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    DRUG CLASS:

    MEK2 inhibitor

    Related drugs:
    11d
    Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis (clinicaltrials.gov)
    P=N/A, N=120, Recruiting, West China Second University Hospital
    New trial
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    CD20 positive
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    vincristine • prednisone • Fu Mai Ning (luvometinib) • mercaptopurine
    22d
    Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas (clinicaltrials.gov)
    P3, N=177, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P3 trial
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    NF1 (Neurofibromin 1)
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    TQ-B3234
    29d
    A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation (clinicaltrials.gov)
    P2, N=18, Terminated, Recursion Pharmaceuticals Inc. | N=60 --> 18 | Trial completion date: Jan 2027 --> Feb 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2027 --> Feb 2025; Study was terminated due to sponsor decision. This decision was not related to safety concerns.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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    APC (APC Regulator Of WNT Signaling Pathway) • RAS (Rat Sarcoma Virus) • AXIN1 (Axin 1)
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    REC-4881
    1m
    Application Demonstration Program of Luvometinib for Pediatric and Adolescent Patients Aged 2 Years and Older with Symptomatic, Unresectable Plexiform Neurofibromas (PN) Associated with Neurofibromatosis Type 1 (NF1)(Demonstration project for the application of luvometinib in the treatment of neurofibromatosis type 1(rare disease)) (ChiCTR2500115360)
    P4, N=100, Not yet recruiting, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Ninth People's Hospital, Shanghai Jiao Tong University Sc
    New P4 trial
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    NF1 (Neurofibromin 1)
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    Fu Mai Ning (luvometinib)
    1m
    Luvometinib in Pediatric SS-LCH With Special-site Single/Multifocal Bone Lesions (clinicaltrials.gov)
    P=N/A, N=62, Recruiting, West China Second University Hospital
    New trial
    |
    Fu Mai Ning (luvometinib)
    4ms
    A single center, single arm, prospective clinical study initiated by a researcher on the efficacy and safety of FCN-159 table (ChiCTR2500109679)
    P=N/A, N=20, Completed, Beijing Childrens Hospital,Capital Medical University; Beijing Childrens Hospital,Capital Medical University
    New trial
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    Fu Mai Ning (luvometinib)
    4ms
    Phase 1 Study of Luvometinib Use in Pediatric Patients with Neurofibromatosis Type 1-Related Unresectable Plexiform Neurofibromas. (PubMed, Target Oncol)
    Luvometinib had a manageable safety profile in pediatric patients with unresectable NF1-related PN. Encouraging preliminary efficacy was observed, particularly among patients receiving the RP2D of 5 mg/m2, supporting further investigation of luvometinib in this setting.
    P1 data • Journal
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    NF1 (Neurofibromin 1)
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    Fu Mai Ning (luvometinib)
    6ms
    IMM1104-101: A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=209, Active, not recruiting, Immuneering Corporation | Recruiting --> Active, not recruiting | N=320 --> 209
    Enrollment closed • Enrollment change
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    KRAS (KRAS proto-oncogene GTPase) • HRAS (Harvey rat sarcoma viral oncogene homolog) • APC (APC Regulator Of WNT Signaling Pathway)
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    KRAS mutation • NRAS mutation • KRAS wild-type • RAS mutation • HRAS mutation
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    Keytruda (pembrolizumab) • Tafinlar (dabrafenib) • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • atebimetinib (IMM-1-104)
    7ms
    E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma (clinicaltrials.gov)
    P1, N=13, Terminated, Mayo Clinic | N=25 --> 13 | Trial completion date: Dec 2026 --> Jun 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Nov 2024; Financial issues
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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    BRAF mutation • BRAF V600
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    Tafinlar (dabrafenib) • E6201
    7ms
    Luvometinib: First Approval. (PubMed, Drugs)
    In May 2025, luvometinib was approved in china for the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms and for the treatment of paediatric patients aged ≥ 2 years with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. This article summarizes the milestones in the development of luvometinib leading to this first approval for the treatment of adult patients with LCH/histiocytic tumours and children and adolescents aged ≥ 2 years with NF1 with symptomatic, inoperable PN.
    Journal
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    NF1 (Neurofibromin 1)
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    Ivesa (firmonertinib) • Fu Mai Ning (luvometinib)
    7ms
    Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors (clinicaltrials.gov)
    P2, N=30, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Fu Mai Ning (luvometinib)
    9ms
    Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov)
    P1/2, N=65, Not yet recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
    New P1/2 trial
    |
    Ivesa (firmonertinib) • Fu Mai Ning (luvometinib)