Umbralisib
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Explore 203 assets in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma →Floatz Rating
CCC50/100
Confidence
Indicative
Sponsor
Weill Medical College of Cornell University
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
42High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT04149821CT.gov Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy | — | Terminated | — | — | — |
NCT04624633CT.gov Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL | — | Active Not Recruiting | — | — | — |
NCT04163718CT.gov TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL) | — | Terminated | — | — | — |
NCT04016805CT.gov Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax | — | Terminated | — | — | — |
NCT03828448CT.gov Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma | — | Terminated | — | — | — |
NCT03801525CT.gov 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) | — | Terminated | — | — | — |
NCT03671590CT.gov Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies | — | Terminated | — | — | — |
NCT03379051CT.gov Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL | — | Terminated | — | — | — |
NCT03283137CT.gov Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-cell NHL | — | Active Not Recruiting | — | — | — |
NCT03207256CT.gov Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials | — | Terminated | — | — | — |
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NCT02793583CT.gov Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma | — | Terminated | — | — | — |
NCT02742090CT.gov Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy | — | Terminated | — | — | — |
NCT02656303CT.gov A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304 | — | Terminated | — | — | — |
NCT02612311CT.gov Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia | — | Terminated | — | — | — |
NCT02535286CT.gov Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation | — | Completed | — | — | — |
NCT02268851CT.gov A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL | — | Completed | — | — | — |
NCT02100852CT.gov TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL) | — | Completed | — | — | — |
NCT02006485CT.gov Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies | — | Completed | — | — | — |
NCT01767766CT.gov Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Umbralisib (this asset) | Weill Medical College of Cornell University | P3 | CCC · 50 |
| Chlorambucil | Ascentage Pharma Group Inc. | P4 | BBB |
| Etoposide | Weill Medical College of Cornell University | P2 | BBB |
| Lisaftoclax | Henan Cancer Hospital | P3 | BBB |
| Prednisone | AstraZeneca | P3 | BBB |
| Irinotecan | IGM Biosciences, Inc. | P2 | BBB |
| Alvocidib | Sanofi | P2 | BB |
| Ppsv23 | Region Örebro County | P4 | BB |
| Cyclophosphamide | M.D. Anderson Cancer Center | P4 | BB |
+42 more in the Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma cohort
Other indications for Umbralisib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Marginal Zone Lymphoma | — | P2/3 | CCC · 52 |
| Follicular Lymphoma | — | P2/3 | CCC · 50 |
| Non-Hodgkin Lymphoma | — | P2 | CCC · 48 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Umbralisib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/umbralisib-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma
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