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    DRUG:

    Zejula (niraparib)

    i
    Other names: MK-4827, JNJ-64091742, ZL-2306, GSK-3985771, GSK3985771, GSK 3985771, JNJ64091742, MK4827, ZL2306, GTPL-8275, GTPL8275, JNJ 64091742, MK 4827, ZL 2306, GTPL 8275
    Company:
    GSK, J&J, Medison, Takeda, ZAI Lab
    Drug class:
    PARP inhibitor
    Related drugs:
    3ms
    Gliofocus: A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma (clinicaltrials.gov)
    P3, N=450, Active, not recruiting, Ivy Brain Tumor Center | Recruiting --> Active, not recruiting
    Enrollment closed
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    MGMT (6-O-methylguanine-DNA methyltransferase)
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    MGMT promoter methylation
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    temozolomide • Zejula (niraparib)
    3ms
    Updated patient-reported outcomes and the effect of disease progression on health-related quality of life in the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer. (PubMed, Gynecol Oncol)
    In the final PRIMA PRO analysis, results confirmed that niraparib first-line maintenance did not negatively affect HRQOL versus placebo. Disease progression caused sustained HRQOL deterioration across arms, emphasizing the clinical importance of extending progression-free survival to preserve patient HRQOL.
    Journal • HEOR
    |
    HRD (Homologous Recombination Deficiency)
    |
    HRD
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    Zejula (niraparib)
    3ms
    TOPAZ: A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers (clinicaltrials.gov)
    P1, N=3, Terminated, University of Iowa | Phase classification: P1/2 --> P1 | Trial completion date: Dec 2024 --> Nov 2025
    Phase classification • Trial completion date
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    3ms
    Micellar curcumol reprograms tumor-associated macrophages and reverses PARP inhibitor resistance in recurrent ovarian cancer. (PubMed, Phytomedicine)
    Our study reveals that MC could promote macrophage activation by inhibiting NDUFA4 and increase the sensitivity of OC cells to Niraparib.
    Journal • PARP Biomarker
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • HMOX1 (Heme Oxygenase 1) • IL18 (Interleukin 18) • TGFB1 (Transforming Growth Factor Beta 1) • IL1B (Interleukin 1, beta) • MRC1 (Mannose Receptor C-Type 1)
    |
    Zejula (niraparib)
    3ms
    Progression-Free Survival with PARP Inhibitors According to Clinical Risk in Patients with Ovarian Cancer: An Indirect Comparison Using Reconstructed Data. (PubMed, Oncol Res)
    In the BRCA+ high-risk population, olaparib monotherapy (median PFS 41.2 months) and olaparib plus bevacizumab (median PFS 42.5 months) demonstrated the greatest PFS benefit, marginally outperforming niraparib (median PFS 31.2 months). RMST analysis also indicated an advantage of 8.5 months for the combination, though this did not reach statistical significance. PARPi treatment benefit in ovarian cancer is meaningfully influenced by genetic profile and relapse risk, supporting biomarker-driven treatment selection in clinical practice.
    Clinical • Journal • BRCA Biomarker • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • HRD + BRCA wild-type
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • Zejula (niraparib)
    3ms
    piR-26681 suppresses ovarian cancer progression by enhancing METTL3/METTL14-mediated m6A modification of FBXO16 and impairing DNA repair via MORF4L1 degradation. (PubMed, Cell Mol Biol Lett)
    Our study identifies a novel piR-26681-METTL3/METTL14-FBXO16-MORF4L1 regulatory axis that impairs DNA repair and suppresses ovarian cancer progression. piR-26681 represents a promising therapeutic target for sensitizing HR-proficient ovarian cancers to DNA-damaging therapies.
    Journal • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency) • IGF2BP2 (Insulin Like Growth Factor 2 MRNA Binding Protein 2) • METTL14 (Methyltransferase 14) • METTL3 (Methyltransferase Like 3)
    |
    Zejula (niraparib)
    3ms
    Niraparib treatment patterns and outcomes in first-line maintenance therapy for ovarian cancer: The RENI-1 study. (PubMed, Chin Med J (Engl))
    As the first prospective real-world study of niraparib 1LMT in China, RENI-1 provides powerful complementary evidence to pivotal randomized controlled trials conducted in highly selective populations, further supporting niraparib as the first-line maintenance standard treatment.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
    |
    BRCA2 mutation • BRCA1 mutation • HRD • BRCA wild-type
    |
    Zejula (niraparib)
    3ms
    Efficacy and safety of PARP inhibitor maintenance therapy in elderly ovarian cancer patients: a real-world single-center retrospective cohort study. (PubMed, Front Oncol)
    PARP inhibitor (olaparib and niraparib) maintenance therapy yields favorable clinical outcomes for elderly ovarian cancer patients. Three clinical factors, attainment R0(no residual disease) after initial surgery, BRCA mutation, and CA-125 ≤10 U/mL before PARP inhibitor treatment, were predictive of longer PFS in elderly ovarian cancer patients undergoing first-line maintenance therapy with PARP inhibitors.
    Retrospective data • Journal • Real-world evidence • BRCA Biomarker • PARP Biomarker
    |
    BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA mutation
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    Lynparza (olaparib) • Zejula (niraparib)
    3ms
    PROGNOSTIC and PREDICTIVE VALUE of HRD in EARLY TRIPLE NEGATIVE BREAST CANCER (TNBC). (PubMed, Crit Rev Oncol Hematol)
    Agents such as olaparib, talazoparib, and niraparib have demonstrated promising efficacy in both neoadjuvant and adjuvant settings with some trials suggesting that selected patients may avoid chemotherapy. Overall, current evidence supports the role of HRD as a promising biomarker in TNBC. However, further research is required to refine its clinical utility and to integrate HRD testing into personalized treatment strategies, especially in combination with emerging therapies such as immunotherapy.
    Review • Journal • BRCA Biomarker • PARP Biomarker • IO biomarker
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Lynparza (olaparib) • Talzenna (talazoparib) • Zejula (niraparib)
    3ms
    Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer (clinicaltrials.gov)
    P2, N=200, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jun 2026 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    Zejula (niraparib) • abiraterone acetate • apalutamide
    3ms
    Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer (clinicaltrials.gov)
    P2, N=51, Active, not recruiting, University Health Network, Toronto | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    PTEN (Phosphatase and tensin homolog)
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    3ms
    Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P1, N=31, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Jun 2026 | Trial primary completion date: Dec 2026 --> Jun 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA mutation
    |
    Zejula (niraparib) • Aliqopa (copanlisib)