Drugs / Pirtobrutinib
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic lymphocytic leukemia/small lymphocytic lymphoma 1 milestone | |||||
| Filed | US (FDA) | Jaypirca | chronic lymphocytic leukemia/small lymphocytic lymphoma | 2025-02-28 | “Lilly has submitted supplemental marketing applications for Jaypirca in the post-BTK inhibitor setting for CLL/SLL patients around the globe, including in the U.S.” lilly.com ↗ |
| Filed mantle cell lymphoma 2 milestones | |||||
| Filed | US (FDA) | — | mantle cell lymphoma | 2022-08-04 | “The FDA also accepted, with Priority Review designation, pirtobrutinib for mantle cell lymphoma for patients previously treated with a BTK inhibitor” lilly.com ↗ |
| Filed | US (FDA) | — | mantle cell lymphoma | 2021-12-15 | “The company initiated a rolling submission to the FDA for pirtobrutinib, seeking accelerated approval in mantle cell lymphoma” lilly.com ↗ “Lilly initiated a rolling submission to the FDA for pirtobrutinib, seeking accelerated approval in mantle cell lymphoma” lilly.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | JAYPIRCA | — | 2023-12-01 – 2025-12-02 | fda.gov ↗ |
| Approved · conditional | EU (EMA) | Jaypirca | — | 2023-10-30 | europa.eu ↗ |
| Approved | US (FDA) | JAYPIRCA | — | 2023-01-27 | fda.gov ↗ |
Trials 70 · started per year
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US approved 2023
EU approved 2023
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07428707 | Mar 2026 → Feb 2030 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase 117 trials | ||||||
| Phase 1 | NCT05990465 | Feb 2025 → Jul 2026 overdue | Burkitt lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma +1 | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 1 | NCT05176314 | Jan → Apr 2022 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05024045 | Sep 2021 → Jun 2023 | B-cell chronic lymphocytic leukemia, Waldenstrom macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma +1 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06258174 | Sep → Dec 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06194214 | Mar → Jun 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06190678 | Feb → Jun 2021 | impaired renal function disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06215430 | Jan → Apr 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06180980 | Jan → Mar 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06190691 | Dec 2020 → Dec 2021 | liver disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06215521 | Dec 2020 → Mar 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06165146 | Nov → Dec 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06180954 | Sep → Nov 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06180967 | Sep → Oct 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06181006 | Aug → Dec 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05134337 | Feb → Oct 2020 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05134350 | Feb → Mar 2020 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03666000 | Mar 2019 → Jun 2027 expected | B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma | Imugene Limited | Recruiting | No outcome recorded |
| Phase 1/24 trials · 1 missed | ||||||
| Phase 1/2 | NCT06721013 | Jul 2025 → Feb 2028 expected | autoimmune thrombocytopenia | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05317936 | Nov 2022 → Oct 2025 | chronic lymphocytic leukemia/small lymphocytic lymphoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT04623541 | Nov 2020 → Dec 2027 expected | Richter transformation, chronic lymphocytic leukemia/small lymphocytic lymphoma | Genmab | Active not recruiting | Missed primary |
| Phase 1/2 | NCT03740529 | Mar 2019 → Jan 2025 | Waldenstrom macroglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, marginal zone lymphoma | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 237 trials | ||||||
| Phase 2 | NCT07548450 | Nov 2026 → Nov 2034 expected | Waldenstrom macroglobulinemia | University of Utah | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07860775 | Sep 2026 → Oct 2030 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | HOVON Foundation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07831395 | Sep 2026 → Dec 2030 expected | Richter transformation | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07812493 | Sep 2026 → Sep 2028 expected | diffuse large B-cell lymphoma | Pengpeng Xu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07624799 | Sep 2026 → Sep 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | French Innovative Leukemia Organisation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07685717 | Jul 2026 → Dec 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Jennifer Woyach | Recruiting | No outcome recorded |
| Phase 2 | NCT07684950 | Jun 2026 → Oct 2028 expected | mantle cell lymphoma | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07622784 | Jun 2026 → Jun 2028 expected | B-cell non-Hodgkin lymphoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07604987 | May 2026 → May 2028 expected | primary central nervous system lymphoma | Zou Dehui | Recruiting | No outcome recorded |
| Phase 2 | NCT07416890 | Feb 2026 → Aug 2028 expected | central nervous system non-hodgkin lymphoma | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07207785 | Feb 2026 → Feb 2028 expected | mantle cell lymphoma | Fondazione Italiana Linfomi - ETS | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07350850 | Dec 2025 → Dec 2028 expected | primary central nervous system lymphoma | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07255963 | Nov 2025 → Sep 2028 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 2 | NCT06948786 | Nov 2025 → Jul 2031 expected | follicular lymphoma | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT07231952 | Nov 2025 → Apr 2028 expected | Waldenstrom macroglobulinemia | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07285590 | Sep 2025 → Dec 2032 expected | mantle cell lymphoma | Spanish Lymphoma Cooperative Group | Recruiting | No outcome recorded |
| Phase 2 | NCT07162181 | Aug 2025 → May 2030 expected | B-cell chronic lymphocytic leukemia | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07122609 | Aug 2025 → Aug 2026 overdue | relapsed/refractory diffuse large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06967610 | Jul 2025 → Jun 2031 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06839872 | Jun 2025 → Jul 2028 | chronic lymphocytic leukemia/small lymphocytic lymphoma | AstraZeneca | Withdrawn | No outcome recorded |
| Phase 2 | NCT06812715 | May 2025 → May 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Peter MacCallum Cancer Centre, Australia | Recruiting | No outcome recorded |
| Phase 2 | NCT06390956 | Feb 2025 → Dec 2031 expected | marginal zone lymphoma | University of Utah | Recruiting | No outcome recorded |
| Phase 2 | NCT06522386 | Jan 2025 → Feb 2027 expected | mantle cell lymphoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06588478 | Jan 2025 → Jun 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Loxo Oncology, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06466122 | Nov 2024 → Dec 2026 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Kerry Rogers | Recruiting | No outcome recorded |
| Phase 2 | NCT06553872 | Aug 2024 → Aug 2029 expected | mantle cell lymphoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06252675 | Jun 2024 → Jul 2028 expected | mantle cell lymphoma | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 2 | NCT06263491 | May 2024 → Nov 2026 expected | mantle cell lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06104683 | May 2024 → Jan 2026 | multiple sclerosis | Loxo Oncology, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06333262 | Apr 2024 → Jul 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Inhye Ahn | Recruiting | No outcome recorded |
| Phase 2 | NCT06043674 | Jan 2024 → Jan 2028 expected | B-cell chronic lymphocytic leukemia, Richter transformation | Christine Ryan | Recruiting | No outcome recorded |
| Phase 2 | NCT05833763 | Oct 2023 → Apr 2032 expected | mantle cell lymphoma | Australasian Leukaemia and Lymphoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05734495 | May 2023 → Jan 2029 expected | Waldenstrom macroglobulinemia | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05677919 | Jan 2023 → Nov 2026 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05529069 | Jan 2023 → Apr 2027 expected | mantle cell lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05536349 | Dec 2022 → Apr 2028 expected | leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04849416 | May 2021 → Apr 2023 | B-cell chronic lymphocytic leukemia, diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 37 trials · 4 met primary | ||||||
| Phase 3 | NCT07220187 | Aug 2026 → Oct 2035 expected | Richter transformation | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07516093 | Aug 2026 → Oct 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Nurix Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05254743 | Jul 2022 → Oct 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Loxo Oncology, Inc. | Recruiting | Met primary |
| Phase 3 | NCT05023980 | Sep 2021 → Jul 2025 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Loxo Oncology, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT04965493 | Sep 2021 → Oct 2026 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Loxo Oncology, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT04662255 | Apr 2021 → Nov 2027 expected | mantle cell lymphoma | Loxo Oncology, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04666038 | Mar 2021 → Aug 2023 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Loxo Oncology, Inc. | Active not recruiting | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT07218341 | Mar 2026 → May 2030 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 4 | NCT06876662 | May 2025 → May 2030 expected | B-cell chronic lymphocytic leukemia | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 4 | NCT06876649 | May 2025 → May 2030 expected | B-cell chronic lymphocytic leukemia | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05172700 | — | Richter transformation, Waldenstrom macroglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma | Loxo Oncology, Inc. | Approved for marketing | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1/2 | NCT07052695 Background | Nov 2025 → Dec 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Inhye Ahn | Recruiting | No outcome recorded |
| Phase 3 | NCT07342478 Comparator | Apr 2026 → Oct 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Newave Pharmaceutical Inc | Recruiting | No outcome recorded |
| Phase 3 | NCT06973187 Comparator | Sep 2025 → Apr 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2026-10-02 | Eli Lilly and Company | Regulatory Lilly's Jaypirca (pirtobrutinib), the first-and-only approved non-covalent BTK inhibitor, receives expanded indication from U.S. FDA for certain patients with previously untreated CLL/SLL lilly.com ↗
This new approval in the U.S. authorizes Jaypirca for adult patients with previously untreated CLL/SLL with no known 17p deletion. |
| 2026-09-28 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Jaypirca® (pirtobrutinib) Approved in China for a New Indication in Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) Across All Lines of Therapy innoventbio.com ↗
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, announced that the China National Medical Products Administration (NMPA) has approved Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, as a monotherapy for the treatment of adult patient with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). |
| 2026-06-26 | Eli Lilly and Company | Regulatory Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with chronic lymphocytic leukemia (CLL) across all lines of therapy lilly.com ↗
Following this positive opinion, the application is now referred to the European Commission for final action. |
| 2026-06-14 | Eli Lilly and Company | Results Lilly's Jaypirca (pirtobrutinib) significantly reduced the risk of disease progression or death by 45% when added to a venetoclax time-limited regimen in people with previously treated CLL/SLL lilly.com ↗ |
| 2026-06-02 | Eli Lilly and Company | Results Lilly to spotlight growing hematology portfolio at 2026 European Hematology Association (EHA) Annual Meeting lilly.com ↗
Positive results from the Phase 3 BRUIN CLL-322 study comparing time-limited pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory CLL/SLL will be highlighted in a late-breaking oral presentation |
| 2026-04-13 | Eli Lilly and Company | Results Lilly's Jaypirca (pirtobrutinib) significantly extended progression-free survival when added to a venetoclax time-limited regimen in patients with previously treated CLL/SLL lilly.com ↗
The study met its primary endpoint, demonstrating that the addition of pirtobrutinib to venetoclax plus rituximab led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS), as assessed by an independent review committee (IRC). |
| 2026-03-02 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Jaypirca® (Pirtobrutinib) Approved in China for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma innoventbio.com ↗
Jaypirca® (pirtobrutinib), has received approval by the National Medical Products Administration (NMPA) in China for a new indication for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least one line of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. |
| 2025-12-09 | Eli Lilly and Company | Results Lilly's Jaypirca (pirtobrutinib) significantly improved progression-free survival, reducing the risk of progression or death by 80%, versus chemoimmunotherapy in patients with treatment-naïve CLL/SLL lilly.com ↗
Pirtobrutinib met its primary endpoint demonstrating a reduction in the risk of disease progression or death by 80% (HR=0.20 [95% CI, 0.11-0.37]; p<0.0001). |
| 2025-12-07 | Eli Lilly and Company | Results Lilly's Jaypirca (pirtobrutinib) met its primary endpoint in first-of-its-kind, head-to-head Phase 3 study versus Imbruvica (ibrutinib) lilly.com ↗
Pirtobrutinib met its primary endpoint of non-inferiority on overall response rate (ORR) compared to ibrutinib (87.0% [95% CI, 82.90-90.44] versus 78.5% [95% CI, 73.73-82.85]; p<0.0001) in the intent-to-treat (ITT) population. |
| 2025-12-06 | Adaptive Biotechnologies | Results Adaptive Biotechnologies Showcases Leadership in Hematology-Oncology MRD with New clonoSEQ® Data Driving Treatment Interventions at 2025 ASH Annual Meeting adaptivebiotech.com ↗
Data from a Phase II study of 80 patients with previously untreated CLL showed that time-limited pirtobrutinib, venetoclax, and obinutuzumab (PVO) achieved notably deep and durable remissions based on MRD assessment at a threshold of 10 -6 . |
| 2025-12-03 | Eli Lilly and Company | Regulatory U.S. FDA approves expanded indication for Lilly's Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor. |
| 2025-09-08 | Eli Lilly and Company | Results Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, significantly improved progression-free survival in patients with treatment-naïve CLL/SLL lilly.com ↗ |
| 2025-07-29 | Eli Lilly and Company | Results Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus Imbruvica (ibrutinib) in CLL/SLL lilly.com ↗
ORR favored pirtobrutinib with a nominal P-value for superiority1 (p <0.05). |
| 2025-02-28 | Eli Lilly and Company | Regulatory Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) previously treated with a BTK inhibitor lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have been previously treated with a BTK inhibitor. |
| 2024-12-09 | Eli Lilly and Company | Results Phase 3 results for Lilly's Jaypirca® (pirtobrutinib) in covalent BTK inhibitor pre-treated chronic lymphocytic leukemia or small lymphocytic lymphoma to be presented at the 2024 ASH Annual Meeting lilly.com ↗
Today's updated results corresponding to the final prespecified analysis, demonstrate consistent improvement in PFS for patients treated with pirtobrutinib, with a reduction in risk of relapse, disease or death by 46% compared to IdelaR or BR. |
| 2023-12-11 | Eli Lilly and Company | Results Updated Data from the BRUIN Phase 1/2 Study of Pirtobrutinib in Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma Presented at the 2023 ASH Annual Meeting lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced updated clinical data from the international Phase 1/2 BRUIN trial of pirtobrutinib, a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult patients with a range of B-cell malignancies. |
| 2023-12-01 | Eli Lilly and Company | Regulatory Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor lilly.com ↗
Jaypirca was approved under the FDA's Accelerated Approval pathway based on overall response rate (ORR) and duration of response (DOR) from the open-label, single-arm, multicohort, international, Phase 1/2 BRUIN trial. |
| 2023-07-06 | Eli Lilly and Company | Results New England Journal of Medicine Publishes BRUIN Phase 1/2 Trial Data for Pirtobrutinib in BTK Inhibitor Pre-Treated Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma lilly.com ↗
The NEJM publication provides additional clinical details from the data set that was presented at the 2022 American Society of Hematology (ASH) Annual Meeting. |
| 2023-06-02 | Eli Lilly and Company | Results Lilly Highlights Verzenio® (abemaciclib) and Jaypirca™ (pirtobrutinib) Data at 2023 ASCO® Annual Meeting lilly.com ↗
Updated data from the Phase 1/2 BRUIN trial of Jaypirca in patients with covalent BTK inhibitor pre-treated relapsed or refractory MCL continue to demonstrate durable efficacy and no newly identified safety signals |
| 2023-01-27 | Eli Lilly and Company | Regulatory U.S. FDA Approves Jaypirca™ (pirtobrutinib), the First and Only Non-Covalent (Reversible) BTK Inhibitor, for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma After at Least Two Lines of Systemic Therapy, Including a BTK Inhibitor lilly.com ↗
Jaypirca was approved under the FDA's Accelerated Approval pathway based on response rate from the open-label, single-arm, international, Phase 1/2 study, called the BRUIN trial. |
| 2022-12-12 | Eli Lilly and Company | Results Loxo@Lilly Presents Updated Pirtobrutinib Data from the Phase 1/2 BRUIN Clinical Trial at the 2022 American Society of Hematology Annual Meeting lilly.com ↗
These results show that pirtobrutinib may potentially help to address multiple areas of growing unmet need. |
| 2022-08-04 | Eli Lilly and Company | Regulatory Lilly Reports Second-Quarter Financial Results, Highlights Momentum of New Medicines and Pipeline Advancements lilly.com ↗
The FDA also accepted, with Priority Review designation, pirtobrutinib for mantle cell lymphoma for patients previously treated with a BTK inhibitor for review under the accelerated approval pathway. |
| 2021-12-12 | Eli Lilly and Company | Results Loxo Oncology at Lilly Announces Updated Data from the Phase 1/2 BRUIN Clinical Trial for Pirtobrutinib at the American Society of Hematology Annual Meeting lilly.com ↗
Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), today announced updated clinical data from the pirtobrutinib global Phase 1/2 BRUIN clinical trial in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL). |
| 2021-03-05 | Eli Lilly and Company | Results Loxo Oncology at Lilly Announces Publication of Pirtobrutinib (LOXO-305) Phase 1/2 Data in The Lancet lilly.com ↗
These data establish that the third generation BTK inhibitor pirtobrutinib possesses a compelling efficacy and safety profile with the potential to address this exact unmet need. |
| 2020-12-07 | Eli Lilly and Company | Results Loxo Oncology at Lilly Announces Updated Data from the Phase 1/2 BRUIN Clinical Trial for LOXO-305 in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma at the American Society of Hematology Annual Meeting lilly.com ↗
Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), today announced clinical data from the LOXO-305 global Phase 1/2 BRUIN clinical trial in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). |
| 2020-12-05 | Eli Lilly and Company | Results Loxo Oncology at Lilly Announces Updated Data from the Phase 1/2 BRUIN Clinical Trial for LOXO-305 in Mantle Cell Lymphoma and Non-Hodgkin Lymphomas at the American Society of Hematology (ASH) Annual Meeting lilly.com ↗
Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), today announced clinical data from the LOXO-305 global Phase 1/2 BRUIN clinical trial in mantle cell lymphoma (MCL) and other non-Hodgkin lymphomas. |
| 2019-12-08 | Eli Lilly and Company | Results Lilly Presents Interim Clinical Data from LOXO-305 Dose Escalation Trial in B-Cell Leukemias and Lymphomas at the American Society Hematology Annual Meeting lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced interim clinical data from the LOXO-305 global Phase 1/2 BRUIN dose escalation trial. |
All press releases naming this drug 32 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 76 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pirtobrutinib | “pirtobrutinib (P, 200 mg once daily) is taken orally on days 4-21” NCT07604987 ↗ |
| Known as | [14C]-LOXO-305 | “single dose of 200 milligram (mg) LOXO-305 radiolabelled with carbon-14, i.e., \[14C\]-LOXO-305 (approximately 200 microcurie radioactivity) administered as an oral solution.” NCT06180954 ↗ |
| Known as | Jaypirca | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650485 ↗ |
| Known as | LOXO-305 | “A Study of Pirtobrutinib (LY3527727 [LOXO-305]) Versus Placebo in Participants With Relapsing Multiple Sclerosis” NCT06104683 ↗7“pirtobrutinib (also called LOXO-305)” NCT06263491 ↗ “Pirtobrutinib (LOXO-305)” NCT06190691 ↗ “LOXO-305” NCT05024045 ↗ |
| Known as | LY3527727 | “A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma” NCT07218341 ↗ |
| Known as | RXC-005 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650485 ↗ |
| Action | Inhibit | “Pirtobrutinib inhibited BTK activation as well as downstream signaling in MEC-1 isogenic cells overexpressing BTKWT, BTKC481S, or BTKC481R.” PMID 35595730 ↗ May 2022 |
| Modality | Small molecule | — CHEMBL4650485 ↗ |
| Route | Oral | “100-300 mg oral pirtobrutinib once a day” PMID 42069409 ↗ May 2026 |
| Target | BTK | “Pirtobrutinib inhibits wild-type and mutant Bruton's tyrosine kinase-mediated signaling in chronic lymphocytic leukemia.” PMID 35595730 ↗ May 2022 |