drug · small molecule
pirtobrutinib
Marketedupdated 5mo 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
- phase3A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- phase3Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
- phase2Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
- phase2Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
- phase3A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL).
- 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 of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jan 27, 2028
~1.3 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)4.2y
- Dec 1, 2030ODE-451Orphan Drug (7y)4.2y
- Jan 27, 2030ODE-424Orphan Drug (7y)3.3y
- Jan 27, 2030ODE-424Orphan Drug (7y)3.3y
- Dec 2, 2028I-981Indication (3y)2.2y
- Dec 2, 2028I-981Indication (3y)2.2y
- Jan 27, 2028NCENew Chemical Entity (5y)1.3y
- Jan 27, 2028NCENew Chemical Entity (5y)1.3y
News(10)
- STAT+: New Trump regulations would clean up health care pricing disclosuresThe Trump administration is continuing its effort to bring more transparency to the cost of health care.stat · 1h ago
- STAT+: Prices, prices, pricesWhy is health insurance so expensive? Read the latest stort in STAT's "Out of Pocket, Out of Reach" series to find out.stat · 3h ago
- STAT+: Utah plows ahead with more health AI pilots for prescriptions, women’s healthUtah plans to allow an AI product to evaluate patients and write new drug prescriptions without prior human review.stat · 4h ago
- Genmab details ovarian cancer data; Lilly's Jaypirca gets a label expansionPlus news about Biogen and Gate Bioscience. Genmab shares ovarian cancer data for Rina-S: The drugmaker's FRα-directed ADC attained a 45.9% objective response rate in patients with platinum-resista…endpoints · 5h ago
- Optogenetics researchers win a Nobel Prize; Roche bets on Alector brain drugThe Nobel laureates “laid the foundation” for a new field of brain research, the award committee wrote. Elsewhere, Roche and CSL cut licensing deals and the FDA endorsed broader use of a Lilly medi…biopharma_dive · 6h ago
- STAT+: Lilly’s Jaypirca approved as first-line CLL therapyEli Lilly’s Jaypirca has won FDA approval for previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma.stat · 6h ago
- 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 · 3mo 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 · 3mo 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 · 4mo 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 · 4mo ago
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