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    DRUG CLASS:

    ACVR1 inhibitor

    Related drugs:
    19h
    A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=20, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
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    FLT3 (Fms-related tyrosine kinase 3)
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    FLT3-ITD mutation • FLT3 mutation
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    Xospata (gilteritinib) • Ojjaara (momelotinib)
    8d
    PAC303: PACIFICA: A Phase 3 Study of Pacritinib in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis (2024-515953-52-00)
    P2/3, N=207, Active, not recruiting, Sobi Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
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    prednisone • dexamethasone • Vonjo (pacritinib) • hydroxyurea
    13d
    Pacritinib Impact on QT Interval: Results of a Thorough QT Study and Post Hoc Analysis of Prospective Clinical Trial Data. (PubMed, Clin Pharmacol Drug Dev)
    In the TQT study, 42 subjects received single doses of pacritinib 400 mg, moxifloxacin 400 mg (positive control), and placebo in a crossover design. Median QTcF changes from pre-dose to 4 h post-dose were minimal (+2.7 and -0.3 ms, respectively), and no dose-response relationship was identified. These findings suggest that pacritinib exposure is unlikely to be correlated with QT prolongation.
    Clinical • Retrospective data • Journal
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    JAK1 (Janus Kinase 1) • ACVR1 (Activin A Receptor Type 1) • IRAK1 (Interleukin 1 Receptor Associated Kinase 1)
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    Vonjo (pacritinib)
    16d
    Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=4, Terminated, The University of Texas Health Science Center at San Antonio | N=44 --> 4 | Trial completion date: Sep 2027 --> May 2026 | Recruiting --> Terminated | Trial primary completion date: Sep 2027 --> May 2026; Investigational drug limitations
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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    PD-L1 (Programmed death ligand 1)
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    Keytruda (pembrolizumab) • erlotinib • docetaxel • bemcentinib (BGB324) • Vonjo (pacritinib)
    17d
    Interferon-primed immune landscapes predict immune-related adverse events during immune checkpoint inhibitor therapy. (PubMed, Front Cell Dev Biol)
    Perturbation-based screening identified multiple compounds capable of reversing these interferon-amplified signatures, and in vitro experiments demonstrated that alpinetin and momelotinib suppress interferon-γ signaling through distinct STAT1-and JAK-STAT-dependent mechanisms. irAEs may arise from the convergence of pre-existing myeloid inflammation and interferon-driven lymphocyte activation before therapy. Our study provides a predictive framework for identifying high-risk patients and highlights mechanistically grounded compounds for potential irAE mitigation.
    Journal • Adverse events • Checkpoint inhibition • IO biomarker
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    IFNG (Interferon, gamma) • STAT1 (Signal Transducer And Activator Of Transcription 1)
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    Ojjaara (momelotinib)
    29d
    Clinical benefit and predictors of response to momelotinib after ruxolitinib failure: A cooperative real-world study. (PubMed, Cancer)
    Momelotinib demonstrated meaningful clinical benefit and acceptable safety in cytopenic patients pretreated with ruxolitinib, which supports its role after ruxolitinib failure.
    Retrospective data • Journal • Real-world evidence
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    JAK2 (Janus kinase 2) • JAK1 (Janus Kinase 1) • ACVR1 (Activin A Receptor Type 1)
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    Jakafi (ruxolitinib) • Ojjaara (momelotinib)
    1m
    ATLAS: A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) Syndrome (clinicaltrials.gov)
    P2/3, N=192, Not yet recruiting, GlaxoSmithKline
    New P2/3 trial
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    Ojjaara (momelotinib)
    1m
    Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined (clinicaltrials.gov)
    P1, N=20, Recruiting, University of Kansas Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
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    Elzonris (tagraxofusp-erzs) • Vonjo (pacritinib)
    1m
    POSTPONE: Pacritinib in Participants With Metastatic Castrate-Resistant Prostate Cancer That Progressed on or After Prior Treatment With Androgen Receptor Signaling Inhibitors (clinicaltrials.gov)
    P2, N=32, Not yet recruiting, Medical College of Wisconsin | Initiation date: Mar 2026 --> Jul 2026
    Trial initiation date
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    STAT5A (Signal Transducer And Activator Of Transcription 5A)
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    Vonjo (pacritinib)
    1m
    PACIFICA: A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis (clinicaltrials.gov)
    P3, N=407, Active, not recruiting, Swedish Orphan Biovitrum | Recruiting --> Active, not recruiting | Trial completion date: Jul 2027 --> Oct 2028
    Enrollment closed • Trial completion date
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    Jakafi (ruxolitinib) • Vonjo (pacritinib) • hydroxyurea
    1m
    A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P2, N=80, Recruiting, GlaxoSmithKline | N=56 --> 80
    Enrollment change
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    Ojjaara (momelotinib)
    2ms
    FALKON: A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP). (clinicaltrials.gov)
    P2, N=113, Terminated, Clementia Pharmaceuticals Inc. | Trial completion date: Mar 2029 --> Mar 2026 | Completed --> Terminated | Trial primary completion date: Mar 2029 --> Mar 2026; Following the planned FALKON Part A primary analysis, the study did not meet its primary endpoint of reducing heterotopic ossification (HO) volume compared with placebo and met predefined futility criteria.
    Trial completion date • Trial termination • Trial primary completion date
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    ACVR1 (Activin A Receptor Type 1)