Umbralisib (TGR-1202) has been evaluated across numerous Phase 1, Phase 2, and Phase 3 clinical trials for various hematologic malignancies, including chronic lymphocytic leukemia, non-Hodgkin lymphoma, follicular lymphoma, marginal zone lymphoma, and myelofibrosis. Sponsored by industry entities such as TG Therapeutics, Inc., alongside academic and clinical institutions like Columbia University and the National Cancer Institute, these monotherapy and combination studies span recruitment statuses ranging from active and completed to terminated and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03283137 | ACTIVE_NOT_RECRUITING | CLL; B-cell Non Hodgkin Lymphoma |
University of Chicago |
2018-01-23 | PHASE1 |
| NCT03269669 | ACTIVE_NOT_RECRUITING | Grade 1 Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3a Follicular Lymphoma; Recurrent Follicular Lymphoma; Refractory Follicular Lymphoma |
National Cancer Institute (NCI) |
2018-01-23 | PHASE2 |
| NCT05152459 | WITHDRAWN | Recurrent Follicular Lymphoma; Refractory Follicular Lymphoma |
City of Hope Medical Center |
2023-05-01 | PHASE1; PHASE2 |
| NCT03671590 | TERMINATED | Non Hodgkin Lymphoma; Chronic Lymphocytic Leukemia |
TG Therapeutics, Inc. |
2018-09-10 | PHASE1 |
| NCT03919175 | TERMINATED | Lymphoma; Follicular Lymphoma; Follicular Lymphoma, Grade 1; Follicular Lymphoma Grade 2; Follicular Lymphoma Grade IIIa; Marginal Zone Lymphoma; Marginal Zone B Cell Lymphoma |
Massachusetts General Hospital |
2019-09-01 | PHASE2 |
| NCT04635683 | WITHDRAWN | Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Recurrent Follicular Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3a Follicular Lymphoma; Recurrent Lymphoplasmacytic Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Nodal Marginal Zone Lymphoma; Recurrent Splenic Marginal Zone Lymphoma; Recurrent Waldenstrom Macroglobulinemia; Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Refractory Follicular Lymphoma; Refractory Grade 1 Follicular Lymphoma; Refractory Grade 2 Follicular Lymphoma; Refractory Grade 3a Follicular Lymphoma; Refractory Lymphoplasmacytic Lymphoma; Refractory Mantle Cell Lymphoma; Refractory Marginal Zone Lymphoma; Refractory Nodal Marginal Zone Lymphoma; Refractory Splenic Marginal Zone Lymphoma; Refractory Waldenstrom Macroglobulinemia |
Yazeed Sawalha |
2022-09-30 | PHASE1 |
| NCT04624633 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Relapsed Chronic Lymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia |
Jennifer R. Brown, MD, PhD |
2020-12-15 | PHASE2 |
| NCT02493530 | COMPLETED | Myelofibrosis; Polycythemia Vera |
Vanderbilt-Ingram Cancer Center |
2015-07 | PHASE1 |
| NCT02612311 | TERMINATED | Chronic Lymphocytic Leukemia |
TG Therapeutics, Inc. |
2015-11-19 | PHASE3 |
| NCT03801525 | TERMINATED | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
TG Therapeutics, Inc. |
2019-05-16 | PHASE2; PHASE3 |
| NCT04163718 | TERMINATED | Chronic Lymphocytic Leukemia |
H. Lee Moffitt Cancer Center and Research Institute |
2019-11-12 | PHASE2 |
| NCT04783415 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma |
City of Hope Medical Center |
2021-03-26 | PHASE2 |
| NCT04508647 | COMPLETED | Marginal Zone Lymphoma; Follicular Lymphoma |
University of Colorado, Denver |
2020-11-23 | PHASE2 |
| NCT04692155 | TERMINATED | Mantle Cell Lymphoma |
University of Alabama at Birmingham |
2021-08-31 | PHASE1; PHASE2 |
| NCT02793583 | TERMINATED | Diffuse Large B-Cell Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Small Lymphocytic Lymphoma |
TG Therapeutics, Inc. |
2016-05-25 | PHASE2; PHASE3 |
| NCT03379051 | TERMINATED | Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma |
TG Therapeutics, Inc. |
2018-03-27 | PHASE1; PHASE2 |
| NCT02656303 | TERMINATED | Chronic Lymphocytic Leukemia |
TG Therapeutics, Inc. |
2016-01-07 | PHASE2 |
| NCT03207256 | TERMINATED | Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma |
TG Therapeutics, Inc. |
2017-08-09 | PHASE2 |
| NCT04016805 | TERMINATED | Chronic Lymphocytic Leukemia |
TG Therapeutics, Inc. |
2019-08-05 | PHASE2 |
| NCT03828448 | TERMINATED | Follicular Lymphoma; Small Lymphocytic Lymphoma |
TG Therapeutics, Inc. |
2019-07-10 | PHASE2 |
| NCT03364231 | COMPLETED | Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia; Non Follicular Indolent Non-Hodgkin Lymphoma |
TG Therapeutics, Inc. |
2017-11-30 | PHASE2 |
| NCT04149821 | TERMINATED | Chronic Lymphocytic Leukemia; CLL Progression; CLL/SLL |
Weill Medical College of Cornell University |
2021-02-10 | PHASE2 |
| NCT02535286 | COMPLETED | Chronic Lymphocytic Leukemia; Richter Syndrome |
TG Therapeutics, Inc. |
2015-09-18 | PHASE1 |
| NCT03776864 | TERMINATED | Hodgkin's Lymphoma |
University of Washington |
2019-09-26 | PHASE2 |
| NCT02742090 | TERMINATED | Chronic Lymphocytic Leukemia |
TG Therapeutics, Inc. |
2016-04-21 | PHASE2 |
| NCT02867618 | TERMINATED | Hodgkin Disease; Lymphoma, Non-hodgkin |
Columbia University |
2016-10-16 | PHASE1; PHASE2 |
| NCT03178201 | TERMINATED | Follicular Lymphoma |
Columbia University |
2017-08-20 | PHASE2 |
| NCT02006485 | COMPLETED | Chronic Lymphocytic Leukemia; Non-Hodgkin's Lymphoma |
TG Therapeutics, Inc. |
2013-12-13 | PHASE1 |
| NCT02874404 | COMPLETED | Recurrent Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma |
University of Nebraska |
2016-10-07 | PHASE2 |
| NCT02574663 | COMPLETED | Pancreatic Cancer; Colorectal Cancer; Rectal Cancer; Gastric Cancer; Esophageal Cancer; Gastrointestinal Stromal Tumor (GIST) |
TG Therapeutics, Inc. |
2015-09-11 | PHASE1 |
| NCT02268851 | COMPLETED | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Mantle Cell Lymphoma |
Dana-Farber Cancer Institute |
2014-11 | PHASE1 |
| NCT01767766 | COMPLETED | Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Peripheral T-Cell Lymphoma; Hodgkin's Lymphoma |
TG Therapeutics, Inc. |
2013-01-07 | PHASE1 |
| NCT02100852 | COMPLETED | Chronic Lymphocytic Leukemia |
TG Therapeutics, Inc. |
2014-03-12 | PHASE1 |
| NCT03207256 | Terminated | Chronic Lymphocytic Leukemia|Non Hodgkin Lymphoma |
TG Therapeutics Inc. |
2017-08-09 | Phase 2 |
| NCT03178201 | Terminated | Follicular Lymphoma |
Columbia University|TG Therapeutics Inc. |
2017-08-20 | Phase 2 |
| NCT02867618 | Terminated | Hodgkin Disease|Lymphoma Non-hodgkin |
Columbia University |
2016-10-16 | Phase 1|Phase 2 |
| NCT02164006 | COMPLETED | Hodgkin's Lymphoma |
TG Therapeutics, Inc. |
2014-06-11 | PHASE1 |
| NCT02493530 | Active not recruiting | Myelofibrosis|Polycythemia Vera |
Vanderbilt-Ingram Cancer Center |
2015-07 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2025-02-07)
Check the
umbralisib (TGR-1202)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- umbralisib (TGR-1202) Solubility in DMSO
- umbralisib (TGR-1202) Stock Solution
- umbralisib (TGR-1202) Storage
- umbralisib (TGR-1202) Stability
- umbralisib (TGR-1202) Molecular Weight
- umbralisib (TGR-1202) SMILES
- umbralisib (TGR-1202) CAS Number
- umbralisib (TGR-1202) Chemical Structure (2D and 3D)
- umbralisib (TGR-1202) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.