Generalized Lipodystrophy

• CLINICAL_TRIALS trial_result · 2026-07-29
  Clinical Trial Update: A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD) [Phase 3]

  Phase 3 trial assessing safety of Mibavademab in adults and children with Generalized Lipodystrophy switching from Metreleptin; study comple…

• CLINICAL_TRIALS trial_result · 2026-04-13
  Clinical Trial Update: Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy [Phase 3]

  Phase 3 trial evaluating efficacy and safety of Mibavademab for generalized lipodystrophy, currently recruiting in adult and pediatric patie…

• CLINICAL_TRIALS trial_result · 2026-04-07
  Clinical Trial Update: A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD) [Phase 3]

  Phase 3 study assessing the safety of switching from metreleptin to mibavademab in adults and children with Generalized lipodystrophy; the t…

• CLINICAL_TRIALS research · 2026-03-24
  Clinical Trial Update: Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy [Phase 3]

  Compassionate-use update for metreleptin in people with generalized lipodystrophy in a Phase 3 program that remains active but not recruitin…

• CLINICAL_TRIALS research · 2026-03-12
  Clinical Trial Update: Expanded Access to REGN4461 for Patients With Diseases Associated With Deficient Leptin Signaling

  Regeneron announced expanded access to REGN4461 for patients with diseases tied to deficient leptin signaling, including lipodystrophy and m…

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• CLINICAL_TRIALS research · 2026-01-20
  Clinical Trial Update: Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy [Phase 3]

  Open-label Phase 3 trial evaluating metreleptin in children under 6 with generalized lipodystrophy; the study is currently recruiting.

• CLINICAL_TRIALS research · 2026-01-20
  Clinical Trial Update: MEASuRE: Metreleptin Effectiveness And Safety Registry

  MEASuRE is a registry studying the effectiveness and safety of metreleptin for generalized lipodystrophy and partial lipodystrophy. The stud…

• CLINICAL_TRIALS trial_result · 2025-11-26
  Clinical Trial Update: Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy [Phase 4]

  Phase 4 trial assessing the immunogenicity of metreleptin in patients with generalized lipodystrophy; results have been posted.

• FDA approval · 2025-09-17
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc.

• CLINICAL_TRIALS trial_result · 2025-02-25
  Clinical Trial Update: Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy [Phase 2]

  Phase 2 study of REGN4461, a leptin receptor agonist antibody, in patients with Generalized Lipodystrophy has completed and results have bee…

• FDA approval · 2023-03-31
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc.

• FDA approval · 2022-02-28
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc. The action updates the product's labeling/ap…

• FDA approval · 2021-06-09
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc., signaling regulatory approval of an updated…

• FDA approval · 2020-07-13
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  The FDA granted approval of a supplemental application for MYALEPT (metreleptin) filed by Chiesi USA, Inc.

• FDA approval · 2020-05-15
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc.

• CLINICAL_TRIALS trial_result · 2019-03-05
  Clinical Trial Update: Trial of Leptin Replacement Therapy in Patients With Lipodystrophy [Phase 2, Phase 3]

  Phase 2/3 trial evaluating leptin replacement therapy in lipodystrophy patients has completed with results posted.

• FDA approval · 2018-12-21
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for MYALEPT (metreleptin) from Chiesi USA, Inc.

• FDA approval · 2015-09-22
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc. This action authorizes changes proposed …

• FDA approval · 2015-08-27
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc.

• FDA approval · 2014-06-30
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  FDA approves a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc.