Multicenter, Open Label Trial to Investigate the Efficacy and Safety of a Single Oral Dose of 1.0 mg/kg Macimorelin Acetate as Growth Hormone Stimulation Test (GHST) in Pediatric Patients With Suspected Growth Hormone Deficiency (GHD)

This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children. The stimulation test will use a new growth hormone stimulating substance called macimorelin. By now, only adults in the USA can get this new stimulation test. The results of this study are expected to help children and teenagers with suspected GHD to get the macimorelin stimulation test.
The macimorelin test will be compared to a clonidine and an arginine test. Both are known standard stimulation tests. Altogether two macimorelin tests are planned to be performed in the study, to show how repeatable macimorelin tests results are (under a set of similar conditions).

开始日期2021-11-16

申办/合作机构

Æterna Zentaris, Inc.

NCT03844217

/ CompletedN/AIIT

Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers - The Macicop-Study

This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.

开始日期2019-03-07

申办/合作机构

Universitätsspital Basel

EUCTR2018-001988-23-HU

/ Not yet recruiting临床2期

Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD)

开始日期2018-11-07

申办/合作机构

AEterna Zentaris GmbH

100 项与马西瑞林相关的临床结果

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100 项与马西瑞林相关的转化医学

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100 项与马西瑞林相关的专利（医药）

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项与马西瑞林相关的文献（医药）

2025-06-01·Pituitary

Consensus and controversies about diagnosing GH deficiency: a Delphi survey by the GH research society

Review

作者: Grimberg, A ; Karavitaki, N ; Higham, C E ; Bidlingmaier, M ; Giustina, A ; Johannsson, G ; Mauras, N ; Boguszewski, C L ; Choong, C S ; Strasburger, C J ; Schilbach, K ; Ross, R ; van Santen, H M ; Bollerslev, J ; Cianfarani, S ; Melmed, S ; Savendahl, L ; Fleseriu, M ; Juul, A ; Tritos, N A ; Yuen, K C J ; Radovick, S ; Collett-Solberg, P F ; Clayton, P E ; Christ, E ; Höybye, C ; Rosenfeld, R ; Horikawa, R ; Biller, B M K ; Neggers, S J C M M ; Chanson, P ; Dauber, A ; Ho, K K Y ; Jorgensen, J O L ; Hoffman, A R ; Lodish, M ; Miller, K K ; Cohen, P ; Boguszewski, M C S ; Brue, T ; Gebauer, J ; Luo, X ; Arlien-Søborg, M C ; Backeljauw, P

PURPOSE:

Biochemical tests are required for diagnosing GH-deficiency in children and adults, but controversies remain regarding diagnostic criteria and type of biochemical tests. The aim of the study is to map the clinical practices of GHD diagnosis in children and adults.

METHODS:

The Growth Hormone Research Society members initiated a Delphi survey of the diagnosis of GHD in children and adults. Pediatric (n = 18) and adult (n = 25) endocrinologists from 14 countries participated and rated their extent of agreement with 61 statements using a Likert-type-scale (1-7). Consensus was predefined as ≥ 80% of panelists rating their agreement unidirectionally as either ≥ 5 (agreement) or ≤ 3 (disagreement).

RESULTS:

The pediatric panel reached consensus on 17 of 29 (59%) statements on diagnosis in children, whereas the adult panel reached consensus on 28 of 32 (88%) statements on adult patients. There was general agreement to test for GHD in an appropriate clinical context and also on the timing of testing for GHD in both children and adults. A subnormal IGF-I level was considered diagnostic in both children and adults with panhypopituitarism. In children, there was consensus to recommend the arginine stimulation test and the glucagon test. The insulin tolerance test (ITT) was considered gold standard in adults and there was also consensus to recommend the macimorelin test. A stimulated GH cut-off < 5μg/l was consistent with severe GHD in children, whereas test-specific cut-offs were recommended in adults.

CONCLUSION:

Consensus on the GHD diagnosis was lower in pediatric practice, mainly with respect to choice and interpretation of GH stimulation tests.

2025-04-01·Drug Testing and Analysis

Elucidating important factors and corresponding method optimization for sensitive detection of small peptide drugs in human urine by solid‐phase extraction and UPLC‐HRMS: The influence of MS scan modes, protein precipitants, and ammonium formate

Article

作者: Liu, Yunxi ; Chang, Wei ; He, Genye ; Ma, Congcong ; Zhang, Yufeng ; Liu, Lu ; Dong, Tianyu ; Wang, Zhanliang ; Yan, Kuan

Abstract:

Small peptide hormones are widely used in sports as performance‐enhancing substances, making it crucial to develop sensitive analytical methods for their detection in doping control analysis. Various factors significantly affect analytical sensitivity, such as the selection of ultra‐performance liquid chromatography (UPLC) mobile phase, high‐resolution mass spectrometry (HRMS) scanning modes, and extraction solvents for pretreatment. Herein, comparative study approach was utilized to investigate the sensitivity of each peptide analyte under both full scan and parallel reaction monitoring (PRM) modes of HRMS and assess the effects of some protein precipitants as a part of extraction solvents on solid‐phase extraction (SPE). The results showed that full scan should be selected as the primary scan mode of HRMS, and the combination with PRM mode could effectively compensate for the limitations of full scan, and the addition of protein precipitants would adversely affect the detection of certain small peptide analytes. Meanwhile, influences of ammonium formate in reverse UPLC mobile phase on the charge state distribution of small peptides were investigated and elucidated. Based on these findings, a sensitive and reliable UPLC‐HRMS analytical method combining full scan and PRM mode was validated for screening and confirmation of 63 small peptide analytes after SPE, with limits of detection (LODs) ranging between 0.010 and 0.473 ng/ml and limits of identification (LOIs) ranging between 0.015 and 1.512 ng/ml. Additionally, suggestions were provided for the detection of [Arg8]‐vasopressin, dermorphin, and its analogues.

2025-03-27·JOURNAL OF MEDICINAL CHEMISTRY

Design, Biological Characterization, and Discovery of Capromorelin Derivatives as Oral Growth Hormone Secretagogue Receptor Type 1a Agonist for the Treatment of Growth Hormone Deficiency

Article

作者: Yang, Fanglong ; Jin, Lei ; Liu, Meng ; Wang, Siqin ; Jia, Xiangyu ; Zhao, Sheng ; Xia, Yuanfeng ; Lu, Biao ; Xu, Hang

Recombinant human growth hormone (rhGH) is a well-established treatment for children with growth deficiencies worldwide. However, its requirement for subcutaneous administration limits convenience compared to that of oral therapies. Starting from capromorelin, we designed, synthesized, and characterized a novel orally active GHSR-1a agonist, compound 4b (hGHSR-1a EC₅₀ = 0.49 nM), which effectively stimulates endogenous GH release in rats at oral doses as low as 0.1 mg/kg─100-fold more potent than ibutamoren (10 mg/kg). Notably, 10 day oral administration of 4b increased body weight and length in 4-week-old rats. To date, comprehensive preclinical studies on oral agents for short stature remain limited, and existing GHSR-1a agonists lack approval for this indication. Compound 4b exhibited superior pharmacokinetic exposure in dogs (oral bioavailability: 43.6%; half-life: 1.2 h) relative to other species. This study details the optimization of 4b, which demonstrates a promising pharmacological profile for clinical translation as a growth hormone replacement therapy.

项与马西瑞林相关的新闻（医药）

2025-05-26

·EINPresswire

COSCIENS Biopharma Inc. Acknowledges Receipt of Intended Director Nominations from Goodwood for the Upcoming Annual and Special Meeting of Shareholders

TORONTO, ONTARIO, May 26, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”), a life sciences company developing and commercializing a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products, today confirmed that its Board of Directors has received a letter from Goodwood Fund and Puccetti Funds Management Inc.(“Goodwood”) regarding six (6) director nominations for the Company’s upcoming Annual and Special Meeting of Shareholders. “We respectfully acknowledge receipt of the statement regarding the intentions from Goodwood and are carefully reviewing its contents,” said Ronnie Miller, Chair of the Board of COSCIENS Biopharma. “With this in hand, the Board will evaluate and determine its path forward and remains fully committed to acting in the best interests of COSCIENS and our shareholders.” The Company will continue to provide updates to shareholders related to this matter. About COSCIENS Biopharma Inc. COSCIENS is a life sciences company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products. Our technology includes proprietary extraction technology, which is applied to the production of active ingredients from renewable plant resources currently used in cosmeceutical products (i.e., oat beta glucan and avenanthramides which are found in leading skincare product brands like Aveeno and Burt's Bees formulations) and being developed as potential nutraceuticals and/or pharmaceuticals. Our consolidated portfolio also includes macimorelin (Macrilen ® ; Ghryvelin ® ), the first and only U.S. FDA and European Medicines Agency approved oral test indicated for the diagnosis of adult growth hormone deficiency (“AGHD”). The company is listed on the NASDAQ Capital Market and the Toronto Stock Exchange, and trades on both exchanges under the ticker symbol "CSCI". For more information, please visit COSCIENS' website at www.cosciensbio.com . Forward-Looking Statements Certain statements in this news release, referred to herein as "forward-looking statements", constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended, and "forward-looking information" under the provisions of Canadian securities laws. All statements, other than statements of historical fact, that address circumstances, events, activities, or developments that could or may or will occur are forward-looking statements. When used in this news release, words such as "anticipate", "assume", "believe", "could", "expect", "forecast", "future", "goal", "guidance", "intend", "likely", "may", "would" or the negative or comparable terminology as well as terms usually used in the future and the conditional are generally intended to identify forward-looking statements, although not all forward-looking statements include such words. Forward-looking statements in this news release include, but are not limited to, statements relating to: our plans for the Phase 2a Clinical Efficacy Study of its Avenanthramides tablets, our goal to commercialize our nutraceutical products (including our OBG chewable bar and YBG powder), the potential of our PGX technology and our goals and expectations regarding our other plans related to the development, manufacture or commercialization of our products. Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by the Company as of the date of such statements, are inherently subject to significant business, economic, operational and other risks, uncertainties, contingencies and other factors, including those described below, which could cause actual results, performance or achievements of the combined Company to be materially different from results, performance or achievements expressed or implied by such forward-looking statements and, as such, undue reliance must not be placed on them. Forward-looking statements involve known and unknown risks and uncertainties which include, among others: the combined Company's present and future business strategies; operations and performance within expected ranges; anticipated future cash flows; local and global economic conditions and the environment in which the combined Company operates; anticipated capital and operating costs; uncertainty in our revenue generation from our marketed products, product development and related clinical trials and validation studies; results from our products under development may not be successful or may not support advancing the product; the failure of the DETECT-trial to achieve its primary endpoint in children (CGHD) may impact the market for macimorelin (Macrilen ® ; Ghryvelin ® ) in adults (AGHD) and the existing relationships we have for that product; ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence on sales by and revenue from our main distributor of our legacy Ceapro products and its customers, the continued availability of funds and resources to successfully commercialize our products; the ability to secure strategic partners for late stage development, marketing, and distribution of our products; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our ability to protect and enforce our patent portfolio and intellectual property; and our ability to continue to list our common shares on the NASDAQ Capital Market. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those discussed in our Annual Report on Form 20-F and MD&A filed under the Company's profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov . We disclaim any obligation to update any such risks or uncertainties or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law. No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this news release. Issuer: Anna Biehn Chief Executive Officer E: ABiehn@cosciensbio.com Investor Contact: Jenene Thomas JTC Team T: (US): +1 (908) 824-0775 E: csci@jtcir.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床2期

2025-01-01

·GlobeNewswire-Health Care

COSCIENS Biopharma Inc. Provides Corporate Update and Highlights Pipeline Prioritization

Company leveraging core competencies to develop and commercialize natural-based products to improve health and wellness Streamlined efficiencies and cost cutting measures taken to refine operations and development pathway forward New corporate presentation outlining key development areas to be available in January 2025 Dec. 23, 2024 -- COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”), a specialty biopharmaceutical company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products, today provided a corporate update and reiterated its pipeline prioritization. “Over the course of the last several months following the merger, we have taken strategic and deliberate steps to evaluate and prioritize our combined pipeline of products and programs. Through this effort, we have thoroughly evaluated the potential of our assets and prioritized the areas that we believe are high-value opportunities, and we plan to move forward focusing our resources on advancing a pipeline of natural-based products leveraging our core technologies. We believe that this focus, spanning cosmeceuticals, nutraceuticals and pharmaceuticals, positions us with near and long-term life science growth drivers and the potential to become a global leader in natural-based products for health and wellness,” stated Gilles Gagnon, M.Sc., MBA, President and CEO of COSCIENS. “In addition, we have continued to make progress driving revenues and growing our active ingredients base business. We are looking to kick off 2025 with a clear line of sight towards execution of our business plan and believe we are well-positioned for a transformational year.” Pharmaceuticals: Avenanthramides Tablets (Avs) in Development as an Anti-Inflammatory: The Phase 1-2a clinical trial being conducted at the Montreal Heart Institute has fully completed the Phase 1 part of the study with 72 subjects tested. No significant side effects have been observed from ascending doses ranging from 30 mg to 960 mg. The Company expects the Phase 2a efficacy study will be initiated in Q1 2025, with expected completion in Q3 2025. Cosmeceuticals: Enriched Oat Flour with High Concentration of Avenanthramides: We have successfully produced and sold small batches for inclusion in cream formulations. JuventeDC Product Line: New website, juventedc.com, was launched on December 19, 2024. Nutraceuticals: Yeast Beta Glucan (YBG) Powder - Immune Booster: Our YBG product has been successfully manufactured as part of our PGX scale up project in Edmonton, Alberta. Our YBG product is being finalized in capsule form with the goal to commercialize it as an immune booster in Q2 2025. Oat Beta Glucan (OBG) Chewable Bar – Cholesterol Reduction: We have successfully developed a unique, standardized formulation for a healthy confection which includes a high concentration of OBG with daily dosage according to approved claims in 10 developed countries. The substantive claims include reduction of LDL cholesterol, supporting cardiovascular health reduction of Type 2 diabetes risks, source of fiber for the maintenance of general good health and support of a healthy digestive system. COSCIENS’ team anticipates the official commercial launch of its chewable bar OBG natural health product in Q1 2025, marking an important chapter in the Company's journey toward promoting wellness while expanding its business model. Macimorelin: On August 27, 2024, the Company announced that the Phase 3 safety and efficacy study AEZS-130-P02 (the "DETECT-trial") evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency ("CGHD") had failed to meet its primary endpoints according to the definitions in the study protocol. Based on the results of the study, we are prioritizing our pipeline moving forward and repositioning the Company as a pure play Life Science’s business offering natural-based products. Therefore, while maintaining the current commercial indication for the use of macimorelin for the diagnosis of Adult Growth Hormone Deficiency (“AGHD”), the Company has decided to not make any future investments in macimorelin for the diagnosis of CGHD. Consequently, in order to further ensure the streamlining of operations and reduce costs, the roles of some additional members of management have been terminated, including Dr. Nicola Ammer, Chief Medical Officer, which will be ending on March 31, 2025. “On behalf of the entire Board and Company, we are grateful to the members of the team for their years of dedicated service. Nicola has been a long-standing, valued member of our team and provided years of expertise for the development of macimorelin (Macrilen®; Ghryvelin®), the first and only U.S. FDA and European Medicines Agency approved oral test indicated for the diagnosis of adult growth hormone deficiency. We are thankful to each member of our team and sincerely thank them for the key roles they played,” concluded Mr. Gagnon. The Company plans to release a new corporate presentation outlining key development areas and upcoming milestones in January 2025. COSCIENS is a specialty biopharmaceutical company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products. Our technology includes proprietary extraction technology, which is applied to the production of active ingredients from renewable plant resources currently used in cosmeceutical products (i.e., oat beta glucan and avenanthramides which are found in leading skincare product brands like Aveeno and Burt's Bees formulations) and being developed as potential nutraceuticals and/or pharmaceuticals. Our consolidated portfolio also includes macimorelin (Macrilen®; Ghryvelin®), the first and only U.S. FDA and European Medicines Agency approved oral test indicated for the diagnosis of adult growth hormone deficiency (“AGHD”). The Company is listed on the NASDAQ Capital Market and the Toronto Stock Exchange, and trades on both exchanges under the ticker symbol "CSCI". For more information, please visit COSCIENS' website at www.cosciensbio.com. The content above comes from the network. if any infringement, please contact us to modify.

临床研究

2024-10-08

·GlobeNewswire-Health Care

COSCIENS Biopharma Announces Change to Board of Directors

TORONTO, ONTARIO, Oct. 08, 2024 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products, today announced the resignation of Carolyn Egbert from the Board of Directors, effective immediately. “We are extremely grateful to Carolyn for her twelve years of dedicated service to the Company as a member of the Board of Directors, including serving eight years as Chair. Throughout her tenure as a board member of Aeterna Zentaris, now CONSCIENS, she provided valuable contributions and insight,” said Chair of the Board, Ronald Miller. “With Carolyn’s decision to resign from the Board and as the Company continues to evolve at various levels, we have made the strategic decision to streamline our board structure and move forward with six members, including five independent directors which we believe more closely aligns with the industry standard for a Company at our stage.” About COSCIENS Biopharma Inc. COSCIENS is a specialty biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of pharmaceutical and diagnostic products, including those focused on areas of significant unmet medical need. One of COSCIENS' lead products is macimorelin (Macrilen®; Ghryvelin®), the first and only U.S. FDA and European Medicines Agency approved oral test indicated for the diagnosis of adult growth hormone deficiency (“AGHD”). COSCIENS is also engaged in the development of therapeutic assets and proprietary extraction technology, which is applied to the production of active ingredients from renewable plant resources currently used in cosmeceutical products (i.e., oat beta glucan and avenanthramides which are found in leading skincare product brands like Aveeno and Burt's Bees formulations) and being developed as potential nutraceuticals and/or pharmaceuticals. The company is listed on the NASDAQ Capital Market and the Toronto Stock Exchange, and trades on both exchanges under the ticker symbol "CSCI". For more information, please visit COSCIENS' website at www.cosciensbio.com. Forward-Looking Statements The information in this news release has been prepared as of October 1, 2024. Certain statements in this news release, referred to herein as "forward-looking statements", constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended, and "forward-looking information" under the provisions of Canadian securities laws. All statements, other than statements of historical fact, that address circumstances, events, activities, or developments that could or may or will occur are forward-looking statements. When used in this news release, words such as "anticipate", "assume", "believe", "could", "expect", "forecast", "future", "goal", "guidance", "intend", "likely", "may", "would" or the negative or comparable terminology as well as terms usually used in the future and the conditional are generally intended to identify forward-looking statements, although not all forward-looking statements include such words. Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by the Company as of the date of such statements, are inherently subject to significant business, economic, operational and other risks, uncertainties, contingencies and other factors, including those described below, which could cause actual results, performance or achievements of the combined Company to be materially different from results, performance or achievements expressed or implied by such forward-looking statements and, as such, undue reliance must not be placed on them. Forward-looking statements involve known and unknown risks and uncertainties which include, among others: the combined Company's present and future business strategies; operations and performance within expected ranges; anticipated future cash flows; local and global economic conditions and the environment in which the combined Company operates; anticipated capital and operating costs; uncertainty in our revenue generation from our marketed products, product development and related clinical trials and validation studies; results from our products under development may not be successful or may not support advancing the product; the failure of the DETECT-trial to achieve its primary endpoint in Childhood Growth Hormone Deficiency may impact the market for macimorelin (Macrilen®; Ghryvelin®) in AGHD and the existing relationships we have for that product; ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence on sales by and revenue from our main distributor of our legacy Ceapro products and its customers, the continued availability of funds and resources to successfully commercialize our products; the ability to secure strategic partners for late stage development, marketing, and distribution of our products; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our ability to protect and enforce our patent portfolio and intellectual property; and our ability to continue to list our common shares on the NASDAQ Capital Market. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those discussed in our Annual Report on Form 20-F and MD&A filed under the Company's profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. We disclaim any obligation to update any such risks or uncertainties or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law. No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this news release. Issuer:Gilles R. GagnonPresident & CEOggagnon@ceapro.com+1 (780) 421-4555 Investor Contact:Jenene ThomasJTC TeamT (US): +1 (908) 824-0775E: csci@jtcir.com

高管变更

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外链

KEGG	Wiki	ATC	Drug Bank
D10562	马西瑞林	V04CD06	DB13074

研发状态

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适应症	国家/地区	公司	日期
生长激素缺乏症	美国	Novo Nordisk, Inc.	2017-12-20

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适应症	最高研发状态	国家/地区	公司	日期
生长激素缺乏症与垂体异常	临床3期	美国	Æterna Zentaris, Inc.	2015-12-03
生长激素缺乏症与垂体异常	临床3期	奥地利	Æterna Zentaris, Inc.	2015-12-03
生长激素缺乏症与垂体异常	临床3期	法国	Æterna Zentaris, Inc.	2015-12-03
生长激素缺乏症与垂体异常	临床3期	德国	Æterna Zentaris, Inc.	2015-12-03
生长激素缺乏症与垂体异常	临床3期	意大利	Æterna Zentaris, Inc.	2015-12-03
生长激素缺乏症与垂体异常	临床3期	波兰	Æterna Zentaris, Inc.	2015-12-03
生长激素缺乏症与垂体异常	临床3期	塞尔维亚	Æterna Zentaris, Inc.	2015-12-03
生长激素缺乏症与垂体异常	临床3期	西班牙	Æterna Zentaris, Inc.	2015-12-03
生长激素缺乏症与垂体异常	临床3期	英国	Æterna Zentaris, Inc.	2015-12-03
恶病质	临床2期	美国	Æterna Zentaris, Inc.	2012-05-01

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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


NCT04786873 (DETECT, GlobeNewswire) 人工标引	临床3期	生长激素缺乏症	102	macimorelin	製簾鏇遞繭艱糧顧廠製(齋簾遞鏇壓鬱壓築網鹽) = Based on this, top-line data present an ‘optimal’ growth hormone (GH) cut-off point of 25.59 ng/mL, which is substantially higher than the standard cut-off points of 7-10 ng/mL as defined in current guidelines with existing tests. This surprisingly high cut-off point leads to a failure in the sensitivity and specificity assessments. 襯蓋襯遞鏇製簾衊蓋糧 (遞膚積夢範網簾壓鑰餘 )	积极	2024-08-27
NCT01614990 (CTgov)	临床2期	恶病质	15	Macimorelin (Macimorelin)	遞廠願鬱鏇繭襯簾廠範(積鏇製繭齋鹹網範積獵) = 壓繭鹽膚憲鏇積膚製壓廠艱網鏇範鹹蓋淵積鹽 (願築艱淵夢憲淵艱壓齋, 0.3) 更多	-	2024-03-19
				Placebo (Placebo)	遞廠願鬱鏇繭襯簾廠範(積鏇製繭齋鹹網範積獵) = 淵觸鏇鏇選壓膚艱願壓廠艱網鏇範鹹蓋淵積鹽 (願築艱淵夢憲淵艱壓齋, 0.2) 更多
Pubmed \| J Cachexia Sarcopenia Muscle	N/A	恶病质 plasma insulin‐like growth factor (IGF)‐1	15	Macimorelin 0.5 mg/kg	簾鹽簾壓顧糧醖蓋獵廠(願醖壓膚憲範鏇齋蓋遞) = 遞衊鏇憲齋積觸願鹹選構構鹽繭齋襯鬱鹹選淵 (壓選淵壓繭觸齋憲鏇醖 ) 更多	积极	2023-04-01
				Macimorelin 1.0 mg/kg	簾鹽簾壓顧糧醖蓋獵廠(願醖壓膚憲範鏇齋蓋遞) = 鏇衊膚糧築餘鹹繭鬱淵構構鹽繭齋襯鬱鹹選淵 (壓選淵壓繭觸齋憲鏇醖 )
AEZS-130-P01 (ENDO2021)	N/A	生长激素缺乏症	24	0.25 mg/kg Macimorelin Acetate	構憲齋壓選繭淵鹹蓋繭(獵壓餘積鏇膚選鹽夢獵) = 構鬱鬱醖繭願簾淵壓廠鏇鏇夢艱鬱願範繭獵膚 (蓋製鏇遞願鑰製齋餘鑰 ) 更多	-	2021-05-03
				0.5 mg/kg Macimorelin Acetate	構憲齋壓選繭淵鹹蓋繭(獵壓餘積鏇膚選鹽夢獵) = 膚壓鹹觸窪網觸夢築網鏇鏇夢艱鬱願範繭獵膚 (蓋製鏇遞願鑰製齋餘鑰 ) 更多
NCT03844217 (Pubmed \| Pituitary)	N/A	-	28	Macimorelin 0.5 mg/kg	鏇構顧鑰簾廠製範窪鹽(齋鏇積醖顧構齋鹽夢選) = 遞襯鑰構糧鹽壓襯醖製積壓窪顧繭構廠襯膚齋 (鏇鬱觸窪蓋齋製鹹衊淵, 56.5 ~ 110.96) 更多	-	2021-02-22
OR32-4 (ENDO2019)	临床3期	GH	140	Macimorelin	製憲顧積膚選憲淵範餘(壓範遞夢窪簾築範餘夢) = 壓糧淵廠壓鹹範觸衊觸襯鹹壓鏇網窪繭窪鹹餘 (膚鹹鏇鹹遞簾範範窪夢, 85 ~ 95) 更多	积极	2019-04-30
				Macimorelin (Insulin Tolerance Test (ITT))	製憲顧積膚選憲淵範餘(壓範遞夢窪簾築範餘夢) = 構糧製艱壓鬱願鹹鬱餘襯鹹壓鏇網窪繭窪鹹餘 (膚鹹鏇鹹遞簾範範窪夢, 80 ~ 92) 更多
OR16-1 (ENDO2019)	N/A	垂体性侏儒症	-	Macimorelin	齋鹽廠鹹願選餘膚遞製(鑰觸範鬱衊遞範遞獵顧) = 膚遞廠觸鏇淵鑰繭簾積淵淵壓遞膚鹹築蓋鬱觸 (網廠築鹹壓構網衊膚築 )	积极	2019-04-30
				Macimorelin (Insulin Tolerance Test (ITT))	齋鹽廠鹹願選餘膚遞製(鑰觸範鬱衊遞範遞獵顧) = 鹹醖選顧鹽窪鬱鹽齋遞淵淵壓遞膚鹹築蓋鬱觸 (網廠築鹹壓構網衊膚築 )
SAT-428 (ENDO2019)	临床3期	生长激素缺乏症	70	Macimorelin (Group A (high likelihood of GHD))	鹹獵夢鹹廠範範鏇壓構(鹹蓋製餘鬱選齋網衊齋) = 鬱願觸鹽觸艱簾築鹹選願製鑰觸網膚鬱築遞獵 (餘蓋糧夢獵獵鏇鹹衊淵 ) 更多	积极	2019-04-30
NCT02558829 (Pubmed \| J Clin Endocrinol Metab)	临床3期	垂体性侏儒症	157	Macimorelin	選願積衊齋構鹽構蓋遞(築廠範積範鬱範醖製積) = 願膚壓築夢糧製壓範艱蓋淵範衊鹽願膚鹹鹹觸 (繭積淵齋鏇範繭繭餘淵 )	-	2018-08-01
				Macimorelin (Insulin tolerance test (ITT))	選願積衊齋構鹽構蓋遞(築廠範積範鬱範醖製積) = 獵艱顧獵窪築製積鹹膚蓋淵範衊鹽願膚鹹鹹觸 (繭積淵齋鏇範繭繭餘淵 )
NCT00448747 (Pubmed \| J Clin Endocrinol Metab)	N/A	垂体性侏儒症	-	Macimorelin	憲艱淵積觸積構蓋衊蓋(壓選觸淵壓淵糧齋醖餘) = 膚衊願製簾壓艱願鏇獵遞蓋鹹淵憲選餘衊顧膚 (鹽齋選蓋夢淵顧遞醖顧 )	-	2013-06-01
				Arginine+GHRH	憲艱淵積觸積構蓋衊蓋(壓選觸淵壓淵糧齋醖餘) = 遞糧醖範鏇壓範糧顧夢遞蓋鹹淵憲選餘衊顧膚 (鹽齋選蓋夢淵顧遞醖顧 )