Delving into the Latest Updates on Nedaplatin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(glycolato-O,O')diammineplatinum(II), CDGP, Nedaplatin (JAN/INN)

+ [11]

Target

DNA

Action

inhibitors

Mechanism

DNA inhibitors(DNA inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

NeoplasmsBladder CancerEsophageal Carcinoma+ [6]

Inactive Indication-

Originator Organization

Nichi-Iko Pharmaceutical Co., Ltd.

Active Organization

Nichi-Iko Pharmaceutical Co., Ltd.Simcere Zaiming Pharmaceutical Co., Ltd.

Shionogi & Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (30 Jun 1995),

Bladder CancerEsophageal CarcinomaHead and Neck Neoplasms+ [5]

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC2H8N2O3Pt

InChIKeyGYAVMUDJCHAASE-UHFFFAOYSA-M

CAS Registry95734-82-0

This is a phase I/II study to preliminarily explore of the safety, tolerability, pharmacokinetics, and efficacy of WJB001 combination therapy, consisting of three stages: Dose escalation (Phase Ia), dose extension (Phase Ib), and efficacy extension (Phase II). The preliminary plan includes five combination therapy regimens, namely Arm A: WJB001+taxanes (A1: WJB001+paclitaxel, A2: WJB001+albumin paclitaxel); Arm B: WJB001+platinum (B1: WJB001+carboplatin, B2: WJB001+nedaplatin); Arm C: WJB001+paclitaxel+carboplatin; Arm D: WJB001+PARP inhibitor; Arm E: WJB001+VEGF inhibitor.

Start Date20 May 2025

Sponsor / Collaborator

Wigen Biomedicine Technology (Shanghai) Co. , Ltd.

NCT06508229

/ Not yet recruitingPhase 2IIT

Adebrelimab Combined With Albumin Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma：a Prospective, Single Arm, Phase 2 Clinical Study

This is a multi-center, single-arm, phase II clinical study designed to observe and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.

Start Date30 Jul 2024

Sponsor / Collaborator

Harbin Medical University

NCT06010212

/ Not yet recruitingPhase 1/2IIT

Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin as First Line Treatment in Patients With Recurrent Esophageal Squamous Cell Carcinoma

This Study is a Single-center, Single-arm, Phase II Clinical Study. The Primary Objective is to Evaluate the Efficacy and Safety of Fruquintinib, Carrelizumab, Paclitaxel Liposomes combined with Nidaplatin as First-line Treatment in Advanced Esophageal squamous cell carcinoma .

Start Date25 Aug 2023

Sponsor / Collaborator

Jiangsu Provincial People's Hospital

100 Clinical Results associated with Nedaplatin

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100 Translational Medicine associated with Nedaplatin

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100 Patents (Medical) associated with Nedaplatin

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1,560

Literatures (Medical) associated with Nedaplatin

01 Jul 2025·Clinical and Translational Radiation Oncology

Concurrent chemoradiotherapy versus radiotherapy alone in postoperative high-risk adenoid cystic carcinoma of the head and neck: A propensity score matched analysis

Article

Author: Dou, Shengjin ; Liu, Shengwen ; Wang, Yu ; Li, Rongrong ; Ye, Lulu ; Wang, Xin ; Xiao, Ying ; Zhang, Lin ; Jiang, Wen ; Zhu, Guopei ; He, Yining

BackgroundThe role of concurrent chemoradiotherapy (CCRT) in postoperative head and neck adenoid cystic carcinoma (ACC) remains controversial due to the limited evidence from randomized trials. This study assessed the effectiveness of CCRT by comparing a prospective CCRT group with a retrospective radiation（RT） alone group using propensity score matching (PSM).Methods and materialsPostoperative head and neck ACC patients with T3-4/N1-3 M0 disease or after R1/R2 resection were enrolled. All patients underwent intensity-modulated radiation therapy (IMRT), and CCRT group received two cycles of concurrent docetaxel and nedaplatin. To ensure comparability, PSM were utilized. Following PSM, survival outcomes were analyzed using Kaplan-Meier curves and compared using the log-rank test.ResultsA prospective CCRT group of 55 patients and a retrospective RT alone group of 160 patients were included. The multivariate Cox regression analysis showed no association between CCRT and overall survival (OS) (hazard ratio [HR] = 0.71, 95 %CI: 0.24-2.08, p = 0.537), or other survival outcomes. To mitigate potential confounding factors, a 1: 1 PSM analysis was performed. With a median follow-up of 51 months, post-PSM analysis (including 48 patients in each group) indicated no significant differences in OS (estimated 5-year OS rates: 90.7 % versus 84.3 %, p = 0.331), locoregional recurrence-free survival (LRRFS) (p = 0.261), distant metastasis-free survival (DMFS) (p = 0.425), or disease-free survival (DFS) (p = 0.600) between two groups. The multivariate Cox regression analysis also showed no association between CCRT and OS (HR = 0.29, 95 %CI: 0.06-1.38, p = 0.119), or other survival outcomes.ConclusionThe addition of concurrent chemotherapy to postoperative IMRT did not confer a survival benefit in terms of LRRFS, DMFS, DFS, or OS in patients with head and neck ACC. Upcoming results from randomized studies are anticipated to shed more light on this debated issue. CCRT should be avoided outside of clinical trials.

01 Jun 2025·Toxicology Reports

Cilostazol protective effect on nedaplatin-induced genotoxicity in cultured human lymphocytes

Article

Author: Alzoubi, Karem H ; Nuseir, Fian ; Khabour, Omar F ; Rababa'h, Abeer M

BackgroundNedaplatin has demonstrated remarkable efficacy in combating various malignancies. However, the administration of nedaplatin has been associated with the induction of DNA damage within normal cells. Cilostazol is a phosphodiesterase III inhibitor with an antioxidant mechanism that could protect cells from genotoxicity. We aimed to evaluate the genotoxic effect of nedaplatin on cultured human lymphocytes and the potential protective effect of cilostazol on chromosomal damage induced by nedaplatin.MethodsThe proposed nedaplatin's genotoxic effect was studied in vitro by evaluating the frequencies of sister chromatid exchanges (SCEs) in human cultured lymphocytes. Both the mitotic and proliferative indices (MI and PI, respectively) were used to assess the cytotoxic effects of nedaplatin.ResultsNedaplatin significantly increased the frequency of SCEs compared to control and cilostazol-treated cells. The chromosomal injury induced by nedaplatin was significantly reduced by pretreatment of cells with cilostazol (P < 0.0001). Treating with cilostazol alone also reduced the frequency of SCEs, MI, and PI compared to the control group. Nedaplatin induced significant decreases in the MI and PI compared to the control group. Pretreatment with cilostazol partially debilitated the nedaplatin-induced changes in MI but not PI.ConclusionCilostazol ameliorated the genotoxicity of nedaplatin in cultured human lymphocytes.

01 Apr 2025·eClinicalMedicine

Safety and efficacy of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced esophageal squamous cell carcinoma in China (GASTO 1071): a non-randomised, two-cohort, phase 2 trial

Article

Author: Rong, YuMing ; Wang, MengRu ; Hu, Yi ; Liu, Hui ; Zhang, HaoTing ; Zheng, ShiYang ; Xie, ChuanMiao ; Qiu, Bo ; Yin, ShaoHan ; Wei, ShiHong ; Liu, FangJie ; SiTu, Yu ; Wang, DaQuan ; Zhang, PengXin

BackgroundWe aimed to explore the efficacy and safety of neoadjuvant toripalimab plus chemotherapy followed by concurrent chemoradiotherapy (CCRT) in locally advanced esophageal squamous cell carcinoma (ESCC).MethodsThis phase II, non-randomized, 2-cohort study enrolled patients with unresectable, stage T1-4N0-3M0-1 ESCC (M1 only includes patients with lymph node metastasis in the supraclavicular region). Patients received neoadjuvant therapy comprised of albumin-bound paclitaxel, nedaplatin and toripalimab every 3 weeks, for 2 cycles, followed by CCRT (total dose 60Gy in cohort A, 50Gy in cohort B, combined with oral capecitabine). The primary endpoint was progression-free survival (PFS). The trial is registered with ClinicalTrials.gov, NCT04844385.FindingsBetween February 26, 2021 and June 20, 2023, 124 patients were enrolled, and 118 (95.2%) patients completed treatment. The objective response rate to neoadjuvant chemo-immunotherapy was 91.9% overall, and was 93.7% in cohort A-60Gy and 93.4% in cohort B-50Gy after CCRT. With a median follow-up of 30.8 months, the 18-month PFS rates were 65.0% (95% CI, 53.9-78.3%) in cohort A-60Gy and 65.1% (95% CI, 53.7-78.8%) in cohort B-50Gy. Grade (G) 3 and G5 pneumonitis occurred in two (3.2%) and one patient (1.6%) in cohort A-60Gy, respectively, with no ≥G3 pneumonitis in cohort B-50Gy. Improvements on patient reported outcomes from baseline to 12 months post-CCRT were observed overall.InterpretationNeoadjuvant chemo-immunotherapy, radiotherapy and concurrent capecitabine achieved promising efficacy in locally advanced ESCC. Further investigation is warranted.FundingNone.

100 Deals associated with Nedaplatin

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External Link

KEGG	Wiki	ATC	Drug Bank
D01416	Nedaplatin	L01XA	DB13145

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Neoplasms	Japan	Shionogi & Co., Ltd.	05 Sep 1995
Bladder Cancer	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1995
Esophageal Carcinoma	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1995
Head and Neck Neoplasms	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1995
Non-Small Cell Lung Cancer	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1995
Ovarian Cancer	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1995
Small Cell Lung Cancer	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1995
Testicular Neoplasms	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1995
Uterine Cervical Cancer	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1995

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06010212 (ASCO_GI2025) Manual	Phase 2	Advanced Esophageal Squamous Cell Carcinoma First line	11	Fruquintinib + camrelizumab +paclitaxel liposome + nedaplatin	(clgfojkijv) = ztubrfqhoi pphjpwqrxi (zsrbeqqgqd, 42.1 - 99.6) View more	Positive	23 Jan 2025
NCT04834206 (ASCO 12023 \| ASCO 22023) Manual	Phase 2	Nasopharyngeal Carcinoma First line	32	intensity-modulated radiotherapy+nedaplatin+docetaxel+5-fluorouracil	(dhueyvnndo) = ewexbylgwg rcaloxmgiy (xhygxnemnw ) View more	Positive	31 May 2023
ChiCTR2100049693 (ASCO 12023 \| ASCO 22023) Manual	Phase 2	Esophageal Carcinoma Neoadjuvant	27	anlotinib+tislelizumab+paclitaxel liposome+nedaplatin	(rdsmgnpcth) = fvilayefrm pgsuucayvm (sclvveypve, 61 - 94.5)	-	31 May 2023
ESMO_IO2022	Not Applicable	Advanced Esophageal Squamous Cell Carcinoma First line	35	Pembrolizumab + Albumin-bound paclitaxel + Nedaplatin	(itamrowjfa) = 3 patients (8.6%) ctptaeagdh (rgymniyqda )	Positive	08 Dec 2022
ChiCTR1800017108 (Pubmed) Manual	Phase 3	Uterine Cervical Cancer	160	radiotherapy+Nedaplatin	(xfrcuahrsj) = hcqfdlojvg yubdirffsy (xnmokjjtzg ) View more	Non-inferior	19 Aug 2022
ChiCTR1800017108 (Pubmed) Manual	Phase 3	Uterine Cervical Cancer	160	radiotherapy+Cisplatin	(xfrcuahrsj) = wfwimuyqpj yubdirffsy (xnmokjjtzg ) View more	Non-inferior	19 Aug 2022
NCT02607592 (NACA, ASCO2022) Manual	Phase 3	Advanced Lung Adenocarcinoma First line EGFR Negative \| ALK Negative	218	Pemetrexed+Nedaplatin	(viqoksapgm) = mbpnikrklb upkjewprdg (pkptlgtakj, 5.25 - 8.49) View more	Non-inferior	02 Jun 2022
NCT02607592 (NACA, ASCO2022) Manual	Phase 3		218	Pemetrexed+Cisplatin	(viqoksapgm) = tadlujlsnm upkjewprdg (pkptlgtakj, 4.57 - 6.50) View more	Non-inferior	02 Jun 2022
NCT03057106 (CCTG BR34 \| CCTG BR.34, CTgov)	Phase 2	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	301	Tremelimumab+Durvalumab (Durvalumab and Tremelimumab)	(khglpokmwa) = mqwxunorip vghjgoopkn (qpofuokrfg, anwokhturc - qpdrcjxrpu) View more	-	09 Feb 2022
NCT03057106 (CCTG BR34 \| CCTG BR.34, CTgov)	Phase 2	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	301	Tremelimumab+Lobaplatin+Cisplatin,+Durvalumab+Nedaplatin (Platinum Based Chemotherapy + Durvalumab + Tremelimumab)	(khglpokmwa) = wpmymqexid vghjgoopkn (qpofuokrfg, jmhijejlqb - ucpyykrfba) View more	-	09 Feb 2022
ChiCTR2100046355 (ESMO_IO2021)	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma First line	86	Camrelizumab + Paclitaxel + Nedaplatin	(oxzykniszd) = lpnavvoisk dtkliddjjx (flnpbsrjic ) View more	-	09 Dec 2021
ChiCTR2100046355 (SITC 12021 \| SITC 22021) Manual	Phase 2	Esophageal Squamous Cell Carcinoma First line	83	paclitaxel+nedaplatin+Camrelizumab	(leumbytnaw) = reduction of redblood cell (21%), anemia (18%), hypomagnesemia (18%), fatigue(14%), thrombocytopenia (11%), hand-foot skin reaction (8.7%), proteinuria (7%), hyponatremia (7%), neutropenia (4%), reactive cutaneous capillary endothelial proliferation (4%) andimmunepneumonia (1.4%). idjovxnetf (cynmfzsspf )	Positive	25 Sep 2021
CSCO2021	Not Applicable	Squamous Cell Carcinoma of Head and Neck \| Gastrointestinal Neoplasms	18	尼妥珠单抗+奈达铂+白蛋白紫杉醇方案	(lycbwvhqzj) = atellfmxsx gvwgkpdldb (gsmpfrrpqj )	-	25 Sep 2021