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更新于：2026-04-02

Sodium Thiosulfate

硫代硫酸钠

更新于：2026-04-02

概要

基本信息

药物类型

小分子化药

别名

Monosulfanemonosulfonic acid、Sodium Aurotiosulfate、Sodium thiosulfate (USP)

+ [12]

靶点-

作用方式

供体

作用机制

硫原子供体

治疗领域

耳鼻咽喉疾病其他疾病神经系统疾病

在研适应症

听力损失耳毒性消毒剂+ [2]

非在研适应症

钙化防御眼部疾病

原研机构

Nichi-Iko Pharmaceutical Co., Ltd.

在研机构

諾金有限公司

Fennec Pharmaceuticals, Inc.

Kenei Pharmaceutical Co Ltd.

+ [4]

非在研机构

Byondis BV

Decibel Therapeutics, Inc.

U.S. Army War College

权益机构

諾金有限公司

Fennec Pharmaceuticals, Inc.

最高研发阶段批准上市

首次获批日期

日本 (1984-05-11),

中毒

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、快速通道 (美国)

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结构/序列

分子式H12Na2O8S2

InChIKeyJIWXHKJJHDWKGC-UHFFFAOYSA-N

CAS号10102-17-7

关联

项与硫代硫酸钠相关的临床试验

NCT07407582

/ Not yet recruiting临床1/2期IIT

Phase I/II Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)

The purpose of this study is to assess the safety and effectiveness of a drug called Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy. The safety and effectiveness of STS in reducing hearing loss has been well established in children and is approved for use in the pediatric and young adult population. However, information in adult patients is limited. As most cisplatin is administered in the adult population, this investigation would be of benefit.

开始日期2026-04-30

申办/合作机构

University of Arizona

[+1]

NCT07218913

/ Recruiting临床1期IIT

Phase 1 Trial of Pedmark in Men Receiving Cisplatin for Metastatic Germ Cell Tumor

This phase I trial evaluates whether adding Pedmark to standard of care cisplatin-based chemotherapy reduces drug-induced ear damage (ototoxicity) in men with stage II-III testicular germ cell tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Cisplatin-induced ototoxicity remains a major concern in adult patients with germ cell tumors as nearly four out of five patients develop hearing loss after treatment. Cisplatin is thought to cause ear damage by the production of chemically reactive molecules called reactive oxygen species. These molecules can cause damage when their levels get too high. Pedmark may reduce the negative side effects of cisplatin by neutralizing these reactive molecules. Pedmark has been approved for reducing the risk of cisplatin-induced ototoxicity in pediatric patients and older patients with solid tumors that haven't spread to other parts of the body. Adding Pedmark to cisplatin-based chemotherapy treatment may reduce ototoxicity in adult men with stage I-III testicular metastatic germ cell tumors.

开始日期2026-03-04

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07228429

/ RecruitingN/AIIT

Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images

The main purpose of this study is to develop sensitive radiographic measurement techniques that can be used as outcome measures along with patient-reported outcome instruments in clinical trials of calcinosis cutis treatments, and potentially be used to assess disease course and treatment response in clinical practice. The goal is to test the performance of the software.

开始日期2025-10-14

申办/合作机构

Yale University

[+1]

100 项与硫代硫酸钠相关的临床结果

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100 项与硫代硫酸钠相关的转化医学

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100 项与硫代硫酸钠相关的专利（医药）

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2,451

项与硫代硫酸钠相关的文献（医药）

2026-12-31·ANNALS OF MEDICINE

Advances in the clinical applications of sodium thiosulphate

Review

作者: Ke, Jingjing ; Zang, Hualong ; Deng, Yiting ; Liu, Yang ; Wang, Ping

BACKGROUND:

Sodium thiosulphate (STS) is a clinically approved pharmaceutical agent known for its antioxidant and sulphide-releasing properties. Currently, it is commonly employed in the detoxification treatment of various chemical intoxications, including cyanide, arsenic, and lead poisoning. In recent years, research into the clinical applications of STS has advanced rapidly, resulting in numerous significant breakthroughs. However, awareness and adoption of these developments remain limited among clinical practitioners.

DISCUSSION:

In addition to its research progress in the treatment of cyanide poisoning, STS has also demonstrated protective effects against chemotherapeutic drug-induced ototoxicity and nephrotoxicity, as well as in conditions such as vascular calcification and uraemic pruritus. Furthermore, STS has been shown to exert protective effects on multiple organs, including the heart, brain, and kidneys, by mitigating ischaemia-reperfusion injury. There is also evidence suggesting that STS may offer protection in diseases such as preeclampsia and hypertensive renal injury. However, these studies exhibit considerable variability in terms of STS administration strategies.

CONCLUSIONS:

This paper provides a comprehensive review of current preclinical and clinical studies on STS, with the aim of highlighting its potential therapeutic applications in chemical intoxications, cancer treatment, vascular calcification, uraemic pruritus, and other related pathological conditions. Owing to its multiple biological protective effects and a favourable safety profile, STS is anticipated to receive growing recognition among the medical community, which may pave the way for the exploration of novel clinical indications and contribute meaningfully to public health.

2026-03-01·OTOLOGY & NEUROTOLOGY

Impact of pH on Intratympanic Sodium Thiosulfate-hyaluronan Gel in Preventing Cisplatin-induced Ototoxicity

Article

作者: Fransson, Anette ; Laurell, Göran ; Videhult Pierre, Pernilla

Hypothesis::

The pH of an intratympanic gel influences the level of protection against the ototoxic effects of systemic cisplatin.

Background::

Nucleophiles reduce cisplatin-induced ototoxicity by chemically inactivating cisplatin and counteracting oxidative stress. pH is a factor influencing cisplatin’s reactivity. Here, intratympanic administration of a hyaluronan-based gel containing the nucleophile sodium thiosulfate (STS) was used to investigate the role of pH in otoprotection.

Methods::

Guinea pigs (n=32) received a unilateral transtympanic injection of a hyaluronan-based gel (0.10 to 0.15 mL) with either STS at pH 6.5 or pH 8.0, or NaCl at pH 6.5 or pH 8.0. The contralateral ear served as control. After 30 minutes, cisplatin (8 mg/kg b.w., i.v.) was administered. Cochleae were harvested 4 days later for hair cell quantification.

Results::

Mean percentage of outer hair cell (OHC) loss per mm in the region ≤10 mm from the round window had a median absolute intraindividual difference of 6.0% (quartiles 1 and 2: 3.8% to 11%; P =0.012; n=8) in group STS pH 6.5 and 5.8% (1.8% to 18%; P =0.046; n=6) in group STS pH 8.0, favoring the gel-treated ear. The corresponding numbers in the NaCl groups were −0.2% (−2.2 to 8.7%; P =1.000; n=8) in group NaCl pH 6.5 and 3.3% (−8.1% to 22%; P =0.237; n=7) in group NaCl pH 8.0. The difference between nontreated and gel-treated ears did not differ significantly between the 2 STS groups.

Conclusion::

STS in a hyaluronan-based gel reduced OHC loss equally well at both pH levels, while NaCl was ineffective.

2026-03-01·Kidney Medicine

A Large Deletion With a Large Impact: Homozygous 5,600 bp Deletion of the GALNT3 Gene Causing Hyperphosphatemic Tumoral Calcinosis

Article

作者: Seeger, Harald ; Portmann, Julia Maria ; Bahr, Angela ; Wagner, Carsten A ; Martini, Katharina ; Ritter, Alexander

Hyperphosphatemic familial tumoral calcinosis (HTC) is a rare disease caused by autosomal recessive loss of function variants in the genes encoding fibroblast growth factor 23 (FGF-23), Klotho, or GalNAc-T3. This results in reduced phosphate excretion in the renal proximal tubule, leading to hyperphosphatemia. The clinical manifestations of HTC are mainly periarticular calcifications accompanied by pain and disability, inflammation, and dental problems. Inactive forms or reduced levels of FGF-23 or resistance to the FGF-23/Klotho complex are the main pathophysiologic characteristics underlying this disease. Treatment options to reduce blood phosphate levels have only been studied in case reports and small cohorts, with positive effects from phosphate binders, acetazolamide, anti-inflammatory drugs, probenecid, nicotinamide, and sodium thiosulfate. In this report, we present the case of a 50-year-old woman with a large (at least 5,600 base pair) deletion in the gene encoding for GalNAc-T3 (GALNT3) who experienced bone pain during childhood and calcifications of her lower limbs at least since her mid-thirties. Intragenic GALNT3 copy number variants have, to our knowledge, not yet been described as a cause of HTC.

164

项与硫代硫酸钠相关的新闻（医药）

2026-04-01

·中国听力医学发展基金会

《中国感音神经性听力损失治疗的研究现状及发展趋势》——《中国听力健康报告2025·老年听力健康》分报告解读

导语 >>> 2025年12月16日，由中国听力医学发展基金会研创，社会科学文献出版社出版的《中国听力健康报告2025》蓝皮书在北京成功发布。该书是我国首部聚焦老年耳与听力健康的专项蓝皮书，是继《中国听力健康报告（2021）》后的又一行业重磅智库成果，填补了我国老年耳与听力健康系统化研究的空白，对推进“健康中国”建设、积极应对人口老龄化背景下的耳与听力健康挑战具有里程碑意义。舒易来,中国听力医学发展基金会第六届专家指导委员会常务委员，听觉医学创新与转化专家组主任委员；复旦大学附属眼耳鼻喉科医院副院长、主任医师，遗传性耳聋诊治中心主任，主要研究方向为听力损失的诊治、基因治疗研发和临床转化。左右滑动查看更多摘要：感音神经性听力损失的治疗在听力健康领域至关重要,先天因素如遗传,后天因素如感染、噪声、耳毒性药物、老化等均可引起听力损失。目前临床仍以助听器、人工耳蜗等治疗为主,基于病因学的根治手段匮乏。近年来针对感音神经性听力损失的治疗研究取得了突破性进展,主要集中在基因治疗、药物研发和再生医学等领域。这些跨学科的技术融合,如基因治疗、材料科学和生物工程的结合,将继续推动治疗策略的创新,为未来实现从对症干预到病因根治的跨越提供希望。中国感音神经性听力损失治疗的研究现状及发展趋势本文系《中国感音神经性听力损失治疗的研究现状及发展趋势》章节的简化呈现，相关研究背景、数据与完整论述详见《中国听力健康报告2025》蓝皮书。感音神经性听力损失指由耳蜗和/或听神经等的病变或功能障碍导致的听力损失。其致病因素包括遗传因素和多种环境因素。其中，部分环境因素可在全生命周期内对个体听力产生影响，但在生命的某些关键时期，如出生前或婴幼儿期，听觉系统对不良环境因素更为敏感。在生命周期的不同阶段，影响听力的主要因素也不尽相同，例如新生儿期主要与遗传因素和围产期感染相关，成年期则以噪声接触、耳毒性药物和年龄相关性因素为主。此外，随着年龄增长，听力损失的患病率和听力损失程度逐渐升高。一、感音神经性听力损失的研究现状 (一)先天性感音神经性听力损失新生儿听力损失的患病率为2‰-3‰，其中约60%的先天性听力损失与遗传因素有关。先天性感音神经性听力损失由遗传和环境因素共同导致，其中遗传因素占比约为60%。截至2025年2月15日，已有超过200个基因被报道与听力损失有关，遗传机制包括常染色体显性遗传、常染色体隐性遗传、X连锁遗传、Y连锁遗传和线粒体遗传等。在我国，常见的致病基因包括GJB2、SLC26A4、线粒体12SrRNA、MYO15A、OTOF及MITF等。既往对遗传性听力损失缺乏有效药物治疗方法。进入21世纪以来，随着生物医药技术的发展，腺相关病毒（AAV）介导的基因置换策略以及基于CRISPR-Cas系统的基因编辑技术在遗传性听力损失治疗领域取得重要进展，基因治疗有望根治遗传性听力损失。基因置换是修复功能丧失突变最常用且最直接的基因治疗策略。研究显示，AAV介导的基因置换可在多种先天性听力损失小鼠模型中恢复听力功能，并推动了遗传性听力损失基因治疗研究的开展。目前，针对GJB2、KCNQ1、MPZL2、STRC等多个基因的置换策略已在动物模型中获得概念性验证。但基因置换存在正常基因表达量不可控、异位表达可能引发安全性风险，且难以应用于显性负效应导致的遗传性疾病等局限。因此，研究人员开始聚焦更为精准的基因编辑技术。CRISPR-Cas9系统在遗传性听力损失中的应用表明，其可在活体内对内耳感觉细胞进行基因编辑，并在多种常染色体显性或隐性遗传性听力损失小鼠模型中显著改善听力功能，进一步凸显了基因编辑策略的治疗潜力。近年来，基于CRISPR-Cas9的碱基编辑器无需断裂双链DNA即可实现特定突变位点的精确修复，在遗传性听力损失动物模型中展现出应用潜力。相关研究表明，双AAV介导的碱基编辑策略可在部分模型中恢复或改善听力，其中针对OTOF基因致病突变的研究在动物模型中实现了长期、稳定的听力恢复。在众多致病基因中，OTOF基因因其特殊致病机制成为重要的基因治疗靶点。OTOF基因突变可导致常染色体隐性遗传性听力损失9型（DFNB9），占先天性非综合征型听力损失的2%~8%。近年来，国内外已开展多项基于基因置换或基因编辑策略的OTOF相关临床试验。复旦大学附属眼耳鼻喉科医院已完成全球首批多例DFNB9患者治疗，临床结果显示部分基因治疗药物具有初步的安全性和有效性，为遗传性听力损失乃至其它听力损失的治疗提供了新的方向。 (二)噪声性听力损失噪声性听力损失是仅次于年龄相关性听力损失的感音神经性听力损失。在我国，职业性噪声听力损失已成为紧随尘肺病之后的第二大职业健康威胁。根据国家卫生健康委公开数据，职业性耳鼻喉口腔疾病2023年新增2228例，其中职业性噪声性听力损失是主要类型之一。非职业性噪声性听力损失影响人群更广，但因缺乏全国性统计，暂无权威数据。噪声性听力损失的发病机制涉及细胞通路多样，是一个错综复杂的生理病理过程，会影响耳蜗及中枢神经系统。其核心在于强噪声对Corti’s器的直接损伤及由此触发的一系列生理功能失衡。长期或高强度噪声暴露可导致带状突触、螺旋神经节神经元及毛细胞等关键结构遭受损伤，相关机制包括机械性创伤、内耳微循环障碍以及噪声诱发的无菌性炎症、氧化应激和兴奋性神经毒性等。随着工业化与城市化进程的加快，噪声污染日益严重，因此“噪声性听力损失重在预防”刻不容缓。近年来，基于其发病机制，研究人员在动物实验中对多种药物进行了探索，包括抗氧化剂和抗炎性药物等。研究表明，部分抗氧化剂可通过减少活性氧的产生或积蓄减轻听力损失，相关化合物在动物模型中对噪声诱导的毛细胞损伤具有保护作用。随着药学、材料科学及其交叉领域的发展，内耳局部递送等新兴治疗策略不断涌现。利用具备药物缓释功能的生物医学材料进行耳蜗局部给药，可提升内耳局部药物浓度并增强治疗效果。多种材料载体在噪声性听力损失动物模型中展现出良好的防治效果，为未来临床防治提供了新的思路。噪声性听力损失治疗的临床研究主要集中在再生医学和药物治疗领域，部分药物通过修复听觉毛细胞或减少神经炎症显示出潜在疗效。此外，中药成分及其他干预方式也正在通过临床研究探索其在噪声性听力损失治疗中的应用潜力。 (三)药物相关性听力损失药物相关感音神经性听力损失（简称“药物性聋”）主要由耳毒性药物引发，包括某些抗生素、化疗药物、抗疟药及非甾体抗炎药等。药物通过影响内耳毛细胞、螺旋神经节细胞和血管纹的功能导致听力损失。我国针对药物性聋的全国性流行病学数据较为匮乏，但调查显示，不同人群听力损失现患率存在显著差异，可能与耳毒性药物暴露程度、遗传易感性及医疗资源可及性有关。既往研究发现有超过150种药物可能导致内耳功能障碍或细胞变性，引发感音神经性听力损失。其主要机制包括氧化应激、程序性细胞死亡（如凋亡、自噬、铁死亡）及细胞坏死等。目前尚无有效的逆转性治疗方法，临床上以停用耳毒性药物和听力康复为主，药物性聋的发生率因地区、用药种类和人群而异。顺铂作为常用化疗药物，广泛用于多种肿瘤治疗，超过60%的患者在治疗过程中出现双侧、进行性和永久性神经性听力损失。顺铂所致听力损失常表现为毛细胞功能紊乱、突触丢失及耳蜗神经损伤。相关研究表明，硫代硫酸钠可通过阻止顺铂进入细胞内抑制其细胞毒性作用，为药物性聋的干预提供了新的靶点。相关临床试验及药物研究显示，其在降低顺铂相关耳毒性方面具有良好的安全性和有效性。氨基糖苷类药物虽为治疗革兰氏阴性菌感染的一线药物，但具有较高耳毒性。研究显示，部分患者在使用后会出现耳毒性副作用并导致听力下降。近年来，基础研究发现，通过抑制铁死亡、保护线粒体功能或调节线粒体自噬，可在动物模型中降低氨基糖苷类药物的耳毒性。此外，遗传背景在药物相关听力损失中起重要作用。携带线粒体12SrRNA基因突变的个体对氨基糖苷类药物更为敏感。CRISPR-Cas9基因编辑技术为预防药物相关感音神经性听力损失提供了新的研究思路，相关动物研究显示，通过特异性敲除靶基因可有效预防耳毒性所致的毛细胞损伤。 (四)年龄相关感音神经性听力损失由年龄因素导致的感音神经性听力损失又称年龄相关性听力损失或老年性聋，已被证明与社交活动表现不佳、痴呆、晚发性抑郁症以及更高的总体死亡率有关。老年性聋的发病机制复杂且尚未完全明确，可能涉及氧化损伤、遗传因素及环境因素等，因此相关治疗靶点及药物疗效探索成为研究重点。由于临床模型进展缓慢、观察时程较长且成本较高，相较于临床干预措施，基础研究进展更为丰硕。研究人员围绕氧化应激与活性氧堆积、凋亡和线粒体自噬失衡等机制，开展了一系列药物干预研究。老年性聋的基础研究主要通过动物模型进行，其中以小鼠模型最为常见。相关研究发现，部分药物或中药复方可在动物模型中改善毛细胞丢失、降低氧化应激水平或抑制细胞凋亡，从而延缓年龄相关性听力损失的发生发展。在临床研究方面，我国针对老年性聋药物治疗的探索也在持续开展。截至2025年6月，已有多项注册的临床试验，主要聚焦于中药或神经保护剂对老年性聋及相关症状的干预效果，但目前尚未有结论性数据公开发表。尽管临床试验尚未取得突破性进展，我国在老年性聋治疗方面的临床研究仍在逐步深入。多项研究表明，中药方剂及神经保护剂在老年性聋干预中显示出一定潜力，部分研究结果提示其对听力保护及耳鸣缓解具有积极作用。二、存在的问题 (一)筛查与诊断滞后在农村和偏远地区，新生儿听力筛查覆盖率和技术水平不足，部分患儿漏诊或确诊延迟，错过语言发育关键期；老年性聋及噪声性听力损失缺乏系统性的成人听力筛查机制；药物性聋高危人群缺乏针对性的遗传筛查，增加了药物相关听力损失风险。同时，部分医疗机构因缺乏基因检测和影像学检查能力难以明确病因，噪声性和药物性听力损失缺乏早期监测机制，往往错过最佳干预时机。 (二)治疗资源与技术限制目前治疗手段整体较为局限。先天性听力损失主要依赖助听器和人工耳蜗，基因治疗仍处于临床试验阶段；噪声性听力损失缺乏特异性治疗药物；药物性聋尚无逆转性疗法；老年性聋仍以助听干预为主，缺乏特效药物。此外，优质医疗资源多集中于一、二线城市，农村和偏远地区患者可及性差，经济负担较重。 (三)科研与临床转化瓶颈现有动物模型存在局限，难以全面模拟人类噪声暴露环境及老年性聋的病理特征，限制了机制研究和药物筛选。噪声性、药物性及老年性听力损失的发病机制复杂，多因素相互作用关系尚不明确，研究深度仍显不足。同时，部分药物在动物模型中有效，但临床试验失败率较高，耳毒性药物替代品研发投入不足。感音神经性听力损失研究涉及多学科，但学科壁垒仍然存在，影响研发效率与创新进展。 (四)技术挑战与风险基因治疗受限于AAV载体容量，基因编辑技术仍存在脱靶风险，长期安全性有待验证。生物材料递送系统虽具潜力，但高浓度使用可能引发二次听力损伤，其长期耳毒性及降解产物影响仍需进一步评估。 (五)社会支持与政策短板听力康复机构和专业康复师数量不足，尤其在农村和偏远地区更为突出；耳毒性药物监测制度尚不完善，科研资金投入分散，多学科协作机制不足。患者及其家庭对听力损失风险和早期干预重要性的认知有限，影响听力辅助设备的使用依从性。三、对策建议 (一)筛查与诊断体系优化构建覆盖全生命周期的听力筛查网络，推广新生儿听力筛查与基因检测联合筛查，扩大对偏远地区的覆盖范围；针对职业噪声暴露人群、老年人群及耳毒性药物使用患者，建立动态听力监测机制，并结合人工智能辅助诊断实现早筛查、早诊断；同时，建立区域性听力损失基因数据库，明确“基因型—表型”关联，结合多模态影像技术和生物标志物，提高噪声性听力损失与老年性聋的病因诊断率。 (二)治疗技术创新与资源下沉优化AAV载体递送策略，推动CRISPR-Cas9碱基编辑等技术的临床转化；在干细胞与组织工程领域，探索毛细胞再生及功能性听力重建相关技术，积极开发新型递送系统。同时，通过基层医生培训和技术支持，提高助听器验配率与听力康复服务的可及性，推动优质医疗资源向基层下沉。 (三)科研转化与机制突破加大科研投入力度，利用前沿技术深入研究感音神经性听力损失的发病机制。通过设立跨学科专项基金，推动相关学科交叉融合，促进产学研协作，加快相关技术的临床转化周期。 (四)政策支持与监管强化将耳毒性药物使用纳入医疗质量管理体系，推进用药前遗传筛查；扩大人工耳蜗与助听器医保报销范围，探索多样化支付模式。完善药物性聋防治的专家共识和临床路径，建立全国性监测网络，加强不良反应追踪。对创新治疗药物给予政策支持，推动安全有效的基因治疗产品加快审批和应用。 (五)社会支持与公众教育完善听力康复服务体系，培养专业康复人才，推广远程康复模式；持续开展听力健康科普宣传，提高公众对听力损失风险和早期干预重要性的认知；针对职业噪声暴露人群实施听力保护措施，整合多方资源，推动感音神经性听力损失防治协作机制建设。四、未来展望随着高通量测序技术的广泛应用，更多先天性感音神经性听力损失患者将获得精确的基因诊断，为相关研究和治疗带来新的机遇。未来，感音神经性听力损失的治疗研究将持续聚焦精准遗传学与基因组学，深化“基因型—表型”关联研究，推动个体化诊断和治疗的发展。同时，基因编辑、干细胞和再生医学等技术有望在修复听觉结构、恢复听力功能方面取得进一步突破。基于基因组数据开发靶向治疗药物，并探索多种治疗手段的联合应用，将为实现从对症干预向“对因治疗”的转变提供可能。如您需要本书,请联系我们: 小林老师 13263187252（微信) 小听老师 19278118898

2026-03-31

·GlobeNewswire-Health Care

Fennec Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

RESEARCH TRIANGLE PARK, N.C., March 31, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX) (“Fennec” or the “Company”), a specialty pharmaceutical company, today announced that on March 17, 2026, the Compensation Committee of the Company’s Board of Directors approved the grant of incentive stock option awards (“ISOs”) to purchase an aggregate of 377,500 of the Company’s common shares to 24 new non-executive employees of the Company with a grant date of March 31, 2026 under the Company’s 2026 Equity Inducement Plan (the “Inducement Plan”). The ISOs were granted as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of the Company, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with the Company, pursuant to Nasdaq Listing Rule 5635(c)(4). All ISOs have an exercise price of $5.77 per share, which is equal to the closing price of the Company’s common shares on The Nasdaq Capital Market on March 30, 2026, and a term of ten years from the date of grant. One-third of the shares underlying each ISO vest on the one-year anniversary of the grant date and continue to vest monthly thereafter over 24 months, subject to each employee’s continued employment with Company as of each such vesting date. The stock options are subject to the terms and conditions of the Inducement Plan and the terms and conditions of an ISO agreement covering the grant. About Fennec Pharmaceuticals Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK® received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI®. In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI® in Europe, U.K., Australia and New Zealand. PEDMARQSI® is now commercially available in the U.K. and Germany. PEDMARK® has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI® has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. For more information, please visit www.fennecpharma.com and follow on LinkedIn. Forward Looking Statements Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about the Company’s business strategy, timeline and other goals, plans and prospects, including the Company’s commercialization plans respecting PEDMARK®/PEDMARQSI®, the market opportunity for and market impact of PEDMARK®/ PEDMARQSI®, its potential impact on patients and anticipated benefits associated with its use, future commercial and regulatory milestone and royalty payments from Norgine, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company’s ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2025. Fennec disclaims any obligation to update these forward-looking statements except as required by law. For a more detailed discussion of related risk factors, please refer to the Company’s public filings available at www.sec.gov and www.sedar.com. PEDMARK®, PEDMARQSI® and Fennec® are registered trademarks of Fennec Pharmaceuticals Inc. ©2025 Fennec Pharmaceuticals Inc. All rights reserved For further information, please contact: Investors:Robert AndradeChief Financial OfficerFennec Pharmaceuticals Inc.+1 919-246-5299 Corporate and Media:Lindsay Rocco Elixir Health Public Relations+1 862-596-1304lrocco@elixirhealthpr.com

孤儿药引进/卖出上市批准

2026-03-31

·BioSpace

Fennec Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - March 31, 2026

RESEARCH TRIANGLE PARK, N.C., March 31, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX) (“Fennec” or the “Company”), a specialty pharmaceutical company, today announced that on March 17, 2026, the Compensation Committee of the Company’s Board of Directors approved the grant of incentive stock option awards (“ISOs”) to purchase an aggregate of 377,500 of the Company’s common shares to 24 new non-executive employees of the Company with a grant date of March 31, 2026 under the Company’s 2026 Equity Inducement Plan (the “Inducement Plan”). The ISOs were granted as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of the Company, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with the Company, pursuant to Nasdaq Listing Rule 5635(c)(4). All ISOs have an exercise price of $5.77 per share, which is equal to the closing price of the Company’s common shares on The Nasdaq Capital Market on March 30, 2026, and a term of ten years from the date of grant. One-third of the shares underlying each ISO vest on the one-year anniversary of the grant date and continue to vest monthly thereafter over 24 months, subject to each employee’s continued employment with Company as of each such vesting date. The stock options are subject to the terms and conditions of the Inducement Plan and the terms and conditions of an ISO agreement covering the grant. About Fennec Pharmaceuticals Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK ® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK ® received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI ® . In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI ® in Europe, U.K., Australia and New Zealand. PEDMARQSI ® is now commercially available in the U.K. and Germany. PEDMARK ® has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI ® has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. For more information, please visit and follow on LinkedIn. Forward Looking Statements Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about the Company’s business strategy, timeline and other goals, plans and prospects, including the Company’s commercialization plans respecting PEDMARK ® /PEDMARQSI ® , the market opportunity for and market impact of PEDMARK ® / PEDMARQSI ® , its potential impact on patients and anticipated benefits associated with its use, future commercial and regulatory milestone and royalty payments from Norgine, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company’s ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2025. Fennec disclaims any obligation to update these forward-looking statements except as required by law. For a more detailed discussion of related risk factors, please refer to the Company’s public filings available at and PEDMARK ® , PEDMARQSI ® and Fennec ® are registered trademarks of Fennec Pharmaceuticals Inc. ©2025 Fennec Pharmaceuticals Inc. All rights reserved For further information, please contact: Investors: Robert Andrade Chief Financial Officer Fennec Pharmaceuticals Inc. +1 919-246-5299 Corporate and Media: Lindsay Rocco Elixir Health Public Relations +1 862-596-1304 lrocco@elixirhealthpr.com

上市批准引进/卖出孤儿药

100 项与硫代硫酸钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01091	硫代硫酸钠	V03AB06	DB09499

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
听力损失	瑞士	諾金有限公司	2026-03-26
耳毒性	美国	Fennec Pharmaceuticals, Inc.	2022-09-20
消毒剂	日本	Kenei Pharmaceutical Co Ltd.	2013-11-12
氰化物中毒	澳大利亚	Pfizer Australia Pty Ltd.	2007-08-30
中毒	日本	Nichi-Iko Pharmaceutical Co., Ltd.	1984-05-11

未上市

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
钙化防御	临床3期	美国	Hope Pharmaceuticals, Inc.	2017-05-24
钙化防御	临床3期	加拿大	Hope Pharmaceuticals, Inc.	2017-05-24
钙化防御	临床3期	英国	Hope Pharmaceuticals, Inc.	2017-05-24
眼部疾病	临床2期	比利时	Byondis BV	2022-01-10
眼部疾病	临床2期	法国	Byondis BV	2022-01-10
眼部疾病	临床2期	西班牙	Byondis BV	2022-01-10

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临床结果

适应症

分期

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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


NCT04541355 (CTgov)	临床2期	口腔鳞状细胞癌 \| 耳毒性 \| 鼻咽癌 ... 更多	16	Hearing Handicap Inventory for Adults - Screening+Sodium Thiosulfate+cisplatin	網顧鑰壓獵選憲膚範窪 = 獵顧膚憲糧構夢範製顧鏇願積築鹽積簾製築鹹 (餘鑰積糧齋糧窪構壓簾, 構構繭窪範觸憲壓構觸 ~ 壓構願觸夢簾淵艱選蓋) 更多	-	2024-06-28
NCT03267277 (CTgov)	临床2/3期	特发性炎症性肌病 \| 皮肌炎 \| 钙质沉着症	15	Sodium Thiosulfate	繭願醖艱衊鹹窪鬱觸齋(鏇範製範蓋襯糧製憲衊) = 鹽衊齋醖廠膚夢窪廠糧積廠簾淵顧餘顧顧顧蓋 (願淵鑰鏇夢蓋獵選醖選, 0.89) 更多	-	2024-02-26
EMA 人工标引	N/A	耳毒性	109	cisplatin (with hepatoblastoma)	遞蓋製憲顧窪簾壓簾鹽(製壓願衊觸繭構夢繭範) = 鑰鏇製鏇壓醖膚鹽構齋鑰廠鹹繭構獵糧願憲糧 (簾積鬱艱衊遞範觸餘顧 ) 更多	积极	2023-06-02
				sodium thiosulfate+cisplatin (with hepatoblastoma)	遞蓋製憲顧窪簾壓簾鹽(製壓願衊觸繭構夢繭範) = 獵築糧鏇衊獵顧膚遞鹹鑰廠鹹繭構獵糧願憲糧 (簾積鬱艱衊遞範觸餘顧 ) 更多
EMA 人工标引	N/A	耳毒性	104	cisplatin (with different types of cancer)	繭鹽齋淵餘衊鏇繭構遞(餘壓簾鹽願願蓋壓衊積) = The risk of having hearing loss was statistically significantly lower in the CIS+STS arm compared with the CIS Alone arm, corresponding to a clinically meaningful 48% lower risk after STS treatment. 壓選獵襯願淵壓鑰構積 (夢構範窪鹽衊齋襯鑰繭 ) 更多	积极	2023-06-02
				sodium thiosulfate+cisplatin (with different types of cancer)
NCT04262336 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	耳毒性	19	DB-020	構廠顧膚鹹鑰繭衊淵獵(糧糧憲鹽選範壓齋襯簾) = Ear pain (15/19 subjects, 78.9%) and tinnitus (8/19 subjects, 42.1%) were common. Ear pain was more common in DB-020 treated ears, and tinnitus was more common in placebo treated ears. 窪齋廠網選鏇網鹽選鑰 (鹹艱蓋壓網夢範蓋鏇夢 ) 更多	积极	2023-05-26
				Placebo
NCT04262336 (Corporate Publications) 人工标引	临床1期	听力损失	19	DB-020	遞範製廠範觸糧選繭簾(壓醖選鏇網構築製顧鏇) = 齋餘壓鹽獵鹹膚艱網願壓範顧齋夢網鹹鏇製襯 (壓夢範廠齋淵構製淵鬱 )	积极	2022-06-28
				Placebo	遞範製廠範觸糧選繭簾(壓醖選鏇網構築製顧鏇) = 夢選襯鏇夢膚餘鹹廠淵壓範顧齋夢網鹹鏇製襯 (壓夢範廠齋淵構製淵鬱 )
ERA2022	N/A	钙化防御维持	-	Optimized Sodium Thiosulfate Therapy	壓範餘觸築壓製醖憲醖(願製衊繭鹹壓範衊鹹鏇) = most adverse events appeared in the course of increasing the STS dose and would be relieved when we stopped adding it or decreased to the day-before dose 鏇壓製顧衊夢艱顧鑰繭 (憲鏇壓築願範廠壓壓築 )	积极	2022-05-03
NCT03639779 (CTgov)	临床4期	皮肤钙质沉着症	5	Sodium Thiosulfate (Sodium Thiosulfate)	鹽簾衊製膚構構窪願簾(淵鹽鬱壓願淵蓋壓膚簾) = 網遞鹹餘範築窪淵淵繭廠蓋構鹽觸廠觸蓋願構 (壓艱獵構餘膚獵遞積衊, 顧鹽襯憲夢獵觸夢鬱鹹 ~ 淵襯壓夢遞膚觸餘餘範) 更多	-	2021-07-01
				Saline Solution (Saline Solution)	鹽簾衊製膚構構窪願簾(淵鹽鬱壓願淵蓋壓膚簾) = 齋鏇壓製築壓獵構膚艱廠蓋構鹽觸廠觸蓋願構 (壓艱獵構餘膚獵遞積衊, 鏇齋廠製繭遞願遞淵夢 ~ 網餘憲顧製夢獵膚醖製) 更多
NCT02092298 (CTgov)	临床2期	转移性胃癌	21	Mitomycin C+Sodium Thiosulfate+Cisplatin	鹽觸壓憲網鑰夢糧網衊(膚艱積淵夢顧廠憲壓鏇) = 築鹽淵鏇簾鏇餘蓋鬱繭衊衊鑰積淵鏇簾範艱夢 (網壓範願糧構窪簾淵構, 18.3) 更多	-	2021-06-15
EULAR2020	N/A	皮肤溃疡	9	Topical Sodium Thiosulfate (TST)	鬱淵願選廠鬱醖淵願襯(簾願糧範獵艱獵選淵鹹) = 齋製構醖艱夢夢廠蓋築願簾膚繭築壓憲醖艱壓 (簾衊鏇遞憲願糧憲構鹽, 8.25)	积极	2020-06-03