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ibrutinib

Trade name: imbruvica

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Nov 13, 2013

Ibrutinib is an orally bioavailable Bruton's tyrosine kinase (BTK) inhibitor indicated for the treatment of mantle cell lymphoma (MCL) patients that previously received at least one therapy. The drug was jointly developed by Janssen Biotech and Pharmacyclics. Ibrutinib selectively binds to Cys-481 residue in the allosteric inhibitory segment of BTK (TK/SH1 domain), and irreversibly blocks its enzymatic activity thus preventing B-cell activation and signaling, totally blocking the B-cell receptor and cytokine receptor pathways. This leads to an inhibition of the growth of malignant B cells that overexpress BTK. Apart from mantle cell lymphoma Ibrutinib is approved for the treatment of chronic lymphocytic leukemia and Waldenstrom Macroglobulinemia. — NCATS

Clinical trial activity

339 trials · 161 clinical orgs · 7 marketing orgs

Phase 1
139
Phase 2
244
Phase 3
45
Phase 4
5

Earliest trial started Feb 1, 2009 (NCT00849654)

Timeline

2000s

  1. Jan 1, 2009

    Pharmacyclics — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Pharmacyclics — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2012

    Pharmacyclics — Earliest Phase 3 Sponsor(trial)

  3. Apr 6, 2012

    Orphan Drug Designation

  4. Nov 13, 2013

    Pharmacyclics — Earliest FDA Approval

  5. Nov 13, 2013

    Pharmacyclics — NDA Organization

  6. Nov 13, 2013

    Pharmacyclics — Marketing Organization

  7. Feb 16, 2018

    AbbVie — NDA Secondary Org

2020s

  1. Mar 1, 2021

    Teva — Marketing Organization

  2. May 11, 2021

    Sandoz — Marketing Organization

  3. Jun 3, 2021

    Alvogen — Marketing Organization

  4. Jul 19, 2021

    Zydus Discovery DMCC — Marketing Organization

  5. Mar 15, 2022

    Novartis — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackBreakthroughNov 13, 2013

Chemistry & pharmacology

Loading structure…

SMILES

NC1=C2C(=NC=N1)N(N=C2C3=CC=C(OC4=CC=CC=C4)C=C3)[C@@H]5CCCN(C5)C(=O)C=C
Mol. weight
440.4971 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • 1-[(3r)-3-[4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one
  • 1-[(3r)-3-[4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one
  • cra-032765
  • cra-032765
  • cra-032765
  • ibrutinib
  • ibrutinib
  • ibrutinib
  • ibrutinib
  • ibrutinib
  • ibrutinib
  • ibrutinib
  • ibrutinib
  • ibrutinib
  • ibrutinib
  • ibrutinib
  • imbruvica
  • imbruvica
  • imbruvica
  • imbruvica
  • imbruvica
  • imbruvica
  • imbruvica
  • pci32765
  • pci 32765
  • pci 32765
  • pci 32765
  • pci-32765
  • pci-32765
  • pci-32765
  • pci-32765
  • pci-32765
  • pci-32765-00
  • pci-32765-00
  • pci-32765-00

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06958705Phase 2Dec 1, 2025AbbVie, Nanjing Medical University
NCT07052695Phase 1/Phase 2 (Phase 2)Nov 30, 2025Genentech, Harvard University
NCT07169565Phase 1Sep 1, 2025China Academy of Chinese Medical Sciences
NCT07082868Phase 1Aug 13, 2025Memorial Sloan-Kettering Cancer Center
NCT06649812Phase 2Jan 17, 2025ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
NCT06520098Phase 2Jan 1, 2025Department of Veteran Affairs
NCT06788509Phase 1Dec 30, 2024Johnson and Johnson
NCT06683885Phase 1/Phase 2 (Phase 2)Nov 20, 2024Zhengzhou University
NCT06271616Phase 2Nov 1, 2024Mayo Clinic
NCT06536049Phase 1/Phase 2 (Phase 2)Oct 31, 2024AbbVie, Genmab, Ohio State University
NCT06357676Phase 1/Phase 2 (Phase 2)May 1, 2024Genentech, OHSU Knight Cancer Institute, Oregon Health and Science University
NCT05963074Phase 2Feb 27, 2024Pharmacyclics
NCT06482684Phase 2Feb 15, 2024Johannes Gutenburg University, Ludwig Maximilians University
NCT06136559Phase 3Dec 13, 2023Merck
NCT06134284Phase 4Dec 1, 2023Ningbo No. 1 Hospital
NCT05998642Phase 2Nov 30, 2023Canadian Cancer Trials Group, Janssen Pharmaceutica NV, University of Toronto
NCT05694312Phase 2Nov 24, 2023Gruppo Italiano Malattie EMatologiche dell'Adulto
NCT05864742Phase 2Sep 7, 2023Peter MacCallum Cancer Centre
NCT05672173Phase 2Jun 2, 2023City of Hope National Medical Center, National Cancer Institute (NCI)
NCT05564052Phase 2/Phase 3 (Phase 3)Dec 21, 2022Pharmacyclics
Showing 20 of 339 trials
Page 1 / 17

Organizations

Research & Development (161)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PharmacyclicsFor profit903352009
Johnson and JohnsonFor profit583352010
National Cancer Institute (NCI)Government582442013
Janssen Pharmaceutica NVFor profit37442011
University of Texas at HoustonAcademic/Hospital252332012
Ohio State UniversityAcademic/Hospital181122010
AbbVieFor profit14522015
Harvard UniversityAcademic/Hospital141322012
CelgeneFor profit12322013
Mayo ClinicAcademic/Hospital10812013
GenentechFor profit9022015
Cornell UniversityAcademic/Hospital7532014
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital7732017
NovartisFor profit7322016
German CLL Study GroupAcademic/Hospital6522014
MerckFor profit5122017
Stanford UniversityAcademic/Hospital5522015
Swiss Group for Clinical Cancer ResearchAcademic/Hospital5322015
TG Therapeutics, Inc.For profit5432013
University of California, DavisAcademic/Hospital5522016
161 organizations
Page 1 / 9

Marketing (11)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Feb 16, 2018
AlvogenFor profitMKTGJun 3, 2021
AlvogenFor profitSYNApr 9, 2021
NovartisFor profitMKTGMar 15, 2022
PharmacyclicsFor profitNDANov 13, 2013
PharmacyclicsFor profitMKTGNov 13, 2013
SandozFor profitMKTGMay 11, 2021
TevaFor profitMKTGMar 1, 2021
Zydus Discovery DMCCFor profitMKTGMar 31, 2021
Zydus Discovery DMCCFor profitMKTGJul 19, 2021
Zydus Discovery DMCCFor profitSYNMar 31, 2021