setmelanotide
Trade name: Imcivree
PeptideapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Nov 25, 2020
Setmelanotide, sold under the brand name Imcivree, is a medication used for the treatment of genetic obesity caused by a rare single-gene mutation. — Wikipedia
Clinical trial activity
24 trials · 3 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
15
Phase 3
11
Phase 4
1
Earliest trial started Jan 1, 2012 (NCT02431442)
Timeline
2010s
- Jan 1, 2012
Rhythm Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2012
Rhythm Pharmaceuticals, Inc. — Earliest Phase 2 Sponsor(trial)
- Apr 4, 2016
Orphan Drug Designation
- Jan 1, 2017
Rhythm Pharmaceuticals, Inc. — Earliest Phase 3 Sponsor(trial)
2020s
- Nov 25, 2020
Rhythm Pharmaceuticals, Inc. — Earliest FDA Approval
- Nov 25, 2020
Rhythm Pharmaceuticals, Inc. — Marketing Organization
- Nov 25, 2020
Rhythm Pharmaceuticals, Inc. — NDA Secondary Org
- Nov 25, 2020
Rhythm Pharmaceuticals, Inc. — NDA Organization
Indications
Approved for
Studied for
- Alstrom Syndrome · Phase 3
- Bardet-Biedl Syndrome · Phase 3
- Healthy Volunteers · Phase 4
- Hyperphagia · Phase 2
- Hypopituitarism · Phase 3
- Melanocortins · Phase 3
- Mutation · Phase 2
- Obesity · Phase 3
- Obesity, Morbid · Phase 1
- Optic Nerve Hypoplasia · Phase 3
- Overweight · Phase 2
- Pituitary Diseases · Phase 3
- Prader-Willi Syndrome · Phase 2
- Renal Insufficiency · Phase 1
- Septo-Optic Dysplasia · Phase 3
- Smith-Magenis Syndrome · Phase 2/Phase 3
Mechanism of action
- Melanocortin receptor 4AGONIST
MC4R agonist
Peptide
Approval history
- approvedPriority reviewBreakthroughNov 25, 2020
Chemistry & pharmacology
Loading structure…
SMILES
CC(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@H]1CSSC[C@@H](C(N)=O)NC(=O)[C@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](Cc2ccccc2)NC(=O)[C@H](Cc2c[nH]cn2)NC(=O)[C@@H](C)NC1=O- Mol. weight
- 1117.33 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaSetmelanotide ↗
- ChEMBLCHEMBL4650273 ↗
- ChEMBLCHEMBL3301624 ↗
Also known as
- bim-22493
- bim-22493
- bim-22493
- rm-493
- rm-493
- rm-493
- rm-493
- setmelanotide
- setmelanotide
- setmelanotide
- setmelanotide
- setmelanotide
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06760546 | Phase 3 | Mar 30, 2025 | Rhythm Pharmaceuticals, Inc. |
| NCT06772597 | Phase 2 | Mar 3, 2025 | Rhythm Pharmaceuticals, Inc. |
| NCT06596135 | Phase 3 | Oct 23, 2024 | Rhythm Pharmaceuticals, Inc. |
| NCT05774756 | Phase 3 | Apr 26, 2023 | Rhythm Pharmaceuticals, Inc. |
| NCT05093634 | Phase 3 | Dec 31, 2021 | Rhythm Pharmaceuticals, Inc. |
| NCT05194124 | Phase 3 | Dec 21, 2021 | Rhythm Pharmaceuticals, Inc. |
| NCT04963231 | Phase 2 | Oct 31, 2021 | Rhythm Pharmaceuticals, Inc. |
| NCT04966741 | Phase 3 | Oct 1, 2021 | Rhythm Pharmaceuticals, Inc. |
| NCT05046132 | Phase 4 | Aug 5, 2021 | Rhythm Pharmaceuticals, Inc. |
| NCT04725240 | Phase 2 | Jun 7, 2021 | Rhythm Pharmaceuticals, Inc. |
| NCT04348175 | Phase 1 | Apr 15, 2020 | Rhythm Pharmaceuticals, Inc. |
| NCT03746522 | Phase 3 | Dec 10, 2018 | Rhythm Pharmaceuticals, Inc. |
| NCT03651765 | Phase 2/Phase 3 (Phase 3) | Jul 15, 2018 | Rhythm Pharmaceuticals, Inc. |
| NCT02896192 | Phase 2/Phase 3 (Phase 3) | Feb 14, 2017 | Rhythm Pharmaceuticals, Inc. |
| NCT03287960 | Phase 3 | Jan 31, 2017 | Rhythm Pharmaceuticals, Inc. |
| NCT03013543 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2017 | Rhythm Pharmaceuticals, Inc. |
| NCT02311673 | Phase 2 | Feb 1, 2015 | Rhythm Pharmaceuticals, Inc. |
| NCT02507492 | Phase 2 | Jan 1, 2015 | Humboldt University |
| NCT02041195 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2014 | Rhythm Pharmaceuticals, Inc. |
| NCT01867437 | Phase 1 | May 1, 2013 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Rhythm Pharmaceuticals, Inc. |
Showing 20 of 24 trials
Page 1 / 2
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Rhythm Pharmaceuticals, Inc. | For profit | 23 | 23 | 5 | 2012 |
| Humboldt University | Academic/Hospital | 1 | 1 | 1 | 2015 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 1 | 0 | 1 | 2013 |
3 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Rhythm Pharmaceuticals, Inc. | For profit | MKTG | Nov 25, 2020 |
| Rhythm Pharmaceuticals, Inc. | For profit | MKTG | Nov 25, 2020 |
| Rhythm Pharmaceuticals, Inc. | For profit | NDA2 | Nov 25, 2020 |
| Rhythm Pharmaceuticals, Inc. | For profit | NDA | Nov 25, 2020 |