Niraparib

Generic Name: Niraparib

Brand Names: Zejula

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₀N_₄O

CAS Number: 1038915-60-4

Unique Ingredient Identifier: HMC2H89N35

Background: Niraparib is an orally active poly (ADP-ribose) polymerase (PARP) inhibitor. By blocking the enzymes responsible for DNA repair, niraparib induces cytotoxicity in cancer cells. Niraparib is selective towards PARP-1 and PARP-2. First approved by the FDA on March 27, 2017, niraparib is used to treat epithelial ovarian, fallopian tube, or primary peritoneal cancer. Niraparib was approved by the European Commission on November 16, 2017 and by Health Canada on June 27, 2019.

Indication: Niraparib is indicated for the maintenance treatment of adult patients with advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

In Canada and the US, niraparib is also available in a combination product with abiraterone, which is indicated with prednisone for the treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). In Canada, this combination product is also used with prednisolone and is reserved for patients who are asymptomatic or mildly symptomatic, and in whom chemotherapy is not clinically indicated.

Associated Conditions: Advanced Epithelial Ovarian Cancer, Advanced Primary Peritoneal Carcinoma, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Primary Peritoneal Cancer, Advanced Fallopian Tubes Cancer

Associated Therapies: Maintenance therapy

Clinical Trials

SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy

Phase 2

Recruiting

Conditions: Ovarian Cancer Recurrent

Interventions: Drug: Niraparib oral capsule
Radiation: SBRT

First Posted Date: 2023-08-14

Last Posted Date: 2025-04-22

Lead Sponsor: Institute of Cancer Research, United Kingdom

Target Recruit Count: 42

Registration Number: NCT05990192

Locations: 🇬🇧
Western General Hospital, Edinburgh, Scotland, United Kingdom
🇬🇧
The Christie NHS Foundation Trust, Manchester, United Kingdom
🇬🇧
The Royal Marsden NHS Foundation Trust, London, United Kingdom

and more 1 locations

Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer

Phase 2

Recruiting

Conditions: Ovarian Cancer
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
High Grade Ovarian Serous Adenocarcinoma

Interventions: Drug: Niraparib

First Posted Date: 2023-07-27

Last Posted Date: 2023-11-22

Lead Sponsor: Sunnybrook Health Sciences Centre

Target Recruit Count: 40

Registration Number: NCT05961124

Locations: 🇨🇦
Sunnybrook Research Institute, Toronto, Ontario, Canada

Study of ART6043 in Advanced/Metastatic Solid Tumors Patients

Phase 1

Recruiting

Conditions: Metastatic Solid Tumor
Advanced Solid Tumor

Interventions: Drug: ART6043
Drug: Niraparib
Drug: Olaparib

First Posted Date: 2023-06-12

Last Posted Date: 2024-10-29

Lead Sponsor: Artios Pharma Ltd

Target Recruit Count: 260

Registration Number: NCT05898399

Locations: 🇺🇸
Jefferson University Hospitals - Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
SCRI oncology partners, Nashville, Tennessee, United States
🇺🇸
South Texas Accelerated Research Therapeutics (START) - Midwest, Grand Rapids, Michigan, United States

and more 3 locations

Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

Phase 2

Active, not recruiting

Conditions: Recurrent Endometrial Serous Adenocarcinoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Biological: Dostarlimab
Procedure: Magnetic Resonance Imaging
Drug: Niraparib

First Posted Date: 2023-05-23

Last Posted Date: 2025-02-12

Lead Sponsor: Casey Cosgrove

Target Recruit Count: 8

Registration Number: NCT05870761

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma

Phase 1

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Dostarlimab
Drug: cisplatin plus radiotherapy
Drug: Niraparib

First Posted Date: 2023-03-24

Last Posted Date: 2025-03-13

Lead Sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Target Recruit Count: 34

Registration Number: NCT05784012

Locations: 🇪🇸
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
🇪🇸
Institut Catalá d'Oncologia (ICO) Hospitalet, Hospitalet de Llobregat, Cataluña, Spain
🇪🇸
Institut Catalá d'Oncologia (ICO) BADALONA, Badalona, Cataluña, Spain

and more 2 locations