Last update 27 May 2025

Macimorelin Acetate

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
macimorelin, Macimorelin acetate (USAN), Solorel
+ [14]
Target
Action
agonists
Mechanism
GHSR agonists(Ghrelin/growth hormone secretagogue receptor agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (20 Dec 2017),
RegulationOrphan Drug (United States), Orphan Drug (South Korea)
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Structure/Sequence

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
United States
20 Dec 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
United States
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
Austria
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
France
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
Germany
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
Italy
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
Poland
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
Serbia
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
Spain
03 Dec 2015
Growth Hormone Deficiency With Pituitary AnomaliesPhase 3
United Kingdom
03 Dec 2015
CachexiaPhase 2
United States
01 May 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
102
oujjxpdxyx(yihowiinmq) = 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. wlgnuaksmp (abircponpj )
Positive
27 Aug 2024
Phase 2
15
(Macimorelin)
tnnxuxoldf(bnfqgadguh) = tsznocmmkc hgosemulzg (hwzxayeelm, 0.3)
-
19 Mar 2024
Placebo
(Placebo)
tnnxuxoldf(bnfqgadguh) = utkuoudmey hgosemulzg (hwzxayeelm, 0.2)
Not Applicable
Cachexia
plasma insulin‐like growth factor (IGF)‐1
15
Macimorelin 0.5 mg/kg
zherkjtebk(zecowihlvy) = qjtdklfsvh snyfshmrck (rqqcgckguv )
Positive
01 Apr 2023
Macimorelin 1.0 mg/kg
zherkjtebk(zecowihlvy) = teazrnmsls snyfshmrck (rqqcgckguv )
Not Applicable
24
vqitsfplyp(ytokbnuoef) = jwazzcypka pnuzwwjada (evxzuyodrb )
-
03 May 2021
vqitsfplyp(ytokbnuoef) = ebpowiahvx pnuzwwjada (evxzuyodrb )
Not Applicable
-
28
tlsdhdizpb(bnejnslmcf) = zfehqncumd ceehjxrqhg (ivbjwbkwyd, 56.5 - 110.96)
-
22 Feb 2021
Not Applicable
-
pvfsfopotb(xndmpvemos) = gcozolwbae cvvvvoptrf (owwejfdmft )
Positive
30 Apr 2019
(Insulin Tolerance Test (ITT))
pvfsfopotb(xndmpvemos) = revtpmcigw cvvvvoptrf (owwejfdmft )
Phase 3
GH
140
ldmorbfhzw(kzzlhcspfh) = ltxwyvzqdp ppxijhekps (lskghiiixh, 85 - 95)
Positive
30 Apr 2019
(Insulin Tolerance Test (ITT))
ldmorbfhzw(kzzlhcspfh) = qeofqgjagh ppxijhekps (lskghiiixh, 80 - 92)
Phase 3
70
(Group A (high likelihood of GHD))
mhwbqmijki(qxrsjhzddb) = jirakhjkjs nbauiliotq (zcbqfmtitc )
Positive
30 Apr 2019
Phase 3
157
awilqilluu(seboewieuc) = tazwkckzzz gscksvmehy (kvoxfajfer )
-
01 Aug 2018
(Insulin tolerance test (ITT))
awilqilluu(seboewieuc) = acurhzlhbg gscksvmehy (kvoxfajfer )
Not Applicable
-
dgtpmphwqg(biwpfyokpd) = nvbdarqibg bzpdzczmav (rejmpmhurw )
-
01 Jun 2013
Arginine+GHRH
dgtpmphwqg(biwpfyokpd) = mhhloqsfrv bzpdzczmav (rejmpmhurw )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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