Drugs / Umbralisib
last change Jul 2026 re-read 2 minutes ago

Umbralisib

Small molecule targets ABL1, CSNK1E, PIK3CD via inhibition

Developed for
chronic lymphocytic leukemia/small lymphocytic lymphoma · follicular lymphoma · mantle cell lymphoma · B-cell chronic lymphocytic leukemia · marginal zone lymphoma · Hodgkins lymphoma · diffuse large B-cell lymphoma · Waldenstrom macroglobulinemia
+14 more · acquired polycythemia vera · classic Hodgkin lymphoma · esophageal cancer · gastric cancer · gastrointestinal stromal tumor · MALT lymphoma · myelofibrosis · nodal marginal zone B-cell lymphoma · non-Hodgkin lymphoma · pancreatic adenocarcinoma · peripheral T-cell lymphoma, not otherwise specified · rectal cancer · Richter transformation · splenic marginal zone lymphoma
Investigated by
TG Therapeutics, Inc. · National Cancer Institute (NCI) · City of Hope Medical Center · Columbia University · SCRI Development Innovations, LLC · AstraZeneca
+15 more · Blood Cancer Research Partnership · Dana-Farber Cancer Institute · H. Lee Moffitt Cancer Center and Research Institute · Jennifer R. Brown, MD, PhD · Massachusetts General Hospital · Memorial Sloan Kettering Cancer Center · The Leukemia and Lymphoma Society · University of Alabama at Birmingham · University of Chicago · University of Colorado, Denver · University of Nebraska · University of Washington · Vanderbilt-Ingram Cancer Center · Weill Medical College of Cornell University · Yazeed Sawalha

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) UKONIQ 2021-02-05 fda.gov

Trials 32 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 110 trials
Phase 1 NCT04635683 Sep 2022 → Dec 2023 MALT lymphoma, Waldenstrom macroglobulinemia, follicular lymphoma, mantle cell lymphoma +2 Yazeed Sawalha Withdrawn No outcome recorded
Phase 1 NCT03671590 Sep 2018 → May 2024 chronic lymphocytic leukemia/small lymphocytic lymphoma TG Therapeutics, Inc. Terminated No outcome recorded
Phase 1 NCT03283137 Jan 2018 → Dec 2027 expected chronic lymphocytic leukemia/small lymphocytic lymphoma University of Chicago Active not recruiting No outcome recorded
Phase 1 NCT02535286 Sep 2015 → Nov 2021 Richter transformation, chronic lymphocytic leukemia/small lymphocytic lymphoma TG Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02574663 Sep 2015 → Aug 2018 esophageal cancer, gastric cancer, gastrointestinal stromal tumor, pancreatic adenocarcinoma +1 TG Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02493530 Jul 2015 → Mar 2023 acquired polycythemia vera, myelofibrosis Vanderbilt-Ingram Cancer Center Completed No outcome recorded
Phase 1 NCT02268851 Nov 2014 → May 2018 chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma Dana-Farber Cancer Institute Completed No outcome recorded
Phase 1 NCT02164006 Jun 2014 → May 2016 Hodgkins lymphoma TG Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02100852 Mar 2014 → Nov 2017 chronic lymphocytic leukemia/small lymphocytic lymphoma TG Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT01767766 Jan 2013 → Feb 2018 B-cell chronic lymphocytic leukemia, Hodgkins lymphoma, peripheral T-cell lymphoma, not otherwise specified TG Therapeutics, Inc. Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05152459 May 2023 → Dec 2024 follicular lymphoma City of Hope Medical Center Withdrawn No outcome recorded
Phase 1/2 NCT04692155 Aug 2021 → Jun 2022 mantle cell lymphoma University of Alabama at Birmingham Terminated No outcome recorded
Phase 1/2 NCT02867618 Oct 2016 → Jun 2020 Hodgkins lymphoma, non-Hodgkin lymphoma Columbia University Terminated No outcome recorded
Phase 216 trials
Phase 2 NCT04783415 Mar 2021 → Jul 2022 overdue mantle cell lymphoma City of Hope Medical Center Active not recruiting No outcome recorded
Phase 2 NCT04149821 Feb 2021 → Jan 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma Weill Medical College of Cornell University Terminated No outcome recorded
Phase 2 NCT04624633 Dec 2020 → Dec 2023 overdue chronic lymphocytic leukemia/small lymphocytic lymphoma Jennifer R. Brown, MD, PhD Active not recruiting No outcome recorded
Phase 2 NCT04508647 Nov 2020 → Jul 2022 follicular lymphoma, marginal zone lymphoma University of Colorado, Denver Completed No outcome recorded
Phase 2 NCT04163718 Nov 2019 → Oct 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma H. Lee Moffitt Cancer Center and Research Institute Terminated No outcome recorded
Phase 2 NCT03776864 Sep 2019 → Sep 2021 classic Hodgkin lymphoma University of Washington Terminated No outcome recorded
Phase 2 NCT03919175 Sep 2019 → May 2024 follicular lymphoma, marginal zone lymphoma Massachusetts General Hospital Terminated No outcome recorded
Phase 2 NCT04016805 Aug 2019 → May 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma TG Therapeutics, Inc. Terminated No outcome recorded
Phase 2 NCT03828448 Jul 2019 → May 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma TG Therapeutics, Inc. Terminated No outcome recorded
Phase 2 NCT03269669 Jan 2018 → Dec 2025 overdue follicular lymphoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT03801525 May 2019 → Dec 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma TG Therapeutics, Inc. Terminated No outcome recorded
Phase 2/3 NCT02793583 May 2016 → May 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma +1 TG Therapeutics, Inc. Terminated No outcome recorded
Phase 31 trial
Phase 3 NCT02612311 Nov 2015 → Feb 2023 B-cell chronic lymphocytic leukemia TG Therapeutics, Inc. Terminated No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT03379051 Background Mar 2018 → May 2022 B-cell chronic lymphocytic leukemia TG Therapeutics, Inc. Terminated No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 34 sources stand behind the page.

FieldValueCited text
Known as Umbralisib Umbralisib (TGR-1202) is a novel next-generation inhibitor of phosphatidylinositol 3-kinase (PI3K) isoform p110δ (PI3Kδ), which is structurally distinct from other PI3Kδ...” PMID 29475723 Feb 2018
22

“TGR-1202 (Umbralisib)” NCT02612311

NCT03801525

NCT03364231

NCT02742090

NCT04163718

NCT04635683

NCT04624633

NCT04016805

NCT02535286

NCT03919175

NCT03776864

NCT03828448

NCT02793583

NCT03269669

NCT04149821

NCT03671590

NCT04692155

NCT04508647

NCT02656303

NCT04783415

NCT03379051

NCT05152459

Known as RP-5264 ChEMBL registry synonym — accepted as the source's own label CHEMBL3948730
Known as RP-5307 ChEMBL registry synonym — accepted as the source's own label CHEMBL3948730
Known as TGR 1202 “This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's...” NCT03364231
14

“Umbralisib (TGR-1202) is a novel next-generation inhibitor of phosphatidylinositol 3-kinase (PI3K) isoform p110δ (PI3Kδ), which is structurally distinct from other PI3Kδ...” PMID 29475723 Feb 2018

“A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed...” NCT02574663

“receive ublituximab (TG-1101) treatment in combination with umbralisib (TGR-1202)” NCT02656303

NCT02874404

NCT02100852

NCT02164006

NCT03207256

NCT03283137

NCT02493530

NCT03178201

NCT02268851

NCT02574663

NCT02612311

NCT02867618

Known as TGR-1202 (4-METHYLBENZENESULFONATE) ChEMBL registry synonym — accepted as the source's own label CHEMBL3948730
Known as TGR-1202 base ChEMBL registry synonym — accepted as the source's own label CHEMBL3948730
Known as TGR-1202 FREE BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL3948730
Known as Ukoniq ChEMBL registry synonym — accepted as the source's own label CHEMBL3948730
Known as UMBRALISIB TOSYLATE ChEMBL registry synonym — accepted as the source's own label CHEMBL3948730
Action Inhibit “Umbralisib also uniquely inhibits casein kinase-1ε, a major regulator of protein translation.” PMID 29475723 Feb 2018
3

“PI3-kinase p110-delta subunit inhibitor” CHEMBL3948730

“Tyrosine-protein kinase ABL inhibitor” CHEMBL3948730

“Casein kinase I epsilon inhibitor” CHEMBL3948730

Modality Small molecule “Umbralisib is a highly-specific and orally available dual inhibitor of phosphoinositide-3-kinase (PI3K) delta (δ) and casein kinase 1 epsilon (CK1ε)” NCT04692155
Route Oral “Patients self-administered an umbralisib oral tablet once per day in 28-day cycles” PMID 29475723 Feb 2018
Target ABL1 “Tyrosine-protein kinase ABL inhibitor” CHEMBL3948730
Target CSNK1E “Casein kinase I epsilon inhibitor” CHEMBL3948730
Target PIK3CD “PI3-kinase p110-delta subunit inhibitor” CHEMBL3948730