drug · small molecule
pirtobrutinib
Marketedupdated 3mo agoby Eli Lilly and Co🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 2Small molecule drug with a maximum clinical stage of Approval (across all indications), with 5 approved and 3 investigational indications.
targets
Tyrosine-protein kinase BTK
all catalysts(0)
nothing on the calendar yet
Trials studying pirtobrutinib
- phase3ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
- phase4A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- phase3A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- phase3A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- phase2Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial
- phase3Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- phase2Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER)
- phase2Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jan 27, 2028
~1.4 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (14)
- Sep 14, 2041formulationUS 12109193
- Sep 14, 2041formulationUS 12109193
- Jul 29, 2039formulationUS 12268666
- Jul 29, 2039formulationUS 12268666
- Dec 16, 2036compositionUS 10342780
- Dec 16, 2036compositionUS 10342780
- Dec 16, 2036method-of-use (U-4362)US 10464905
- Dec 16, 2036method-of-use (U-4362)US 10464905
- Dec 16, 2036compositionUS 10695323
- Dec 16, 2036compositionUS 10695323
- Dec 16, 2036method-of-use (U-4362)US 10918622
- Dec 16, 2036method-of-use (U-4362)US 10918622
- Dec 16, 2036compositionUS 12220401
- Dec 16, 2036compositionUS 12220401
FDA exclusivities (8)
- Dec 1, 2030ODE-451Orphan Drug (7y)4.3y
- Dec 1, 2030ODE-451Orphan Drug (7y)4.3y
- Jan 27, 2030ODE-424Orphan Drug (7y)3.4y
- Jan 27, 2030ODE-424Orphan Drug (7y)3.4y
- Dec 2, 2028I-981Indication (3y)2.3y
- Dec 2, 2028I-981Indication (3y)2.3y
- Jan 27, 2028NCENew Chemical Entity (5y)1.4y
- Jan 27, 2028NCENew Chemical Entity (5y)1.4y
News(4)
- On second try, Acadia drug gets nod from European regulatorsThe influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.biopharma_dive · 1mo ago
- Lilly puts its stamp at #EHA26 with Jaypirca combo data in CLL, first clinical data from Ajax buyoutEli Lilly made a push in blood cancer at this year’s European Hematology Association meeting in Stockholm over the weekend. The drugmaker presented data for Jaypirca combined with the standard of c…endpoints · 2mo ago
- CLL-321 Trial Efficacy and Safety Results AnalysisPhase 3 results: pirtobrutinib boosts PFS, delays next treatment after prior BTK therapy, and shows low cardiac toxicity.onclive · 3mo ago
- BRUIN CLL-321 Trial Impact and Treatment SelectionExperts outline relapse workup in CLL, using PET-CT and biopsy for suspected Richter’s, plus resistance and TP53 testing to guide next therapy.onclive · 3mo ago
Data sources
last refreshed 16m ago
Found something off?
comments(0)
5-min edit window · permanent after that