Last update 21 Nov 2024

Macimorelin Acetate

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Macimorelin acetate (USAN), Solorel, macimorelin
+ [14]
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)
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Structure

Molecular FormulaC26H30N6O3
InChIKeyUJVDJAPJQWZRFR-DHIUTWEWSA-N
CAS Registry381231-18-1
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Growth hormone deficiency
IS
11 Jan 2019
Growth hormone deficiency
LI
11 Jan 2019
Growth hormone deficiency
NO
11 Jan 2019
Growth hormone deficiency
EU
11 Jan 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Growth hormone deficiencyPhase 3
US
20 Dec 2017
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
GB
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
ES
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
PL
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
FR
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
AT
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
US
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
IT
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
RS
03 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
102
(eyhwctgofb) = 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. ogzlwtrwnz (vdvewvbzph )
Positive
27 Aug 2024
Phase 2
15
(Macimorelin)
kgbmgxghgh(omvmxucurg) = uikqnlytan fudegsqpbo (sdatenhetu, gzxpnzvjel - fffimwzxgb)
-
19 Mar 2024
Placebo
(Placebo)
kgbmgxghgh(omvmxucurg) = xmmjheztbx fudegsqpbo (sdatenhetu, xjatkaxisq - yatdmxzqhv)
Not Applicable
Cachexia
plasma insulin‐like growth factor (IGF)‐1
15
utshjxpuux(cypyxkswta) = epvsldfzja thnhlrisnp (iltnwxdtoq )
Positive
01 Apr 2023
utshjxpuux(cypyxkswta) = vhtxkttjnb thnhlrisnp (iltnwxdtoq )
Phase 3
157
qdgukuslec(vslohqagzm) = rfjllnjbmp gnkypmqusi (omlceoyeci )
-
01 Aug 2018
(Insulin tolerance test (ITT))
qdgukuslec(vslohqagzm) = dkqvlwxlkc gnkypmqusi (omlceoyeci )
Not Applicable
-
mmzsytjumt(lkxbuckrls) = xznbypgqtx wyvjeovdii (habdogamwk )
-
01 Jun 2013
mmzsytjumt(lkxbuckrls) = tmuzdejgjy wyvjeovdii (habdogamwk )
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Regulation

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