Floatz Rating
CCC48/100
Confidence
Indicative
Sponsor
Yazeed Sawalha
Modality
Small molecule
Development Phase
Phase 2/3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
40High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT04635683CT.gov Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma | — | Withdrawn | — | — | — |
NCT04692155CT.gov Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL) | — | Terminated | — | — | — |
NCT04783415CT.gov Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma | — | Active Not Recruiting | — | — | — |
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 | — | — | — |
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 | — | — | — |
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 · Mantle Cell Lymphoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Umbralisib (this asset) | Yazeed Sawalha | P2/3 | CCC · 48 |
| Etoposide | Ruijin Hospital | P4 | BBB |
| Cis-Diamminedichloroplatinum Ii | National Cancer Institute (NCI) | P4 | BBB |
| Vincristine Sulfate | M.D. Anderson Cancer Center | P2 | BBB |
| Irinotecan | University of Michigan Rogel Cancer Center | P2 | BBB |
| Busulfanum | City of Hope Medical Center | P2 | BBB |
| Cyclosporin A | Fred Hutchinson Cancer Center | P3 | BBB |
| Cediranib | City of Hope Medical Center | P2 | BB |
| Cyclophosphamide | Miltenyi Biomedicine GmbH | P4 | BB |
+42 more in the Mantle Cell Lymphoma cohort
Other indications for Umbralisib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Marginal Zone Lymphoma | — | P2/3 | CCC · 52 |
| Follicular Lymphoma | — | P2/3 | CCC · 50 |
| Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | — | P3 | CCC · 50 |
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 Mantle Cell 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-mantle-cell-lymphoma
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