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Myalept

(Metreleptin)

Phase 3Small molecule

Chiesi Farmaceutici S.p.A.

Metreleptin is used to treat a rare condition where the body doesn't produce enough leptin, a hormone that helps regulate hunger and weight. It helps patients with this condition manage their weight and metabolism.[1] Myalept is currently being investigated across 17 indications[3], with its most advanced program in Phase 3.[1]

Myalept is one of 360 small molecule programs targeting Insulin resistance. It is currently in Phase 3.

17

Indications

21

Total Trials

10

Active Trials

359

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Insulin ResistanceActive, not recruiting

Generalized LipodystrophyActive, not recruiting

Metabolic SyndromeActive, not recruiting

LipomatosisActive, not recruiting

HepatitisActive, not recruiting

Non-Alcoholic Fatty Liver DiseaseActive, not recruiting

LipodystrophyActive, not recruiting

Alcoholic Fatty Liver DiseaseActive, not recruiting

Anorexia NervosaActive, not recruiting

Partial LipodystrophyActive, not recruiting

Insulin ResistancePhase 2

Active, not recruiting

Generalized LipodystrophyPhase 3

Active, not recruiting

Metabolic SyndromePhase 2

Active, not recruiting

LipomatosisPhase 2

Active, not recruiting

HepatitisPhase 2

Active, not recruiting

Non-Alcoholic Fatty Liver DiseasePhase 2

Active, not recruiting

LipodystrophyPhase 3

Active, not recruiting

Alcoholic Fatty Liver DiseasePhase 2

Active, not recruiting

Anorexia NervosaPhase 2

Active, not recruiting

Partial LipodystrophyPhase 3

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

392 competitors in Obesity

#DrugCompanyPhaseTrials

Myalept

Chiesi Farmaceutici S.p.A.

Actemra

Amidate

Calciferol

Alnylam Pharmaceuticals

Adenocard

Activella

Colcrys

Alnylam Pharmaceuticals

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Cetrotide

Advil

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Anorexia Nervosa

NCT06305182

Phase 3Recruiting

Lipodystrophy

NCT06502990

Q4 2026

Phase 3Active, not recruiting

Safety and Efficacy

NCT05164341

Q3 2027

Phase 2Active, not recruiting

Diabetes

NCT02262806

Phase 3Active, not recruiting

Lipodystrophy

NCT02262832

Q1 2028

Post-ApprovalRecruiting

Partial Lipodystrophy

NCT06484868

Clinical

Trials by Indication[1]

Lipodystrophy4 trials

Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy

Recruiting·AAmryt Pharma·Phase 3·NCT06502990·15 enrolled

Leptin to Treat Lipodystrophy

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00025883·103 enrolled

Short-term Effects of Leptin in People With Lipodystrophy

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT01778556·25 enrolled

Show 1 more trial

Compassionate Use of Metreleptin in Previously-Treated Patients With Generalized Lipodystrophy

Active, not recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT02262832·24 enrolled

Partial Lipodystrophy3 trials

Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

Recruiting·AAmryt Pharma·Phase 3·NCT06679270·24 enrolled

Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

Recruiting·AAmryt Pharma·Phase 4·NCT06484868·12 enrolled

CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy

Completed·UUniversity of Michigan·Phase 2·NCT02654977·11 enrolled

Overweight2 trials

Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00673387·636 enrolled

A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00392925·177 enrolled

ESS1 trial

Expanded Access Metreleptin Study

Available·UUniversity of Michigan··NCT02404896

Effectiveness1 trial

MEASuRE: Metreleptin Effectiveness And Safety Registry

Recruiting·AAmryt Pharma··NCT02325674·100 enrolled

10 more indications

Alcoholic Fatty Liver Disease1 trial

Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy

Completed·UUniversity of Michigan·Phase 2·NCT01679197·23 enrolled

Anorexia Nervosa1 trial

Metreleptin in Anorexia Nervosa

Recruiting·GGabriella Milos·Phase 2·NCT06305182·50 enrolled

Insulin resistance1 trial

Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance

Active, not recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00085982·11 enrolled

Hepatitis1 trial

Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)

Completed·EElif Oral·Phase 2·NCT00596934·9 enrolled

Lipomatosis1 trial

Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL)

Active, not recruiting·UUniversity of Michigan·Phase 2·NCT05351164·4 enrolled

Generalized Lipodystrophy1 trial

Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy

Completed·AAegerion Pharmaceuticals, Inc.·Phase 4·NCT04026178·11 enrolled

Safety and Efficacy1 trial

Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL

Active, not recruiting·AAmryt Pharma·Phase 3·NCT05164341·69 enrolled

Hypertriglyceridemia1 trial

An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00677313·41 enrolled

Diabetes1 trial

Compassionate Use of Metreleptin in Previously-Treated Patients With Partial Lipodystrophy

Active, not recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT02262806·29 enrolled

Unspecified1 trial

The Effects of Metreleptin in Congenital Leptin Deficiency

Completed·NNorthwestern University··NCT04063488·2 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 24, 2014

MYALEPT

BLA BLA125390

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Metreleptin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Metreleptin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Metreleptin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125390). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Chiesi Farmaceutici S.p.A. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Leptin Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Chiesi Farmaceutici S.p.A.

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