Product Description
VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 109/L. (Sourced from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4b5ab444-0e1a-4984-99db-76ad11a298ee)
Mechanisms of Action: JAK2 Inhibitor, IRAK1 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Accelerated Approval - Myelofibrosis|Thrombocytopenia *
Approval Status: Approved
Approved Countries: United States
Approved Indications: None
Known Adverse Events: None
Company: CTI BioPharma
Company Location: SEATTLE WA 98121
Company CEO: Adam R. Craig
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Belarus, Belgium, Bosnia, Bulgaria, Canada, Czech Republic, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea, Netherlands, Poland, Romania, Russia, Serbia, Spain, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 14
Recent & Upcoming Milestones
- Summary: CTI Biopharma Corp. is working towards a new therapeutic option for cytopenic myelofibrosis patients by the February 28, 2021, PDUFA data.
- FDA extended review period for pacritinib NDA for myelofibrosis, shifting PDUFA date to February 28, 2022. Approval essential for acquisition.
- CTI Biopharma awaits FDA decision on Pacritinib for myelofibrosis, with a PDUFA target action date of November 30, 2021.
Highest Development Phases
Phase 3: Myelofibrosis|Polycythemia Vera|Thrombocythemia, Essential|Thrombocytosis
Phase 2: Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Allogeneic Stem Cell Transplant|B-Cell Marginal Zone Lymphoma|Bone Cancer|Bone Marrow Transplantation|Chronic Myelomonocytic Leukemia|Hematopoietic Stem Cell Transplant|Juvenile Myelomonocytic Leukemia,|Myelodysplastic Syndrome|Waldenstrom Macroglobulinemia
Phase 1: Healthy Volunteers|Hepatic Insufficiency|Thrombocytopenia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| PAC110 | P1 |
Completed |
Hepatic Insufficiency |
2024-06-10 |
50% |
2024-10-22 |
Primary Endpoints |
| RG1125470 | P2 |
Not yet recruiting |
Allogeneic Stem Cell Transplant|Hematopoietic Stem Cell Transplant|Bone Cancer|Bone Marrow Transplantation |
2028-12-31 |
12% |
2025-08-30 |
Primary Endpoints|Treatments |
| NCT06986174 | P2 |
Recruiting |
Waldenstrom Macroglobulinemia|B-Cell Marginal Zone Lymphoma |
2028-10-01 |
12% |
2025-09-04 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| PAXIS | P2 |
Recruiting |
Myelodysplastic Syndrome |
2027-08-01 |
12% |
2025-05-14 |
|
| PACIFICA | P3 |
Recruiting |
Myelofibrosis|Thrombocythemia, Essential|Polycythemia Vera|Thrombocytosis |
2026-12-31 |
39% |
2025-01-30 |
|
| GCO 23-1514 | P2 |
Recruiting |
Juvenile Myelomonocytic Leukemia,|Chronic Myelomonocytic Leukemia|Acute Myelomonocytic Leukemia|Acute Monocytic Leukemia |
2027-07-01 |
12% |
2025-08-22 |
|
| NCT06538181 | P1 |
Recruiting |
Myelofibrosis|Thrombocytopenia |
2027-03-31 |
50% |
2025-07-17 |
Primary Endpoints|Treatments |
| PAC303 | P3 |
Recruiting |
Myelofibrosis |
2027-06-30 |
2025-05-02 |
Treatments |
|
| PAC109 | P1 |
Completed |
Healthy Volunteers |
2023-06-08 |
69% |
2024-07-23 |
Primary Endpoints |
| PROSPERA | P2 |
Not yet recruiting |
Chronic Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia, |
2028-07-01 |
12% |
2025-06-25 |
|
| PAC601 | P2 |
Not yet recruiting |
Unknown |
2027-08-26 |
12% |
2025-05-02 |
Treatments |
| jRCT2031250172 | P2 |
Recruiting |
Unknown |
2027-06-30 |
|||
| HOVON134MF | P2 |
Active, not recruiting |
Myelofibrosis |
2023-07-01 |
36% |
2022-08-23 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| jRCT2031240668 | P3 |
Recruiting |
Myelofibrosis |
2027-07-31 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/07/2025 |
News Article |
Shinobi Therapeutics Announces the Appointment of Dr. Laurent Fischer as Chair of its Board of Directors |
|
10/20/2025 |
News Article |
DRI Healthcare Trust Announces Acquisition of a Synthetic Royalty Interest in the U.S. Sales of Veligrotug and VRDN-003 for the Treatment of Thyroid Eye Disease (TED) |
|
10/16/2025 |
News Article |
DRI Healthcare to Host Third Quarter 2025 Earnings Call and Webcast on November 6, 2025 |
|
09/19/2025 |
News Article |
DRI Healthcare Trust Promotes Zaheed Mawani to Chief Financial Officer |