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    DRUG:

    Vonjo (pacritinib)

    i
    Other names: SB 1518, ONX 0803, BAX 2201, SB1518, SB-1518, ONX-0803, BAX-2201, BAX2201, ONX0803
    Company:
    SOBI
    Drug class:
    JAK2 inhibitor, FLT3 inhibitor, ACVR1 inhibitor, IRAK-1 inhibitor
    Related drugs:
    7d
    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
    |
    prednisone • dexamethasone • Vonjo (pacritinib) • hydroxyurea
    12d
    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
    |
    JAK1 (Janus Kinase 1) • ACVR1 (Activin A Receptor Type 1) • IRAK1 (Interleukin 1 Receptor Associated Kinase 1)
    |
    Vonjo (pacritinib)
    15d
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • erlotinib • docetaxel • bemcentinib (BGB324) • Vonjo (pacritinib)
    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
    |
    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
    |
    STAT5A (Signal Transducer And Activator Of Transcription 5A)
    |
    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
    |
    Jakafi (ruxolitinib) • Vonjo (pacritinib) • hydroxyurea
    2ms
    Comparison of the enzymatic and cellular profiles of clinical JAK inhibitors for the treatment of myelofibrosis. (PubMed, Blood Neoplasia)
    In conclusion, ruxolitinib was the most potent, and selective JAKinib with no relevant effects in JAK2-independent cells. In contrast, fedratinib, pacritinib, and momelotinib inhibited many other kinases and inhibited cell growth by JAK2-unrelated mechanisms at clinically relevant concentrations.
    Journal
    |
    ACVR1 (Activin A Receptor Type 1)
    |
    Jakafi (ruxolitinib) • Vonjo (pacritinib) • Inrebic (fedratinib) • Ojjaara (momelotinib)
    2ms
    A pharmacological profile of pacritinib for the treatment of myelofibrosis. (PubMed, Expert Rev Clin Pharmacol)
    While no JAK inhibitor has demonstrated clear disease-modifying effects in MF, pacritinib's non-myelosuppressive profile, unique activity against IRAK1, and potential anemia benefit via ACVR1 inhibition suggests potential utility as a backbone for future combination strategies. Ongoing and future studies will be critical to further define its role in phenotype-driven MF management.
    Review • Journal
    |
    JAK2 (Janus kinase 2) • JAK1 (Janus Kinase 1) • ACVR1 (Activin A Receptor Type 1) • IRAK1 (Interleukin 1 Receptor Associated Kinase 1)
    |
    Vonjo (pacritinib)
    3ms
    Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms (clinicaltrials.gov)
    P1/2, N=160, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Vonjo (pacritinib)
    3ms
    A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS) (clinicaltrials.gov)
    P2, N=78, Recruiting, Swedish Orphan Biovitrum | Active, not recruiting --> Recruiting
    Enrollment open
    |
    Vonjo (pacritinib)
    4ms
    Pacritinib With Standard of Care Azacitidine or Decitabine as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant for Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms (clinicaltrials.gov)
    P2, N=27, Recruiting, University of Washington | Not yet recruiting --> Recruiting
    Enrollment open
    |
    azacitidine • Inqovi (decitabine/cedazuridine) • Vonjo (pacritinib)
    4ms
    SENTRY-2: A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia (clinicaltrials.gov)
    P2, N=58, Recruiting, Karyopharm Therapeutics Inc | N=118 --> 58 | Trial primary completion date: Apr 2026 --> Jun 2027
    Enrollment change • Trial primary completion date
    |
    Jakafi (ruxolitinib) • Xpovio (selinexor) • Vonjo (pacritinib) • Ojjaara (momelotinib)