Drugs / Setmelanotide
Setmelanotide
also known as
RM-493 · BIM-22493 · Imcivree · RM-493 ACETATE · Setmelanotida · SETMELANOTIDE ACETATE
Protein / enzyme biologic targets MC4R via activation
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | IMCIVREE | — | 2022-06-16 – 2026-03-19 | fda.gov ↗ |
| Approved | EU (EMA) | Imcivree | — | 2021-07-16 | europa.eu ↗ |
| Approved | US (FDA) | IMCIVREE | — | 2020-11-25 | fda.gov ↗ |
Trials 23 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01867437 Comparator | May 2013 → Mar 2014 | morbid obesity | Rhythm Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02431442 Comparator | Jan 2012 → Jan 2014 | obesity disorder | Rhythm Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02041195 Comparator | Jan → Aug 2014 | morbid obesity | Rhythm Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05812183 Background | Jul 2023 → Feb 2025 | — | University of California, Los Angeles | Withdrawn | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Setmelanotide | “Setmelanotide (Imcivree)” NCT05812183 ↗23 |
| Known as | BIM-22493 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301624 ↗ |
| Known as | Imcivree | “Setmelanotide (Imcivree)” NCT05812183 ↗ |
| Known as | RM-493 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02507492 ↗ |
| Known as | RM-493 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301624 ↗ |
| Known as | Setmelanotida | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301624 ↗ |
| Known as | SETMELANOTIDE ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301624 ↗ |
| Action | Activate | “a Melanocortin 4 Receptor (MC4R) Agonist” NCT02311673 ↗ |
| Modality | Peptide | “RM-493 is a potent, selective peptide agonist for the MC4R” NCT01867437 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL3301624 ↗ |
| Route | Subcutaneous | “RM-493 (1 mg/24 h) or placebo by continuous subcutaneous infusion over 72 hours” PMID 25675384 ↗ Feb 2015 |
| Target | MC4R | “RM-493 is a potent, selective peptide agonist for the MC4R” NCT01867437 ↗ |