients After Total Gastrectomy

开始日期2023-08-17

申办/合作机构-

JPRN-jRCTs041220165 / Recruiting临床2期

The efficacy and safety of anamorelin for patients with idiopathic pleuroparenchymal fibroelastosis (iPPFE)

开始日期2023-06-02

申办/合作机构-

100 项与盐酸阿拉莫林相关的临床结果

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100 项与盐酸阿拉莫林相关的转化医学

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100 项与盐酸阿拉莫林相关的专利（医药）

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86

项与盐酸阿拉莫林相关的文献（医药）

2024-02-08·The Tohoku journal of experimental medicine

Anamorelin Induced Acute Hyperglycemia in a Patient with Advanced Pancreatic Cancer and Diabetes: A Case Report.

Article

作者: Junpei Yamamoto ; Hiroshi Onodera ; Yuki Kaminaga ; Yoko Kayaba ; Masahiro Usui

2024-01-12·Clinical nutrition (Edinburgh, Scotland)

Addressing cancer anorexia-cachexia in older patients: Potential therapeutic strategies and molecular pathways.

Review

作者: Theocharis Ispoglou ; Deaglan McCullough ; Angela Windle ; Sherena Nair ; Natalie Cox ; Helen White ; Dermot Burke ; Anastasios Kanatas ; Konstantinos Prokopidis

Cancer cachexia (CC) syndrome, a feature of cancer-associated muscle wasting, is particularly pronounced in older patients, and is characterised by decreased energy intake and upregulated skeletal muscle catabolic pathways. To address CC, appetite stimulants, anabolic drugs, cytokine mediators, essential amino acid supplementation, nutritional counselling, cognitive behavioural therapy, and enteral nutrition have been utilised. However, pharmacological treatments that have also shown promising results, such as megestrol acetate, anamorelin, thalidomide, and delta-9-tetrahydrocannabinol, have been associated with gastrointestinal and cardiovascular complications. Emerging evidence on the efficacy of probiotics in modulating gut microbiota also presents a promising adjunct to traditional therapies, potentially enhancing nutritional absorption and systemic inflammation control. Additionally, low-dose olanzapine has demonstrated improved appetite and weight management in older patients undergoing chemotherapy, offering a potential refinement to current therapeutic approaches. This review aims to elucidate the molecular mechanisms underpinning CC, with a particular focus on the role of anorexia in exacerbating muscle wasting, and to propose pharmacological and non-pharmacological strategies to mitigate this syndrome, particularly emphasising the needs of an older demographic. Future research targeting CC should focus on refining appetite-stimulating drugs with fewer side-effects, specifically catering to the needs of older patients, and investigating nutritional factors that can either enhance appetite or minimise suppression of appetite in individuals with CC, especially within this vulnerable group.

2024-01-01·Oncology letters

Predictors of efficacy of anamorelin in patients with non‑small cell lung cancer and cachexia: A retrospective study.

Article

作者: Yoshiko Ishioka ; Hisashi Tanaka ; Tomonori Makiguchi ; Syunsuke Fujishima ; Yasuhito Nunomura ; Hiroaki Sakamoto ; Toshihiro Shiratori ; Kageaki Taima ; Sadatomo Tasaka

Anamorelin, a ghrelin receptor agonist, is approved in Japan for the treatment of cachexia in patients with lung and gastrointestinal cancer. However, there is limited research on the usefulness of anamorelin in clinical settings, therefore, the present study evaluated its efficacy using patient characteristics. A total of 40 patients with non-small cell lung cancer and cachexia who were prescribed anamorelin in the Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine (Aomori, Japan) between July 2021 and November 2022, were retrospectively assessed. Anamorelin was prescribed at a dose of 100 mg once daily to patients who had lost >5% of their body weight within 6 months. All patients were weighed before treatment and those who continued anamorelin treatment for 12 weeks were also weighed at 12 weeks. A logistic regression analysis was used to analyze the association between background characteristics and early discontinuation of treatment with anamorelin (within 4 weeks). The median age was 67 years (range, 36-88), and 65% of the patients were male. There were 24 patients (60.0%) with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score 1, 11 patients (27.5%) with an ECOG-PS score 2 and five patients (12.5%) with an ECOG-PS score 3. The early discontinuation group included 11 patients (27.5%). An ECOG-PS score ≥2 (odds ratio, 7.85; 95% confidence interval, 1.43-43.21; P=0.018) was associated with early discontinuation. A total of 18/40 patients (45.0%) were able to continue anamorelin treatment for 12 weeks, and the mean change in body weight was +2.31 kg, which was a significant change from the weight recorded at baseline (P=0.027). The mean changes in lean body mass and soft lean mass between baseline and 12 weeks were +1.97 kg (P=0.14) and +1.26 kg (P=0.15), respectively. The results from the present study indicate that anamorelin is unlikely to be useful for patients with a poor general condition (ECOG-PS score ≥2).

7

项与盐酸阿拉莫林相关的新闻（医药）

2024-02-13

·BioSpace

Yinuoke publication demonstrates a new orally delivered molecule that reverses cancer cachexia and increases survival using in vivo models

Yinuoke, a biopharmaceutical company pioneering breakthrough therapeutics for late-stage cancer patients announced today the publication of a manuscript in the peer-reviewed Journal of Cachexia, Sarcopenia and Muscle demonstrating the effectiveness of a new compound in alleviating cachexia and increasing the survival of tumor-bearing mice in a T-cell dependent manner. Cancer cachexia, a devastating tumor-induced immune disorder leading to body wasting and reduced tolerability to therapeutics, occurs in 80% of all cancer patients and causes 25% of deaths. Previous attempts to treat cachexia have failed due to lack of efficacy in stabilizing patient weight and strength. Yinuoke treats cachexia as a tumor-driven autoimmune disorder rather than a metabolic condition. YNK105 reduces systemic inflammation without the toxic side effects caused by NSAIDS that limit its use. The data shows a significant improvement in cachexigenic tumor-bearing mice in overall survival, increases in body, fat, and muscle weight, and reductions in plasma IL-6 and tissue- derived Stat3. Most impressively, cachectic mice achieved a 100% survival rate with a combination treatment of YNK105 and chemotherapy. “This research is the first demonstration that severe cachexia can be halted and reversed”, said Dr. Lingbing Zhang, founder and CEO of Yinuoke. “The ability to reverse cachexia expands the options for late-stage cancer patients to extend survival and live a higher quality of life. Reversing cachexia requires modulating the immune system’s inflammatory response for longer than an NSAID will allow. We identified R-ketorolac as a potential treatment for cachexia and now have significant evidence to support a superior efficacy and safety pro to current approaches using GDF-15 inhibitors or Anamorelin.” “YNK105 has the potential to be a breakthrough treatment for cancer cachexia that I am excited to bring into the clinic,” said Dr. Andrew Hendifar of Cedars-Sinai. “Pancreatic cancer patients are highly susceptible to cachexia and treatment outcomes are severely impacted. Getting control of cachexia is critical for overall survival of patients with pancreatic cancer and especially for stage 4 and late diagnosed patients. These early studies support moving this program into clinical trials.” The research appearing in the February 1st issue of the Journal of Cachexia, Sarcopenia and Muscle is led by Dr. Martina Schweiger and a team of scientists at the Institute of Molecular Biosciences, University of Graz, Austria. About Yinuoke Yinuoke is on a mission to save lives and conquer late-stage cancer through groundbreaking science and the development of first-in-class therapies where no options currently exist. Our vision is to revolutionize late-stage cancer by pushing boundaries and transforming it from a terminal disease to a manageable lifelong condition. Through innovative approaches and tailored treatments, we aim to empower patients with new possibilities for long-term remission and improved quality of life. For inquiries on partnering and investing please contact Suzanne Kennedy at skennedy@yinuokeus.com.

临床结果

2023-08-03

·Pharmaceutical Technology

Taiho Oncology and Taiho Pharmaceutical gain FDA approval for Lonsurf

Lonsurf has been approved to treat adult patients with metastatic colorectal cancer. Credit: crystal light / Shutterstock.com. Taiho Oncology and Taiho Pharmaceutical have received approval from the US Food and Drug Administration (FDA) for Lonsurf to treat adult patients with metastatic colorectal cancer (mCRC). The approval is intended for using Lonsurf either as a single agent or with bevacizumab in patients previously treated with oxaliplatin, fluoropyrimidine and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type [without mutations], with an anti-EGFR therapy. Recommended Reports Reports LOA and PTSR Model - Anamorelin Hydrochloride in Chemotherapy Effects GlobalData Reports Innovation in Pharmaceuticals: Pancreatic extract-based compositions GlobalData View all Companies Intelligence Taiho Pharmaceutical Co Ltd Taiho Oncology Inc SUN LIGHT CORPORATION View all Taiho Pharmaceutical discovered and developed Lonsurf, an oral nucleoside antitumour agent. It contains trifluridine, a nucleoside analogue based on thymidine, along with tipiracil, an inhibitor of thymidine phosphorylase (TP). This combination enhances exposure to trifluridine by inhibiting its metabolism by TP. Based on data from the Phase III SUNLIGHT study, the FDA granted approval for the combination of Lonsurf and bevacizumab. This combination showed improvements in progression-free survival and overall survival in patients with mCRC after disease progression or who could not tolerate two previous chemotherapy regimens. These results were compared to the outcomes using LONSURF alone. Taiho Oncology president and CEO Timothy Whitten stated: “The treatment of advanced colorectal cancer has been a core focus of our work at Taiho Oncology since our inception and with good reason: approximately 22% of patients with colorectal cancer in the US are diagnosed after the cancer has metastasised. “The FDA approval of Lonsurf in combination with bevacizumab is another example of how we are continuing to advance care in this disease and provide new hope to patients and their families.”

上市批准临床结果临床3期

2023-05-08

·PRNewswire

Global Pancreatic Cancer Competitive Landscape Report 2023: Comprehensive Insights about 250+ Companies and 300+ Drugs

DUBLIN, May 8, 2023 /PRNewswire/ -- The "Pancreatic Cancer - Competitive landscape, 2023" report has been added to ResearchAndMarkets.com's offering. This "Pancreatic Cancer- Competitive landscape, 2023" report provides comprehensive insights about 250+ companies and 300+ drugs in Pancreatic Cancer Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. In March 2023, Adaptimmune Therapeutics plc. and TCR Therapeutics Inc. (NASDAQ: TCRR), announced entry into a definitive agreement under which Adaptimmune will combine with TCR in an all-stock transaction to create a preeminent cell therapy company focused on treating solid tumors. The combination provides extensive benefits for clinical development and product delivery supported by complementary technology platforms. As a result, and following the closing of the transaction, it is anticipated that the combined company's cash runway will extend into 2026. In February 2023, Akamis Bio, announced an expansion of its ongoing partnership with the Parker Institute for Cancer Immunotherapy (PICI) to include a clinical collaboration with the Cancer Research Institute (CRI) that will focus on advancing novel treatments for pancreatic cancer. As part of the Akamis Bio, PICI, and CRI partnership, NG-350A, an immuno-stimulatory tumor gene therapy driving intratumoral expression of a CD40 agonist monoclonal antibody, will be evaluated in combination with standard-of-care chemotherapy and the CTLA-4 inhibitor ipilimumab (YERVOY). In February 2023, Gritstone bio, Inc. announced that it has entered into a clinical trial agreement with the National Cancer Institute (NCI), an institute of the National Institutes of Health, to evaluate an autologous T cell therapy expressing a T cell receptor targeting mutated KRAS in combination with Gritstone's KRAS-directed vaccine candidate, SLATE-KRAS, in a Phase 1 study. Under the terms of the agreement, NCI will identify patients with metastatic cancer that are eligible for adoptive cell transfer based on the presence of a G12V or G12D KRAS mutation (KRASmut). In February 2023, Keymed Biosciences Inc., jointly announced a global exclusive license agreement with AstraZeneca for CMG901, a potential first-in-class Claudin 18.2 antibody drug conjugate (ADC). Under the license agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialization of CMG901 globally. CMG901 is currently in a Phase I clinical trial for the treatment of Claudin 18.2-positive solid tumors. In January 2023, AIM ImmunoTech Inc. announced it has entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca. Under the agreement, Erasmus MC is planning to perform an investigator-initiated clinical study, entitled "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect. DURIPANC Study," in which it will use both Study Drugs provided by AstraZeneca and AIM ImmunoTech. Pancreatic Cancer Analytical Perspective In-depth Commercial Assessment: Pancreatic Cancer Collaboration Analysis by Companies The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form. Key Questions Answered Current Treatment Scenario and Emerging Therapies: How many companies are developing Pancreatic Cancer drugs? How many Pancreatic Cancer drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Pancreatic Cancer? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Pancreatic Cancer therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Pancreatic Cancer and their status? What are the key designations that have been granted to the emerging and approved drugs? Key Players Panbela Therapeutics ERYtech Pharma Jiangsu HengRui Medicine Co., Ltd. FibroGen Novartis AG AB Science TME Pharma AG Intensity Therapeutics Silenseed LTD SynerGene Therapeutics Elevation oncology Salspera LLC Redx Pharma Plc AIM ImmunoTech Inc. Rain Oncology Jazz Pharmaceuticals Invyte Corporation Immodulon Therapeutics Ltd GSK plc Merck Sharp & Dohme LLC Roche Helsinn Healthcare SA Argenus Inc. Actuate Therapeutics OSE Immunotherapeutics Incyte Corporation Galera Therapeutics CSPC ZhongQi Pharmaceutical Technology Astellas Pharma Global Development, Inc. NanOlogy Theriva Biologics AstraZeneca Berg, LLC Agenus ABVC BioPharma, Inc. Boehringer Ingelheim Alligator Bioscience CARsgenTherapeutics Co.,Ltd Purple Biotech Ltd. Lisata Therapeutics Chongqing Precision Biotech Co., Ltd Cybrexa Therapeutics Bold Therapeutics BioNTech SE Bristol-Myers Squibb DEKA Biosciences Senhwa Biosciences Cue Biopharma Carisma Therapeutics Inc Key Products Olaptesed pegol INT230-6 SBP-101 Masitinib NIS793 siG12D LODER SGT-53 Seribantumab Salmonella-IL2 RXC004 Rintatolimod RAIN-32 Lurbinectedin Retifanlimab IMM-101 GSK2256098 Belzutifan Atezolizumab Anamorelin AGEN1423 Elraglusib OSE2101 Epacadostat GC4711 Docetaxel Zolbetuximab NanoPac VCN-01 Danvatirsen BPM31510 Botensilimab ABV-1703 BI 907828 Mitazalimab CT041 CM24 CEND-1 CEA-targeted CAR-T cells CBX-12 BOLD-100 BNT141 BMS-813160 DK210 CX-5461 CUE-102 CT-0508 For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

免疫疗法引进/卖出疫苗临床1期抗体药物偶联物

100 项与盐酸阿拉莫林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08856	盐酸阿拉莫林	V03	DB06645

研发状态

适应症	最高研发状态	国家/地区	公司
恶病质	批准上市	日本更多	Ono Pharmaceutical Co., Ltd. 更多
厌食症	临床3期	澳大利亚更多	Helsinn Healthcare SA 更多
非小细胞肺癌	临床3期	美国更多	Helsinn Healthcare SA 更多
疲劳	临床2期	美国更多	Helsinn Therapeutics (U.S.), Inc. 更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01387269 (ROMANA 1, ESMO2018)	临床3期	恶病质 \| 非小细胞肺癌	477	Anamorelin 100mg	鏇齋衊築衊廠齋壓鹽鏇(繭鬱夢獵選繭膚鏇構襯) = 糧製糧蓋獵蓋網選蓋淵齋鬱鹹餘積顧夢製積襯 (窪糧鹹鑰壓選襯觸窪壓 ) 更多	-	2018-10-22
Ono-7643-05 (ESMO_ASIA2023)	N/A	恶病质 \| 胰腺癌 Glasgow prognostic score (GPS)	110	Anamorelin	醖蓋淵築獵觸憲築艱觸(壓遞糧窪積鏇糧廠艱蓋) = The main AEs were gastrointestinal disorders such as nausea and vomiting 築鏇願鑰膚範範襯餘築 (衊獵餘膚積憲膚齋製顧 ) 更多	-	2023-12-02
NCT01387282 \| NCT01387269 (ROMANA 1, ROMANA 2, ASCO2017)	临床3期	非小细胞肺癌	829	Anamorelin	(鬱觸齋襯積淵衊製鹽鑰) = 夢夢襯願夢艱網壓憲築簾艱蓋鹹鹹餘遞遞網鑰 (蓋衊醖築網醖廠簾糧鑰 )	-	2017-05-30
				Placebo	(鬱觸齋襯積淵衊製鹽鑰) = 窪鹽獵願淵夢齋鑰顧淵簾艱蓋鹹鹹餘遞遞網鑰 (蓋衊醖築網醖廠簾糧鑰 )
SCALA-1 \| SCALA-2 (ESMO2023) 人工标引	临床3期	恶病质 \| 非小细胞肺癌	636	Anamorelin 100 mg	衊廠積蓋獵鹹蓋簾艱獵(鬱衊窪衊築鏇選簾遞鏇) = Changes of 5-IASS scores for anamorelin versus placebo were not significantly different in both studies 憲鏇齋膚醖網構廠簾構 (壓蓋艱簾鑰鑰繭齋鬱鬱 )	积极	2023-10-20
				placebo
NCT01387282 \| NCT01395914 \| NCT01387269 (ROMANA 3, Pubmed \| Ann Oncol) 人工标引	临床3期	恶病质 \| 非小细胞肺癌	513	anamorelin	(願鹹廠築憲壓膚鬱齋蓋) = 選製鑰築廠範襯窪顧願顧鏇簾鑰簾鹽衊範衊範 (蓋獵獵構觸製壓繭繭選 ) 更多	积极	2017-08-01
				Placebo	(願鹹廠築憲壓膚鬱齋蓋) = 膚鬱膚鹹範齋構顧鬱鹹顧鏇簾鑰簾鹽衊範衊範 (蓋獵獵構觸製壓繭繭選 ) 更多
NCT01387269 (ROMANA 1, Pubmed \| Lancet Oncol) 人工标引	临床3期	恶病质 \| 非小细胞肺癌	484	Anamorelin	(網顧構衊製範衊膚衊壓) = 膚憲餘膚壓餘窪糧顧憲鑰觸壓網積窪衊網糧衊 (糧鹹艱艱醖淵憲積壓繭 ) 更多	积极	2016-04-01
				Placebo	(網顧構衊製範衊膚衊壓) = 艱衊顧築構窪繭積艱鏇鑰觸壓網積窪衊網糧衊 (糧鹹艱艱醖淵憲積壓繭 ) 更多
ESMO_ASIA2023	N/A	非小细胞肺癌	68	Anamorelin	繭願鏇鏇製鹹齋網糧窪(淵構艱築齋夢構膚膚選) = 3 patients 鏇網顧醖選襯餘醖築艱 (窪鹽積廠積鹹鏇願鑰獵 ) 更多	-	2023-12-02
ASCO_GI2023	N/A	结直肠癌	103	anamorelin (Gastric cancer)	(憲觸餘網衊網襯簾衊繭) = 簾蓋鬱網衊糧遞構網鹽膚鹽衊鏇構壓願膚範壓 (壓膚簾淵簾窪餘鏇糧範 )	-	2023-01-24
				anamorelin (Pancreatic cancer)	(憲觸餘網衊網襯簾衊繭) = 廠醖壓構餘餘網淵範鑰膚鹽衊鏇構壓願膚範壓 (壓膚簾淵簾窪餘鏇糧範 )
NCT01387282 \| NCT01387269 (ROMANA 1 and 2, ASCO2022)	临床3期	恶病质 \| 非小细胞肺癌	-	Anamorelin	遞醖鹽衊壓範顧遞廠選(願鬱窪鏇遞糧繭齋窪淵) = 遞憲膚繭鬱艱範鏇醖壓壓鏇築簾齋願鹹齋齋衊 (選鬱廠遞築願觸襯襯膚 ) 更多	积极	2022-06-02
				Placebo	遞醖鹽衊壓範顧遞廠選(願鬱窪鏇遞糧繭齋窪淵) = 簾鹽遞願糧衊獵壓積繭壓鏇築簾齋願鹹齋齋衊 (選鬱廠遞築願觸襯襯膚 ) 更多
ESMO_ASIA2023	N/A	不可切除的非小细胞肺癌	73	Anamorelin hydrochloride	(觸艱窪鑰憲廠築蓋選構) = Hyperglycemia should be noted as one of frequent adverse events 艱夢鏇膚齋糧構蓋繭遞 (製選鏇選膚築廠襯獵壓 ) 更多	-	2023-12-02