Drugs / Pirtobrutinib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 66 · started per year
today
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 116 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 1/24 trials | ||||||
| Phase 1/2 | NCT06721013 | Jul 2025 → May 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 | No outcome recorded |
| 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 234 trials | ||||||
| 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 | Aug 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 | NCT07548450 | Jun 2026 → Jun 2034 expected | Waldenstrom macroglobulinemia | University of Utah | 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 |
| 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 | ||||||
| Phase 3 | NCT07220187 | Aug 2026 → Oct 2035 expected | Richter transformation | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07516093 | Jun 2026 → Oct 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Nurix Therapeutics, Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05254743 | Jul 2022 → Oct 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Loxo Oncology, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05023980 | Sep 2021 → Jul 2025 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Loxo Oncology, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04965493 | Sep 2021 → Oct 2026 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Loxo Oncology, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04662255 | Apr 2021 → Jan 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07052695 Background | Nov 2025 → Dec 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Inhye Ahn | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| 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 |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 72 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 ↗64 |
| 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 | Other / unclassified | “Pirtobrutinib is in a class of medications called kinase inhibitors.” NCT06252675 ↗ |
| 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 |