Drugs / rigosertib
last change Dec 2025 re-read 2 minutes ago

rigosertib

Small molecule

Developed for
myelodysplastic syndrome · cancer · acute myeloid leukemia · chronic myelomonocytic leukemia · myelodysplastic syndrome with excess blasts · chronic myeloid leukemia · head and neck squamous cell carcinoma · acute lymphoblastic leukemia
+23 more · adenocarcinoma · anal squamous cell carcinoma · cervical squamous cell carcinoma · chromosome 8, trisomy · chronic lymphocytic leukemia/small lymphocytic lymphoma · cutaneous melanoma · epidermolysis bullosa dystrophica · esophageal squamous cell carcinoma · hairy cell leukemia · hepatocellular carcinoma · mantle cell lymphoma · metastatic melanoma · myelofibrosis · non-small cell lung carcinoma · non-small cell squamous lung carcinoma · ovarian cancer · pancreatic adenocarcinoma · plasma cell myeloma · recessive dystrophic epidermolysis bullosa · skin squamous cell carcinoma · squamous cell carcinoma · squamous cell carcinoma of penis · Waldenstrom macroglobulinemia
Investigated by
Traws Pharma, Inc. · SymBio Pharmaceuticals · National Heart, Lung, and Blood Institute (NHLBI) · Academic GI Cancer Consortium (AGICC) · Bristol-Myers Squibb · Icahn School of Medicine at Mount Sinai
+5 more · M.D. Anderson Cancer Center · Prof. Johann Bauer · The Leukemia and Lymphoma Society · Thomas Jefferson University · Vanderbilt-Ingram Cancer Center

Trials 38 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04177498 Aug 2021 → May 2025 recessive dystrophic epidermolysis bullosa Thomas Jefferson University Completed No outcome recorded
Phase 120 trials
Phase 1 NCT03495167 Oct 2017 → May 2019 myelodysplastic syndrome SymBio Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02783547 Dec 2015 → Jun 2017 myelodysplastic syndrome SymBio Pharmaceuticals Withdrawn No outcome recorded
Phase 1 NCT02000154 Dec 2014 → May 2015 myelodysplastic syndrome SymBio Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02075034 May 2014 → Aug 2019 myelodysplastic syndrome Traws Pharma, Inc. Withdrawn No outcome recorded
Phase 1 NCT02030639 Jan → Dec 2014 Traws Pharma, Inc. Completed No outcome recorded
Phase 1 NCT02107235 Jan → Oct 2014 head and neck squamous cell carcinoma Traws Pharma, Inc. Completed No outcome recorded
Phase 1 NCT02002936 Aug 2013 → Dec 2014 myelodysplastic syndrome SymBio Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02014051 Mar 2013 → Nov 2014 myelodysplastic syndrome SymBio Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01700335 Jun 2012 → Feb 2015 myelodysplastic syndrome SymBio Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01168011 Jul 2010 → Dec 2015 cancer Traws Pharma, Inc. Completed No outcome recorded
Phase 1/26 trials
Phase 1/2 NCT03786237 Apr 2021 → Dec 2025 epidermolysis bullosa dystrophica, squamous cell carcinoma Prof. Johann Bauer Completed No outcome recorded
Phase 1/2 NCT04263090 Jun 2020 → Dec 2023 adenocarcinoma, non-small cell lung carcinoma Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 1/2 NCT01926587 Aug 2013 → Dec 2020 acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome Traws Pharma, Inc. Completed No outcome recorded
Phase 1/2 NCT01167166 Jul 2010 → Dec 2013 acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia Traws Pharma, Inc. Completed No outcome recorded
Phase 1/2 NCT00867061 Mar 2009 → Jun 2010 myelodysplastic syndrome Traws Pharma, Inc. Withdrawn No outcome recorded
Phase 1/2 NCT00854945 Jan 2009 → Sep 2013 acute myeloid leukemia, myelodysplastic syndrome Traws Pharma, Inc. Completed No outcome recorded
Phase 27 trials
Phase 2 NCT05764395 May 2023 → May 2028 expected cutaneous melanoma, metastatic melanoma Vanderbilt-Ingram Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT02730884 Aug 2017 → Aug 2019 anemia, leukemia, myelofibrosis, splenic disorder M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 2 NCT01904682 Jul 2013 → Dec 2020 myelodysplastic syndrome Traws Pharma, Inc. Completed No outcome recorded
Phase 2 NCT01807546 Mar 2013 → Mar 2015 anal squamous cell carcinoma, cervical squamous cell carcinoma, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma +3 Traws Pharma, Inc. Completed No outcome recorded
Phase 2 NCT01584531 May 2012 → May 2015 chromosome 8, trisomy, myelodysplastic syndrome Traws Pharma, Inc. Completed No outcome recorded
Phase 2 NCT00906334 May 2009 → Nov 2013 myelodysplastic syndrome Traws Pharma, Inc. Completed No outcome recorded
Phase 2 NCT00856791 Mar 2009 → Jul 2011 ovarian cancer Traws Pharma, Inc. Completed No outcome recorded
Phase 34 trials
Phase 3 NCT02562443 Dec 2015 → Jul 2020 myelodysplastic syndrome with excess blasts Traws Pharma, Inc. Terminated No outcome recorded
Phase 3 NCT01928537 Aug 2013 → Jun 2017 chronic myelomonocytic leukemia, myelodysplastic syndrome with excess blasts Traws Pharma, Inc. Completed No outcome recorded
Phase 3 NCT01360853 May 2011 → Jun 2015 pancreatic adenocarcinoma Traws Pharma, Inc. Completed No outcome recorded
Phase 3 NCT01241500 Nov 2010 → Oct 2018 chronic myelomonocytic leukemia, myelodysplastic syndrome with excess blasts Traws Pharma, Inc. Completed No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 42 sources stand behind the page.

FieldValueCited text
Known as Rigosertib Rigosertib (ON 01910.Na), a first-in-class Ras mimetic and small-molecule inhibitor of multiple signaling pathways including polo-like kinase 1 (PLK1) and phosphoinositide...” PMID 26091808 Jun 2015
21

“SyB C-1101 (rigosertib sodium) will be administered to two cohorts of patients; each receives either twice daily (560 mg before breakfast and 560 mg before dinner) or twice...” NCT03495167

Rigosertib (ON 01910.Na) is an inhibitor of the phosphoinositide 3-kinase and polo-like kinase pathways that induces mitotic arrest and apoptosis in neoplastic cells, while...” PMID 24777753 Apr 2014

“SyB L-1101 (rigosertib sodium) will be administered intravenously 72 continuous hours (3 days), followed by 25-day observation period.” NCT02000154

NCT01928537

NCT01584531

NCT03786237

NCT01926587

NCT04263090

NCT02107235

NCT02075034

NCT01904682

NCT02030639

NCT02730884

NCT01538563

NCT01538537

NCT01167166

NCT02562443

NCT05764395

NCT01807546

NCT01168011

NCT04177498

Known as Estybon ChEMBL registry synonym — accepted as the source's own label CHEMBL1241855
Known as ON 01910 “A Phase II Study to Evaluate the Safety and Efficacy of Rigosertib (ON 01910) Plus Pembrolizumab in Patients With Metastatic Melanoma Refractory to Immune Checkpoint Blockade” NCT05764395
Known as ON 01910 SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL1241855
Known as ON 01910.Na “We next treated twelve patients with higher risk MDS and two trisomy 8 AML patients with ON 01910.Na on a phase I clinical protocol (NCT00533416).” PMID 22524974 Apr 2012
13

“One such investigational drug, ON 01910.Na, is a potent and selective inhibitor of the cell cycle and leads to reduction in cyclin D1 expression.” NCT00861510

NCT01048619

NCT01165905

NCT01125891

NCT00854646

NCT00906334

NCT00867061

NCT01241500

NCT00861328

NCT00856791

NCT00861783

NCT00854945

NCT01360853

Known as rigosertib sodium “SyB C-1101 (rigosertib sodium) will be administered to two cohorts of patients; each receives either twice daily (560 mg before breakfast and 560 mg before dinner) or twice...” NCT03495167
7

“The primary objective of this study is to determine the largest dose of ON 01910.Na (rigosertib sodium) that can be given safely as a 3-day continuous infusion once every 2...” NCT01538537

“SyB L-1101 (rigosertib sodium) will be administered intravenously 72 continuous hours (3 days), followed by 25-day observation period.” NCT02000154

“SyB C-1101(rigosertib sodium) will be administered orally twice daily for 14 consecutive days, followed by 7-day observation period.” NCT02002936

“SyB L-1101(rigosertib sodium) will be administered to two cohorts at either 1200 mg/day or 1800 mg/day.” NCT01700335

“SyB C-1101(rigosertib sodium) will be administered to two cohorts at either 280 mg/day or 560 mg/day.” NCT02014051

“SyB C-1101 (rigosertib sodium)” NCT02783547

“Drug: rigosertib sodiumNCT01928537

Known as SyB C-1101 SyB C-1101 (rigosertib sodium) will be administered to two cohorts of patients; each receives either twice daily (560 mg before breakfast and 560 mg before dinner) or twice...” NCT03495167
3

NCT02002936

NCT02014051

NCT02783547

Known as SyB L-1101 SyB L-1101 (rigosertib sodium) will be administered intravenously 72 continuous hours (3 days), followed by 25-day observation period.” NCT02000154
1

NCT01700335

Action Inhibit “ON 01910.Na inhibited cyclin D1 expression” PMID 22524974 Apr 2012
Modality Small molecule “preclinical studies using BMMNCs from patients with MDS and AML to examine the effects of the styryl sulfone ON 01910.Na” PMID 22524974 Apr 2012
Route Intravenous “Participants receive ON 01910.Na in 2-week treatment cycles, with 3 to 5 days of drug infusion through a vein” NCT00533416