Name: Lirafugratinib (Lyrfigtu) in Previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma: Generic, brand name and therapeutic class of product
Published: 2026-09-27T09:44:05-04:00

Manufacturer: Elevar Therapeutics

“On September 23, 2026, the Food and Drug Administration approved lirafugratinib (Lyrfigtu, Elevar Therapeutics, Inc.), a kinase inhibitor” (opens the source at this quote in a new tab)

“Elevar has an exclusive license to lirafugratinib from Relay Therapeutics, Inc. for commercialization worldwide.” (opens the source at this quote in a new tab)
“Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for cancer patients” (opens the source at this quote in a new tab)

Nonproprietary name, brand name, and development code

“Lyrfigtu (lirafugratinib, aka RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers.” (opens the source at this quote in a new tab)

“The proposed name Lyrfigtu (pronounced leer fig tu) was developed in accordance with the FDA’s guidance on proprietary names.” (opens the source at this quote in a new tab)

Therapeutic class

“LYRFIGTU is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring a FGFR2 fusion or other rearrangement.” (opens the prescribing information at this quote)
“Lirafugratinib is a small molecule kinase inhibitor that inhibits FGFR2. Lirafugratinib covalently binds FGFR2.” (opens the prescribing information at this quote)

“Lirafugratinib is an irreversible inhibitor that selectively targets FGFR2, differentiating it from existing pan-FGFR inhibitors that broadly inhibit FGFR1, FGFR3, and/or FGFR4 in addition to FGFR2.” (opens the source at this quote in a new tab)

Chemical description and salt form

“Lirafugratinib hydrochloride is the salt form of lirafugratinib, a kinase inhibitor.” (opens the prescribing information at this quote)
“Lirafugratinib hydrochloride is practically insoluble in water.” (opens the prescribing information at this quote)

Originator and license: Relay Therapeutics

“In December 2024, the Company and Elevar Therapeutics, Inc. ("Elevar") entered into the Exclusive License Agreement (as amended from time to time, the "Elevar Agreement"), pursuant to which Elevar was granted exclusive global development and commercialization rights for lirafugratinib (RLY-4008), the Company's selective oral small molecule inhibitor of fibroblast growth factor receptor 2 ("FGFR2").” (opens the source at this quote in a new tab)
“Under the terms of the Elevar Agreement, we received $5.0 million upon execution, $3.7 million upon transfer of active pharmaceutical ingredient and other materials, and $10.0 million in milestone payments as of June 30, 2026. We are eligible to receive up to $485.0 million in regulatory and commercial milestone payments, as well as tiered royalties.” (opens the source at this quote in a new tab)

“Relay Therapeutics is eligible to receive up to $75 million in upfront and regulatory milestones, plus up to $425 million in potential commercial milestone payments, as well as tiered royalties up to the low-teens percentage.” (opens the source at this quote in a new tab)

Manufacturing, packaging, and distribution

“Manufactured by Quotient Sciences - Philadelphia, LLC” (opens the prescribing information at this quote)
“Distributed by: Elevar Therapeutics, Inc. Fort Lee, NJ 07024, USA” (opens the prescribing information at this quote)