Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (3)

Jul 4, 2034formulationUS 11129869
Aug 21, 2032compositionUS 8039435
Oct 13, 2027compositionUS 94581951.1y

FDA exclusivities (5)

Dec 20, 2031ODE-508Orphan Drug (7y)
Dec 20, 2031ODE-509Orphan Drug (7y)
Jun 16, 2029ODE-402Orphan Drug (7y)2.8y
Dec 20, 2027NPPNew Product (3y)1.3y
Nov 25, 2027ODE-336Orphan Drug (7y)1.3y

News(0)

no news has mentioned this drug yet

brand

Imcivree

generic

setmelanotide

MOA

12.1 Mechanism of Action Setmelanotide is an MC4 receptor agonist with 20-fold less activity at the melanocortin 3 (MC3) and melanocortin 1 (MC1) receptors. MC4 receptors in the brain are involved in regulation of hunger, satiety, and energy expenditure. Based on nonclinical evidence, setmelanotide may re establish MC4 receptor pathway activity to reduce food intake and promote weight loss through decreased caloric intake and increased energy expenditure in patients with obesity due to acquired HO, BBS, or POMC, PCSK1, or LEPR deficiency associated with insufficient activation of the MC4 receptor. The MC1 receptor is expressed on melanocytes, and activation of this receptor leads to accumulation of melanin and increased skin pigmentation independently of ultraviolet light [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].

indication

Obesity

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 26m ago

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setmelanotide

Marketedupdated 3mo ago

by $RYTM RHYTHM PHARMACEUTICALS, INC.

Approved

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🐶 often sniffed alongside

top 2

Protein drug with a maximum clinical stage of Approval, with an approval for obesity.

indications

investigational

Obesity

all catalysts(6)

approval · 6

IMCIVREE (SETMELANOTIDE ACETATE) — FDA approval

IMCIVREE (SETMELANOTIDE ACETATE) — FDA approval

IMCIVREE (SETMELANOTIDE ACETATE) — FDA approval

IMCIVREE (SETMELANOTIDE ACETATE) — FDA approval

IMCIVREE (SETMELANOTIDE ACETATE) — FDA approval

IMCIVREE (SETMELANOTIDE ACETATE) — FDA approval

setmelanotide

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Trials studying setmelanotide

phase3A Trial of Setmelanotide in Acquired Hypothalamic Obesityactive not recruitingn=143
phase3Open-Label Extension Study of Setmelanotidecompletedn=28
phase2A Study of Setmelanotide in Patients With Prader-Willi Syndromeactive not recruitingn=18
phase3A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)recruitingn=39
phase3EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathwayactive not recruitingn=296
phase2DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathwaycompletedn=164
phase3Long Term Extension Trial of Setmelanotidecompletedn=205
phase2Open-Label Study of Setmelanotide in Hypothalamic Obesitycompletedn=18

more trials →

Patent cliff

source: FDA Orange Book

first barrier falls

Oct 13, 2027

~1.1 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (3)

Jul 4, 2034formulationUS 11129869
Aug 21, 2032compositionUS 8039435
Oct 13, 2027compositionUS 94581951.1y

FDA exclusivities (5)

Dec 20, 2031ODE-508Orphan Drug (7y)
Dec 20, 2031ODE-509Orphan Drug (7y)
Jun 16, 2029ODE-402Orphan Drug (7y)2.8y
Dec 20, 2027NPPNew Product (3y)1.3y
Nov 25, 2027ODE-336Orphan Drug (7y)1.3y

News(0)

no news has mentioned this drug yet

brand

Imcivree

generic

setmelanotide

MOA

indication

Obesity

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 26m ago

Found something off?

comments(0)

5-min edit window · permanent after that

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setmelanotide

🐶 often sniffed alongside

indications

all catalysts(6)

Trials studying setmelanotide

Patent cliff

patents (3)

FDA exclusivities (5)

News(0)

Report a data issue

comments(0)

setmelanotide

🐶 often sniffed alongside

indications

all catalysts(6)

Trials studying setmelanotide

Patent cliff

patents (3)

FDA exclusivities (5)

News(0)

Report a data issue

comments(0)