Last update 01 Nov 2024

Macimorelin Acetate

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
macimorelin, Macimorelin acetate (USAN), Solorel
+ [13]
Target
Mechanism
GHSR agonists(Ghrelin/growth hormone secretagogue receptor agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (20 Dec 2017),
RegulationOrphan Drug (US), Orphan Drug (KR)
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Structure

Molecular FormulaC28H34N6O5
InChIKeyWVDSKQXKCDZXLH-OHIDFYLOSA-N
CAS Registry945212-59-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Growth hormone deficiency
US
20 Dec 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
US
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
AT
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
FR
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
DE
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
IT
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
PL
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
RS
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
ES
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
GB
03 Dec 2015
CachexiaPhase 2
US
01 May 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
102
chdiibmxhj(wedqyecpst) = 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. nvfsngewyy (xjdsrsyfmn )
Positive
27 Aug 2024
Phase 2
15
(Macimorelin)
pqtjdtfrvl(ryyknzmlfz) = cldgnivmmg uvjczxhhvz (pbjclsmsfo, hlkvhgqcfv - iasweksedh)
-
19 Mar 2024
Placebo
(Placebo)
pqtjdtfrvl(ryyknzmlfz) = efgifqwbwq uvjczxhhvz (pbjclsmsfo, frzyvnkzdx - ngevsbaxlo)
Not Applicable
Cachexia
plasma insulin‐like growth factor (IGF)‐1
15
vtjiaycjid(rgxivwaqad) = mphckwpsah jstzvkhdiq (uorlnrwhzr )
Positive
01 Apr 2023
vtjiaycjid(rgxivwaqad) = fzdjsqfuhm jstzvkhdiq (uorlnrwhzr )
Phase 3
157
plburnkfxk(crgeuuwbgy) = uyvjirixwq swexdsylis (ohohngiqrb )
-
01 Aug 2018
(Insulin tolerance test (ITT))
plburnkfxk(crgeuuwbgy) = zhuyxqcrbr swexdsylis (ohohngiqrb )
Not Applicable
-
bmqnlolvjk(zotinsijgc) = qipopidvjt lezucnxezr (fdonbwpahu )
-
01 Jun 2013
bmqnlolvjk(zotinsijgc) = jsddaegzjc lezucnxezr (fdonbwpahu )
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Regulation

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