Drugs / Metreleptin
Metreleptin
Regulatory milestones approvals, filings & regulatory actions · 3 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 ↗ |
| Filed | US (FDA) | — | metabolic disorders associated with lipodystrophy | 2013-06-04 | “FDA has accepted and granted a Priority Review designation for the Biologics License Application (BLA) for metreleptin” bms.com ↗ |
Trials 23
| 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 215 trials · 5 met primary · 1 missed | ||||||
| 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 | Met primary |
| 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 | Missed primary |
| Phase 2 | NCT00819234 | Nov 2008 → Oct 2009 | obesity disorder | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT00673387 | Apr 2008 → Apr 2009 | obesity disorder | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT00392925 | Oct 2006 → Sep 2007 | obesity disorder | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT00596934 | Feb 2006 → Mar 2009 | NAFLD1 | Elif Oral | Completed | Met primary |
| 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 | Mixed |
| 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 overdue | 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 · 1 missed | ||||||
| — | 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 | Missed primary |
| Comparator or background therapy5 trials | ||||||
| Phase 1/2 | NCT00140231 Comparator | Oct 2002 → Mar 2011 | — | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00140244 Comparator | Dec 2001 → Jun 2011 | lipodystrophy | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT05164341 Comparator | Dec 2021 → Jul 2026 overdue | partial lipodystrophy | Chiesi Farmaceutici S.p.A. | Active not recruiting | No outcome recorded |
| — | NCT00691158 Comparator | Jan 2006 → Jul 2024 | obesity disorder | Oregon Health and Science University | Unknown | No outcome recorded |
| — | NCT02404896 Background | — | familial partial lipodystrophy | University of Michigan | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2014-02-25 | AstraZeneca | Regulatory US FDA approves orphan drug MYALEPT™ (metreleptin for injection) astrazeneca.com ↗
MYALEPT, a recombinant analogue (laboratory-created form) of human leptin, is the first and only treatment approved by the FDA for these patients. |
| 2013-12-12 | AstraZeneca | Regulatory FDA Advisory Committee votes on investigational medicine metreleptin astrazeneca.com ↗
Specifically, EMDAC determined by a vote of 11 to 1 that there is substantial evidence that the benefits of metreleptin exceed the risks for the treatment of paediatric and adult patients with generalised lipodystrophy. |
| 2013-12-11 | Bristol-Myers Squibb | Regulatory FDA Advisory Committee Votes on Investigational Medicine Metreleptin bms.com ↗
Specifically, EMDAC determined by a vote of 11 to 1 that there is substantial evidence that the benefits of metreleptin exceed the risks for the treatment of pediatric and adult patients with generalized lipodystrophy. |
| 2013-07-25 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Reports Second Quarter 2013 Financial Results bms.com ↗ |
| 2013-06-04 | Bristol-Myers Squibb | Regulatory U.S. FDA Grants Priority Review to Bristol-Myers Squibb and AstraZeneca’s Metreleptin, an Investigational Agent for Treatment of Metabolic Disorders Associated with Rare Forms of Lipodystrophy bms.com ↗
The FDA’s granting of Priority Review for the metreleptin BLA highlights the significant unmet medical need for patients affected by lipodystrophy and brings us an important step closer to potentially bringing a treatment option to these patients, |
| 2013-05-06 | Bristol-Myers Squibb | Results Sub-Group Analysis Shows Investigational Metreleptin Treatment Demonstrated Reductions in HbA1c, Triglycerides and Liver Function Tests in Pediatric Patients with Lipodystrophy During a 12-Month Period bms.com ↗ |
All press releases naming this drug 7 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 32 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 | r-MetHuLeptin | “Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake” NCT05164341 ↗8“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 ↗ “r-MetHuLeptin SubQ once daily” NCT00140244 ↗ |
| 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 20104“Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake” NCT06679270 ↗ “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 ↗ |
| 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 ↗ |