Delving into the Latest Updates on Niraparib Tosylate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

niraparib, niraparib hydrochloride, Niraparib Tosilate

+ [14]

Target

PARP1 x PARP2

Action

inhibitors

Mechanism

PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [6]

Active Indication

BRCA-mutated Ovarian CancerOvarian CancerPeritoneal Neoplasms+ [84]

Inactive Indication

Adenocarcinoma of EsophagusAdenocarcinoma, metastaticAdrenocortical Carcinoma+ [45]

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

GSK PlcJanssen Research & Development LLCGlaxoSmithKline Australia Pty Ltd.

+ [10]

Inactive Organization

QS Pharma, LLC

Merck Sharp & Dohme Corp.

Xian-Janssen Pharmaceutical Ltd.

+ [2]

License Organization

Zentalis Pharmaceuticals, Inc.

AnaptysBio, Inc.

Takeda Pharmaceutical Co., Ltd.

+ [6]

Drug Highest PhaseApproved

First Approval Date

United States (27 Mar 2017),

Fallopian Tube CarcinomaOvarian Epithelial CarcinomaPrimary peritoneal carcinoma

RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Conditional marketing approval (China), Orphan Drug (South Korea), Priority Review (China)

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Structure/Sequence

Molecular FormulaC26H30N4O5S

InChIKeyACNPUCQQZDAPJH-FMOMHUKBSA-N

CAS Registry1613220-15-7

The purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the maintenance treatment has women with ovarian cancer. In this study, an investigational medication called niraparib is being tested for the treatment of ovarian cancer. Niraparib works by blocking the ability of cancer cells to fix their genes. Cancer cells with damaged genes have a harder time growing and spreading in the body and can even die.

Start Date01 Aug 2025

Sponsor / Collaborator

University of Miami

[+1]

NCT06915025

/ RecruitingPhase 3

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

This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.

Start Date11 Jul 2025

Sponsor / Collaborator

Imunon, Inc.

NCT06682780

/ Not yet recruitingPhase 1/2

An Open-label, Dose-escalation, and Dose-expansion Phase I/II Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of LM-2417 for Injection Alone or in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors

This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.

Start Date05 Jun 2025

Sponsor / Collaborator

LaNova Medicines Ltd.

100 Clinical Results associated with Niraparib Tosylate

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100 Translational Medicine associated with Niraparib Tosylate

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100 Patents (Medical) associated with Niraparib Tosylate

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1,046

Literatures (Medical) associated with Niraparib Tosylate

31 Dec 2025·OncoImmunology

PARP inhibitors accumulate B7-H3 on fibroblasts via blocking autophagic flux to potentiate immune evasion in ovarian cancer

Article

Author: Wang, Mengjie ; Liu, Dan ; Wang, Siyuan ; Qian, Yiyu ; Zhao, Guang-Nian ; Xia, Yu ; Jin, Ning ; Li, Ying ; Fang, Yong ; Zhang, Qi ; Wang, Ya ; Xiong, Xiaoming ; Xu, Tao ; Li, Xiaoting ; Xu, Sen ; Gao, Qinglei ; Jin, Ping ; Li, Huayi ; Wang, Zhen ; Xu, Cheng ; Fang, Tian ; Huang, Pu ; Zhou, Dongchen

Besides targeting tumor cells via canonical synthetic lethality, poly(ADP-ribose) polymerase inhibitors (PARPis) can remodel tumor immune microenvironment (TIME), which then affects PARPis' anti-tumor capabilities. However, exact function of PARPis on TIME remains insufficiently explored. Here, by leveraging paired samples during neoadjuvant PARPi Niraparib treatment derived from a prospective clinical trial, we discovered that the expression of immune checkpoint ligand B7-H3 was induced by PARPis in cancer-associated fibroblasts (CAFs) of ovarian cancer. Depletion of B7-H3 in CAFs by using host cd276 (coding B7-H3) knockout mice or B7-H3 deficient fibroblast cells both boosted T cell functions and enhanced the anti-tumor capacities of PARPis in immunocompetent mouse models. Besides, increased B7-H3 on CAFs also attenuated the anti-tumor potentials of T cells in co-culture system. Mechanistically, PARPis blocked autophagic flux by inhibiting PIP4K2A expression, a critical regulator of autophagosome and lysosome fusion, and therefore dampening the lysosomal degradation of B7-H3. Importantly, neutralizing B7-H3 antibodies had synergistic effects with PARPis and achieved superior therapeutic efficacy than PARPis plus PD-1 blockade in a syngeneic mouse ovarian cancer model. Collectively, this study revealed an autophagy-mediated pathway by which PARPis contribute to immune evasion via enhanced B7-H3 accumulation on CAFs, highlighting the complexity of the regulation of PARPis on TIME and the potential application of combining PARPis with B7-H3 blockade in the treatment of ovarian cancer.

01 Nov 2025·TALANTA

Advanced sensor technologies for niraparib detection: A comparative study of molecularly imprinted polymer and nanosensor systems

Article

Author: Ozkan, Sibel A ; Samanci, Seyda Nur ; Ozcelikay-Akyildiz, Goksu ; Bellur Atici, Esen

Poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors are crucial for maintenance therapy in ovarian cancer patients with BRCA mutations, with niraparib (NRB) being a significant example in this class of drugs. This study focuses on developing and comparing two distinct sensor technologies, a molecularly imprinted polymer (MIP)-based sensor and a nanosensor, for the sensitive and selective detection of NRB. The MIP-based electrochemical sensor was constructed using electropolymerization in the presence of aniline (ANI), 3-aminophenyl boronic acid (3-APBA), and NRB as the template molecule. Conversely, the nanosensor incorporated zinc oxide (ZnO) and gold nanoparticles (AuNPs) to enhance signal detection. The sensors were characterized using scanning electron microscopy (SEM) to ensure structural integrity and material composition. The performance of both sensors was optimized, and their analytical capabilities were assessed and compared. The MIP-based sensor demonstrated a concentration range of 2-10 pM with a detection limit (LOD) of 0.408 pM, as measured by differential pulse voltammetry (DPV). The nanosensor, optimized using adsorptive stripping differential pulse voltammetry (AdSDPV), displayed a broader concentration range of 80-600 nM and a LOD of 0.893 nM. This comparison revealed that the MIP-based sensor had superior sensitivity for NRB detection. Both sensors were successfully applied to the analysis of commercial human serum samples, showing excellent repeatability (n = 5) with a relative standard deviation (RSD) below 2.0 %. Recovery rates were highly satisfactory, ranging from 98.83 % to 101.33 %. These findings underscore the effectiveness of both sensors for precise, selective, and sensitive NRB detection, with the MIP-based sensor offering heightened sensitivity.

01 Sep 2025·Cancer Genetics

Acute cardiac dysfunction in patients with ovarian cancer treated with Niraparib due to TFAM mutation: A case series and functional analysis

Article

Author: Li, Danya ; Liu, Wen ; Wen, Yuan ; Tu, Chunhua ; Peng, Xiaoping ; Liu, Fei

BACKGROUND:

Ovarian cancer is a leading cause of gynecological cancer mortality. Despite Niraparib's efficacy in increasing progression-free survival for recurrent ovarian cancer, its potential cardiotoxic effects are underexplored.

OBJECTIVE:

We performed a case series analysis involving two postmenopausal sisters who developed heart failure subsequent to Niraparib therapy for recurrent ovarian cancer.

METHODS:

Utilizing targeted next-generation sequencing (NGS), we identified a novel missense mutation c.98T>A in Mitochondrial Transcription Factor A (TFAM) gene, which was subsequently confirmed by Sanger sequencing. To investigate the cardiotoxic effects of Niraparib, we generated human induced pluripotent stem cell-derived cardiomyocytes (hiPSCCMs) carrying the identified mutation. The impact of the mutation on gene expression and protein levels was evaluated through real-time PCR and Western blot analyses.

RESULTS:

Two postmenopausal sisters treated with Niraparib suffered significant cardiac dysfunction. NGS identified a novel c.98T>A variant in TFAM gene, resulting in a missense mutation. HEK293T cells transfected with mutant plasmids demonstrated normal expression of full-length TFAM mRNA and protein. hiPSCCMs model revealed the variant alone did not induce cardiomyopathy. However, it predisposed to Niraparib-induced cardiomyopathy-like toxicity, mediated by metabolic dysregulation and increased cellular apoptosis CONCLUSION: Our study revealed a novel TFAM variant which might induce potential cardiovascular toxicity of anticancer Niraparib therapies.

326

News (Medical) associated with Niraparib Tosylate

07 Jul 2025

·www.pharmaceutical-technology.com

J&J eyes prostate cancer label expansion for Akeega

The application comes hot on the heels of positive data for Akeega unveiled at this year’s American Society of Clinical Oncology (ASCO) conference. Michael Vi via Shutterstock. Johnson & Johnson (J&J) has applied to the European Medicines Agency (EMA) to extend the indication of Akeega (niraparib and abiraterone acetate) in prostate cancer. Akeega has been approved in Europe for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in combination with steroid hormone prednisolone since 2023. J&J is now attempting to widen the drug’s application to patients with metastatic hormone-sensitive prostate cancer (mHSPC). J&J’s drug is an option for patients where medical or surgical treatment to lower testosterone levels has not worked, and in those who have BRCA 1/2 mutations – a subset of homologous recombination repair (HRR) mutations – in whom chemotherapy is not indicated. Akeega combines the active ingredients in GSK’s PARP inhibitor Zejula (niraparib) and J&J’s androgen blocker Zytiga (abiraterone). Given as a dual-action tablet, the therapy works by targeting DNA repair and inhibiting androgen production. J&J gained prostate cancer rights for Zejula from Tesaro in 2016, the latter company was acquired by GSK. The application comes hot on the heels of positive data for Akeega unveiled at this year’s American Society of Clinical Oncology (ASCO) conference. Akeega reduced the risk of tumour progression or death by 37% compared to J&J’s prostate cancer previous blockbuster Zytiga (abiraterone acetate) in the Phase III AMPLITUDE trial (NCT04497844). GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Both therapies were given alongside prednisolone, with Akeega outperforming Zytiga in other efficacy endpoints within the HRR group. AMPLITUDE is the first study to show the efficacy of combining a PARP inhibitor and androgen receptor pathway inhibitor (ARPi) in this patient population. “Despite significant progress in prostate cancer, individuals with HRR gene alterations often face limited treatment options, faster onset of symptoms and poorer outcomes,” said Henar Hevia, EMEA therapy area head of oncology at Johnson & Johnson Innovative Medicine . “With this submission to the EMA, we have the opportunity to offer patients with HRR-mutated mHSPC a treatment specifically targeted to the underlying biology of their disease.” Zytiga once saw peak annual sales globally of $2.5bn, though revenue has been slashed by the market entry of generics. J&J’s Akeega is forecast to generate revenue of $178m by 2031, according to GlobalData’s Pharma Intelligence Centre. Most of J&J’s prostate cancer revenue is expected to come from Erleada (apalutamide). The hormone therapy, approved in 2019, is forecast to see annual sales of $5.3bn by 2031. There is fierce competition in the prostate cancer treatment landscape. AstraZeneca and MSD’s Lynparza (olaparib) has a range of indications in men with prostate cancer who have BRCA1 and BRCA2 mutations. Another rival, Pfizer’s Talzenna (talazoparib), has the advantage of being approved in combination with Xtandi (enzalutamide), a drug that Pfizer is partnered with Astellas for. The combo therapy is approved for homologous recombination repair ( HRR )-mutated mCRPC. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

Drug ApprovalPhase 3AcquisitionASCOClinical Result

30 Jun 2025

·www.einpresswire.com

January - March 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

ELEVIDYS (delandistrogene moxeparvovec-rokl) Hepatotoxicity-associated fatalities in non-ambulatory patients with Duchenne muscular dystrophy FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on June 24, 2025: FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS Finasteride (compounded product) topical Adverse event FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products Janus kinase (JAK) inhibitors Cerebral venous sinus thrombosis FDA is evaluating the need for regulatory action. Leqembi (lecanemab-irmb) injection Amyloid related imaging abnormality-edema/effusion FDA is evaluating the need for regulatory action. Ocaliva (obeticholic acid) tablets Liver disorder FDA is evaluating the need for regulatory action. Olanzapine-containing products Lybalvi (olanzapine and samidorphan) tablets Symbyax (olanzapine and fluoxetine) capsules Zyprexa (olanzapine) tablets Zyprexa Intramuscular (olanzapine) injection Zyprexa Relprevv (olanzapine) injectable suspension Zyprexa Zydis (olanzapine) tablets Inappropriate antidiuretic hormone secretion FDA is evaluating the need for regulatory action. Poly (ADP-ribose) polymerase (PARP) inhibitors Akeega (niraparib and abiraterone acetate) tablets Lynparza (olaparib) tablets Rubraca (rucaparib) tablets Talzenna (talazoparib) capsules Zejula (niraparib) tablets Vasculitis FDA is evaluating the need for regulatory action. Rilutek (riluzole) tablets Tiglutik (riluzole) oral suspension Pancreatitis acute FDA is evaluating the need for regulatory action. Suprep Bowel Pre Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution Hypersensitivity FDA is evaluating the need for regulatory action. Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection Severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy FDA is evaluating the need for regulatory action. Xcopri (cenobamate tablets) Drug-induced liver injury FDA is evaluating the need for regulatory action. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

03 Jun 2025

·www.fiercepharma.com

ASCO: J&J's Akeega gives PARP a novel prostate cancer win, but FDA path in patient subset unclear

In castration-sensitive prostate cancer, the Akeega regimen’s magnitude of progression-free survival benefit was notably bigger at 48% in the BRCA-mutated subgroup when compared with the overall trial population. The FDA has already approved PARP inhibitors in certain patients with metastatic castration-resistant prostate cancer (mCRPC). Now, Johnson & Johnson’s Akeega is giving the class a win in castration-sensitive disease, although the drug’s benefit in a patient subgroup remains unclear.In patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR), Akeega and prednisone significantly reduced the risk of tumor progression or death by 37% versus J&J’s Zytiga and prednisone, according to data shared at the 2025 American Society of Clinical Oncology annual meeting. Akeega is a fixed-dose combination of GSK’s PARP inhibitor Zejula—to which J&J owns prostate cancer rights—and Zytiga.Despite the positive readout from the phase 3 Amplitude trial, saying Akeega has a clear regulatory path ahead in all HRR-mutated mCSPC would be too optimistic.The uncertainty lies in a group of patients without BRCA mutations.Previously, Zejula’s addition to Zytiga and prednisone showed a progression-free survival benefit in HRR-mutated mCRPC in the phase 3 Magnitude trial. But after speaking with the FDA and realizing that the drug was most beneficial in the BRCA-mutated population, J&J filed for—and received—an approval only in that subset of patients. Now, Amplitude is facing the same BRCA/non-BRCA question. Compared with the entire trial population, the Akeega regimen’s magnitude of progression-free survival benefit was notably bigger at 48% in the BRCA-mutated subgroup.“The benefit may be greatest in patients with BRCA alterations,” lead study author Gerhardt Attard, M.D., Ph.D., from University College London, said during a press briefing.The result is still in favor of Akeega in the non-BRCA subgroup, with an improvement of around 20%, Attard noted.“There is efficacy in the non-BRCA subgroup,” Attard said. “It’s heterogeneous, and it’s a number of different smaller gene subgroups.”“You’re going to need to do meta-analysis of multiple different trials to have certainty which subgroup has clear evidence of efficacy.”The non-BRCA subgroup is not small, accounting for 45% of the Amplitude population. Based on the current data, Akeega doesn’t appear to work in patients with the PALB2 mutation, but there are positive trends in other subtypes, Mark Wildgust, Ph.D., vice president of oncology global medical affairs at J&J Innovative Medicine, said in an interview with Fierce Pharma.“Does it have the same magnitude [of benefit as in BRCA]? I do not believe it does,” Wildgust said. “Is there enough there for regulatory approval? Maybe not right now, but maybe in the future. Maybe we have to wait a bit longer to see longer-term follow up and to understand the question.”J&J will have a discussion with global regulators, including the FDA, on whether the Amplitude trial has shown a positive risk-benefit profile in the overall HRR population, Wildgust said.Besides progression-free survival, researchers also identified a positive trend toward improved overall survival in the Akeega arm. However, data here were immature and didn’t meet statistical significance at the current analysis. The preliminary death reduction was 25% in the BRCA-mutated group and 21% in the overall trial population.Editor's Note: The story was updated to clarify the situation around Akeega's mCRPC indication.

Clinical ResultPhase 3ASCO

100 Deals associated with Niraparib Tosylate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Niraparib Tosylate	L01XX54	DB11793

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
BRCA-mutated Ovarian Cancer	United States	GlaxoSmithKline LLC	23 Oct 2019
Ovarian Cancer	Switzerland	Tesaro, Inc.	03 Oct 2018
Peritoneal Neoplasms	Switzerland	Tesaro, Inc.	03 Oct 2018
Platinum-sensitive epithelial ovarian cancer	European Union	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-sensitive epithelial ovarian cancer	Iceland	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-sensitive epithelial ovarian cancer	Liechtenstein	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-sensitive epithelial ovarian cancer	Norway	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma	European Union	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma	Iceland	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma	Liechtenstein	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma	Norway	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma	European Union	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma	Iceland	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma	Liechtenstein	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma	Norway	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Fallopian Tube Carcinoma	United States	GlaxoSmithKline LLC	27 Mar 2017
Ovarian Epithelial Carcinoma	United States	GlaxoSmithKline LLC	27 Mar 2017
Primary peritoneal carcinoma	United States	GlaxoSmithKline LLC	27 Mar 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
BRCA Mutation Castration-Resistant Prostate Cancer	NDA/BLA	European Union	GlaxoSmithKline (Ireland) Ltd.	27 Feb 2023
Glioblastoma Multiforme	Phase 3	United States	GSK Plc	19 Jun 2024
Glioblastoma Multiforme	Phase 3	France	GSK Plc	19 Jun 2024
Glioblastoma Multiforme	Phase 3	Germany	GSK Plc	19 Jun 2024
Glioblastoma Multiforme	Phase 3	Italy	GSK Plc	19 Jun 2024
Glioblastoma Multiforme	Phase 3	Netherlands	GSK Plc	19 Jun 2024
Glioblastoma Multiforme	Phase 3	Norway	GSK Plc	19 Jun 2024
Glioblastoma Multiforme	Phase 3	Spain	GSK Plc	19 Jun 2024
Glioblastoma Multiforme	Phase 3	United Kingdom	GSK Plc	19 Jun 2024
Pancreatic Cancer	Phase 3	China	Zai Lab (Shanghai) Co., Ltd.	30 May 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03783949 (EUDARIO, CTgov)	Phase 2	Primary peritoneal carcinoma \| Platinum-Sensitive Ovarian Carcinoma \| Fallopian Tube Carcinoma	122	Carboplatin+Gemcitabine+Paclitaxel+niraparib	ceiejnqwcy(fjlumwemvj) = iuruttqxdb jtzvfbecpl (onqoiumdmc, vwjwnggzir - skmdqunsqj) View more	-	11 Jun 2025
NCT04497844 (AMPLITUDE, ASCO2025) Manual	Phase 3	Castration-sensitive prostate cancer Homologous Recombination Deficiency Positive	696	Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP)	fakdbpgcft(dwydblapag) = pgfezqyiaq ywpfhdwkhw (bvggheqstl ) Met View more	Positive	30 May 2025
				abiraterone acetate plus prednisone (AAP)	fakdbpgcft(dwydblapag) = ofppqrhxhu ywpfhdwkhw (bvggheqstl, 25.8 - NR) Met View more
NCT04592237 (C3NIRA, ASCO2025)	Phase 2	Prostatic Cancer Maintenance	120	Cabazitaxel	swcstgnxuk(owaechvfum) = byhdlfudyl jzuwkydzzz (cycpnoqrfh, 2.0 - 4.4)	Positive	30 May 2025
				Niraparib	qzxcanfnvl(vyimexdvjl) = uboszvutkc vvlkghjqfj (qsqqxblnlk, 6.4 - 19.6)
JPRN-jRCT2031220179 (NiraPim (EPOC2102), ASCO2025)	Phase 1	Solid tumor BRCA \| CDK12	30	Niraparib 200 mg + Pimitespib 80 mg	csojtzyemr(judvsclswc) = xdhzjnvyey ddbkfaysqb (otndhiljqg ) View more	Positive	30 May 2025
JPRN-jRCT2051210120 (IMAGENE, ASCO2025)	Phase 2	RET mutation Solid Tumors HRR gene mutation	47	Niraparib + Nivolumab	scpwhqfeus(zemmnbmobl) = tlgmjlccgb lbuzsuzuwl (ybppojzsav, 0.8 - 13.3) View more	Positive	30 May 2025
				Placebo	qxriqjaesu(srhbwockyk) = znujrnukne pduisuhtnn (wbberbpfxb, 29.1 - 53.8)
NCT04030559 (ASCO2025)	Phase 2	Localized Prostate Carcinoma Neoadjuvant BRCA2 \| MSH6 \| CHEK2 ... View more	-	Niraparib 200mg/day	hvompqhuwr(csjjkihuxr) = There was one grade 3+ adverse event (thrombocytopenia) requiring a dose reduction fkcotorhmg (uqylctfpah ) View more	Negative	30 May 2025
ASCO2025	Not Applicable	Ovarian Cancer	20	Niraparib	scaydwohzt(eqjbdvkpkj) = vpckpnuntm sgnwjhtfwy (ykcuxoltzx )	-	30 May 2025
				Placebo	scaydwohzt(eqjbdvkpkj) = eaquwhhipj sgnwjhtfwy (ykcuxoltzx )
NCT04734665 (KGOG3056/NIRVANA-R, ASCO2025)	Phase 2	Maintenance BRCA status \| homologous recombination deficiency (HRD) status \| circulating tumor DNA (ctDNA) ... View more	44	Niraparib rechallenge with bevacizumab	pftjgektwv(irzsmpzjzk) = fvladkbsht emraogtlpm (dkzeawdmhe, 55 - 85)	Positive	30 May 2025
NCT03925350 (Phase II Study of Niraparib, Pubmed \| JCO Precis Oncol)	Phase 2	Melanoma ARID1A/B \| ARID2 \| ATM ... View more	14	Niraparib 300 mg	sbepdxdxyc(qbylfnwzti) = There were no unexpected adverse events related to niraparib treatment zrdscsoqte (alugarwzyg ) View more	Positive	01 May 2025
NCT05455424 (NERO, AACR2025)	Phase 2	Mesothelioma BRCA1/2 \| HRD \| TRCs ... View more	88	ASC + Niraparib	xlioktwodp(ffhklrxzdp) = yxomebvhrv einsxbmbod (gxqvpfaghy, 2.76 - 4.73)	Positive	29 Apr 2025
				ASC	xlioktwodp(ffhklrxzdp) = jxbcmayekt einsxbmbod (gxqvpfaghy, 1.41 - 3.02)