Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of…. Sold as Jaypirca. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Pirtobrutinib (sold as Jaypirca), first approved Jan 27, 2023, with 3 new uses approved and 0 published complete response letters.
First approved: Jan 27, 2023
Applications: 1
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $379M
Orphan exclusivity until: Dec 3, 2032
First approved in the EU: Oct 30, 2023
First approved in Japan: Jun 24, 2024
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 17 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
JaypircaDrugs with a new indication for the treatment of relapsed or refractory chronic lymphocytic leukemia (including small lymphocytic lymphoma) with resistant… · Eli Lilly Japan K.K. · Sep 19, 2025
Jaypirca, new ingredientDrugs with a new active ingredient indicated for the treatment of relapsed or refractory mantle cell lymphoma with resistance or intolerance to other BTK… · Eli Lilly Japan K.K. · Jun 24, 2024 · Review report
Clinical Trials
63 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
