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Clinical trials
catalyst calendar across sponsors →Studies where TGTX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
36 interventional · 4 observational · 11 with posted results
Held by 17 tracked-famous managers (D. E. Shaw & Co., Inc., TWO SIGMA INVESTMENTS, LP, JANE STREET GROUP, LLC, RENAISSANCE TECHNOLOGIES LLC, CITADEL ADVISORS LLC, +12 more) · FINRA short interest 13.6 days to cover (settled 2026-07-31) · government filings 180d: 0 congress / 1 executive
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Long-term Follow-up (LTFU) of Participants Who Received Azer-CelNCT07577583observationalNumber of Participants With Clinically Significant CEI | — | Not yet recruiting | Other: No Intervention | B-cell Mediated Autoimmune Disorders | 32 | 2039-12-01 | in 4,851 d | 2026-05-11 |
| A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)NCT06433765observationalPercentage of Participants with Major Congenital Malformations (MCMs) | — | Recruiting | Other: No intervention | Multiple Sclerosis | 728 | 2035-03-31 | in 3,145 d | 2026-07-17 |
| An Extension Study of Ublituximab in Participants With Relapsing Multiple SclerosisNCT04130997Annualized Relapse Rate (ARR)Open-label · Treatment | Phase 3 | Active, not recruiting | Biological: Ublituximab | Relapsing Multiple Sclerosis (RMS) | 1,100 | 2032-05-31 | in 2,111 d | 2026-07-17 |
| A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)NCT06433752observationalAnnualized Relapse Rate (ARR) | — | Recruiting | Other: No Intervention | Relapsing Multiple Sclerosis, Multiple Sclerosis | 2,000 | 2032-04-01 | in 2,051 d | 2026-07-20 |
| Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple SclerosisNCT07220252Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of UblituximabRandomized · Quadruple-masked · Treatment | Phase 2/3 | Recruiting | Drug: Ublituximab, Placebo, Placebo, Fingolimod | Relapsing Multiple Sclerosis | 240 | 2030-01-01 | in 1,230 d | 2026-07-17 |
| Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With SchizophreniaNCT07680946Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total ScoreOpen-label · Treatment | Phase 2 | Recruiting | Drug: Ublituximab | Schizophrenia | 60 | 2028-12-01 | in 834 d | 2026-07-21 |
| A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)NCT07673744Time to Onset of a Clinical Worsening EventRandomized · Double-masked · Treatment | Phase 2 | Recruiting | Drug: Ublituximab, Placebo | Myasthenia Gravis | 120 | 2028-07-01 | in 681 d | 2026-07-17 |
| Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of UblituximabNCT05877963Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48Randomized · Double-masked · Treatment | Phase 3 | Recruiting | Biological: Ublituximab · Drug: Placebo | Relapsing Multiple Sclerosis | 800 | 2027-12-01 | in 468 d | 2026-07-17 |
| A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune DisordersNCT06680037Number of Participants with Dose-Limiting Toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: Azercabtagene zapreleucel (azer-cel) | B-cell Mediated Autoimmune Disorders | 100 | 2027-12-01 | in 468 d | 2026-07-20 |
| A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)NCT07503873Part 2: Area under the curve (AUC) at Steady State [AUCss] of UblituximabRandomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: Ublituximab, Ublituximab · Device: Prefilled pen | Multiple Sclerosis | 350 | 2027-05-30 | in 283 d | 2026-07-20 |
| A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast MilkNCT06143514observationalArea Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™ | — | Recruiting | Other: No intervention | Relapsing Multiple Sclerosis | 16 | 2026-10-31 | in 72 d | 2026-07-20 |
| A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)NCT07211633Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of UblituximabRandomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Biological: Ublituximab, Ublituximab | Relapsing Multiple Sclerosis | 360 | 2026-10-31 | in 72 d | 2026-07-17 |
| Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic LeukemiaNCT04806035RP2DNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Strategic/Business Decision | Biological: TG-1801, Ublituximab | CLL, SLL, Richter's Transformation, Indolent Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Aggressive Lymphoma, DLBCL, Mediastinal Large B-cell Lymphoma, MCL | 21 | 2024-06-12actual | — | 2024-07-31 |
| Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell MalignanciesNCT03671590Maximum Tolerated Dose acceptable for participantsNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Strategic/Business Decision | Drug: TG-1701, Umbralisib · Biological: Ublituximab | Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia | 172 | 2024-05-21actual | — | 2024-07-19 |
| Study of TG-1801 in Subjects With B-Cell LymphomaNCT03804996Identification of Recommended DoseNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: TG-1801 · Biological: Ublituximab | B-Cell Lymphoma | 50 | 2024-02-21actual | — | 2024-04-08 |
| Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic LeukemiaNCT02612311results2024-05-07Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) CriteriaRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Strategic/Business decision | Biological: Obinutuzumab, Ublituximab · Drug: TGR-1202, Chlorambucil | Chronic Lymphocytic Leukemia | 603 | 2023-02-22actual | — | 2024-12-13 |
| Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)NCT03801525results2024-04-19Phase 2: Complete Response (CR) Rate as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 CriteriaRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2/3 | Terminatedsponsor's stated reason: Strategic/Business decision | Drug: Ublituximab, Umbralisib, Venetoclax | Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma | 277 | 2022-12-20actual | — | 2024-04-19 |
| An Extension of the TG1101-RMS201 TrialNCT03381170Number of participants with treatment-related events as assessed by CTCAE V4.0Open-label · Treatment | Phase 2 | Completed | Biological: Ublituximab | Relapsing Remitting Multiple Sclerosis | 48 | 2022-11-11actual | — | 2022-12-21 |
| Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins LymphomaNCT02793583Overall Response RateRandomized · Open-label · Treatment | Phase 2/3 | Terminatedsponsor's stated reason: Strategic/Business Decision | Biological: Ublituximab, Bendamustine · Drug: Umbralisib | Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Small Lymphocytic Lymphoma | 710 | 2022-05-31actual | — | 2022-07-21 |
| A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304NCT02656303results2023-06-22Overall Response Rate (ORR) as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) CriteriaNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Strategic/Business Decision | Biological: Ublituximab · Drug: Umbralisib | Chronic Lymphocytic Leukemia | 116 | 2022-05-26actual | — | 2023-06-22 |
| Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHLNCT03379051Determine Acceptable Adverse Events That Are Related to TreatmentNon-randomized · Open-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Strategic/Business Decision | Drug: Venetoclax, Umbralisib, Lenalidomide · Biological: Ublituximab | Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma | 78 | 2022-05-26actual | — | 2022-08-22 |
| Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 TrialsNCT03207256Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicitiesNon-randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Strategic/Business Decision | Drug: TGR-1202, TGR-1202 + Ublituximab | Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma | 51 | 2022-05-25actual | — | 2022-07-21 |
| Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or VenetoclaxNCT04016805results2023-07-24Rate of Undetected Minimal Residual Disease (U-MRD)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Strategic/Business decision | Drug: Ublituximab, Umbralisib, Ibrutinib, Venetoclax, Acalabrutinib Oral Capsule | Chronic Lymphocytic Leukemia | 41 | 2022-05-22actual | — | 2023-07-24 |
| Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular LymphomaNCT03828448results2023-07-24Overall Response Rate (ORR)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Strategic/Business Decision | Drug: Ublituximab, Umbralisib | Follicular Lymphoma, Small Lymphocytic Lymphoma | 34 | 2022-05-16actual | — | 2023-07-24 |
| Study of Cosibelimab in Subjects With Relapsed or Refractory LymphomaNCT03778073Adverse Events That Are Related to TreatmentNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Strategic/Business Decision | Drug: Cosibelimab, Cosibelimab + Ublituximab + Bendamustine combination, Cosibelimab + Ublituximab + Bendamustine combination | B-cell Non Hodgkin Lymphoma, Richter's Transformation | 18 | 2022-05-03actual | — | 2022-08-22 |
| Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's LymphomaNCT03364231results2023-06-23Overall Response Rate (ORR) as Assessed by Revised Response Criteria for Non- Hodgkin's Lymphoma (Lugano Classification) and Consensus-Based 6th International Workshop on Waldenstrom's Macroglobulinemia (IWWM)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Umbralisib | Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, Non Follicular Indolent Non-Hodgkin Lymphoma | 21 | 2022-02-15actual | — | 2023-06-23 |
| Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's TransformationNCT02535286Determine Acceptable Adverse Events That Are Related to TreatmentOpen-label · Treatment | Phase 1 | Completed | Drug: Umbralisib · Biological: ublituximab, TG-1501 | Chronic Lymphocytic Leukemia, Richter Syndrome | 27 | 2021-11-04actual | — | 2022-10-20 |
| Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior TherapyNCT02742090results2024-07-03Progression-free SurvivalOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: (Strategic/Business Decision) | Drug: Umbralisib | Chronic Lymphocytic Leukemia | 51 | 2021-06-10actual | — | 2024-07-03 |
| Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)NCT03277248results2021-12-06Annualized Relapse Rate (ARR)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: Ublituximab · Drug: Teriflunomide, Oral Placebo, IV Placebo | Relapsing Multiple Sclerosis (RMS) | 545 | 2020-08-04actual | — | 2021-12-06 |
| Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )NCT03277261results2021-12-06Annualized Relapse Rate (ARR)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: Ublituximab · Drug: Teriflunomide, Oral Placebo, IV Placebo | Relapsing Multiple Sclerosis (RMS) | 549 | 2020-07-23actual | — | 2021-12-06 |
| Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)NCT02301156results2022-05-20Overall Response Rate (ORR)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Ublituximab, Ibrutinib | Chronic Lymphocytic Leukemia | 126 | 2020-04-01actual | — | 2022-05-20 |
| Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell MalignanciesNCT02006485Maximum Tolerated Dose acceptable for participantsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Ublituximab + TGR-1202, Ublituximab + TGR-1202 + ibrutinib, Ublituximab + TGR-1202 + bendamustine | Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma | 160 | Oct 2019actual | — | 2019-11-05 |
| TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid TumorsNCT02574663Adverse events as a measure of safety and tolerability of TGR-1202 as a single agent and in combination in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: TGR-1202, nab-paclitaxel + gemcitabine, Oxaliplatin + Folinic acid + Fluorouracil, Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab | Pancreatic Cancer, Colorectal Cancer, Rectal Cancer, Gastric Cancer, Esophageal Cancer, Gastrointestinal Stromal Tumor (GIST) | 66 | Aug 2018actual | — | 2019-10-02 |
| Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic MalignanciesNCT01767766Maximum Tolerated Dose acceptable for participantsOpen-label · Treatment | Phase 1 | Completed | Drug: TGR-1202 | Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Peripheral T-Cell Lymphoma, Hodgkin's Lymphoma | 90 | Feb 2018actual | — | 2021-08-23 |
| TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)NCT02100852Maximum Tolerated Dose acceptable for participantsOpen-label · Treatment | Phase 1 | Completed | Drug: TGR-1202 + Obinutuzumab + Chlorambucil | Chronic Lymphocytic Leukemia | 19 | Nov 2017actual | — | 2019-10-02 |
| Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple SclerosisNCT02738775results2021-07-15Responder Rate of B-Cell Depletion at Week 4Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: Ublituximab · Drug: Placebo | Multiple Sclerosis | 49 | 2017-09-27actual | — | 2021-07-15 |
| Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma PatientsNCT02164006Maximum Tolerated Dose acceptable for participantsOpen-label · Treatment | Phase 1 | Completed | Drug: TGR-1202 + brentuximab vedotin | Hodgkin's Lymphoma | 16 | May 2016actual | — | 2019-10-02 |
| Ublituximab + Ibrutinib in Select B-cell MalignanciesNCT02013128To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignanciesOpen-label · Treatment | Phase 1/2 | Completed | Drug: Ublituximab, Ibrutinib | Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma | 66 | Dec 2015actual | — | 2022-10-24 |
| Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin LymphomaNCT01647971Number of Participants with Adverse Events as a Measure of Safety and TolerabilityOpen-label · Treatment | Phase 1/2 | Completed | Drug: Ublituximab | Non-Hodgkins Lymphoma, B-cell Lymphoma, Waldenstrom's Macroglobulinemia, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Primary Central Nervous System Lymphoma | 39 | May 2015actual | — | 2022-11-21 |
| Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid MalignanciesNCT01744912Maximum Tolerated Dose acceptable for participantsOpen-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Sponsor's decision | Drug: Ublituximab, Lenalidomide | Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, B-cell Lymphomas, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Waldenstrom's Macroglobulinemia | 10 | 2014-02-07actual | — | 2022-05-11 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19