This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.

开始日期2024-10-02

申办/合作机构

Processa Pharmaceuticals, Inc.

NCT04861987

/ Completed临床1期

A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 with Escalating Doses of Capecitabine Administered Orally to Patients with Advanced, Refractory Gastrointestinal Tract Tumors

This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.

开始日期2021-06-18

申办/合作机构

Processa Pharmaceuticals, Inc.

NCT01231802

/ Unknown status临床2期

A Comparative, Multicenter, Open-Label, Randomized, Phase 2 Study of the Safety and Antitumor Activity of Oral Eniluracil + 5 Fluorouracil + Leucovorin Versus Capecitabine Monotherapy in Subjects With Metastatic Breast Cancer

The purpose of the study is to determine if eniluracil/5-FU/leucovorin in metastatic breast cancer (MBC) may have efficacy and tolerability advantages over capecitabine monotherapy.

开始日期2011-04-01

申办/合作机构

Fennec Pharmaceuticals, Inc.

100 项与恩尿嘧啶相关的临床结果

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100 项与恩尿嘧啶相关的转化医学

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100 项与恩尿嘧啶相关的专利（医药）

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154

项与恩尿嘧啶相关的文献（医药）

2025-02-01·ESC Heart Failure

Eniluracil Blocks AREG Signalling-Induced Pro-Inflammatory Fibroblasts of Melanoma in Heart Failure

Article

作者: Chen, Long ; Ran, Qin

Abstract:

Aims:

Heart failure (HF) is characterized by a heightened risk of melanoma, which often metastasizes to the heart. The overlap pathology between HF and melanoma includes chronic low-grade inflammation and dysregulation of inflammatory cancer-associated fibroblasts (iCAFs). The impact of HF on iCAF-driven tumour inflammation remains obscure.

Methods and Results:

To identify critical genes for HF development, transcriptomic data (GSE57338) containing 313 clinical HF samples [136 healthy controls, 95 ischaemia (ISCH) and 82 dilated cardiomyopathy (DCM)] were analysed to screen differentially expressed genes (DEGs) and perform enrichment analysis. Fifty-one DEGs in ISCH and 62 DEGs in DCM were identified with log2|fold change (FC)| ≥ 1 and P value ≤0.05. All these genes are involved in extracellular matrix organization, immune/inflammatory responses and Wnt signalling pathways. Then, the overall survival curves and prognostic models of DEGs in melanoma were evaluated. The correlation of gene expression with lymphocyte infiltration levels was assessed. Only aldehyde oxidase 1 (AOX1) and amphiregulin (AREG) maintained the same trend in melanoma as in HF, negatively affecting prognosis by regulating lymphocyte infiltration (log-rank P value = 0.0017 and 0.0019). The potential drug molecules were screened, and the binding energies were calculated via molecular docking. Eniluracil, a known AOX1 targeting drug, was found to stably bind with AREG (hydrogen bond binding energies: −65.633, −63.592 and −62.813 kcal/mol).

Conclusions:

The increased prevalence of melanoma in HF patients and its propensity for cardiac metastasis may be due to AREG-mediated systemic low-grade inflammation. Eniluracil holds promise as a therapeutic agent that may block AREG signalling, inhibiting the activation of iCAF mediated by regulatory T cell (Treg) and neutrophil.

2024-12-01·Sustainable Chemistry and Pharmacy

A silica gel-supported schiff base palladium nanocatalyst for sonogashira cross-coupling and synthesis of an anti-cancer chemotherapeutic agent

作者: Sarkar, Shaheen M. ; O'Reilly, Emmet J. ; Khan, Maksudur Rahman Md. ; Hasan, Kamrul ; Rahman, Lutfor Md

This work outlines the synthesis of a low-cost reusable silica gel-supported Schiff-base palladium nanocatalyst and its application in the synthesis of anti-cancer agent Eniuracil via the Sonogashira reaction.Silica gel was functionalized with amino containing silyl followed by the generation of a Schiff base through reaction with 1,10-phenanthroline-2,9-dicarboxaldehyde.Palladium was then coupled in the presence of hydrazine hydrate, resulting in the formation of the silica gel-supported Schiff-base palladium nanocatalys.Successful palladium incorporation was confirmed through Fourier-transform IR spectroscopy (FTIR) and X-ray diffraction (XRD) analyses.Scanning Electron Microscope (SEM) images revealed spherical silica gel particles and Transmission Electron Microscopy (TEM) anal. indicated an average palladium nanoparticle size of 5.92 ± 0.1 nm.The Inductively Coupled Plasma (ICP) and Energy Dispersive X-ray (EDX) data confirmed the anchoring of 0.27 mol% of palladium to the Schiff-base in the catalyst.The industrial efficacy of the catalysts is demonstrated through its application in carbon-to-carbon bond formation between aryl halides and aromatic alkyne via the Sonogashira reaction.Furthermore, the catalyst proved effective in the synthesis of the anti-cancer agent Eniuracil, a vital component in fluoropyrimidine-based chemotherapy.The catalyst exhibited reusability without significant loss of productivity.

2023-05-01·JOURNAL OF MOLECULAR LIQUIDS

Adsorption of 40 low molecular weight drugs on pristine and fluorinated C60 fullerenes: Ab initio, statistical and neural networks analysis

作者: Yusupbek A. Bauetdinov ; Mikhail M. Maslov ; Konstantin P. Katin ; Elizaveta B. Kalika ; Anastasiya A. Grekova ; Nikolay V. Bondarev ; Alexey I. Kochaev ; Savas Kaya

Loading of 40 small drugs mols. with mol. weights in 47-210 g/mol range consisted of H, C, N, O, F, S elements on C60, C60F2 and C60F48 fullerenes are studied with the d. functional theory.Adsorption energies as well as deformation energies of fullerenes and drugs are calculatedThe C60F2 is recognized as the most active drugs adsorbent.Mean adsorption energies averaged over all considered drugs are 0.41, 0.59 and 0.54 eV with standard deviations of 0.10, 0.09 and 0.14 eV for C60, C60F2 and C60F48 fullerenes, resp.Mean energies of drug-induced deformations of C60, C60F2 and C60F48 are 8.6, 12.0 and 16.6 meV, resp.Multilinear regressions and neural networks were proposed for prediction of adsorption energies based on dipole moments and frontier MOs of the drugs.Achievable accuracy of such predictions is about 0.1 eV.Altretamine antibiotic is recognized as the notable drug possessing extremely high binding energies about 1 eV with fullerenes.IR spectral shifts due to its loading on fullerene carriers are calculated

项与恩尿嘧啶相关的新闻（医药）

2026-01-12

·GlobeNewswire-Health Care

Processa Pharmaceuticals to Attend 44th Annual J.P. Morgan Healthcare Conference

VERO BEACH, Fla., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today announced that George Ng, Chief Executive Officer, and Patrick Lin, Chief Business & Strategy Officer and Founder, will attend the 44th Annual J.P. Morgan Healthcare Conference, taking place January 12-15, 2026, in San Francisco, California. During the conference, Mr. Ng and Mr. Lin will be available for one-on-one meetings with investors and potential partners to discuss Processa’s clinical pipeline, including the ongoing Phase 2 study evaluating NGC-Cap in patients with advanced or metastatic breast cancer. Preliminary Phase 2 data have demonstrated that NGC-Cap increases exposure to capecitabine’s cancer-killing metabolites while maintaining a safety profile comparable to standard capecitabine monotherapy. The Company expects to complete a formal interim analysis from the first 20 patients enrolled in early 2026. Investors and interested parties who wish to schedule a meeting with Processa management during the conference are encouraged to contact Wendy Guy, Founder & Chief Administrative Officer (email: wguy@processapharmaceuticals.com). About NGC-Cap (PCS6422+Capecitabine) NGC-Cap is Processa’s lead oncology asset and a key component of its Next Generation Cancer (NGC) platform. When administered, NGC-Cap is designed to increase systemic exposure to active cancer-killing anabolite metabolites while reducing formation of toxic catabolite metabolites, potentially improving the therapeutic index of Capecitabine-based therapy. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value. For more information, visit our website at www.processapharma.com. Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact:Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations:Dave GentryRedChip Companies, Inc.1-407-644-4256PCSA@redchip.com

临床2期

2026-01-07

·GlobeNewswire-Health Care

Processa Pharmaceuticals Completes Enrollment of 20th Patient for Formal Interim Analysis in Phase 2 NGC-Cap Breast Cancer Study

Jan. 05, 2026 -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today reported that it completed the enrollment and dosing of the 20 patients required for the planned formal interim analysis in its ongoing Phase 2 clinical study evaluating NGC-Cap, Processa’s proprietary combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer. “This is an important milestone because it allows us to assess whether NGC-Cap can demonstrate a meaningful improvement over capecitabine monotherapy in both safety and efficacy for patients who have already undergone multiple prior cancer treatments.,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. The randomized, FDA-recommended Phase 2 study is designed to compare NGC-Cap (Arm A) with standard-of-care capecitabine monotherapy (Mono-Cap, Arm C) in patients with advanced or metastatic breast cancer. Patients enrolled in the study were required to have received at least one prior cancer treatment, with a median of two to three prior treatment regimens across the enrolled population. NGC-Cap consists of a single dose of PCS6422 administered one day prior to capecitabine, followed by capecitabine at 150 mg twice daily for seven days on treatment and seven days off. The Mono-Cap arm consists of capecitabine administered at 1,000 mg/m² twice daily for 14 days followed by seven days off treatment. PCS6422 is designed to re-engineer capecitabine metabolism by increasing the formation of cancer-killing metabolites (anabolites) while decreasing the formation of metabolites associated primarily with side effects (catabolites). The formal interim analysis will compare safety and preliminary efficacy outcomes between the NGC-Cap and Mono-Cap treatment arms and is expected to be completed in the first quarter of 2026. Key objectives of the interim analysis include: Evaluating the comparative safety and efficacy of NGC-Cap versus Mono-Cap Determining whether a higher or lower dose of NGC-Cap should be added as a third study arm Assessing whether the overall sample size of the Phase 2 study should be adjusted based on interim findings “The interim analysis is designed to evaluate early signals of clinical benefit and to guide potential optimization of dose selection and overall study design,” said Dr. David Young, President of Research and Development at Processa. “These data will be critical as we determine the most appropriate path forward to maximize the therapeutic potential of NGC-Cap.” NGC-Cap is Processa’s lead oncology asset and a key component of its Next Generation Cancer (NGC) platform. When administered, NGC-Cap is designed to increase systemic exposure to active cancer-killing anabolite metabolites while reducing formation of toxic catabolite metabolites, potentially improving the therapeutic index of Capecitabine-based therapy. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value. The content above comes from the network. if any infringement, please contact us to modify.

临床研究

2025-12-22

·三阴姐妹互助圈

卡培他滨组合方案，有望让转移性乳腺癌药效更好，减轻手足综合征症状

关注公众号，获取三阴抗癌资料包三阴姐妹互助交流病友群（点击） ⭕️ 一、NGC‑Cap 是什么？对于晚期或转移性乳腺癌患者，卡培他滨是一种常见的口服化疗药。很多人一边指望它“杀癌细胞”，一边又担心手足综合征等副作用，确实很纠结。 NGC‑Cap是一个“组合升级方案”，包括两部分： PCS6422：PCS6422是生物制药公司Processa Pharmaceuticals正在开发的一种实验性抗癌药物，旨在与常用化疗药卡培他滨（Capecitabine, Xeloda）联用，以增强疗效，同时减少副作用，如手足综合征（Hand-Foot Syndrome）。它通过提高免疫反应和改善传统化疗的效率来达到目的，目前正处于临床试验阶段。卡培他滨：已经用了多年的化疗药。两者一起组合，就叫 NGC‑Cap。研究人员的目标是：在不明显增加副作用的前提下，让体内真正“负责杀癌”的有效成分更多，从而提升抗癌效果。目前，Processa Pharmaceuticals 公司正在进行2 期临床试验。早期结果还在观察当中。 ⭕️ 二、19 名患者的试验：一组用“升级方案”，一组用“老方案” 这项试验一共纳入了 19 名转移性乳腺癌患者，随机分成两组： 1. NGC‑Cap 组（联合用药） PCS6422：150 mg/㎡，每天 2 次；卡培他滨：和 PCS6422 一起服用。 2. Mono‑Cap 组（标准卡培他滨单药）只用卡培他滨：1000 mg/㎡，每天 2 次。目前对安全性的分析，是基于前 16 名已经有完整数据的患者。该公司在新闻稿中提到：和单独用卡培他滨相比， NGC‑Cap 组体内，那些“已经被证实可以杀癌细胞”的特定成分的暴露量明显更高。可以把它理解成：同样是吃卡培他滨，NGC‑Cap 方案能让“杀癌成分”在体内停留更久、力量更足。 ⭕️ 三、副作用“次数多了”，但“严重程度没有加重” 目前的观察是： NGC‑Cap 组因为抗癌活性更强，报告的不良反应次数更多；但两组患者的副作用严重程度差不多，没有因为方案“更猛”就出现更多重度毒副作用。也就是说，在这个小样本里看到的是：抗癌成分更高 ≠ 对身体的总体伤害更重。到目前为止，还没有发现明显变“更危险”的安全性信号。 ⭕️ 四、最亮眼的一点：手足综合征的程度变轻了卡培他滨进入人体后，会被分解成好几种成分（叫“代谢产物”），其中有一个叫 FBAL 的成分，被认为和手足综合征等副作用有关。手足综合征的表现包括：手脚发红、肿胀、脱皮；有灼热感、疼痛，严重时走路都困难。在这项研究中发现： NGC‑Cap 组患者体内的 FBAL 暴露量，比单用卡培他滨的患者，可以降低到原来的 1/10 左右；两组当中，出现手足综合征的患者人数差不多，但严重程度有明显差别： NGC‑Cap 组：只出现 1 级（轻度）手足综合征；标准卡培他滨组：出现 2 级（中度）手足综合征。也就是说：患者“得手足综合征”的比例差不多，但症状更轻了。对于需要长期口服化疗、坚持治疗的患者，这一点非常关键：副作用更轻，生活质量更好，也更容易把治疗坚持下去。由于微信公众平台的机制调整，恳请各位姐妹花一秒钟帮我们点亮文章下方的【小手】和【爱心】，让更多需要我们的姐妹“看见”我们。感谢大家！ ◇ 回复关键词"资料"领取《恶性肿瘤患者膳食指导》文件温馨提示：加入🌷希望花园·三阴“卡友”陪跑专项群，和姐妹们温暖同行❤️ 科普视频合集 👇👇👇 乳癌全知道系列1 | “最难搞” 的三阴性乳腺癌，确诊后怎么办？怎么治疗？珍藏版科普视频来了！乳癌全知道系列2 | 都是乳腺癌，为什么有的人确诊不到一年就走了，而有的人治愈了？乳癌全知道系列3 | 做好这件事，早期乳腺癌治愈率接近100% 乳癌全知道系列4 | 如果乳房会说话，它想告诉你这些关于乳腺癌的秘密乳癌全知道系列5 | 87%患癌vs 100%预防，科学预防遗传性乳腺癌乳癌全知道系列6 | 从化疗到ADC药物，这些乳腺癌靶向药都进医保了！乳癌全知道系列7 | 当乳腺癌遇上内分泌治疗：一场精准的 “断粮” 行动乳癌全知道系列8 | 治疗结束≠抗癌结束！结疗后这样做，让复发风险降到最低 >>想看更多动画视频请关注公众号参考来源 https://www.processapharmaceuticals.com/news-media/press-releases/detail/142/processa-pharmaceuticals-provides-clinical-update-on-phase

100 项与恩尿嘧啶相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03998	-	-	DB03516

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期结直肠腺癌	临床3期	美国	National Cancer Institute	1999-04-01
直肠腺癌	临床3期	美国	National Cancer Institute	1999-04-01
复发性结肠癌	临床3期	美国	National Cancer Institute	1999-04-01
结直肠癌	临床3期	美国	GSK Plc	-
结直肠癌	临床3期	英国	GSK Plc	-
胰腺癌	临床3期	英国	GSK Plc	-
HER2 阴性乳腺癌	临床2期	美国	Processa Pharmaceuticals, Inc.	2024-10-02
三阴性乳腺癌	临床2期	美国	Processa Pharmaceuticals, Inc.	2024-10-02
转移性乳腺癌	临床2期	美国	Fennec Pharmaceuticals, Inc.	2011-04-01
转移性乳腺癌	临床2期	俄罗斯	Fennec Pharmaceuticals, Inc.	2011-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04861987 (ASCO2025)	临床1期	难治性癌症 \| 胃癌 \| 晚期癌症 dihydropyrimidine dehydrogenase (DPD)	18	Eniluracil + Capecitabine (6422 + Cap)	壓襯鏇繭餘網襯窪鑰鹹(築簾築淵膚餘構鏇齋顧) = 36.4% of the patients in the 150 mg BID and 225 mg BID cohorts had grade 3-4 adverse events (AEs) associated with anabolites, similar to the incidence reported for Mono-Cap 鬱選網壓築糧選積網餘 (醖鬱鹽鹽獵鹹製艱艱積 ) 更多	积极	2025-05-30
NCT04861987 (GlobeNewswire) 人工标引	临床1期	胃肠道肿瘤	12	PCS6422 + Capecitabine	餘膚簾憲選遞鑰網蓋醖(顧淵構獵艱憲鹽淵夢餘) = 築範糧膚顧範繭蓋蓋夢淵膚夢鹹襯構糧鹽鹽觸 (選選夢範製築夢憲繭觸 ) 更多	积极	2024-06-11
AACR2024 人工标引	临床1期	肿瘤	18	NGC-Cap (150 mg bid)	獵鬱獵襯鏇窪蓋淵繭範(夢襯膚淵獵製憲膚獵鏇) = 顧廠觸觸網獵醖壓繭顧鹹壓窪壓鹹淵醖積廠鹽 (醖構遞繭網顧醖製鏇遞, 23) 更多	积极	2024-04-05
AACR2024 人工标引	临床1期	肿瘤	18	NGC-Cap (225 mg bid)	獵鬱獵襯鏇窪蓋淵繭範(夢襯膚淵獵製憲膚獵鏇) = 願鏇壓夢鹽膚網淵構艱鹹壓窪壓鹹淵醖積廠鹽 (醖構遞繭網顧醖製鏇遞, 37) 更多	积极	2024-04-05
NCT04861987 (GlobeNewswire) 人工标引	临床1期	肿瘤	-	PCS6422+Capecitabine	鹹蓋齋糧壓夢鏇構蓋蓋(廠鬱醖齋夢糧範鏇選鑰) = the side effect profile for 5-FU exposures from NGC-Cap had a similar anabolite side effect profile to FDA-approved capecitabine. In addition, the side effects associated with FBAL (fluoro-beta-alanine, the primary catabolite formed from the metabolism of 5-FU), such as hand-foot syndrome, that can lead to capecitabine intolerance, were almost non-existent, likely because FBAL exposure was approximately 1% of the exposure seen after FDA-approved capecitabine administration. 鹹範製繭壓範網齋鏇鏇 (鏇觸鑰鏇鹹襯淵鏇繭築 )	积极	2023-12-19
ASCO2007	临床1期	-	5	Eniluracil (EU)	觸艱觸憲醖遞顧鹹網齋(獵廠憲顧鹹襯窪糧顧鬱) = 糧廠艱餘鹽鹽築觸選艱選鹹膚齋鏇餘鹹鑰憲餘 (範積鹽蓋構遞蓋願鏇選, 11)	-	2007-06-20
NCT00003254 (Pubmed \| Invest New Drugs)	临床2期	结直肠癌	75	Eniluracil and 5-Fluorouracil	襯襯鏇觸憲糧鏇願鹽艱(顧蓋網鏇構鬱構襯鏇憲) = 夢繭繭醖蓋選顧願餘蓋糧夢簾願憲範觸蓋壓衊 (壓鹹壓鏇鑰廠願觸鏇簾 )	不佳	2002-11-01