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ON 01910.Na
ON 01910.Na is a MDM2 inhibitor Small molecule drug developed by Traws Pharma, Inc.. It is currently in Phase 3 development for Relapsed or refractory acute myeloid leukemia. Also known as: rigosertib sodium, rigosertib, ON 01910, Sodium(E)2,4,6trimethoxystyryl-4methoxy-3glycylbenzylsulfone.
ON 01910.Na is a small molecule that targets the MDM2 protein.
ON 01910.Na is a small molecule that targets the MDM2 protein. Used for Relapsed or refractory acute myeloid leukemia.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | ON 01910.Na |
|---|---|
| Also known as | rigosertib sodium, rigosertib, ON 01910, Sodium(E)2,4,6trimethoxystyryl-4methoxy-3glycylbenzylsulfone |
| Sponsor | Traws Pharma, Inc. |
| Drug class | MDM2 inhibitor |
| Target | MDM2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
MDM2 is a negative regulator of the p53 tumor suppressor protein. By inhibiting MDM2, ON 01910.Na can increase p53 levels and induce apoptosis in cancer cells.
Approved indications
- Relapsed or refractory acute myeloid leukemia
Common side effects
- Fatigue
- Nausea
- Vomiting
Key clinical trials
- Rigosertib for RDEB-SCC (PHASE1, PHASE2)
- Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC (EARLY_PHASE1)
- Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors (PHASE2)
- Rigosertib Plus Nivolumab for KRAS+ NSCLC Patients Who Progressed on First-Line Treatment (PHASE1, PHASE2)
- Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA (PHASE3)
- Phase II Part 2 Expansion of Oral Rigosertib in Combination With Azacitidine (PHASE1, PHASE2)
- Oral Rigosertib in Low Risk MDS Patients Refractory to ESAs (PHASE2)
- Single-Arm Study of the Efficacy and Safety of Oral Rigosertib in Patients With Myelofibrosis (MF) and Anemia (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ON 01910.Na CI brief — competitive landscape report
- ON 01910.Na updates RSS · CI watch RSS
- Traws Pharma, Inc. portfolio CI
Frequently asked questions about ON 01910.Na
What is ON 01910.Na?
How does ON 01910.Na work?
What is ON 01910.Na used for?
Who makes ON 01910.Na?
Is ON 01910.Na also known as anything else?
What drug class is ON 01910.Na in?
What development phase is ON 01910.Na in?
What are the side effects of ON 01910.Na?
What does ON 01910.Na target?
Related
- Drug class: All MDM2 inhibitor drugs
- Target: All drugs targeting MDM2
- Manufacturer: Traws Pharma, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory acute myeloid leukemia
- Also known as: rigosertib sodium, rigosertib, ON 01910, Sodium(E)2,4,6trimethoxystyryl-4methoxy-3glycylbenzylsulfone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing