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Priya Life Science Compound trial record
Compound · clinical trials

Luvometinib clinical trials

Also listed in trial records as FCN-159
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 11 trials in our China register that name Luvometinib as an intervention. Synced 10 Nov 2026
11Current trials
6Recruiting now
6Lead sponsors
1Country register
At a glance

Luvometinib is named as an intervention in 11 current clinical trials in our China register. 6 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd (4). The most-studied condition is Langerhans Cell Histiocytosis (LCH).

How Luvometinib works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • Low grade gliomaPhase 3
  • Plexiform neurofibromaPhase 3
  • Langerhans cell histiocytosisPhase 2
  • NF2-related schwannomatosisPhase 2
  • Arteriovenous malformations of the brainPhase 2
  • Nerve sheath neoplasmPhase 2
  • NeurofibromaPhase 2
  • Neurofibromatosis type 1Phase 2
  • Non-small cell lung carcinomaPhase 2

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL6068059, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 13495, 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 Luvometinib

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-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.

Trials by status

  • Recruiting655%
  • Not yet open545%

Trials by phase

  • Phase 2655%
  • Not applicable218%
  • Phase 1/2218%
  • Phase 319%
01

Clinical trials of Luvometinib

11 trials
StudyPhaseStatusLead sponsorRegisters
To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH
NCT05997602 · ClinicalTrials.gov ↗ · Langerhans Cell Histiocytosis, LCH
Phase 2 Recruiting Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd China
Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
NCT06553365 · ClinicalTrials.gov ↗ · Nerve Sheath Tumor
Phase 2 Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences China
An Exploratory Study to Evaluate the Efficacy and Safety of FCN-159 in Patients With Brain Arteriovenous Malformations
NCT06913725 · ClinicalTrials.gov ↗ · Brain Arteriovenous Malformations
Phase 2 Recruiting Xuanwu Hospital, Beijing China
A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC
NCT07562581 · ClinicalTrials.gov ↗ · Non-small Cell Lung Caner, KRAS-mutated, Metastasis
Phase 2 Recruiting Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd China
Luvometinib in Pediatric SS-LCH With Special-site Single/Multifocal Bone Lesions
NCT07371182 · ClinicalTrials.gov ↗ · Langerhans Cell Histiocytosis (LCH)
Not applicable Recruiting West China Second University Hospital China
Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis
NCT07431060 · ClinicalTrials.gov ↗ · Langerhans Cell Histiocytosis (LCH)
Not applicable Recruiting West China Second University Hospital China
FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration
NCT07004075 · ClinicalTrials.gov ↗ · Low-grade Glioma, Pediatric Low-grade Gliomas, pLGG With BRAF Alteration
Phase 3 Not yet open Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd China
Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2)
NCT07713745 · ClinicalTrials.gov ↗ · Neurofibromatosis Type 2, Vestibular Schwannoma, Non-vestibular Schwannoma
Phase 2 Not yet open Beijing Tiantan Hospital China
Response-adapted Luvometinib With or Without Cytarabine in Langerhans Cell Histiocytosis
NCT07728201 · ClinicalTrials.gov ↗ · Langerhans Cell Histiocytosis
Phase 2 Not yet open Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University China
Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1
NCT07024394 · ClinicalTrials.gov ↗ · Neurofibromatosis 1, Plexiform Neurofibroma, NF1
Phase 1/2 Not yet open Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd China
Luvometinib in Combination With Serplulimab for NF2-Related Tumors
NCT07708285 · ClinicalTrials.gov ↗ · NF2-related Schwannomatosis, NF2, Neurofibromatosis Type 2
Phase 1/2 Not yet open Beijing Tiantan Hospital China

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.

02

Conditions studied with Luvometinib

21 conditions
Langerhans Cell Histiocytosis (LCH)2Neurofibromatosis Type 22Vestibular Schwannoma2Langerhans Cell Histiocytosis2Non-vestibular Schwannoma1Meningioma1Low-grade Glioma1Pediatric Low-grade Gliomas1pLGG With BRAF Alteration1NF2-related Schwannomatosis1NF21Non-small Cell Lung Caner1
All 21 conditions
Condition (as registered)Trials
Langerhans Cell Histiocytosis (LCH)2
Neurofibromatosis Type 22
Vestibular Schwannoma2
Langerhans Cell Histiocytosis2
Non-vestibular Schwannoma1
Meningioma1
Low-grade Glioma1
Pediatric Low-grade Gliomas1
pLGG With BRAF Alteration1
NF2-related Schwannomatosis1
NF21
Non-small Cell Lung Caner1
KRAS-mutated1
Metastasis1
Previous Treamted1
Neurofibromatosis 11
Plexiform Neurofibroma1
NF11
Brain Arteriovenous Malformations1
Nerve Sheath Tumor1
LCH1
05

Related compounds

06

Questions about Luvometinib trials

How many clinical trials are testing Luvometinib?

11 current trials in our China register name Luvometinib (also registered as FCN-159) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Luvometinib trials recruiting patients?

Yes. 6 of the 11 trials are recruiting: 6 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Luvometinib clinical trials?

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd (4), West China Second University Hospital (2), Beijing Tiantan Hospital (2) and Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.

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 Luvometinib works or whether it is effective, and it is not medical advice.

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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 Luvometinib works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Luvometinib (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.