Metreleptin 3mg powder for solution for injection vials
Requires a prescription from a doctor or prescriber
Metreleptin, a recombinant analog of the human hormone leptin, is an orphan drug used to treat complications of leptin deficiency in people with lipodystrophy.
Safety information for pregnancy and breastfeeding
Pregnancy
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
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Suspected adverse reactions reported for Metreleptin
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Myalepta 3mg powder for solution for injection vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
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NICE clinical guidance(1)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Codes for healthcare professionals and prescribing systems
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NHS UK identifiers
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 7 · Randomised trials: 2 · 2009–2026
Showing the 50 most relevant studies, sorted by most relevant.
Johannes Hebebrand, J. Antel, Triinu Peters
European Child & Adolescent Psychiatry, 2023
- Anorexia Nervosa
- Off-Label Use
- Leptin
Off-label metreleptin treatment resulted in cognitive, emotional and behavioral improvements of patients with anorexia nervosa, who presented with hypoleptinemia. We now report a case study of a 16-year-old female patient with atypical anorexia nervosa who was treated off-label with metreleptin for 11 days. She had lost 21 kg over 6 months. Her body mass index at referral for inpatient treatment was 20 kg/m^2, her serum leptin level was just within the normal range (2.4 ng/ml). Dosing resulted in prominent improvements of mood and weight phobia entailing a comparatively brief inpatient treatment. The observed improvements are similar to those observed in patients with AN, suggesting overlapping mechanisms with respect to clinical effects induced by elevations of absolute or relative hypoleptinemia. Randomized controlled trials are warranted for both eating disorders.
Abstract licence: CC BY 4.0
J. Antel, Gertraud Gradl-Dietsch, Triinu Peters, et al.
European Child & Adolescent Psychiatry, 2025
- Leptin
- Self-Injurious Behavior
- Obsessive-Compulsive Disorder
Off-label treatment of a 17-year-old female patient with anorexia nervosa (AN), major depressive disorder (MDD), obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and non-suicidal self-injury (NSSI) with human recombinant leptin (metreleptin) for two dosing periods of 15 and seven days was associated with self- and clinician-rated improvements of eating disorder related psychopathology, OCD, depression, and NSSI. These intermittent improvements occurred despite the patient having high endogenous serum leptin levels ranging up to the 99th centile adjusted for sex, Tanner stage and body mass index (BMI; kg/m²) upon initiation of dosing. The results further extend the hypothesized effects of metreleptin on AN and comorbid psychopathology to patients with adjusted leptin levels in the normal to high range. We hypothesize that for unknown reasons the clinical symptomatology of a subgroup of patients with AN persists despite attainment of endogenous leptin levels well above those characteristic of the state of starvation, potentially entailing a prolonged entrapment in the eating disorder. An insight into the mechanisms underlying this distinct type of leptin resistance may help to promote recovery of such affected patients. Placebo controlled randomized clinical trials are required to assess if and to what extent short and medium term metreleptin treatment indeed improves recovery.
Abstract licence: CC BY
E. Ravussin, Steven R. Smith, J. Mitchell, et al.
Obesity (Silver Spring, Md.), 2009
Cristina Meehan, E. Cochran, Andrea Kassai, et al.
Expert Review of Clinical Pharmacology, 2016
E. Sienkiewicz, F. Magkos, K. Aronis, et al.
Metabolism: clinical and experimental, 2011
Keng-Yu Chou, C. Perry
Drugs, 2013
T. Diker-Cohen, E. Cochran, P. Gorden, et al.
The Journal of clinical endocrinology and metabolism, 2015
H. Moon, G. Matarese, A. Brennan, et al.
Diabetes, 2011
J. Chan, K. Lutz, E. Cochran, et al.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, 2011
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
3.8 to 4.7 hours
Mechanism
Metreleptin is an analog of an endogenous hormone, leptin, which is secreted by…
Food interactions
2 warnings
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
4.0 to 4.3 hours
Half-life
3.8 to 4.7 hours
[L41315]
Volume of distribution
184 mL
Metabolism
Elimination
[L41315]…
Clearance
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
In February 2014, metreleptin was approved by the FDA for the treatment of complications of leptin deficiency, as an adjunct to diet, in patients with congenital generalized or acquired generalized lipodystrophy.[L41315] Metreleptin was approved by Health Canada in January 2024 for the same patient population, in addition to patients with partial lipodystrophy.[L49901]
[L41315][L49901]
In Canada, it is additionally approved for use in patients ≥12 years old with confirmed familial partial lipodystrophy or acquired partial lipodystrophy (Barraquer-Simons syndrome) and persistent significant metabolic disease for whom standard treatments have failed to achieve adequate metabolic control.
[L49901]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 830 interactions
[L41315]
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with metreleptin which can lead to inhibition of endogenous leptin action and loss of drug efficacy.
[L41315]
As part of a Risk Evaluation and Mitigation Strategy (REMS), the FDA has required healthcare providers to be trained in the use of metreleptin before prescribing it and to attest that patients for whom they prescribe metreleptin have a labeled indication for the drug.
[L41315]
Metreleptin is classified as category C (no adequate studies in women) for use during pregnancy.
Two-year carcinogenicity studies in rodents have not been conducted with metreleptin. No proliferative or preneoplastic lesions were observed in mice or dogs following treatment up to six months.
However, leptin is reported in the literature to promote cell proliferation in vitro and tumor progression in some mouse models of cancer. Metreleptin was not mutagenic in the Ames bacterial mutagenicity assay or clastogenic in an in vitro chromosomal aberration assay in Chinese hamster ovary cells and human peripheral blood lymphocytes. Metreleptin was not mutagenic or clastogenic in an in vivo mouse micronucleus assay.
In a fertility study in mice, metreleptin had no adverse effects on mating, fertility, or early embryonic development at doses ranging between 7 and 15 times the maximum recommended clinical dose based on body surface area of a 20- and 60-kg patient, respectively.
[L41315]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L41315]
[L41315]
[L41315]
[L41315]
[L41315]
Proteins and enzymes this drug interacts with in the body
PMID:22405007
On ligand binding, mediates LEP central and peripheral effects through the activation of different signaling pathways such as JAK2/STAT3 and MAPK cascade/FOS. In the hypothalamus, LEP acts as an appetite-regulating factor that induces a decrease in food intake and an increase in energy consumption by inducing anorexinogenic factors and suppressing orexigenic neuropeptides, also regulates bone mass and secretion of hypothalamo-pituitary-adrenal hormones (By similarity) .
PMID:9537324
In the periphery, increases basal metabolism, influences reproductive function, regulates pancreatic beta-cell function and insulin secretion, is pro-angiogenic and affects innate and adaptive immunity .
PMID:12504075 PMID:25060689 PMID:8805376
Control of energy homeostasis and melanocortin production (stimulation of POMC and full repression of AgRP transcription) is mediated by STAT3 signaling, whereas distinct signals regulate NPY and the control of fertility, growth and glucose homeostasis. Involved in the regulation of counter-regulatory response to hypoglycemia by inhibiting neurons of the parabrachial nucleus.
Has a specific effect on T lymphocyte responses, differentially regulating the proliferation of naive and memory T -ells. Leptin increases Th1 and suppresses Th2 cytokine production (By similarity)
ATC A16AA07
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Metreleptin
Additional database identifiers
DrugBank citations
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q17143468), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication. WHO INN from the World Health Organization.