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

A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)

Phase 2

Terminated

Conditions: Ovarian Neoplasms

Interventions: Drug: Niraparib
Drug: Carboplatin
Drug: Paclitaxel

First Posted Date: 2025-05-09

Last Posted Date: 2025-05-09

Lead Sponsor: Tesaro, Inc.

Target Recruit Count: 36

Registration Number: NCT06964165

Locations: 🇪🇸
GSK Investigational Site, Pamplona, ES, Spain

Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer

Phase 3

Not yet recruiting

Conditions: Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Ovarian Cancer
Fallopian Tube Cancer

Interventions: Drug: IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer)
Drug: Paclitaxel
Drug: Carboplatin
Drug: Olaparib
Drug: Niraparib

First Posted Date: 2025-04-07

Last Posted Date: 2025-05-08

Lead Sponsor: Imunon

Target Recruit Count: 500

Registration Number: NCT06915025

A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer

Phase 4

Not yet recruiting

Conditions: Ovarian Neoplasms

Interventions: Drug: Niraparib

First Posted Date: 2025-03-21

Last Posted Date: 2025-03-21

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 67

Registration Number: NCT06887933

Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy

Phase 2

Recruiting

Conditions: Pancreatic Adenocarcinoma Metastatic

Interventions: Drug: Niraparib
Drug: FOLFIRI
Drug: Ipilimumab

First Posted Date: 2024-12-24

Last Posted Date: 2025-05-13

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 68

Registration Number: NCT06747845

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States

A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours

Phase 1

Not yet recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: LM-2417
Drug: Docetaxel
Drug: Toripalimab/Tirelizumab
Drug: Carboplatin
Drug: Niraparib
Drug: Lenvatinib

First Posted Date: 2024-11-12

Last Posted Date: 2025-03-11

Lead Sponsor: LaNova Medicines Limited

Target Recruit Count: 320

Registration Number: NCT06682780

Locations: 🇨🇳
FuDan University Shanghai Cancer Center, Shanghai, Shanghai, China

Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Niraparib 200/300 MG

First Posted Date: 2024-09-26

Last Posted Date: 2024-10-23

Lead Sponsor: Pomeranian Medical University Szczecin

Target Recruit Count: 300

Registration Number: NCT06614790

Locations: 🇵🇱
Oddział Onkologii Ginekologicznej Białostockiego Centrum Onkologii, Białystok, Poland
🇵🇱
Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej Uniwersyteckie Centrum Kliniczne, Gdańsk, Poland
🇵🇱
III Klinika Radioterapii i Chemioterapii Narodowego Instytutu Onkologicznego w Gliwicach, Gliwice, Poland

and more 8 locations

A Study of Niraparib in Combination with Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)

Phase 1

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Niraparib Tosylate Monohydrate

First Posted Date: 2024-09-19

Last Posted Date: 2025-03-28

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Target Recruit Count: 73

Registration Number: NCT06594679

Locations: 🇮🇹
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

Phase 2

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Tuvusertib (M1774)
Drug: Lartesertib (M4076)
Drug: Niraparib

First Posted Date: 2024-05-29

Last Posted Date: 2025-02-03

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 60

Registration Number: NCT06433219

Locations: 🇵🇱
MICS Centrum Medyczne Torun - Medicovernn, Torun, Poland
🇪🇸
Hospital Clinic de Barcelona - Servicio de Oncologia, Barcelona, Spain
🇪🇸
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica, Girona, Spain

and more 55 locations

Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

Phase 4

Suspended

Conditions: Ovarian Cancer

Interventions: Drug: Niraparib

First Posted Date: 2024-05-14

Last Posted Date: 2025-04-25

Lead Sponsor: University of Miami

Target Recruit Count: 70

Registration Number: NCT06412120

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Phase 3

Recruiting

Conditions: Glioblastoma
Brain Tumor
GBM
Brain Neoplasms, Adult, Malignant

Interventions: Drug: Temozolomide
Drug: Niraparib

First Posted Date: 2024-04-29

Last Posted Date: 2025-04-22

Lead Sponsor: Ivy Brain Tumor Center

Target Recruit Count: 450

Registration Number: NCT06388733

Locations: 🇺🇸
Ivy Brain Tumor Center, Phoenix, Arizona, United States
🇺🇸
Moores UCSD Cancer Center, La Jolla, California, United States
🇺🇸
The NeuroMedical Center, Baton Rouge, Louisiana, United States

and more 21 locations

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