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    DRUG CLASS:

    GDF15 inhibitor

    Related drugs:
    3d
    VINCIT: Visugromab in Cachexia International Trial (clinicaltrials.gov)
    P2/3, N=518, Recruiting, CatalYm GmbH
    Trial initiation date
    |
    visugromab (CTL-002)
    17d
    Potential Risks of Blocking GDF15-Based Brain Energy Sensing. (PubMed, J Am Geriatr Soc)
    GDF15 signals energetic stress to the brain, leading to unpleasant symptoms as the body conserves and reallocates energy. In conditions such as frailty and cancer, suppression of GDF15 signaling is expected to lead to an improvement in symptoms, but potentially at the cost of long-term health and survival.
    Journal
    |
    GDF15 (Growth differentiation factor 15)
    |
    ponsegromab (PF-06946860)
    18d
    GDFATHERHCC01: Visugromab, Nivolumab and a Tyrosine Kinase Inhibitor (TKI) Compared to Double Placebo and a TKI in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure (clinicaltrials.gov)
    P2, N=104, Recruiting, CatalYm GmbH | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • visugromab (CTL-002)
    1m
    CTL-002-004: A phase 2 placebo-controlled trial to investigate visugromab and nivolumab with or without docetaxel in second-line treatment of participants with metastatic non-squamous non-small cell lung cancer (NSCLC) (2024-516794-70-00)
    P1/2, N=103, Recruiting, CatalYm GmbH
    New P1/2 trial
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation
    |
    Opdivo (nivolumab) • docetaxel • visugromab (CTL-002)
    1m
    CTL-002-006: Visugromab in Cachexia International Trial (2025-523533-25-00)
    P2/3, N=354, Not yet recruiting, CatalYm GmbH
    New P2/3 trial
    |
    visugromab (CTL-002)
    1m
    CTL-002-004: A phase 2 placebo-controlled trial to investigate visugromab and nivolumab with or without docetaxel in second-line treatment of participants with metastatic non-squamous non-small cell lung cancer (NSCLC) (2024-516794-70-00)
    P1/2, N=89, Recruiting, CatalYm GmbH
    New P1/2 trial
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation
    |
    Opdivo (nivolumab) • docetaxel • visugromab (CTL-002)
    1m
    120-CX-202: A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia. (2025-521730-28-00)
    P1/2, N=54, Not yet recruiting, Ngm Biopharmaceuticals Inc.
    New P1/2 trial
    |
    NGM120
    1m
    C3651021: A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which has Spread and Caused Significant Body Weight Loss and Fatigue (2025-522093-36-00)
    P2/3, N=289, Not yet recruiting, Pfizer Inc.
    New P2/3 trial
    |
    ponsegromab (PF-06946860)
    1m
    CTL-002-005: Visugromab, nivolumab and lenvatinib compared to double placebo and lenvatinib in unresectable or metastatic hepatocellular carcinoma post anti-PD-(L)1 failure (2025-520675-86-00)
    P1/2, N=59, Not yet recruiting, CatalYm GmbH
    New P1/2 trial
    |
    Opdivo (nivolumab) • Lenvima (lenvatinib) • visugromab (CTL-002)
    1m
    CTL-002-006: Visugromab in Cachexia International Trial (2025-523533-25-00)
    P2/3, N=154, Not yet recruiting, CatalYm GmbH
    New P2/3 trial
    |
    visugromab (CTL-002)
    2ms
    Regulation of ferroptosis in colorectal cancer through therapeutic modulation and miRNA targeting. (PubMed, Biochem Biophys Rep)
    Interestingly, we also found that medications such as prasterone, tazemetostat, isoxyl, gemcitabine, ponsegromab, scx-2023, and nicotinamide could potentially be used in combination with the identified miRNAs to target ferroptosis in CRC. To further validate the stability and reliability of the predicted protein-ligand interactions, molecular dynamics (MD) simulations and MM-PBSA analyses were performed on selected top-ranking complexes, which confirmed their stable and favorable binding and supported the robustness of our docking results. These findings suggest that targeting these miRNAs and their associated genes, along with using the identified drugs, could be a promising strategy for CRC treatment, leveraging the potential of ferroptosis-inducing therapies.
    Journal • PARP Biomarker
    |
    PARP1 (Poly(ADP-Ribose) Polymerase 1) • RRM2 (Ribonucleotide Reductase Regulatory Subunit M2) • SLC7A11 (Solute Carrier Family 7 Member 11) • MIR16 (MicroRNA 16) • MIR15A (MicroRNA 15a) • MIR423 (MicroRNA 423) • MIR93 (MicroRNA 93)
    |
    gemcitabine • Tazverik (tazemetostat) • ponsegromab (PF-06946860)
    3ms
    GDFATHER-01: First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER) (clinicaltrials.gov)
    P1/2, N=263, Active, not recruiting, CatalYm GmbH | Trial completion date: Oct 2027 --> Apr 2030 | Trial primary completion date: Oct 2025 --> Apr 2028
    Trial completion date • Trial primary completion date • Checkpoint inhibition • First-in-human
    |
    visugromab (CTL-002)