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

Niraparib and Dostarlimab for Patients with MMR-D/MSI-H Colorectal Cancers

Phase 2

Withdrawn

Conditions: MMR-D/MSI-H Colorectal Cancers

Interventions: Drug: Niraparib
Drug: Dostarlimab

First Posted Date: 2024-04-15

Last Posted Date: 2025-02-03

Lead Sponsor: Ibrahim Halil Sahin

Target Recruit Count: 20

Registration Number: NCT06365970

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer

Phase 1

Not yet recruiting

Conditions: Metastatic Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Castration-resistant Prostate Cancer

Interventions: Drug: 177Lu-PSMA-617
Drug: Niraparib abiraterone acetate
Drug: Prednisone

First Posted Date: 2024-03-26

Last Posted Date: 2024-06-27

Lead Sponsor: Rohan Garje

Target Recruit Count: 30

Registration Number: NCT06329830

Locations: 🇺🇸
Miami Cancer Institute, Miami, Florida, United States

A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer

Phase 3

Recruiting

Conditions: Prostate Cancer Metastatic

Interventions: Radiation: Stereotactic Ablative Body Radiotherapy (SABR)
Drug: Androgen Deprivation Therapy (ADT)
Other: 177Lu-PSMA-617
Drug: Niraparib and Abiraterone Acetate Dual Action Tablet DAT
Drug: Apalutamide
Drug: Androgen Receptor Signalling Inhibitor (ARSI)
Drug: Abiraterone Acetate
Radiation: Local Radiotherapy
Drug: Docetaxel
Drug: Prednisolone

First Posted Date: 2024-03-20

Last Posted Date: 2024-08-09

Lead Sponsor: University College, London

Target Recruit Count: 8000

Registration Number: NCT06320067

Locations: 🇬🇧
University College London Hospitals NHS Foundation Trust, London, United Kingdom
🇬🇧
The Royal Marsden Hospital, Sutton, United Kingdom
🇬🇧
Royal Devon University Hospital Trust, Exeter, United Kingdom

Niraparib and Temozolomide in Patients Glioblastoma

Phase 1

Not yet recruiting

Conditions: Glioma, Malignant

Interventions: Drug: Temodal
Drug: Niraparib

First Posted Date: 2024-02-14

Last Posted Date: 2024-02-14

Lead Sponsor: Armando Santoro, MD

Target Recruit Count: 86

Registration Number: NCT06258018

Locations: 🇮🇹
Istituto clinico humanitas, Rozzano, Mi, Italy

Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency

Phase 2

Not yet recruiting

Conditions: Efficacy

Interventions: Drug: Niraparib

First Posted Date: 2024-02-01

Last Posted Date: 2024-02-01

Lead Sponsor: Korea University Anam Hospital

Target Recruit Count: 33

Registration Number: NCT06237205

Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

Phase 2

Recruiting

Conditions: Oligometastatic Disease
Serous Ovarian Tumor
Ovarian Cancer

Interventions: Drug: Niraparib oral tablets

First Posted Date: 2023-12-22

Last Posted Date: 2025-02-21

Lead Sponsor: MedSIR

Target Recruit Count: 30

Registration Number: NCT06180356

Locations: 🇪🇸
Hospital Universitario Virgen Macarena, Sevilla, Spain
🇪🇸
Hospital Universitari Sant Joan de Reus, Tarragona, Spain
🇪🇸
Hospital Universitario La Paz, Madrid, Spain

and more 6 locations