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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:
    6d
    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)
    8d
    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)
    12d
    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
    22d
    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)
    1m
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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)
    3ms
    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)
    3ms
    MDS: Pacritinib With Aza for Upfront Myelodysplastic Syndrome (clinicaltrials.gov)
    P1/2, N=25, Not yet recruiting, Thomas Jefferson University
    New P1/2 trial
    |
    azacitidine • Vonjo (pacritinib)
    5ms
    A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS) (clinicaltrials.gov)
    P2, N=78, Active, not recruiting, Swedish Orphan Biovitrum | Trial completion date: Aug 2027 --> May 2028 | Trial primary completion date: Aug 2027 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Vonjo (pacritinib)
    5ms
    Current treatments, practical management, and emerging investigational therapies for myelofibrosis. (PubMed, Expert Rev Hematol)
    Equally, there is a major focus on next generation JAK inhibitors and mutant calreticulin antibodies. There is also increasing conversation around the need for novel endpoints, as the limitations of symptom assessment, in particular, become apparent and candidate biomarkers of disease modification emerge.
    Review • Journal
    |
    CALR (Calreticulin)
    |
    CALR mutation
    |
    Jakafi (ruxolitinib) • Vonjo (pacritinib) • Inrebic (fedratinib) • Ojjaara (momelotinib)