MedPath

Niraparib

Generic Name
Niraparib
Brand Names
Zejula
Drug Type
Small Molecule
Chemical Formula
C19H20N4O
CAS Number
1038915-60-4
Unique Ingredient Identifier
HMC2H89N35

Overview

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.

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

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/09
Phase 2
Terminated
2025/04/07
Phase 3
Not yet recruiting
2025/03/21
Phase 4
Not yet recruiting
2024/12/24
Phase 2
Recruiting
2024/11/12
Phase 1
Not yet recruiting
2024/09/26
N/A
Recruiting
Pomeranian Medical University Szczecin
2024/09/19
Phase 1
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
2024/05/29
Phase 2
Recruiting
2024/05/14
Phase 4
Suspended
2024/04/29
Phase 3
Recruiting
Ivy Brain Tumor Center

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Janssen Biotech, Inc.
57894-050
ORAL
50 mg in 1 1
8/22/2023
Janssen Biotech, Inc.
57894-100
ORAL
100 mg in 1 1
8/22/2023
GlaxoSmithKline LLC
69656-103
ORAL
100 mg in 1 1
4/26/2023
GlaxoSmithKline LLC
0173-0912
ORAL
200 mg in 1 1
4/26/2023
GlaxoSmithKline LLC
0173-0915
ORAL
300 mg in 1 1
4/26/2023
GlaxoSmithKline LLC
0173-0909
ORAL
100 mg in 1 1
4/26/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
4/19/2023

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
ZEJULA FILM-COATED TABLET 300MG
SIN16461P
TABLET, FILM COATED
300mg
4/1/2022
ZEJULA FILM-COATED TABLET 100MG
SIN16459P
TABLET, FILM COATED
100mg
4/1/2022
ZEJULA FILM-COATED TABLET 200MG
SIN16460P
TABLET, FILM COATED
200mg
4/1/2022
Akeega Film-coated Tablets 100mg/500mg
SIN17110P
TABLET, FILM COATED
100mg
10/14/2024
Akeega Film-coated Tablets 50mg/500mg
SIN17109P
TABLET, FILM COATED
50mg
10/14/2024

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Niraparib Tosilate Capsules
国药准字H20190035
化学药品
胶囊剂
12/26/2019

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
© Copyright 2025. All Rights Reserved by MedPath