Friday, July 10, 2026

Drug profile · INN

pemigatinib

pemigatinib (PEMAZYRE) is a fibroblast growth factor receptor 1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01EN02
US status approved
Patents linked 0
Pipeline programs 5
News articles 0
Drug details — pemigatinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
5
Data quality
0.84

Quick answer

pemigatinib (PEMAZYRE) is a fibroblast growth factor receptor 1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN pemigatinib
Brand PEMAZYRE
Mechanism Fibroblast growth factor receptor 1 inhibitor
Target Fibroblast growth factor receptor 1
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01EN02

Mechanism of action

Fibroblast growth factor receptor 1 inhibitor

Primary target: Fibroblast growth factor receptor 1

Approval history

Authority Status Date
FDA approved
EMA approved
NMPA clinical trials

Pipeline programs

  1. INCB 54828-302 Phase 3 · Incyte · Cholangiocarcinoma
  2. Pemigatinib Phase 3 · Incyte · Unresectable Cholangiocarcinoma
  3. INCMGA0012-204 Phase 2 · Incyte · Endometrial cancer, Endometrial cancer
  4. Pemazyre 4.5 mg tablets Phase 2 · George Institute for · locally advanced intrahepatic cholangiocarcinoma (iCCA) with
  5. Pemazyre 4.5 mg tablets Phase 2 · Ningbo Cancer Hospital · Recurrent or metastatic solid cancer harboring a FGFR1,2 ,3

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is pemigatinib?

pemigatinib (PEMAZYRE) is a fibroblast growth factor receptor 1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for pemigatinib?

PEMAZYRE is a marketed brand name for pemigatinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of pemigatinib?

pemigatinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.