Metreleptin clinical trials
Metreleptin is named as an intervention in 5 current clinical trials in our USA, UK, Germany, France, Italy, Spain, Netherlands, Belgium, Poland, Canada, Brazil, Israel and Switzerland registers. 4 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Chiesi Farmaceutici S.p.A (3). The most-studied condition is Partial Lipodystrophy.
Where Metreleptin is approved
All regulators →Of the three regulators tracked here, the first to approve Metreleptin was the US, on 24 Feb 2014. It is approved in 3 of the 3 regulators tracked here.
- 4 EU orphan designations, most recently for treatment of Berardinelli-Seip syndrome (17 Jul 2012, positive)
- 2 EU safety letters (DHPC), latest: medicine shortage for Myalepta, 3 Mar 2023
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Metreleptin patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Metreleptin, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Myalepta for treatment of Familial Partial Lipodystrophy: until 1 Aug 2028. Union Register
- Myalepta for treatment of Barraquer-Simons syndrome: until 1 Aug 2028. Union Register
- Myalepta for treatment of Lawrence syndrome: until 1 Aug 2028. Union Register
- Myalepta for treatment of Berardinelli-Seip syndrome: until 1 Aug 2028. Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Metreleptin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Metreleptin works
All drug targets →- Leptin receptor agonist AgonistTarget: LEPR leptin receptorChEMBL only
- Diabetes mellitusPhase 3
- Generalized lipodystrophyPhase 3
- HypertriglyceridemiaPhase 3
- Metabolic dysfunction-associated steatohepatitisPhase 3
- Obesity disorderPhase 3
- Partial lipodystrophyPhase 3
- Polycystic ovary syndromePhase 3
- Insulin resistancePhase 2
- OverweightPhase 2
- Anorexia nervosaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2107857, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7333, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Metreleptin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: MyaleptaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Metreleptin
- ATC code
- A16AA07
- ChEMBL
- CHEMBL2107857
- DrugBank
- DB09046
- CAS number
- 186018-45-1
- FDA UNII
- TL60C27RLH
- Wikidata
- Q17143468
- Wikipedia
- Metreleptin
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Metreleptin
5 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
NCT06484868 · Partial Lipodystrophy
|
Phase 4 | Recruiting | Amryt Pharma | UK, Germany, France, Italy |
|
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
NCT06679270 · Familial Partial Lipodystrophy
|
Phase 3 | Recruiting | Chiesi Farmaceutici S.p.A | USA |
|
Metreleptin in Anorexia Nervosa
NCT06305182 · ClinicalTrials.gov ↗ · Anorexia Nervosa
|
Phase 2 | Recruiting | Gabriella Milos | Switzerland |
|
MEASuRE: Metreleptin Effectiveness And Safety Registry
NCT02325674 · Generalised Lipodystrophy, Partial Lipodystrophy
|
Observational | Recruiting | Chiesi Farmaceutici S.p.A | UK, USA, Germany, France, Italy |
|
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
NCT05164341 · Partial Lipodystrophy
|
Phase 3 | Active, closed | Chiesi Farmaceutici S.p.A | USA, Spain, Netherlands, Belgium, Poland, Canada, Brazil, Israel |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Metreleptin across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Metreleptin on the HPRA medicines list.
- Myalepta 11.3 mg powder for solution for injectionChiesi Farmaceutici S.p.A. · EU/1/18/1276/001-002
Supply shortages
No entry for Metreleptin in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Metreleptin
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Chiesi Farmaceutici S.p.A | 3 |
| Amryt Pharma | 1 |
| Gabriella Milos | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Questions about Metreleptin trials
How many clinical trials are testing Metreleptin?
5 current trials in our USA, UK, Germany, France, Italy, Spain, Netherlands, Belgium, Poland, Canada, Brazil, Israel and Switzerland registers name Metreleptin as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Metreleptin trials recruiting patients?
Yes. 4 of the 5 trials are recruiting: 2 with sites in USA, 2 with sites in UK, 2 with sites in Germany, 2 with sites in France, 2 with sites in Italy and 1 with sites in Switzerland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Metreleptin clinical trials?
Chiesi Farmaceutici S.p.A (3), Amryt Pharma (1) and Gabriella Milos (1). The number in brackets is how many trials each organisation leads.
Is Metreleptin licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Metreleptin, for example Myalepta 11.3 mg powder for solution for injection (Chiesi Farmaceutici S.p.A.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Metreleptin shortage?
Not in the lists we track: Metreleptin has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Metreleptin works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Metreleptin works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Metreleptin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.