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Drug

Niraparib

Approved · EMA
ClassPoly [ADP-ribose] polymerase-1 inhibitorEmerging researchLate-stage development

Also known as Akeega, Zejula.

RxNorm1918231ChEMBLCHEMBL1094636ATCL01XK02UNIIHMC2H89N35
2
Research papers
65
Active clinical trials
2
Protein targets
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase II Study of Niraparib in Soft Tissue Sarcoma Patients With Altered DNA Damage Repair

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

An Open-label, Multicenter Trial of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)

Clinical trial2026-07-30Primary completion · ClinicalTrials.gov

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Clinical trial2026-07-07Results posted · ClinicalTrials.gov

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

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

Clinical trial2026-07-06Results expected Q4 2032 · ClinicalTrials.gov

A Phase 0 Clinical Trial to Evaluate Drug Concentrations and Pharmacodynamic Parameters of Niraparib in Tumor Tissue of Patients With Surgically Accessible Recurrent IDH 1/2 Gliomas

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

A Phase 3, Open-label, Randomized 2-arm Study Comparing the Clinical Efficacy and Safety of Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Clinical trial2026-07-01Results expected Q4 2027 · ClinicalTrials.gov

Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial.

Research2025-10-07Nature medicine

Drug Safety Update: Niraparib (Zejula▼): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment

Regulatory2020-10-22MHRA

Immunogenomic profiling determines responses to combined PARP and PD-1 inhibition in ovarian cancer.

Research2020-03-19Nature communications

Approval: Zejula (EMA)

Regulatory2017-11-16EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Niraparib
Aliases & brands
AkeegaZejula
RxNorm CUI
1918231
ChEMBL ID
CHEMBL1094636
ATC codes
L01XK02
UNII
HMC2H89N35
Primary mechanism
Poly [ADP-ribose] polymerase-1 inhibitor
Regulatory jurisdictions
emamhra

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Poly [ADP-ribose] polymerase 1
PARP1 · P09874
INHIBITORPoly [ADP-ribose] polymerase-1 inhibitor
Poly [ADP-ribose] polymerase 2
PARP2 · Q9UGN5
INHIBITORPoly [ADP-ribose] polymerase 2 inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2017-11-16
Latest approval
2017-11-16
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2017-11-16Approval
Approval: Zejula (EMA)
Indication: Zejula is indicated: as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or… Show full indication

Zejula is indicated: as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2020-10-22Safety communicationSafety
Drug Safety Update: Niraparib (Zejula▼): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

155 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
155
registered trials across all phases
LATEST COMPLETION 2026
65
Active studies
29
Recruiting
22
Late-stage (III+)
41
Completed
49
Discontinued
PHASE DISTRIBUTIONn = 155
Early Phase 14Phase 131Phase 1 / 216Phase 282Phase 2 / 32Phase 316Phase 44

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Single-Arm, Prospective, Multicenter Study Evaluating Safety, Tolerability, and Metabolism of Niraparib as Maintenance Following Front-Line Treatment for Ovarian Cancer in Women of African Ancestry

RecruitingPH IVUniversity of Miamin=702031

A Prospective, Multicentre, Open Labelled, Single Arm Phase-IV Clinical Trial of Niraparib in Indian Patients With Advanced or Relapsed Ovarian Cancer Who Are in Complete or Partial Response Following Platinum Based Chemotherapy

Not yet recruitingPH IVGlaxoSmithKlinen=672026

A Phase IV Open-label, Multicenter Study of Niraparib as Maintenance Therapy in BRCA Wild-type, Newly Diagnosed Advanced Ovarian Cancer Patients in Korea

Unknown statusPH IVSeoul National University Hospitaln=1022025

Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib in Maintenance After Platine-based Chemotherapy for Patients with Ovarian Cancer Late Relapse : the French GINECO - NiQoLe Study

CompletedPH IVARCAGY/ GINECO GROUPn=1412022

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

RecruitingPH IIIImunonn=5002032

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase Ib Study of the Oral PARP Inhibitor Niraparib With the Intravenous PI3K Inhibitor Copanlisib for Recurrent Endometrial and Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

CompletedPH IM.D. Anderson Cancer Centern=312026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum -Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)

CompletedPH IIIGlaxoSmithKlinen=6662026

An Open-label, Phase II Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients

CompletedPH IITrisha Wise-Drapern=102026

Phase 2 Proof-of-Concept Trial Testing the PARP Inhibitor Niraparib in Patients With Pancreatic Cancer Harboring Deficiencies in Homologous Recombination DNA Repair

CompletedPH IIDana-Farber Cancer Instituten=322026

A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination With Niraparib and ZN-c3 Monotherapy in Subjects With Platinum-Resistant Ovarian Cancer

CompletedPH I/IIK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Incn=1172026

A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART4215 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

CompletedPH IArtios Pharma Ltdn=932025

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20202025
Major research themes7
Abiraterone Acetate1Antineoplastic Combined Chemotherapy Protocols1Indazoles1Piperidines1Prednisone1Prostatic Neoplasms, Castration-Resistant1Recombinational DNA Repair1
Journals, researchers & institutions
Top journals
  • Nature communications1
  • Nature medicine1
Leading researchers
  • Agarwal N1
  • Attard G1
  • Baron B1
  • Casado J1
  • Chen YA1
  • Cheng HH1
  • Chi KN1
  • Chowdhury D1
Leading institutions
free-text, unnormalised
  • University of Washington2
  • BC Cancer - Vancouver Center1
  • Brigham and Women's Hospital1
  • Cancer Institute1
  • Chongqing University Cancer Hospital1
  • Dana-Farber Cancer Institute1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Pembrolizumab

Studied across 4 of the same disease areas as Niraparib in the shared literature.

4 shared diseases1 shared paper
Abiraterone Acetate

Studied across 3 of the same disease areas as Niraparib in the shared literature.

3 shared diseases1 shared paper
Prednisone

Studied across 2 of the same disease areas as Niraparib in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.