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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ZEJULA niraparib (as tosilate monohydrate) 100 mg film-coated tablet blister pack | 395406 | Medicine | A | 8/2/2023 | |
ZEJULA niraparib (as tosilate monohydrate) 100 mg capsule blister pack | 305254 | Medicine | A | 6/28/2019 |