Drugs / Pemigatinib
last change Aug 2026 re-read 2 minutes ago

Pemigatinib

Small molecule targets FGFR1, FGFR2, FGFR3 via inhibition

Developed for
cholangiocarcinoma · cancer · non-small cell lung carcinoma · urothelial carcinoma · breast cancer · digestive system cancer · intrahepatic cholangiocarcinoma · endometrial cancer
+23 more · gastric cancer · lung cancer · myeloproliferative neoplasm · acute myeloid leukemia · breast neoplasm · cancer of unknown primary site · colorectal cancer · colorectal carcinoma · dedifferentiated liposarcoma · exocrine pancreatic carcinoma · gastrointestinal stromal tumor · glioblastoma · hematopoietic and lymphoid cell neoplasm · inborn mitochondrial metabolism disorder · mantle cell lymphoma · marginal zone lymphoma · metastatic malignant neoplasm · metastatic neoplasm · non-invasive bladder urothelial carcinoma · plasma cell myeloma · refractory malignant neoplasm · soft tissue sarcoma · carcinoma
Investigated by
Incyte Corporation · Academic and Community Cancer Research United · AstraZeneca · Boehringer Ingelheim · Incyte Corporation · Innovent Biologics (Suzhou) Co. Ltd.
+77 more · National Cancer Institute (NCI) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Tianjin Medical University Cancer Institute and Hospital · AMS Advanced Medical Services GmbH · Amgen · Bayer · Bristol-Myers Squibb · Clovis Oncology - Pharma and · Dana-Farber Cancer Institute · Dutch Cancer Society · Eastern Hepatobiliary Surgery Hospital · Eisai Inc. · Eli Lilly and Company · European Association of Urology Research Foundation · European Network of Gynaecological Oncological Trial Groups (ENGOT) · First Affiliated Hospital of Jinan University · Fondazione per la Medicina Personalizzata · Foundation Medicine · GOG Foundation · Gateway for Cancer Research · Genentech, Inc. · GlaxoSmithKline · H. Lee Moffitt Cancer Center and Research Institute · Haukeland University Hospital · Helse Fonna · Helse Forde · Helse Møre og Romsdal HF · Helse Nord-Trøndelag HF · Helse Stavanger HF · Helsinki University Central Hospital · High Research s.r.l. · Hoffmann-La Roche · HonorHealth Research Institute · Hospital of Southern Norway Trust · Incyte BioSciences France · Innlandet Hospital Trust · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Ipsen · Janssen, LP · Lovisenberg Diakonale Hospital · Lund University Hospital · M.D. Anderson Cancer Center · Massachusetts General Hospital · Mehmet Akce · Merck Sharp & Dohme LLC · National Cancer Institute, France · Nordland Hospital · Novartis · OHSU Knight Cancer Institute · Oregon Health and Science University · Oslo University Hospital · Ostfold Hospital Trust · Pfizer · Roche Pharma AG · Sameek Roychowdhury · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shenzhen University General Hospital · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · St. Olavs Hospital · Stelvio for Life · Sun Yat-sen University · Sykehuset Telemark · The First Affiliated Hospital of Soochow University · The First Affiliated Hospital of Xiamen University · The Fourth Affiliated Hospital of Zhejiang University School of Medicine · The Hospital of Vestfold · The Netherlands Cancer Institute · Tianjin Medical University Second Hospital · UNICANCER · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · University Hospital of North Norway · University Hospital, Akershus · University of Alabama at Birmingham · University of Utah · all 83 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) PEMAZYRE 2022-08-26 fda.gov
Approved · conditional EU (EMA) Pemazyre 2021-03-26 europa.eu
Approved US (FDA) PEMAZYRE 2020-04-17 fda.gov

Trials 49 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT06302621 Apr 2024 → Dec 2027 expected cholangiocarcinoma, metastatic neoplasm, refractory malignant neoplasm Massachusetts General Hospital Recruiting No outcome recorded
Phase 1 NCT04088188 Jan 2021 → Dec 2023 cholangiocarcinoma Academic and Community Cancer Research United Terminated No outcome recorded
Phase 1 NCT04659616 Jan 2021 → Dec 2026 expected acute myeloid leukemia OHSU Knight Cancer Institute Recruiting No outcome recorded
Phase 1 NCT04258527 Mar → Jul 2020 cancer Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 1 NCT03235570 Aug 2017 → Mar 2020 cancer Incyte Corporation Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT06439485 Nov 2024 → Feb 2028 expected cholangiocarcinoma M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT05529667 May 2019 → Aug 2023 Yonsei University Completed No outcome recorded
Phase 1/2 NCT02393248 Feb 2015 → Dec 2021 breast cancer, cholangiocarcinoma, endometrial cancer, gastric cancer +4 Incyte Corporation Terminated No outcome recorded
Phase 238 trials
Phase 2 NCT07434843 May 2026 → Oct 2028 expected gastrointestinal stromal tumor, inborn mitochondrial metabolism disorder Dana-Farber Cancer Institute Recruiting No outcome recorded
Phase 2 NCT06728410 Jan → Jul 2026 overdue intrahepatic cholangiocarcinoma Mehmet Akce Recruiting No outcome recorded
Phase 2 NCT06300528 Oct 2025 → Mar 2026 overdue mantle cell lymphoma, marginal zone lymphoma University of Utah Active not recruiting No outcome recorded
Phase 2 NCT06906562 Aug 2025 → Dec 2026 expected digestive system carcinoma Sameek Roychowdhury Recruiting No outcome recorded
Phase 2 NCT06653777 Mar 2025 → Jun 2027 expected UNICANCER Recruiting No outcome recorded
Phase 2 NCT06551896 Aug 2024 → Jul 2026 overdue breast neoplasm, gastric cancer, lung cancer, soft tissue sarcoma +1 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Not yet recruiting No outcome recorded
Phase 2 NCT06530823 Aug 2024 → Aug 2026 overdue cholangiocarcinoma Eastern Hepatobiliary Surgery Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06389799 Jun 2024 → Dec 2027 expected dedifferentiated liposarcoma Lund University Hospital Recruiting No outcome recorded
Phase 2 NCT05997459 Aug 2023 → Dec 2024 Sun Yat-sen University Unknown No outcome recorded
Phase 2 NCT05913661 Jul 2023 → Nov 2024 intrahepatic cholangiocarcinoma Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Unknown No outcome recorded
Phase 31 trial
Phase 3 NCT03656536 Jun 2019 → Jul 2025 cholangiocarcinoma Incyte Corporation Terminated No outcome recorded
Phase not applicable1 trial
NCT05210946 Dec 2021 → Dec 2023 non-small cell lung carcinoma The First Affiliated Hospital of Soochow University Unknown No outcome recorded
Phase not stated1 trial
NCT03906357 Incyte Corporation No longer available No outcome recorded

Press releases naming this drug 13 releases

DateIssuerRelease
2023-03-27 Incyte Corporation Incyte Announces Japanese Approval of Pemazyre® (pemigatinib) for the Treatment of Patients with Myeloid/Lymphoid Neoplasms (MLNs) incyte.com
2022-08-26 Incyte Corporation Incyte Announces FDA Approval of Pemazyre® (pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement incyte.com
2021-03-29 Incyte Corporation Incyte Announces the European Commission Approval of Pemazyre® (pemigatinib) as a Treatment for Adults with Locally Advanced or Metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement incyte.com
2021-03-23 Incyte Corporation Incyte Announces Approval of Pemazyre® (pemigatinib) in Japan for the Treatment of Patients with Unresectable Biliary Tract Cancer (BTC) with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene, Worsening After Cancer Chemotherapy incyte.com
2021-01-29 Incyte Corporation Incyte Announces Positive CHMP Opinion for Pemigatinib for the Treatment of Adults With Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma With a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement incyte.com
2020-04-17 Incyte Corporation FDA Approves Incyte’s Pemazyre™ (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma incyte.com
2020-01-07 Incyte Corporation Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Pemigatinib in Patients with Cholangiocarcinoma incyte.com
2019-11-27 Incyte Corporation Incyte Announces Acceptance and Priority Review of NDA for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma incyte.com
2019-09-27 Incyte Corporation Incyte Announces Positive Updated Results from Phase 2 Trial of Pemigatinib in Patients with Previously Treated, Advanced Cholangiocarcinoma incyte.com
2019-06-04 Incyte Corporation Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Pemigatinib as a First-Line Therapy for Cholangiocarcinoma incyte.com
2018-10-21 Incyte Corporation Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma incyte.com
2018-10-09 Incyte Corporation Incyte Announces Data for Pemigatinib, its Selective FGFR Inhibitor, to be Featured at the ESMO 2018 Congress incyte.com

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 52 sources stand behind the page.

FieldValueCited text
Known as Pemigatinib ClinicalTrials.gov intervention name — accepted as the source's own label NCT05913661
46

NCT06551896

NCT02924376

NCT04096417

NCT05287386

NCT05560334

NCT04463771

NCT05565794

NCT07434843

NCT04949191

NCT04088188

NCT06022289

NCT06906562

NCT03822117

NCT05210946

NCT04591431

NCT04258527

NCT05997459

NCT05253807

NCT05159245

NCT05004974

NCT05216120

NCT02393248

NCT03498521

NCT03235570

NCT05559775

NCT04659616

NCT03011372

NCT05651672

NCT02872714

NCT06300528

NCT06389799

NCT06728410

NCT05202236

NCT06530823

NCT04294277

NCT05267106

NCT06439485

NCT06302621

NCT06653777

NCT03656536

NCT03906357

NCT04003610

NCT04003623

NCT02925234

NCT03914794

NCT04256980

Known as Fgfr inhibitor incb054828 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297522
Known as INCB054828 “Pemigatinib (INCB054828)” NCT03011372
1

NCT05529667

Known as Pemazyre Pemazyre used outside ofcurrent indication” NCT04817956
Action Inhibit “potent and selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor” PMID 35176457 Feb 2022
Modality Small molecule CHEMBL4297522
Route Oral “Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD)” NCT02393248
Target FGFR1 “BACKGROUND: Fibroblast growth factor receptor 3 (FGFR3) alterations are oncogenic drivers of urothelial carcinoma (UC). Pemigatinib is a selective, oral inhibitor of FGFR1-3...” PMID 37956738 Nov 2023
Target FGFR3 “BACKGROUND: Fibroblast growth factor receptor 3 (FGFR3) alterations are oncogenic drivers of urothelial carcinoma (UC). Pemigatinib is a selective, oral inhibitor of FGFR1-3...” PMID 37956738 Nov 2023