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niraparib

Trade name: zejula

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Mar 27, 2017

Niraparib (MK-4827) displays excellent PARP 1 and 2 inhibition. Inhibition of PARP in the context of defects in other DNA repair mechanisms provide a tumor specific way to kill cancer cells. Niraparib is in development with TESARO, under licence from Merck & Co, for the treatment of cancers (ovarian, fallopian tube and peritoneal cancer, breast cancer, prostate cancer and Ewing's sarcoma). Niraparib was characterized in a number of preclinical models before moving to phase I clinical trials, where it showed excellent human pharmacokinetics suitable for once a day oral dosing, achieved its pharmacodynamic target for PARP inhibition, and had promising activity in cancer patients. It is currently being tested in phase 3 clinical trials as maintenance therapy in ovarian cancer and as a treatment for breast cancer. — NCATS

Clinical trial activity

192 trials · 194 clinical orgs · 4 marketing orgs

Phase 1
66
Phase 2
142
Phase 3
20
Phase 4
5

Earliest trial started Sep 1, 2008 (NCT00749502)

Timeline

2000s

  1. Jan 1, 2008

    Tesaro — Earliest Phase 1 Sponsor(trial)

  2. May 1, 2008

    Merck — IND Organization

  3. May 1, 2008

    Merck — IND Organization

2010s

  1. Jan 1, 2010

    Tesaro — Earliest Phase 2 Sponsor(trial)

  2. Apr 30, 2010

    Orphan Drug Designation

  3. Jan 1, 2013

    Tesaro — Earliest Phase 3 Sponsor(trial)

  4. Mar 27, 2017

    Tesaro — Earliest FDA Approval

  5. Mar 27, 2017

    Tesaro — NDA Secondary Org

  6. Mar 27, 2017

    GlaxoSmithKline — Marketing Organization

  7. Mar 27, 2017

    Tesaro — NDA Organization

  8. Mar 27, 2017

    GlaxoSmithKline — NDA Secondary Org

2020s

  1. Aug 11, 2023

    Johnson and Johnson — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewFast trackBreakthroughMar 27, 2017

Chemistry & pharmacology

Loading structure…

SMILES

Cc1ccc(S(=O)(=O)O)cc1.NC(=O)c1cccc2cn(-c3ccc([C@@H]4CCCNC4)cc3)nc12.O
Mol. weight
510.62 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

Sources

Also known as

  • 2-(4-(piperidin-3-yl)phenyl)-2h-indazole-7-carboxamide
  • mk4827
  • mk 4827
  • mk-4827
  • mk-4827
  • mk-4827
  • mk-4827
  • niraparib
  • niraparib
  • niraparib
  • niraparib
  • niraparib
  • niraparib
  • niraparib
  • niraparib hydrochloride
  • niraparib tosylate
  • niraparib tosylate monohydrate
  • zejula
  • zejula
  • zejula

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06953323Phase 1/Phase 2 (Phase 2)Jul 10, 2025Government of China
NCT06915025Phase 3Jul 9, 2025Celsion, Washington University in St. Louis
NCT06887933Phase 4Apr 22, 2025GlaxoSmithKline
NCT06747845Phase 2Jan 6, 2025Bristol-Myers Squibb, GlaxoSmithKline, Lustgarten Foundation, University of Pennsylvania
NCT06412120Phase 4Jan 1, 2025GlaxoSmithKline, University of Miami
NCT06392841Phase 2Dec 31, 2024Hoosier Cancer Research Network, Janssen Pharmaceutica NV
NCT06682780Phase 1/Phase 2 (Phase 2)Dec 5, 2024LaNova Medicines Limited
NCT06502691Phase 1/Phase 2 (Phase 2)Dec 1, 2024Breast Cancer Research Foundation, University of Washington
NCT06527690Phase 2Nov 29, 2024Janssen Pharmaceutica NV, Latin American Cooperative Oncology Group
NCT06365970Phase 2Oct 31, 2024GlaxoSmithKline, University of Pittsburgh
NCT06329830Phase 1/Phase 2 (Phase 2)Oct 31, 2024Baptist Health, Janssen Pharmaceutica NV, Miami Cancer Institute
NCT06258018Phase 1/Phase 2 (Phase 2)Sep 30, 2024GlaxoSmithKline, Istituto Clinico Humanitas - Rozzano (MI), Italy
NCT06594679Phase 1/Phase 2 (Phase 2)Sep 18, 2024Eli Lilly, GlaxoSmithKline, University of Milan
NCT05615818Phase 3Jul 18, 2024Accord Research, Belgian Group of Digestive Oncology, Cancer Research UK, Center Eugene Marquis, Institut Mutualiste Montsouris, National Cancer Institute, France, Otsuka, Pierre Fabre, Servier, UNICANCER, Université catholique de Louvain, University of London, Zymeworks Inc.
NCT06388733Phase 3Jun 19, 2024GlaxoSmithKline, Ivy Brain Tumor Center
NCT06320067Phase 3Jun 11, 2024Cancer Research UK, Janssen Pharmaceutica NV, Medical Research Council, Novartis, University of London
NCT06212583Phase 2Apr 17, 2024Janssen Pharmaceutica NV, University of Maryland
NCT06237205Phase 2Feb 27, 2024Korea University, Seoul National University, Takeda
NCT05990192Phase 2Jan 31, 2024Royal Marsden Hospital NHS Trust, University of London
NCT06180356Phase 2Dec 31, 2023MedSIR, Universidad Complutense de Madrid
Showing 20 of 192 trials
Page 1 / 10

Organizations

Research & Development (194)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TesaroFor profit472252008
GlaxoSmithKlineFor profit43642018
Janssen Pharmaceutica NVFor profit12332017
Harvard UniversityAcademic/Hospital10832013
Zai Lab Pty. Ltd.For profit10632017
Sun Yat-Sen UniversityAcademic/Hospital8312020
Chinese Academy of Medical SciencesAcademic/Hospital6522020
Myrexis Inc.For profit6022013
TakedaFor profit6332018
European Network for Gynaecological Oncological TrialAcademic/Hospital5022013
National Cancer Institute (NCI)Government5022018
University of PennsylvaniaAcademic/Hospital5412018
University of Texas at HoustonAcademic/Hospital5522018
Fudan UniversityAcademic/Hospital4112019
Hoosier Cancer Research NetworkAcademic/Hospital4222016
RocheFor profit4232018
University of LondonAcademic/Hospital4332023
University of TorontoAcademic/Hospital4312017
Zhejiang UniversityAcademic/Hospital4012020
ARCAGY-GINECOFor profit3332018
194 organizations
Page 1 / 10

Marketing (6)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitMKTGMar 27, 2017
GlaxoSmithKlineFor profitNDA2Mar 27, 2017
Johnson and JohnsonFor profitNDA2Aug 11, 2023
MerckFor profitINDMay 1, 2008
TesaroFor profitNDA2Mar 27, 2017
TesaroFor profitNDAMar 27, 2017