Floatz Rating
B59/100
Confidence
Indicative
Sponsor
Ou Bai, MD/PHD
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.
52Moderate confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07499271CT.gov Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation | — | Recruiting | — | — | — |
NCT07078500CT.gov Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma | — | Recruiting | — | — | — |
NCT06701357CT.gov CR-CHOP+X in Previously Untreated DEL | — | Recruiting | — | — | — |
NCT06647940CT.gov Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial） | — | Recruiting | — | — | — |
NCT07072208CT.gov Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL | — | Recruiting | — | — | — |
NCT06516978CT.gov A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL | — | Not Yet Recruiting | — | — | — |
NCT06530511CT.gov Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL | — | Recruiting | — | — | — |
NCT06015464CT.gov An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL | — | Unknown | — | — | — |
NCT05784987CT.gov R-MINE+X in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma | — | Unknown | — | — | — |
NCT06290817CT.gov Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI | — | Unknown | — | — | — |
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NCT05809180CT.gov Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients | — | Recruiting | — | — | — |
NCT05498259CT.gov Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL | — | Unknown | — | — | — |
NCT05381506CT.gov Study of Orelabrutinib in Combination With Gemox in Refractory / Relapsed Diffuse Large B-cell Lymphoma | — | Unknown | — | — | — |
NCT05351346CT.gov Genotype-guided Treatment in DLBCL | — | Unknown | — | — | — |
NCT05097443CT.gov Orelabrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma | — | Unknown | — | — | — |
NCT04438005CT.gov A Study of ICP-022 in Patients With R/R DLBCL | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Diffuse Large B-Cell Lymphoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Orelabrutinib (this asset) | Ou Bai, MD/PHD | P3 | B · 59 |
| Vincristine Sulfate | National Cancer Institute (NCI) | P2/3 | A |
| Melphalan | Ruijin Hospital | P4 | BBB |
| Axicabtagene Ciloleucel | Ruijin Hospital | P4 | BBB |
| Nivestim | Ruijin Hospital | P3 | BBB |
| Prednisone | Beth Israel Deaconess Medical Center | P4 | BBB |
| Adriamycin | Beth Israel Deaconess Medical Center | P4 | BBB |
| Cyclosporin A | Fred Hutchinson Cancer Center | P3 | BBB |
| Rituximab | Beth Israel Deaconess Medical Center | P4 | BBB |
+42 more in the Diffuse Large B-Cell Lymphoma cohort
Other indications for Orelabrutinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Marginal Zone Lymphoma | — | P4 | BBB · 73 |
| Primary Central Nervous System Lymphoma | — | P3 | BB · 70 |
| Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | — | P3 | BB · 68 |
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. Orelabrutinib in Diffuse Large B-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/orelabrutinib-diffuse-large-b-cell-lymphoma
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