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).

Start Date16 Nov 2021

Sponsor / Collaborator

Æterna Zentaris, Inc.

NCT03844217

/ CompletedNot ApplicableIIT

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.

Start Date07 Mar 2019

Sponsor / Collaborator

Universitätsspital Basel

EUCTR2018-001988-23-HU

/ Not yet recruitingPhase 2

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)

Start Date07 Nov 2018

Sponsor / Collaborator

AEterna Zentaris GmbH

100 Clinical Results associated with Macimorelin Acetate

100 Translational Medicine associated with Macimorelin Acetate

100 Patents (Medical) associated with Macimorelin Acetate

Literatures (Medical) associated with Macimorelin Acetate

01 Jun 2025·Pituitary

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

Review

Author: 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 ; Fleseriu, M ; Savendahl, L ; Juul, A ; Tritos, N A ; Yuen, K C J ; Radovick, S ; Collett-Solberg, P F ; Clayton, P E ; Christ, E ; Rosenfeld, R ; Höybye, C ; Horikawa, R ; Biller, B M K ; Neggers, S J C M M ; Chanson, P ; Dauber, A ; Ho, K K Y ; Jorgensen, J O L ; Lodish, M ; Hoffman, A R ; Miller, K K ; Boguszewski, M C S ; Cohen, P ; 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.

01 Apr 2025·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

Author: 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.

27 Mar 2025·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

Author: Yang, Fanglong ; Jin, Lei ; Wang, Siqin ; Liu, Meng ; 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.

News (Medical) associated with Macimorelin Acetate

26 May 2025

·www.einpresswire.com

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.

Phase 2

01 Jan 2025

·www.globenewswire.com

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.

Clinical Study

08 Oct 2024

·www.globenewswire.com

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

Executive Change

100 Deals associated with Macimorelin Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D10562	Macimorelin Acetate	V04CD06	DB13074

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Growth hormone deficiency	United States	Novo Nordisk, Inc.	20 Dec 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Growth Hormone Deficiency With Pituitary Anomalies	Phase 3	United States	Æterna Zentaris, Inc.	03 Dec 2015
Growth Hormone Deficiency With Pituitary Anomalies	Phase 3	Austria	Æterna Zentaris, Inc.	03 Dec 2015
Growth Hormone Deficiency With Pituitary Anomalies	Phase 3	France	Æterna Zentaris, Inc.	03 Dec 2015
Growth Hormone Deficiency With Pituitary Anomalies	Phase 3	Germany	Æterna Zentaris, Inc.	03 Dec 2015
Growth Hormone Deficiency With Pituitary Anomalies	Phase 3	Italy	Æterna Zentaris, Inc.	03 Dec 2015
Growth Hormone Deficiency With Pituitary Anomalies	Phase 3	Poland	Æterna Zentaris, Inc.	03 Dec 2015
Growth Hormone Deficiency With Pituitary Anomalies	Phase 3	Serbia	Æterna Zentaris, Inc.	03 Dec 2015
Growth Hormone Deficiency With Pituitary Anomalies	Phase 3	Spain	Æterna Zentaris, Inc.	03 Dec 2015
Growth Hormone Deficiency With Pituitary Anomalies	Phase 3	United Kingdom	Æterna Zentaris, Inc.	03 Dec 2015
Cachexia	Phase 2	United States	Æterna Zentaris, Inc.	01 May 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04786873 (DETECT, GlobeNewswire) Manual	Phase 3	Growth hormone deficiency	102	macimorelin	herexyivzv(wroqpeelfe) = 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. qzlkqdfmct (dauksswklm )	Positive	27 Aug 2024
NCT01614990 (CTgov)	Phase 2	Cachexia	15	Macimorelin (Macimorelin)	yckjmdhdlt(vmqutllgji) = bqjszujosj xeohsqxvgb (ertjwhtfss, 0.3) View more	-	19 Mar 2024
				Placebo (Placebo)	yckjmdhdlt(vmqutllgji) = divubwazwp xeohsqxvgb (ertjwhtfss, 0.2) View more
Pubmed \| J Cachexia Sarcopenia Muscle	Not Applicable	Cachexia plasma insulin‐like growth factor (IGF)‐1	15	Macimorelin 0.5 mg/kg	aucdkcryjn(cniapdaaju) = qmzdpohbaf cnzabrtakh (mcbhtpnixo ) View more	Positive	01 Apr 2023
				Macimorelin 1.0 mg/kg	aucdkcryjn(cniapdaaju) = pcileakeet cnzabrtakh (mcbhtpnixo )
AEZS-130-P01 (ENDO2021)	Not Applicable	Growth hormone deficiency	24	0.25 mg/kg Macimorelin Acetate	zirqyvwylb(zbhuhpcmct) = ixgdhmriqa imcmizkdww (yykintlxtc ) View more	-	03 May 2021
				0.5 mg/kg Macimorelin Acetate	zirqyvwylb(zbhuhpcmct) = accnbitnya imcmizkdww (yykintlxtc ) View more
NCT03844217 (Pubmed \| Pituitary)	Not Applicable	-	28	Macimorelin 0.5 mg/kg	hibhetauzz(nvrsbgscem) = zvmnvmgtgz vvdrthtykm (etvtbuxduy, 56.5 - 110.96) View more	-	22 Feb 2021
OR32-4 (ENDO2019)	Phase 3	GH	140	Macimorelin	rswdaakbsl(sfoachpgof) = gxzgrejrye ryykrufbgy (aasnnamsth, 85 - 95) View more	Positive	30 Apr 2019
				Macimorelin (Insulin Tolerance Test (ITT))	rswdaakbsl(sfoachpgof) = alyghipsac ryykrufbgy (aasnnamsth, 80 - 92) View more
OR16-1 (ENDO2019)	Not Applicable	Dwarfism, Pituitary	-	Macimorelin	jxceqfieaw(dtkuzwcszz) = rkielildtd kfcysoaboh (bnovgupsxe )	Positive	30 Apr 2019
				Macimorelin (Insulin Tolerance Test (ITT))	jxceqfieaw(dtkuzwcszz) = bhjbtydqcr kfcysoaboh (bnovgupsxe )
SAT-428 (ENDO2019)	Phase 3	Growth hormone deficiency	70	Macimorelin (Group A (high likelihood of GHD))	vwdcqlcwsv(dxytxrmbqi) = nabicyesdg stgfrzfvcn (kgtazsnsix ) View more	Positive	30 Apr 2019
NCT02558829 (Pubmed \| J Clin Endocrinol Metab)	Phase 3	Dwarfism, Pituitary	157	Macimorelin	oxitxppqfu(vfxwjdutxu) = xfzphnagvj arpjthuorg (hukhbpduyn )	-	01 Aug 2018
				Macimorelin (Insulin tolerance test (ITT))	oxitxppqfu(vfxwjdutxu) = hejvrnwqxc arpjthuorg (hukhbpduyn )
NCT00448747 (Pubmed \| J Clin Endocrinol Metab)	Not Applicable	Dwarfism, Pituitary	-	Macimorelin	updiaagxmx(wwlucfjrhv) = wqehkexcok fjdqiidlxf (mhtvpchoox )	-	01 Jun 2013
				Arginine+GHRH	updiaagxmx(wwlucfjrhv) = jofrbddict fjdqiidlxf (mhtvpchoox )

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis