Tirabrutinib

Name: Tirabrutinib in Primary central nervous system lymphoma: Generic, brand name and therapeutic class of product
Published: 2026-09-14T15:39:06-04:00

Primary central nervous system lymphoma

Manufacturer: Deciphera Pharmaceuticals
Regulatory submission: NDA submitted December 2025
Launch: Anticipated in the fiscal year ending March 2027
Last updated: September 19, 2026

Section

Product information and disease description Product description Product information

Generic, brand name and therapeutic class of product

2 evidence topics · 5 sources

Manufacturer: Deciphera Pharmaceuticals

“Developed in collaboration with Deciphera’s parent company, Ono Pharma.” (opens the source at this quote in a new tab)

“Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd.” (opens the source at this quote in a new tab)
“The FDA’s acceptance of tirabrutinib’s NDA for filing is an exciting milestone as it brings us one step closer to our goal of providing patients with R/R PCNSL an important new treatment option.” (opens the source at this quote in a new tab)
“Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care.” (opens the source at this quote in a new tab)

“As of July 1, 2025, Key function of ONO PHARMA USA was integrated into Deciphera.” (opens the source at this quote in a new tab)

Research name

“Code name: ONO-4059” (opens the source at this quote in a new tab)