Numerous clinical trials evaluate pirtobrutinib across Phase 1 through Phase 4 development, primarily targeting B-cell malignancies—including chronic lymphocytic leukemia, mantle cell lymphoma, and marginal zone lymphoma—alongside exploratory studies in relapsing multiple sclerosis and healthy subjects. Sponsored by industry leaders like Loxo Oncology and Eli Lilly alongside academic networks such as the Dana-Farber Cancer Institute, these protocols encompass varying recruitment statuses, ranging from active Phase 3 comparisons against chemoimmunotherapy in untreated leukemia to completed or withdrawn studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07220187 | NOT_YET_RECRUITING | Richter Syndrome; Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma; Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma |
SWOG Cancer Research Network |
2026-08-31 | PHASE3 |
| NCT07548450 | NOT_YET_RECRUITING | Waldenstrom Macroglobulinemia |
University of Utah |
2026-06 | PHASE2 |
| NCT07285590 | RECRUITING | Mantle Cell Lymphoma (MCL) |
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
2025-09-30 | PHASE2 |
| NCT07784101 | NOT_YET_RECRUITING | Relapsed or Refractory Mantle Cell Lymphoma (MCL) |
Beijing InnoCare Pharma Tech Co., Ltd. |
2026-10 | PHASE3 |
| NCT05833763 | RECRUITING | Mantle Cell Lymphoma; Mantle Cell Lymphoma Refractory |
Australasian Leukaemia and Lymphoma Group |
2023-10-12 | PHASE2 |
| NCT06390956 | RECRUITING | Marginal Zone Lymphoma |
University of Utah |
2025-02-20 | PHASE2 |
| NCT06948786 | RECRUITING | Grade 1 Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3a Follicular Lymphoma; Recurrent Follicular Lymphoma; Refractory Follicular Lymphoma |
University of Washington |
2025-11-17 | PHASE2 |
| NCT06967610 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Leukemia (SLL) |
M.D. Anderson Cancer Center |
2025-07-15 | PHASE2 |
| NCT07796373 | NOT_YET_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Leukemia |
National Heart, Lung, and Blood Institute (NHLBI) |
2026-09-09 | PHASE2 |
| NCT07218341 | RECRUITING | Chronic Lymphocytic Leukemia; Lymphoma, Small Lymphocytic |
Eli Lilly and Company |
2026-03-09 | PHASE4 |
| NCT07162181 | ACTIVE_NOT_RECRUITING | Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; B-cell Lymphoma |
Eli Lilly and Company |
2025-08-07 | PHASE2 |
| NCT06876662 | RECRUITING | Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma |
Eli Lilly and Company |
2025-05-20 | PHASE4 |
| NCT06876649 | RECRUITING | Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma |
Eli Lilly and Company |
2025-05-20 | PHASE4 |
| NCT07428707 | RECRUITING | Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL) |
National Heart, Lung, and Blood Institute (NHLBI) |
2026-03-11 | EARLY_PHASE1 |
| NCT07342478 | RECRUITING | CLL / SLL; CLL (Chronic Lymphocytic Leukemia); CLL, Refractory; CLL, Relapsed; SLL (Small Lymphocytic Lymphoma); SLL; CLL; CLL Progression |
Newave Pharmaceutical Inc |
2026-04-23 | PHASE3 |
| NCT07516093 | RECRUITING | B-cell Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Nurix Therapeutics, Inc. |
2026-08-03 | PHASE3 |
| NCT06553872 | RECRUITING | Mantle Cell Lymphoma |
H. Lee Moffitt Cancer Center and Research Institute |
2024-08-23 | PHASE2 |
| NCT06812715 | RECRUITING | Chronic Lymphocytic Leukemia |
Peter MacCallum Cancer Centre, Australia |
2025-05-05 | PHASE2 |
| NCT05734495 | ACTIVE_NOT_RECRUITING | Waldenstrom Macroglobulinemia |
Dana-Farber Cancer Institute |
2023-05-02 | PHASE2 |
| NCT07052695 | RECRUITING | Leukemia; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Lymphoma |
Inhye Ahn |
2025-11-24 | PHASE1; PHASE2 |
| NCT07350850 | RECRUITING | PCNSL; Primary Central Nervous System Lymphoma |
Tongji Hospital |
2025-12-25 | PHASE2 |
| NCT07684950 | NOT_YET_RECRUITING | Mantle Cell Lymphoma (MCL) |
Henan Cancer Hospital |
2026-06-30 | PHASE2 |
| NCT07255963 | RECRUITING | DLBCL - Diffuse Large B Cell Lymphoma |
The First Affiliated Hospital of Soochow University |
2025-11-30 | PHASE2 |
| NCT07624799 | NOT_YET_RECRUITING | CLL (Chronic Lymphocytic Leukemia) |
French Innovative Leukemia Organisation |
2026-09-01 | PHASE2 |
| NCT07774299 | NOT_YET_RECRUITING | DLBCL |
Ruijin Hospital |
2026-08-25 | PHASE2 |
| NCT07416890 | RECRUITING | Pirtobrutinib; Sintilimab; Central Nervous System Lymphoma |
Zhejiang Cancer Hospital |
2026-02-10 | PHASE2 |
| NCT06252675 | RECRUITING | Mantle Cell Lymphoma |
University of California, San Francisco |
2024-06-11 | PHASE2 |
| NCT07744724 | NOT_YET_RECRUITING | DLBCL - Diffuse Large B Cell Lymphoma; Pirtobrutinib |
Changzhou No.2 People's Hospital |
2026-07-31 | PHASE2 |
| NCT06839872 | WITHDRAWN | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
AstraZeneca |
2025-06-30 | PHASE2 |
| NCT05990465 | RECRUITING | Non Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Burkitt Lymphoma |
Medical College of Wisconsin |
2025-02-06 | PHASE1 |
| NCT06588478 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Loxo Oncology, Inc. |
2025-01-03 | PHASE2 |
| NCT07622784 | NOT_YET_RECRUITING | Relapsed or Refractory B-cell Lymphoma |
Sun Yat-sen University |
2026-06 | PHASE2 |
| NCT07604987 | RECRUITING | Primary Central Nervous System (CNS) Lymphoma |
Zou Dehui |
2026-05-20 | PHASE2 |
| NCT06721013 | RECRUITING | Immune Thrombocytopenia (ITP) |
Eli Lilly and Company |
2025-07-30 | PHASE1; PHASE2 |
| NCT05536349 | RECRUITING | Leukemia |
M.D. Anderson Cancer Center |
2022-12-20 | PHASE2 |
| NCT06973187 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
BeOne Medicines |
2025-09-04 | PHASE3 |
| NCT07231952 | RECRUITING | Waldenstrom Macroglobulinemia; Lymphoplasmacytic Lymphoma |
Memorial Sloan Kettering Cancer Center |
2025-11-11 | PHASE2 |
| NCT07207785 | NOT_YET_RECRUITING | Mantle Cell Lymphoma |
Fondazione Italiana Linfomi - ETS |
2026-02-01 | PHASE2 |
| NCT06043674 | RECRUITING | Chronic Lymphocytic Leukemia; Richter's Transformation |
Christine Ryan |
2024-01-22 | PHASE2 |
| NCT07685717 | RECRUITING | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
Jennifer Woyach |
2026-08-01 | PHASE2 |
| NCT04623541 | ACTIVE_NOT_RECRUITING | Relapsed/Refractory Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Richter's Syndrome; Treatment-naïve High Risk Chronic Lymphocytic Leukemia |
Genmab |
2020-11-25 | PHASE1; PHASE2 |
| NCT05254743 | RECRUITING | Chronic Lymphocytic Leukemia; Leukemia, Lymphocytic; Leukemia, B-cell; Small Lymphocytic Lymphoma |
Loxo Oncology, Inc. |
2022-07-22 | PHASE3 |
| NCT07744750 | NOT_YET_RECRUITING | DLBCL - Diffuse Large B Cell Lymphoma; Richter Transformation; CLL / SLL; MZL |
Changzhou No.2 People's Hospital |
2026-08-30 | PHASE2 |
| NCT07744737 | NOT_YET_RECRUITING | DLBCL - Diffuse Large B Cell Lymphoma; R-CHOP Chemotherapy; Pirtobrutinib |
Changzhou No.2 People's Hospital |
2026-07-30 | PHASE2 |
| NCT06333262 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Inhye Ahn |
2024-04-22 | PHASE2 |
| NCT05529069 | RECRUITING | Mantle Cell Lymphoma; Non Hodgkin Lymphoma; Hematologic Malignancy |
M.D. Anderson Cancer Center |
2023-01-25 | PHASE2 |
| NCT06522386 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma |
M.D. Anderson Cancer Center |
2025-01-30 | PHASE2 |
| NCT04662255 | ACTIVE_NOT_RECRUITING | Lymphoma, Mantle-Cell |
Loxo Oncology, Inc. |
2021-04-08 | PHASE3 |
| NCT06466122 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Kerry Rogers |
2024-11-07 | PHASE2 |
| NCT05677919 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Mayo Clinic |
2023-01-31 | PHASE2 |
| NCT06263491 | RECRUITING | Mantle Cell Lymphoma |
M.D. Anderson Cancer Center |
2024-05-29 | PHASE2 |
| NCT04965493 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Loxo Oncology, Inc. |
2021-09-20 | PHASE3 |
| NCT07122609 | NOT_YET_RECRUITING | Relapsed and Refractory DLBCL |
Ruijin Hospital |
2025-08-05 | PHASE2 |
| NCT06104683 | WITHDRAWN | Relapsing Multiple Sclerosis; Multiple Sclerosis |
Loxo Oncology, Inc. |
2024-05-01 | PHASE2 |
| NCT05317936 | TERMINATED | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
M.D. Anderson Cancer Center |
2022-11-16 | PHASE1; PHASE2 |
| NCT05023980 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Loxo Oncology, Inc. |
2021-09-23 | PHASE3 |
| NCT03740529 | COMPLETED | Chronic Lymphocytic Leukemia; Waldenstrom Macroglobulinemia; Mantle Cell Lymphoma; Marginal Zone Lymphoma; B-cell Lymphoma; Small Lymphocytic Lymphoma |
Loxo Oncology, Inc. |
2019-03-15 | PHASE1; PHASE2 |
| NCT06104683 | Withdrawn | Relapsing Multiple Sclerosis|Multiple Sclerosis |
Loxo Oncology Inc.|Eli Lilly and Company |
2024-05-01 | Phase 2 |
| NCT05990465 | Not yet recruiting | Non Hodgkin Lymphoma|Diffuse Large B Cell Lymphoma|Follicular Lymphoma|Marginal Zone Lymphoma|Mantle Cell Lymphoma|Burkitt Lymphoma |
Medical College of Wisconsin |
2024-04 | Phase 1 |
| NCT06333262 | Recruiting | Chronic Lymphocytic Leukemia|Small Lymphocytic Lymphoma |
Inhye Ahn|Loxo Oncology Inc.|Dana-Farber Cancer Institute |
2024-04-22 | Phase 2 |
| NCT04666038 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Loxo Oncology, Inc. |
2021-03-09 | PHASE3 |
| NCT05024045 | COMPLETED | Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-cell Marginal Zone; Lymphoma, Non-Hodgkin; Multiple Myeloma; B-cell Lymphoma; Waldenstrom Macroglobulinemia; Lymphoma, Mantle-Cell |
Eli Lilly and Company |
2021-09-30 | PHASE1 |
| NCT04849416 | COMPLETED | Leukemia, Lymphoid; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell |
Eli Lilly and Company |
2021-05-14 | PHASE2 |
| NCT05176314 | COMPLETED | Healthy |
Loxo Oncology, Inc. |
2022-01-11 | PHASE1 |
| NCT06190691 | COMPLETED | Healthy; Hepatic Insufficiency |
Eli Lilly and Company |
2020-12-18 | PHASE1 |
| NCT06258174 | COMPLETED | Healthy |
Eli Lilly and Company |
2021-09-28 | PHASE1 |
| NCT06258174 | Completed | Healthy |
Eli Lilly and Company|Loxo Oncology Inc. |
2021-09-28 | Phase 1 |
| NCT05023980 | Active not recruiting | Chronic Lymphocytic Leukemia|Small Lymphocytic Lymphoma |
Loxo Oncology Inc.|Eli Lilly and Company |
2021-09-23 | Phase 3 |
| NCT06194214 | COMPLETED | Healthy |
Eli Lilly and Company |
2021-03-11 | PHASE1 |
| NCT06190678 | COMPLETED | Healthy; Renal Insufficiency |
Eli Lilly and Company |
2021-02-01 | PHASE1 |
| NCT06215430 | COMPLETED | Healthy |
Eli Lilly and Company |
2021-01-11 | PHASE1 |
| NCT06215521 | COMPLETED | Healthy |
Eli Lilly and Company |
2020-12-15 | PHASE1 |
| NCT06180980 | COMPLETED | Healthy |
Eli Lilly and Company |
2021-01-04 | PHASE1 |
| NCT06165146 | COMPLETED | Healthy |
Eli Lilly and Company |
2020-11-10 | PHASE1 |
| NCT06181006 | COMPLETED | Healthy |
Eli Lilly and Company |
2020-08-14 | PHASE1 |
| NCT06180954 | COMPLETED | Healthy |
Eli Lilly and Company |
2020-09-23 | PHASE1 |
| NCT05134337 | COMPLETED | Healthy Volunteers |
Loxo Oncology, Inc. |
2020-02-12 | PHASE1 |
| NCT06180967 | COMPLETED | Healthy |
Eli Lilly and Company |
2020-09-03 | PHASE1 |
| NCT05134350 | COMPLETED | Healthy Volunteers |
Loxo Oncology, Inc. |
2020-02-06 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-06-11)
Check the
Pirtobrutinib (LOXO-305)
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>).
- Pirtobrutinib (LOXO-305) Solubility in DMSO
- Pirtobrutinib (LOXO-305) Stock Solution
- Pirtobrutinib (LOXO-305) Storage
- Pirtobrutinib (LOXO-305) Stability
- Pirtobrutinib (LOXO-305) Molecular Weight
- Pirtobrutinib (LOXO-305) SMILES
- Pirtobrutinib (LOXO-305) CAS Number
- Pirtobrutinib (LOXO-305) Chemical Structure (2D and 3D)
- Pirtobrutinib (LOXO-305) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.