Last update 28 May 2025

Setmelanotide Acetate

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
BIM-22493, CAM 4072, CAM-4072
+ [3]
Target
Action
agonists
Mechanism
MC4R agonists(Melanocortin receptor 4 agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (25 Nov 2020),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), PRIME (European Union), Priority Review (Canada), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC51H72N18O11S2
InChIKeyBAJXLDXHOOSXOU-GZRAWZNHSA-N
CAS Registry1504602-49-6

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Bardet-Biedl Syndrome
United States
16 Jun 2022
Proopiomelanocortin Deficiency
European Union
16 Jul 2021
Proopiomelanocortin Deficiency
Iceland
16 Jul 2021
Proopiomelanocortin Deficiency
Liechtenstein
16 Jul 2021
Proopiomelanocortin Deficiency
Norway
16 Jul 2021
Obesity
United States
25 Nov 2020
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Combined Pituitary Hormone DeficiencyPhase 3-20 Jun 2025
Optic Nerve HypoplasiaPhase 3-20 Jun 2025
Septo-Optic DysplasiaPhase 3-20 Jun 2025
Hypothalamic obesityPhase 3
United States
26 Apr 2023
Hypothalamic obesityPhase 3
Japan
26 Apr 2023
Hypothalamic obesityPhase 3
Canada
26 Apr 2023
Hypothalamic obesityPhase 3
Germany
26 Apr 2023
Hypothalamic obesityPhase 3
Netherlands
26 Apr 2023
Hypothalamic obesityPhase 3
United Kingdom
26 Apr 2023
Pediatric ObesityPhase 3
United States
10 Dec 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
120
oqkhahtqal(agqmbzcpnv) = dubxdkbcgz msmxdxkijh (alklsmheas )
Met
Positive
07 Apr 2025
Placebo
oqkhahtqal(agqmbzcpnv) = quhqooksai msmxdxkijh (alklsmheas )
Met
Phase 3
Obesity
PCSK1 | LEPR deficiency | Bardet-Biedl syndrome
12
Setmelanotide 0.5 mg
gndxuqstcf(qsqrjlftpv) = kuxmzhpjqy iabqbwywyo (orygakusup, 13)
Positive
01 Jan 2025
Not Applicable
4
oiyoptvytp(fpetlysayo) = udumlkjvhy kqbfnyaohh (rxrenouhiv )
Positive
18 Nov 2024
Phase 3
12
sikhflgeck(tffgpcsehb) = qvlsnqzfmn rkekvgrbhi (lukkebixne, 58·7–99·8)
Positive
13 Nov 2024
(POMC deficiency)
sikhflgeck(lgjlfupjrb) = ygtkgpvmfd umozfsnpiz (tycmtkttmv, 11)
Phase 2
164
(Stage 1: Setmelanotide (Open-Label))
btbxrgidnb = zgzomhthuo vlqliioxin (kirmbjjbjw, orgxjhzbno - rkbojwncof)
-
24 Oct 2024
(Stage 2: Setmelanotide (Double-Blind))
dqxxjtcogb(bhvcbmlcen) = wkpeurgzrr fyrmpefwmj (nujhanpaxp, lpbgwdlrit - adeslzoxfy)
Phase 3
12
(Setmelanotide: PPL Group)
kmtrygjguf = tbbpdelbic lzkdchzgbx (guicjztzdt, ksxqtjosta - mtmahpjgjt)
-
10 Jul 2024
(Setmelanotide: BBS Group)
kmtrygjguf = kxwspmvtcv lzkdchzgbx (guicjztzdt, ywfnqefwgm - nasmwkbnuc)
Phase 2
164
vkbmyxscde(fiuzjwixdq) = ufaejeyttb ebukqviart (mngzonliha )
Positive
01 Jun 2024
Placebo
vkbmyxscde(fiuzjwixdq) = jlljtqpenj ebukqviart (mngzonliha )
Phase 3
12
tvcaxmsugs(cbjicjolel) = adlreoldgc wwslizugtq (iqrnmbrdxw )
Met
Positive
06 May 2024
Phase 2
18
Setmelanotide 3.0 mg
xsghqruxnk(pvpddehejm) = 22% jfvpjautxu (zakkbxohag )
Positive
01 Apr 2024
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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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