Product Description
SyB L-1101 / SyB C-1101(Generic Name: Rigosertib) is a novel tumor specific PI-3K (phosphoinositide-3 kinase) and PLK (polo-like kinase) inhibitor targeting the Ras Binding Domain being developed by Onconova Therapeutics ("Onconova") for the treatment of hematologic malignancies and solid tumors. Late-stage clinical trials are currently being conducted in the U.S., Europe and India. In addition to the intravenous (IV) formulation in Phase III development (ONTIME) under Special Protocol Assessment (SPA) and orphan drug designation by U.S. FDA for post-hypomethylating agent (HMA) higher-risk myelodysplastic syndromes (HR-MDS), an oral formulation of rigosertib is in Phase II/III development (ONTARGET) for first-line lower-risk MDS (LR-MDS). (Sourced from: https://www.symbiopharma.com/pipeline_e/03.html)
Mechanisms of Action: PI3K Inhibitor, PLK1 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Intravenous, Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Czech
Approved Indications: None
Known Adverse Events: None
Company: Traws Pharma
Company Location: Eastern America
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Onconova presented P0 Oncology Solid Tumor Unspecified results on 2024-04-08 for Rigosertib
Highest Development Phases
Phase 2: Adenocarcinoma|Non-Small-Cell Lung Cancer
Phase 1: Epidermolysis Bullosa Dystrophica
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04177498 |
19G.527 | P1 |
Completed |
Epidermolysis Bullosa Dystrophica |
2025-05-05 |
50% |
2025-08-05 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04263090 |
GCO 19-2243 | P2 |
Completed |
Non-Small-Cell Lung Cancer|Adenocarcinoma |
2023-12-20 |
21% |
2024-05-10 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |