metreleptin
Trade name: myalept
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
Feb 24, 2014
Metreleptin, sold under the brand name Myalept among others, is a synthetic analog of the hormone leptin used to treat various forms of dyslipidemia. It has been approved in Japan for metabolic disorders including lipodystrophy and in the United States as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. — Wikipedia
Clinical trial activity
30 trials · 17 clinical orgs · 4 marketing orgs
Phase 1
3
Phase 2
23
Phase 3
5
Phase 4
2
Earliest trial started Feb 1, 2001 (NCT00140205)
Timeline
2000s
2010s
- Jan 1, 2014
Earliest Phase 3 Sponsor(trial)
- Feb 24, 2014
Amylin — Earliest FDA Approval
- Feb 24, 2014
Amryt Research Limited — Marketing Organization
- Feb 24, 2014
Amylin — NDA Organization
- Feb 24, 2014
Novelion Therapeutics — Marketing Organization
- Feb 24, 2014
Amryt Research Limited — NDA Secondary Org
- Feb 24, 2014
Chiesi — Marketing Organization
Indications
Approved for
Studied for
- Amenorrhea · Phase 2
- Anorexia Nervosa · Phase 2
- Diabetes Mellitus · Phase 3
- Fasting · Phase 1/Phase 2
- HIV-Associated Lipodystrophy Syndrome · Phase 2
- HIV Infections · Phase 2
- Hyperlipidemias · Phase 3
- Insulin Resistance · Phase 2
- Lipodystrophy, Congenital Generalized · Phase 4
- Lipodystrophy, Familial Partial · Phase 2
- Lipomatosis, Multiple Symmetrical · Phase 1
- Metabolic Syndrome · Phase 2
- Non-alcoholic Fatty Liver Disease · Phase 2
- Obesity · Phase 2
- Overweight · Phase 2
Mechanism of action
- Leptin receptorAGONIST
LEPR agonist
Approval history
- approvedFast trackFeb 24, 2014
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Black box warningFirst in class
Sources
- WikipediaMetreleptin ↗
- NCATSTL60C27RLH ↗
- ChEMBLCHEMBL2107857 ↗
Also known as
- methionyl human leptin
- methionyl human leptin
- methuleptin
- metreleptin
- metreleptin
- metreleptin
- metreleptin
- metreleptin
- metreleptin
- metreleptin
- metreleptin
- metreleptina
- métréleptine
- metreleptinum
- myalept
- myalept
- myalept
- n-methionylleptin
- n-methionylleptin
- recombinant methionyl human leptin
- r-methuleptin
- r-methuleptin
- r-methuleptin
- r-methuleptin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06679270 | Phase 3 | Oct 14, 2024 | Amryt Research Limited |
| NCT06502990 | Phase 3 | Jul 31, 2024 | Amryt Research Limited |
| NCT06305182 | Phase 2 | May 31, 2024 | University of Zurich |
| NCT06484868 | Phase 4 | Feb 8, 2024 | Amryt Research Limited |
| NCT05351164 | Phase 1 | Jul 28, 2022 | Amryt Research Limited, University of Michigan |
| NCT05164341 | Phase 3 | Dec 31, 2021 | Amryt Research Limited |
| NCT04026178 | Phase 4 | Nov 14, 2018 | Novelion Therapeutics |
| NCT02654977 | Phase 2 | Apr 1, 2015 | University of Michigan |
| NCT02404896 | Phase 2 | Jan 1, 2015 | University of Michigan |
| NCT02262832 | Phase 3 | Oct 7, 2014 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT02262806 | Phase 3 | Oct 6, 2014 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT01778556 | Phase 2 | Jan 7, 2013 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT01679197 | Phase 2 | Oct 8, 2012 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan |
| NCT01235741 | Phase 2 | Jan 1, 2011 | Amylin, AstraZeneca, Takeda |
| NCT00130117 | Phase 2 | Apr 1, 2010 | Amgen, Harvard University, National Center for Research Resources (NCRR), National Institutes of Health (NIH) |
| NCT00677313 | N/A | Mar 1, 2009 | Bristol-Myers Squibb |
| NCT00819234 | Phase 2 | Nov 1, 2008 | Amylin, AstraZeneca |
| NCT00673387 | Phase 2 | Apr 1, 2008 | Amylin, AstraZeneca |
| NCT00392925 | Phase 2 | Oct 1, 2006 | Amylin, AstraZeneca |
| NCT00596934 | Phase 2 | Feb 1, 2006 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan |
Showing 20 of 30 trials
Page 1 / 2
Organizations
Research & Development (17)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 11 | 5 | 2 | 2001 |
| Amryt Research Limited | For profit | 5 | 4 | 3 | 2021 |
| Amylin | For profit | 5 | 0 | 1 | 2003 |
| University of Michigan | Academic/Hospital | 5 | 5 | 2 | 2006 |
| Amgen | For profit | 4 | 0 | 2 | 2001 |
| AstraZeneca | For profit | 4 | 4 | 1 | 2006 |
| Harvard University | Academic/Hospital | 4 | 4 | 2 | 2001 |
| National Center for Research Resources (NCRR) | Government | 2 | 0 | 1 | 2002 |
| University of Miami | Academic/Hospital | 2 | 2 | 1 | 2001 |
| Baylor University | Academic/Hospital | 1 | 1 | 1 | 2003 |
| Bristol-Myers Squibb | For profit | 1 | 1 | 1 | 2009 |
| National Institutes of Health (NIH) | Government | 1 | 0 | 1 | 2010 |
| Novelion Therapeutics | For profit | 1 | 1 | 1 | 2018 |
| Oregon Health and Science University | Academic/Hospital | 1 | 1 | 1 | 2006 |
| Takeda | For profit | 1 | 0 | 1 | 2011 |
| The University of Texas, Dallas | Academic/Hospital | 1 | 1 | 1 | 2003 |
| University of Zurich | Academic/Hospital | 1 | 1 | 1 | 2024 |
17 organizations
Page 1 / 1
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amryt Research Limited | For profit | MKTG | Feb 24, 2014 |
| Amryt Research Limited | For profit | NDA2 | Feb 24, 2014 |
| Amylin | For profit | NDA | Feb 24, 2014 |
| Chiesi | For profit | MKTG | Feb 24, 2014 |
| Novelion Therapeutics | For profit | MKTG | Feb 24, 2014 |