pemigatinib

Trade name: Pemazyre

Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Apr 17, 2020

Pemigatinib, sold under the brand name Pemazyre, is an anti-cancer medication used for the treatment of bile duct cancer (cholangiocarcinoma). Pemigatinib works by blocking FGFR2 in tumor cells to prevent them from growing and spreading. — Wikipedia

Clinical trial activity

45 trials · 42 clinical orgs · 2 marketing orgs

Phase 1
7
Phase 2
38
Phase 3
1
Phase 4
0

Earliest trial started Jan 1, 2015 (NCT02393248)

Timeline

2010s

  1. Jan 1, 2015

    Incyte — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Incyte — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2018

    Incyte — Earliest Phase 3 Sponsor(trial)

  4. Mar 12, 2018

    Orphan Drug Designation

2020s

  1. Apr 17, 2020

    Incyte — Earliest FDA Approval

  2. Apr 17, 2020

    Incyte — Marketing Organization

  3. Apr 17, 2020

    Incyte — NDA Secondary Org

  4. Apr 17, 2020

    Incyte — NDA Organization

  5. Jun 1, 2026

    Sandoz — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughApr 17, 2020

Chemistry & pharmacology

Loading structure…

SMILES

CCN1C(=O)N(c2c(F)c(OC)cc(OC)c2F)Cc2cnc3[nH]c(CN4CCOCC4)cc3c21
Mol. weight
487.51 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • incb054828

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06906562Phase 2Aug 26, 2025Incyte, Ohio State University
NCT06728410Phase 2Jan 31, 2025AstraZeneca, Hoosier Cancer Research Network, Incyte, University of Alabama, Birmingham
NCT06653777Phase 2Dec 15, 2024Curie Institute, National Cancer Institute, France, UNICANCER
NCT06300528Phase 2Nov 30, 2024Incyte, University of Utah
NCT06439485Phase 2Nov 29, 2024Genentech, Incyte, University of Texas at Houston
NCT06551896Phase 2Aug 15, 2024Sun Yat-Sen University
NCT06530823Phase 2Aug 1, 2024Eastern Hepatobiliary Surgery Hospital
NCT06302621Phase 1Jul 1, 2024Boehringer Ingelheim, Harvard University, Incyte
NCT06389799Phase 2Jun 20, 2024Lund University
NCT05997459Phase 2Aug 25, 2023Sun Yat-Sen University
NCT05913661Phase 2Jul 31, 2023Jinan University, Shenzhen University, Sun Yat-Sen University
NCT06022289Phase 2May 1, 2023Tianjin Medical University
NCT05651672Phase 2Dec 2, 2022Tianjin Medical University
NCT05565794Phase 2Nov 30, 2022IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest, Incyte
NCT05560334Phase 2Sep 8, 2022Tianjin Medical University
NCT05559775Phase 2Aug 10, 2022Chinese Academy of Medical Sciences
NCT05216120Phase 2Jun 14, 2022HonorHealth Research Institute, Incyte
NCT05267106Phase 2May 20, 2022Incyte
NCT05253807Phase 2Apr 29, 2022Incyte
NCT05287386Phase 2Jan 21, 2022Xiamen University
Showing 20 of 45 trials
Page 1 / 3

Organizations

Research & Development (42)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
IncyteFor profit251542015
Sun Yat-Sen UniversityAcademic/Hospital3312023
Tianjin Medical UniversityAcademic/Hospital3312022
Academic and Community Cancer Research UnitedAcademic/Hospital2222019
Innovent Biologics (Suzhou) Co. Ltd.For profit2222020
National Cancer Institute (NCI)Government2022019
Advanced Medical Services GmbHAcademic/Hospital1012020
AstraZenecaFor profit1012025
Boehringer IngelheimFor profit1012024
Chinese Academy of Medical SciencesAcademic/Hospital1112022
Cornell UniversityAcademic/Hospital101
Curie InstituteAcademic/Hospital1012024
Eastern Hepatobiliary Surgery HospitalAcademic/Hospital1112024
European Association of Urology Research FoundationAcademic/Hospital1112020
European Network for Gynaecological Oncological TrialAcademic/Hospital1012020
GenentechFor profit1012024
GOG Foundation, Inc.Academic/Hospital1012020
Gynecologic Oncology GroupAcademic/Hospital1012020
Harvard UniversityAcademic/Hospital1112024
High Research s.r.l.For profit1012020
42 organizations
Page 1 / 3

Marketing (4)

OrganizationOrg typeRelationshipDate
IncyteFor profitMKTGApr 17, 2020
IncyteFor profitNDA2Apr 17, 2020
IncyteFor profitNDAApr 17, 2020
SandozFor profitMKTGJun 1, 2026