Drug Profile

Pemigatinib - Incyte Corporation

Alternative Names: IBI-375; INCB 54828; INCB-054828; Pemazyre

Latest Information Update: 26 May 2025

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At a glance

Originator Incyte Corporation
Developer Academic and Community Cancer Research United; Incyte Biosciences International; Incyte Corporation; Innovent Biologics; Knight Therapeutics; National Cancer Institute (USA)
Class Antineoplastics; Ethers; Fluorobenzenes; Morpholines; Pyridines; Pyrimidinones; Pyrroles; Small molecules
Mechanism of Action Type 1 fibroblast growth factor receptor antagonists; Type 3 fibroblast growth factor receptor antagonists; Type-2 fibroblast growth factor receptor antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Cholangiocarcinoma; Myeloproliferative disorders; Lymphoma
New Molecular Entity Yes

Marketed Cholangiocarcinoma
Registered Lymphoma; Myeloproliferative disorders
Phase II Adenosquamous carcinoma; Bladder cancer; Colorectal cancer; Endometrial cancer; Glioblastoma; Non-small cell lung cancer; Solid tumours; Urogenital cancer
Phase I/II Cancer

31 Mar 2025 Registered for Cholangiocarcinoma (Late-stage disease, Metastatic disease, Second-line therapy or greater, In adults) in Mexico (PO)
17 Dec 2024 Incyte Corporation completes a phase II FIGHT-209 trial in Glioblastoma (Recurrent, Second-line therapy or greater) in the US, UK, France, Germany, Italy, Denmark, Japan, Netherlands and Spain (PO) (NCT05267106) (EudraCT-2021-004740-24) )
30 Oct 2024 Incyte Corporation completes the phase-IIFIGHT-203 trial in Myeloproliferative disorders (Monotherapy, Second-line therapy or greater) in US, Austria, France, Belgium, Germany, Italy, Spain, Switzerland, the UK, Japan and Canada (PO) (NCT03011372)

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