Drugs / Metreleptin
Metreleptin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Myalepta | — | 2018-07-30 | europa.eu ↗ |
| Approved | US (FDA) | MYALEPT | — | 2014-02-24 | fda.gov ↗ |
Trials 25 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00140205 | Feb 2001 → Jun 2004 | — | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 217 trials | ||||||
| Phase 2 | NCT06305182 | May 2024 → Aug 2026 overdue | anorexia nervosa | Gabriella Milos | Recruiting | No outcome recorded |
| Phase 2 | NCT05351164 | Aug 2023 → Apr 2024 overdue | multiple symmetric lipomatosis | University of Michigan | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02654977 | Sep 2015 → Nov 2019 | NAFLD1, familial partial lipodystrophy, metabolic dysfunction-associated steatohepatitis | University of Michigan | Completed | No outcome recorded |
| Phase 2 | NCT02262806 | Oct 2014 → Jul 2027 expected | diabetes mellitus, hyperlipidemia, partial lipodystrophy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01778556 | Jan 2013 → Feb 2018 | lipodystrophy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT01679197 | Oct 2012 → Jul 2016 | lipodystrophy, metabolic dysfunction-associated steatohepatitis | University of Michigan | Completed | No outcome recorded |
| Phase 2 | NCT01235741 | Jan → Sep 2011 | obesity disorder | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT00130117 | Apr 2010 → Aug 2011 | amenorrhea | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00819234 | Nov 2008 → Oct 2009 | obesity disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00673387 | Apr 2008 → Apr 2009 | obesity disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00392925 | Oct 2006 → Sep 2007 | obesity disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00596934 | Feb 2006 → Mar 2009 | NAFLD1 | Elif Oral | Completed | No outcome recorded |
| Phase 2 | NCT00659828 | Jun 2005 → Apr 2010 | abdominal obesity-metabolic syndrome, diabetes mellitus, obesity disorder | University of Miami | Completed | No outcome recorded |
| Phase 2 | NCT00085982 | Aug 2003 → Oct 2019 overdue | Rabson-Mendenhall syndrome | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00025883 | Oct 2001 → Feb 2015 | lipodystrophy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT00657605 | Jun 2001 → May 2010 | abdominal obesity-metabolic syndrome, diabetes mellitus, obesity disorder | University of Miami | Completed | No outcome recorded |
| Phase 2 | NCT00005905 | Jun 2000 → Apr 2003 | lipodystrophy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06502990 | May 2025 → Sep 2026 expected | generalized lipodystrophy | Amryt Pharma | Recruiting | No outcome recorded |
| Phase 3 | NCT06679270 | Oct 2024 → Mar 2028 expected | familial partial lipodystrophy | Chiesi Farmaceutici S.p.A. | Recruiting | No outcome recorded |
| Phase 3 | NCT02262832 | Oct 2014 → Jul 2027 expected | diabetes mellitus, hyperlipidemia, lipodystrophy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Active not recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06484868 | Feb 2024 → Feb 2028 expected | partial lipodystrophy | Amryt Pharma | Recruiting | No outcome recorded |
| Phase 4 | NCT04026178 | Nov 2018 → Oct 2024 | generalized lipodystrophy | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT00677313 | Mar 2009 → Jan 2015 | lipodystrophy | Bristol-Myers Squibb | Completed | No outcome recorded |
| — | NCT01511016 | Feb 2003 → Jun 2011 | AIDS dysmorphic syndrome | Baylor College of Medicine | Completed | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00140231 Comparator | Oct 2002 → Mar 2011 | — | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00140244 Comparator | Dec 2001 → Jun 2011 | lipodystrophy | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05164341 Comparator | Dec 2021 → Jul 2026 overdue | partial lipodystrophy | Chiesi Farmaceutici S.p.A. | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00691158 Comparator | Jan 2006 → Jul 2024 | obesity disorder | Oregon Health and Science University | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02404896 Background | — | familial partial lipodystrophy | University of Michigan | Available | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | metreleptin | “Evidence suggests that pioglitazone and recombinant methionyl human leptin (metreleptin) administration has beneficial effects in human immunodeficiency virus (HIV)-infected...” PMID 21081243 ↗ Nov 201024“Metreleptin, a human analog of leptin, improved metabolic abnormalities in mixed cohorts of children and adults with lipodystrophy and low leptin.” PMID 28324110 ↗ May 2017 |
| Known as | (originally A100, recombinant-human-methionyl-leptin | “(originally A100, recombinant-human-methionyl-leptin” NCT01679197 ↗ |
| Known as | leptin | “investigational medication called leptin (r-metHuLeptin)” NCT00130117 ↗ |
| Known as | MYALEPT | “MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired...” NCT04026178 ↗ |
| Known as | Recombinant human leptin | “Recombinant human leptin (metreleptin) improves glycaemia and hypertriglyceridaemia in patients with generalized lipodystrophy” PMID 26589105 ↗ Feb 2016 |
| Known as | recombinant human methionyl leptin | “Our objective was to study 1-year effects of recombinant human methionyl leptin (metreleptin) in 5 patients with RMS and 10-year effects in 2 of these patients.” PMID 23969187 ↗ Aug 2013 |
| Known as | recombinant methionyl human leptin | “Evidence suggests that pioglitazone and recombinant methionyl human leptin (metreleptin) administration has beneficial effects in human immunodeficiency virus (HIV)-infected...” PMID 21081243 ↗ Nov 20106“Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake” NCT05164341 ↗ “Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake” NCT06679270 ↗ “Metreleptin [Recombinant-methionyl human Leptin; rmetHuLeptin] for daily injection is a sterile, white, solid lyophilised cake” NCT06502990 ↗ “MyaLept (Recombinant-methionyl Human Leptin (r-metHuLeptin) METRELEPTIN) subcutaneous injections” NCT02654977 ↗ |
| Known as | rmetHuLeptin | “Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake” NCT06679270 ↗8“Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake” NCT05164341 ↗ “Metreleptin [Recombinant-methionyl human Leptin; rmetHuLeptin] for daily injection is a sterile, white, solid lyophilised cake” NCT06502990 ↗ “MyaLept (Recombinant-methionyl Human Leptin (r-metHuLeptin) METRELEPTIN) subcutaneous injections” NCT02654977 ↗ “r-MetHuLeptin SubQ once daily” NCT00140244 ↗ |
| Action | Restore | “leptin replacement therapy” NCT00005905 ↗ |
| Modality | Protein / enzyme biologic | “recombinant methionyl human leptin” NCT00025883 ↗ |
| Route | Subcutaneous | “The drug is injected under the skin twice a day for 4 months” NCT00005905 ↗ |