Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 3 evaluate pacritinib as a single agent and in combination regimens for conditions including myelofibrosis, myelodysplastic syndromes, chronic myelomonocytic leukemia, acute myeloid leukemia, and graft-versus-host disease. Sponsored by industry, academic, and government entities such as CTI BioPharma, Sobi Inc., Washington University School of Medicine, and the National Cancer Institute, these protocols exhibit diverse recruitment statuses ranging from recruiting and completed to withdrawn and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06052618 RECRUITING
KSHV Inflammatory Cytokine Syndrome (KICS); Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease
National Cancer Institute (NCI)
 2025-03-17 PHASE2
NCT07447817 NOT_YET_RECRUITING
Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
John Mascarenhas
 2026-05-04 PHASE2
NCT06303193 RECRUITING
Myelodysplastic Syndromes
National Cancer Institute (NCI)
 2026-09-09 PHASE1; PHASE2
NCT06218628 RECRUITING
Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis; Chronic Myelomonocytic Leukemia; Polycythemia Vera; Essential Thrombocytosis
Fox Chase Cancer Center
 2024-04-05 PHASE1
NCT07226713 NOT_YET_RECRUITING
Prostate Cancer
Medical College of Wisconsin
 2026-07-01 PHASE2
NCT07148947 RECRUITING
Accelerated Phase Myeloproliferative Neoplasm; Blast Phase Myeloproliferative Neoplasm
University of Washington
 2026-03-02 PHASE2
NCT06986174 RECRUITING
Waldenström Macroglobulinemia; Lymphoplasmacytic Lymphoma; B-Cell Lymphoproliferative Disorder; Indolent Lymphoma
Shayna Sarosiek, MD
 2025-11-21 PHASE2
NCT07679334 NOT_YET_RECRUITING
Myeloproliferative Neoplasm
Roswell Park Cancer Institute
 2026-09-01 PHASE1
NCT07033598 RECRUITING
Leukemia, Myelomonocytic, Chronic
Theradex
 2026-01-01 PHASE2
NCT06675123 RECRUITING
Recurrent Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma
City of Hope Medical Center
 2026-10-01 PHASE1
NCT07394153 RECRUITING
Myelofibrosis，MF
Grupo Español de Enfermedades Mieloproliferativas Crónicas PH Negativas
 2026-04-15 PHASE2
NCT04858256 RECRUITING
T-Cell Neoplasm; Lymphoproliferative Disorders
University of Michigan Rogel Cancer Center
 2023-03-29 PHASE2
NCT05531786 RECRUITING
Graft vs Host Disease
National Cancer Institute (NCI)
 2023-03-06 PHASE1; PHASE2
NCT06159491 RECRUITING
Chronic Myelomonocytic Leukemia
Douglas Tremblay
 2024-09-18 PHASE1; PHASE2
NCT05980806 RECRUITING
Myelofibrosis; Moderate Thrombocytopenia; Mild Thrombocytopenia
Karyopharm Therapeutics Inc
 2024-04-22 PHASE2
NCT06538181 RECRUITING
E1 Ubiqutin-activating Enzyme, X-linked, Autoinflammatory, Somatic Syndrome; VEXAS; Vexas Syndrome
Washington University School of Medicine
 2025-02-13 PHASE1
NCT07387354 WITHDRAWN
Myelodysplastic Syndromes; MDS; Myelodysplastic Syndrome, Unclassifiable; Hematologic Diseases; Bone Marrow Disease; Myeloproliferative Neoplasm
Thomas Jefferson University
 2026-09 PHASE1; PHASE2
NCT06782373 ACTIVE_NOT_RECRUITING
VEXAS; VEXAS Syndrome
Swedish Orphan Biovitrum
 2025-05-28 PHASE2
NCT06414681 RECRUITING
Myelofibrosis，MF
University of Kansas Medical Center
 2025-08-25 EARLY_PHASE1
NCT04282187 RECRUITING
Acute Myeloid Leukemia; Essential Thrombocythemia; Myelodysplastic Syndrome; Myelodysplastic/Myeloproliferative Neoplasm; Myeloproliferative Neoplasm; Myeloproliferative Neoplasm, Not Otherwise Specified; Polycythemia Vera; Primary Myelofibrosis; Secondary Myelofibrosis
University of Washington
 2020-03-24 PHASE2
NCT03165734 ACTIVE_NOT_RECRUITING
Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Swedish Orphan Biovitrum
 2017-06-26 PHASE3
NCT04520269 ACTIVE_NOT_RECRUITING
Breast Cancer
National University Hospital, Singapore
 2020-07-13 PHASE1; PHASE2
NCT06516887 TERMINATED
Advanced Lung Adenocarcinoma
The University of Texas Health Science Center at San Antonio
 2024-12-27 PHASE1; PHASE2
NCT05552183 COMPLETED
Hepatic Impairment
CTI BioPharma
 2022-12-12 PHASE1
NCT06303193 Not yet recruiting
Myelodysplastic Syndromes
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2024-05-15 Phase 1|Phase 2
NCT06052618 Not yet recruiting
KSHV Inflammatory Cytokine Syndrome (KICS)|Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2024-05-15 Phase 2
NCT06159491 Not yet recruiting
Chronic Myelomonocytic Leukemia
Douglas Tremblay|Sobi Inc.|Icahn School of Medicine at Mount Sinai
 2024-01-02 Phase 1|Phase 2
NCT04635059 TERMINATED
Prostate Cancer
Medical College of Wisconsin
 2021-06-01 PHASE2
NCT03645824 ACTIVE_NOT_RECRUITING
Myelofibrosis
Stichting Hemato-Oncologie voor Volwassenen Nederland
 2018-06-04 PHASE2
NCT05657613 COMPLETED
Drug Interactions
CTI BioPharma
 2023-01-03 PHASE1
NCT05531786 Recruiting
Graft vs Host Disease
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2023-03-06 Phase 1|Phase 2
NCT02891603 COMPLETED
Graft Vs Host Disease; GVHD
H. Lee Moffitt Cancer Center and Research Institute
 2017-06-08 PHASE1; PHASE2
NCT04404361 TERMINATED
COVID19; COVID-19; COVID
CTI BioPharma
 2020-05-22 PHASE2
NCT02564536 WITHDRAWN
Chronic Myelomonocytic Leukemia; Juvenile Myelomonocytic Leukemia; Atypical Chronic Myeloid Leukemia; Myeloproliferative Neoplasm; Myelodysplastic Syndromes; Myelofibrosis
Washington University School of Medicine
 2017-06 PHASE1
NCT03601819 TERMINATED
Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell, Peripheral; Chronic Lymphocytic Leukemia; Lymphoproliferative Disorders; Waldenstrom Macroglobulinemia; Lymphoplasmacytic Lymphoma; Mantle Cell Lymphoma
University of Michigan Rogel Cancer Center
 2019-05-15 PHASE1
NCT04884191 COMPLETED
Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post- Essential Thrombocythemia Myelofibrosis
CTI BioPharma
 2017-07-31 PHASE2
NCT02677948 WITHDRAWN
Chronic Lymphocytic Leukemia; Lymphoma, Small Lymphocytic
University of Michigan Rogel Cancer Center
 2016-10 PHASE1; PHASE2
NCT02323607 COMPLETED
Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Therapy-Related Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
Bhavana Bhatnagar
 2016-01-12 PHASE1
NCT02342353 TERMINATED
Non-Small Cell Lung Cancer; Nonsmall Cell Lung Cancer; Carcinoma, Non-Small-Cell Lung
Washington University School of Medicine
 2015-05-18 PHASE1
NCT02584777 WITHDRAWN
Primary Myelofibrosis
Baxalta now part of Shire
 2015-11-30 PHASE2
NCT02469415 TERMINATED
Leukemia
M.D. Anderson Cancer Center
 2015-09-30 PHASE2
NCT01620216 TERMINATED
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia
OHSU Knight Cancer Institute
 2012-05-11 PHASE2
NCT02410551 TERMINATED
Myeloproliferative Diseases
M.D. Anderson Cancer Center
 2015-06-15 PHASE2
NCT02055781 TERMINATED
Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
CTI BioPharma
 2014-02 PHASE3
NCT02277093 TERMINATED
Colorectal Cancer
Washington University School of Medicine
 2015-09-22 PHASE2
NCT02532010 TERMINATED
Acute Myeloid Leukemia (AML)
Weill Medical College of Cornell University
 2015-06-15 PHASE2
NCT02823171 COMPLETED
Healthy
CTI BioPharma
 2015-08 PHASE1
NCT02807077 COMPLETED
Myelofibrosis
CTI BioPharma
 2014-11 PHASE1
NCT02765724 COMPLETED
Myelofibrosis
CTI BioPharma
 2015-01 PHASE1
NCT02808455 COMPLETED
Healthy Subjects
CTI BioPharma
 2015-01 PHASE1
NCT02807116 COMPLETED
Healthy Subjects
CTI BioPharma
 2015-01 PHASE1
NCT01773187 TERMINATED
Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
CTI BioPharma
 2013-01 PHASE3
NCT02807207 COMPLETED
Healthy Subjects
CTI BioPharma
 2014-10 PHASE1
NCT02807051 COMPLETED
Drug Interaction Study
CTI BioPharma
 2014-09 PHASE1
NCT02803762 COMPLETED
Healthy
CTI BioPharma
 2014-07 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the Pacritinib (SB1518) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pacritinib selectively binds to and inhibits Janus Kinase 2 (JAK2) and Fms-Like Tyrosine Kinase-3 (FLT3), thereby suppressing downstream STAT phosphorylation and oncogenic signaling pathways. This inhibition reduces malignant cell proliferation and induces apoptosis, providing therapeutic efficacy in clinical conditions such as myelofibrosis and acute myeloid leukemia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.