主要研究目的比较河南羚锐制药股份有限公司研发的受试制剂格拉司琼透皮贴片（规格：34.3mg/52cm2，释药量3.1mg/24h）与持证商为Kyowa Kirin Inc的格拉司琼透皮贴片（商品名：善可舒®，参比制剂）在健康受试者体内的药代动力学，评价外用两种制剂的生物等效性。次要研究目的观察受试制剂和参比制剂在健康受试者中的安全性；观察受试制剂与参比制剂在中国健康受试者用药过程中的黏附力；观察受试制剂与参比制剂对中国健康受试者的皮肤反应性。

开始日期2025-12-27

申办/合作机构

河南羚锐制药股份有限公司

CTR20253534

/ CompletedN/A

格拉司琼透皮贴片在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、两周期、交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Kyowa Kirin Inc为持证商的格拉司琼透皮贴片（商品名：善可舒®，规格：34.3mg/52cm2（释药量3.1mg/24h））为参比制剂，北京亚宝生物药业有限公司生产、亚宝药业集团股份有限公司提供的格拉司琼透皮贴片（规格：34.3mg/52cm2（释药量3.1mg/24h））为受试制剂进行空腹给药条件下的人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹给药条件下的生物等效性。次要研究目的：1、观察中国健康受试者外用受试制剂格拉司琼透皮贴片（规格：34.3mg/52cm2（释药量3.1mg/24h））和参比制剂格拉司琼透皮贴片（商品名：善可舒®，规格：34.3mg/52cm2（释药量3.1mg/24h））后的安全性。2、评估健康志愿受试者在试验期间，外用格拉司琼透皮贴片（规格：34.3mg/52cm2（释药量3.1mg/24h））或参比制剂格拉司琼透皮贴片（商品名：善可舒®，规格：34.3mg/52cm2（释药量3.1mg/24h））的黏附力及外用刺激性情况。

开始日期2025-09-18

申办/合作机构

亚宝药业集团股份有限公司

CTR20252394

/ CompletedN/A

格拉司琼透皮贴片人体生物等效性研究

主要研究目的：研究健康研究参与者空腹状态下单次使用受试制剂格拉司琼透皮贴片【规格：释药量3.1mg/24h，宜昌人福药业有限责任公司持证】与参比制剂格拉司琼透皮贴片【规格：34.3mg/52cm2（释药量3.1mg/24h），Kyowa Kirin Inc持证】后体内的药代动力学，评价空腹状态使用两种制剂的生物等效性。次要研究目的：评价受试制剂格拉司琼透皮贴片【规格：释药量3.1mg/24h】和参比制剂格拉司琼透皮贴片【规格：34.3mg/52cm2（释药量3.1mg/24h）】的黏附性，并评价两制剂在健康研究参与者中的安全性。

开始日期2025-06-30

申办/合作机构

宜昌人福药业有限责任公司

100 项与格拉司琼相关的临床结果

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100 项与格拉司琼相关的转化医学

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100 项与格拉司琼相关的专利（医药）

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1,874

项与格拉司琼相关的文献（医药）

2026-02-05·ONCOLOGIST

Granisetron transdermal delivery system versus palonosetron in the prevention of long-delayed nausea and vomiting: a phase III randomized trial

Article

作者: Du, Yiqun ; Li, Hengyu ; Liu, Xiaojun ; Meng, Yanchun ; Zhang, Jian ; Guan, Xiaoxiang ; Li, Gang ; Mu, Yuxin

Abstract:

Background:

Chemotherapy-induced nausea and vomiting (CINV) significantly impact the patients’ quality of life. Whether the granisetron transdermal delivery system (GTDS) offers better protection than palonosetron against long-delayed (120-168 hours) CINV after highly or moderately emetogenic chemotherapy (HEC/MEC) had not been prospectively tested.

Methods:

A multicenter, randomized clinical study was conducted in China. Patients scheduled to receive either HEC or MEC were randomly assigned (1:1) to GTDS or palonosetron, each in combination with a neurokinin-1 receptor antagonist (NK1-RA) and dexamethasone. The primary endpoint was the complete response (CR; no vomiting and no rescue medication) rate during the long-delayed phase (120-168 hours), stratified by HEC and MEC categories, to demonstrate the superiority of GTDS over palonosetron.

Results:

Overall, 150 patients received either GTDS or palonosetron respectively. We found that the GTDS group demonstrated a significantly higher long-delayed CR rate (97.3%) than the palonosetron group (92%) (P = .04). This advantage was driven predominantly by the HEC subgroup (GTDS 97.5% vs palonosetron 90.8%, P = .028). No significant differences were observed between the groups for the acute (0-24 hours, 92.7% vs 90.0%; P = .412), delayed (24-120 hours, 80.0% vs 76.0%; P = .403), extended-delayed (24-168 hours, 80.7% vs 75.3%; P = .265), or overall (0-168 hours, 78.0% vs 74.0%; P = .417) phases.

Conclusion:

A GTDS-based triple antiemetic regimen can effectively control CINV associated with HEC or MEC. It provides a convenient alternative route for delivering granisetron for up to 7 days, with superior efficacy in controlling long-delayed CINV.

Trial registration:

Clinicaltrials.gov Identifier: NCT04912271 (in-house ethic number: YBCSG-21-04)

2026-02-01·CHEMISTRY & BIODIVERSITY

Serotonergic Neuromodulation of Natural Products Isoreserpine and Isoreserpiline in Adult Zebrafish: An in Silico and In Vivo Investigation

Article

作者: Ferreira, Maria Kueirislene Amâncio ; de Castro Gomes, Andreia Ferreira ; de Menezes, Jane Eire Silva Alencar ; Pinheiro, Nádia Aguiar Portela ; de Sousa Magalhães, Herbert ; Siqueira, Sônia Maria Costa ; Romão, Ivana Carneiro ; Marinho, Márcia Machado ; Marinho, Emmanuel Silva ; Pessoa, Otília Deusdênia Loiola ; dos Santos, Hélcio Silva ; Alves, Amanda Maria Barros

ABSTRACT:

Anxiety is a multidimensional behavioral disorder widely studied in neuroscience due to the involvement of specific neural circuits. Although benzodiazepines are commonly used, their side effects drive the search for new therapeutic alternatives. This study investigated the anxiolytic effects of the indole alkaloids isoreserpine (IRPN) and isoreserpiline (IRPL), extracted from Rauvolfia ligustrina , in adult zebrafish at doses of 4, 12, and 20 mg/kg, along with 3% DMSO and diazepam (4 mg/kg) as controls. Toxicity, locomotor activity, anxiolytic effects, and serotonergic involvement were assessed. Interactions with the 5‐HT3AR receptor were analyzed through molecular docking, and pharmacokinetic properties were evaluated using DMPK. The samples showed no toxicity (LD 50 > 20 mg/kg), reduced locomotor activity, and exhibited anxiolytic effects that were reversed by granisetron. IRPL demonstrated higher affinity for the 5‐HT3AR receptor and better absorption and central nervous system penetration properties, standing out as a promising candidate for the treatment of anxiety.

2026-01-01·HEADACHE

2025 guideline update to acute treatment of migraine for adults in the emergency department: The American Headache Society evidence assessment of parenteral pharmacotherapies

Review

作者: Cortel-LeBlanc, Miguel A ; Cortel-LeBlanc, Achelle ; Friedman, Benjamin W ; Minen, Mia T ; Orr, Serena L ; Robblee, Jennifer

Abstract:

Objective:

To update the 2016 American Headache Society (AHS) guideline on parenteral pharmacologic therapies for the management of migraine attacks in the emergency department (ED).

Methods:

We conducted a systematic review and meta‐analysis using the same methodology as the 2016 guideline. The original search strategy was repeated and expanded to include studies of nerve blocks and sphenopalatine ganglion (SPG) blocks. We searched Medline, Embase, Cochrane, clinicaltrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform through February 10, 2025. Eligible studies were randomized controlled trials (RCTs) involving adults diagnosed with migraine, treated in the ED with intravenous (IV), intramuscular (IM), subcutaneous (SC), or nerve block (including SPG block) interventions. Two reviewers independently screened titles/abstracts and full texts; a third reviewer resolved disagreements. Data were extracted using a standardized form and verified by a second reviewer. Risk of bias was assessed using the American Academy of Neurology (AAN) criteria. Where applicable, meta‐analyses were performed. Efficacy was categorized as highly likely, likely, or possibly effective or ineffective. Clinical recommendations were developed using the AAN guideline development process.

Results:

The search identified 26 new RCTs evaluating 20 injectable treatments. Of these, 12 were rated class I (low risk of bias), 9 class II, and 4 class III. Prochlorperazine IV, dexketoprofen IV, sumatriptan SC, and greater occipital nerve blocks (GONB) were considered highly likely to be effective based on multiple class I studies. Chlorpromazine IV, metoclopramide IV, eptinezumab IV, ketorolac IV, and supraorbital nerve blocks (SONB) were considered likely effective based on one class I or multiple class II studies. Hydromorphone IV, propofol IV, and paracetamol IV were considered likely ineffective based on class I or multiple class II studies. After review of the evidence and a consensus process, recommendations were made for each intervention.

Conclusions:

Prochlorperazine IV and GONB must be offered to eligible adults presenting to the ED with a migraine attack for treatment of headache requiring parenteral therapy (level A – must offer) in those without contraindications, while hydromorphone IV must not be offered (level A – must not offer). Treatments that should be offered when appropriate (level B – should offer) include dexketoprofen IV, ketorolac IV, metoclopramide IV, sumatriptan SC, and SONB. Chlorpromazine IV, dexamethasone IV, and valproate IV may be offered (level C – may offer). Paracetamol IV may not be offered (level C – should not offer). Eptinezumab should be offered (level B) only for patients matching the clinical trial population but is rated level U – no recommendation for an ED‐specific population. Additional evidence is needed for caffeine, granisetron, ibuprofen, ketamine, lidocaine, normal saline, propofol, and SPG blocks, all currently rated level U – no recommendation.

118

项与格拉司琼相关的新闻（医药）

2026-02-07

·PRNewswire

Cumberland Pharmaceuticals Receives FDA Fast Track Designation for its Ifetroban Duchenne Muscular Dystrophy Program

NASHVILLE, Tenn., Feb. 4, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients. The FDA's Fast Track program facilitates the development and expedites the review of a drug designed to treat a serious or life-threatening condition and unmet medical need. This designation provides an opportunity for more frequent communication with the FDA, enabling Cumberland, as the sponsor, to obtain early feedback and guidance. Under Fast Track, Cumberland can also submit portions of an application for marketing approval on a rolling basis. Cumberland requested Fast Track Designation to streamline the regulatory pathway for ifetroban for DMD heart disease. This Fast Track Designation follows the drug's receipt of both Orphan Drug Designation and Rare Pediatric Disease Designation, confirming both the urgency and the significant impact of the product for this indication. Cumberland previously announced positive results from its Phase 2 FIGHT DMD trial evaluating oral thromboxane receptor antagonist ifetroban in DMD heart disease, demonstrating a 5.4% improvement in left ventricular ejection fraction (LVEF) over 12 months of treatment. "The FDA's Fast Track Designation for ifetroban underscores the urgent and critical unmet medical need in DMD heart disease," said A.J. Kazimi, Cumberland founder and CEO. "This designation, combined with our breakthrough Phase 2 results, positions us to work closely with the FDA through more frequent interactions and expedited review processes to advance this promising heart-targeted therapy for DMD patients as efficiently as possible. We look forward to engaging with the Agency and our patient advocacy partners to bring this much-needed therapy to DMD patients and their families." About Duchenne Muscular Dystrophy (DMD) DMD is a rare and incurable pediatric disease affecting approximately 1 in 3,500-5,000 male births caused by mutations in the gene encoding dystrophin, a protein critical for muscle function, including the heart. Patients with DMD slowly lose muscle function, resulting in the inability to walk, difficulty breathing, and heart failure. While current treatments can help manage some DMD symptoms, there are no approved therapies specifically targeting DMD-related heart disease, highlighting a critical unmet medical need. Heart disease is the leading cause of death in DMD patients, with heart damage beginning early and progressing at different rates for each patient. Despite this, no treatments are currently approved specifically for DMD heart disease. The current treatment options include the use of corticosteroids to reduce inflammation and traditional heart disease medications to manage blood pressure and heart rate, reducing strain on the heart. While these therapies slow the onset and progression of DMD heart disease, none of them provides a lasting benefit for this unique form of heart disease or improves patient survival. Additionally, exon-skipping and gene therapies approved for DMD have shown no cardiac benefit to date. About Cumberland Pharmaceuticals Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections; and Talicia® (omeprazole, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection. The company also has a series of Phase 2 clinical programs underway evaluating its ifetroban product candidate in patients with Systemic Sclerosis and Idiopathic Pulmonary Fibrosis, in addition to Duchenne muscular dystrophy. For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, which can be found on the company's website . Forward-Looking Statements This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. SOURCE Cumberland Pharmaceuticals Inc. 21% more press release views with Request a Demo

快速通道临床结果孤儿药

2026-01-28

·日药医点通

日本抗癌神药！卡培他滨片カペシタビン錠300mg如何改写癌症治疗格局

引言：癌症治疗的革命性突破在人类与癌症的漫长斗争中，每一款新型抗癌药物的问世都可能成为改变战局的关键转折点。今天，我们要深入探讨的这款「カペシタビン錠300mg」，正是这样一款具有里程碑意义的抗癌药物。它以其独特的作用机制、显著的治疗效果和相对良好的耐受性，正在重新定义癌症治疗的标准。作为一款口服化疗药物，カペシタビン錠300mg不仅为患者提供了更便捷的治疗选择，更在多种癌症类型的治疗中展现出了卓越的疗效。药物档案：揭秘カペシタビン錠300mg的科学本质1.1 药物基本信息カペシタビン錠300mg，其通用名为Capecitabine，是一种口服的氟嘧啶类抗肿瘤药物。这款药物于1998年首次获得美国FDA批准上市，目前已在全球超过100个国家和地区广泛使用。1.2 作用机制：靶向肿瘤细胞的智能炸弹カペシタビン錠300mg的独特之处在于其智能靶向作用机制。它是一种前体药物，口服后在体内经过三步酶促反应，最终在肿瘤细胞内转化为具有细胞毒性的5-氟尿嘧啶（5-FU）。这一转化过程的关键在于最后一步：肿瘤细胞内高表达的胸腺嘧啶磷酸化酶（TP）将5'-脱氧-5-氟尿嘧啶（5'-DFUR）转化为5-FU。由于肿瘤细胞内TP酶的活性远高于正常细胞，因此カペシタビン能够在肿瘤组织中选择性地形成高浓度的5-FU，从而实现对肿瘤细胞的精准打击，同时减少对正常细胞的损伤。1.3 药物代谢与排泄カペシタビン口服后吸收迅速且完全，生物利用度高达100%。药物主要通过肝脏代谢，最终约80-90%的代谢产物通过肾脏排泄。其血浆半衰期约为0.4-0.8小时，这意味着药物在体内能够快速被清除，减少了药物在体内的蓄积。适应症与使用人群：谁能从カペシタビン治疗中获益？カペシタビン錠300mg适用于多种癌症类型的治疗，具体包括：2.1 乳腺癌适应症：手术不能切除或复发的乳腺癌使用人群：对蒽环类和紫杉类化疗耐药的晚期乳腺癌患者作为单药治疗或与其他药物联合使用特别适用于那些无法耐受静脉化疗的患者2.2 结直肠癌适应症：结肠癌术后辅助化疗无法手术切除或复发的结直肠癌使用人群： Ⅲ期结肠癌患者术后辅助治疗晚期结直肠癌患者的一线或二线治疗可与奥沙利铂等药物联合使用，提高治疗效果2.3 胃癌适应症：无法手术切除或复发的胃癌使用人群：晚期胃癌患者的一线治疗可与铂类药物联合使用，延长患者生存期对于HER2阳性胃癌患者，可与曲妥珠单抗联合使用2.4 其他适应症除了上述主要适应症外，カペシタビン还在胰腺癌、食管癌等其他癌症类型的治疗中显示出一定的疗效。随着临床研究的不断深入，其适应症范围有望进一步扩大。禁忌症与注意事项：安全用药的关键3.1 禁忌症以下人群禁止使用カペシタビン錠300mg：对药物成分过敏者：对カペシタビン或氟尿嘧啶类药物有严重过敏史的患者严重肾功能障碍患者：肌酐清除率<30ml/min的患者孕妇或可能怀孕的女性：动物实验显示药物可能对胎儿造成伤害正在使用或停药7天内使用テガフール・ギメラシル・オテラシルカリウム配合剂的患者：可能导致严重的血液系统不良反应3.2 重要注意事项血液系统毒性：可能导致白细胞减少、血小板减少等骨髓抑制症状，用药期间需定期监测血常规消化系统毒性：常见不良反应包括恶心、呕吐、腹泻、口腔炎等，严重时可能导致脱水手足综合征：表现为手掌和足底的红斑、水疱、疼痛等，严重时可能影响日常生活心脏毒性：可能导致心肌缺血、心律失常等心血管不良反应，有冠心病史的患者需谨慎使用肝功能异常：可能导致转氨酶升高、胆红素升高等肝功能异常，用药期间需定期监测肝功能药物相互作用：与华法林等抗凝药物合用时可能增加出血风险，需密切监测凝血功能使用方法与疗程：科学用药指南4.1 用药剂量与方案カペシタビン錠300mg的用药剂量需根据患者的体表面积、病情严重程度和耐受性进行个体化调整。常见的用药方案包括：4.1.1 乳腺癌治疗方案 A法：根据体表面积，每日两次口服，连续服用21天，休息7天，为一个疗程体表面积<1.31m²：每次900mg 1.31m²≤体表面积<1.64m²：每次1200mg 体表面积≥1.64m²：每次1500mg B法：根据体表面积，每日两次口服，连续服用14天，休息7天，为一个疗程体表面积<1.33m²：每次1500mg 1.33m²≤体表面积<1.57m²：每次1800mg 1.57m²≤体表面积<1.81m²：每次2100mg 体表面积≥1.81m²：每次2400mg4.1.2 结直肠癌治疗方案辅助化疗：通常采用B法，连续治疗6个月（共8个疗程）晚期结直肠癌：可采用B法或与其他药物联合使用，直至疾病进展或出现不可耐受的毒性4.1.3 胃癌治疗方案联合化疗：与铂类药物联合使用，通常采用C法，连续服用14天，休息7天，为一个疗程体表面积<1.36m²：每次1200mg 1.36m²≤体表面积<1.66m²：每次1500mg 1.66m²≤体表面积<1.96m²：每次1800mg 体表面积≥1.96m²：每次2100mg4.2 用药注意事项服药时间：应在餐后30分钟内服用，以提高药物的生物利用度整片吞服：药片应整片吞服，不得咀嚼或碾碎漏服处理：如果漏服一次，应跳过该次剂量，按原定时间服用下一次剂量，不得加倍服用剂量调整：根据患者的耐受性和不良反应情况，医生可能会调整用药剂量或暂停治疗治疗效果与获益：カペシタビン如何改变患者命运5.1 乳腺癌治疗效果多项临床研究表明，カペシタビン在乳腺癌治疗中展现出了显著的疗效：单药治疗：对于蒽环类和紫杉类耐药的晚期乳腺癌患者，カペシタビ单药治疗的客观缓解率可达20-30%，中位生存期约为6-12个月联合治疗：与拉帕替尼联合使用时，客观缓解率可提高至30-40%，中位无进展生存期延长至6-8个月生活质量改善：口服化疗药物的便利性和相对较轻的不良反应，显著提高了患者的生活质量5.2 结直肠癌治疗效果在结直肠癌治疗中，カペシタビ同样表现出色：术后辅助化疗：对于Ⅲ期结肠癌患者，カペシタビ单药辅助化疗的疗效与5-FU/LV方案相当，且不良反应更轻晚期结直肠癌：作为一线治疗方案，カペシタビ单药治疗的客观缓解率可达20-30%，中位生存期约为10-12个月联合治疗：与奥沙利铂联合使用时，客观缓解率可提高至50-60%，中位生存期延长至15-20个月5.3 胃癌治疗效果在胃癌治疗领域，カペシタビ也取得了令人瞩目的成果：一线治疗：与顺铂联合使用时，客观缓解率可达40-50%，中位生存期约为10-12个月二线治疗：对于一线治疗失败的晚期胃癌患者，カペシタビ单药治疗的客观缓解率约为10-20%，中位生存期约为6-8个月转化治疗：对于局部晚期胃癌患者，カペシタビ联合化疗可能使部分患者获得手术机会，提高根治性切除率5.4 治疗获益的综合评估除了显著的肿瘤控制效果外，カペシタビ治疗还为患者带来了多方面的获益：生活质量改善：口服化疗药物避免了静脉输液的不便，减少了住院时间，使患者能够更好地回归正常生活治疗成本降低：与静脉化疗相比，口服化疗药物的治疗成本更低，减轻了患者和社会的经济负担心理压力减轻：相对较轻的不良反应和便捷的用药方式，有助于减轻患者的心理压力，提高治疗依从性副作用与应对策略：科学管理不良反应6.1 常见副作用及发生率尽管カペシタビン的耐受性相对较好，但仍可能出现一些不良反应。以下是常见副作用及其发生率：副作用类型发生率主要表现消化系统反应 60-80% 恶心、呕吐、腹泻、口腔炎等手足综合征 40-60% 手掌和足底的红斑、水疱、疼痛、感觉异常等血液系统毒性 30-50% 白细胞减少、血小板减少、贫血等肝功能异常 20-40% 转氨酶升高、胆红素升高等疲劳乏力 30-50% 全身乏力、精神不振等皮肤反应 20-30% 皮疹、色素沉着、脱发等6.2 副作用的分级与管理根据不良反应的严重程度，通常将其分为1-4级，并采取相应的管理措施： 1级（轻度）：通常无需调整剂量，可通过对症治疗缓解症状 2级（中度）：可能需要暂停治疗或调整剂量，待症状缓解后恢复治疗 3级（重度）：必须暂停治疗，进行积极的对症处理，待症状缓解后以较低剂量恢复治疗 4级（危及生命）：立即停止治疗，进行紧急处理，必要时更换治疗方案6.3 常见副作用的应对策略消化系统反应：恶心呕吐：可使用止吐药物如昂丹司琼、格拉司琼等腹泻：轻度腹泻可使用洛哌丁胺等止泻药物，严重腹泻需暂停治疗并进行补液口腔炎：保持口腔清洁，使用含漱液，必要时使用局部止痛药物手足综合征：早期干预：出现红斑时可使用保湿霜、维生素E软膏等疼痛管理：疼痛明显时可使用非甾体抗炎药剂量调整：严重手足综合征可能需要暂停治疗或调整剂量血液系统毒性：白细胞减少：使用粒细胞集落刺激因子（G-CSF）升高白细胞血小板减少：严重血小板减少时可能需要输注血小板贫血：必要时输注红细胞或使用促红细胞生成素肝功能异常：密切监测肝功能指标轻度异常可继续治疗，严重异常需暂停治疗并进行保肝治疗患者故事与真实体验：カペシタビン带来的生命奇迹故事一：乳腺癌患者的重生之路 45岁的小林女士是一位晚期乳腺癌患者，在经历了蒽环类和紫杉类化疗失败后，她的病情一度陷入绝境。然而，在开始使用カペシタビン治疗后，她的病情出现了戏剧性的好转。 "刚开始用药时，我确实感到了一些不适，比如恶心和手足麻木，但这些副作用都在我可以忍受的范围内。"小林女士回忆道，"更重要的是，治疗效果非常明显。仅仅经过两个疗程，我的肿瘤就缩小了一半，这让我重新看到了希望。" 如今，小林女士已经坚持治疗了两年多，她的病情得到了很好的控制，生活质量也有了显著提高。"カペシタビン不仅延长了我的生命，更让我重新找回了对生活的信心。"她感慨地说。故事二：结直肠癌患者的康复之旅 62岁的佐藤先生是一位Ⅲ期结肠癌患者，在接受手术切除后，他开始使用カペシタビン进行辅助化疗。 "说实话，我对化疗充满了恐惧，担心会出现严重的不良反应。"佐藤先生说，"但使用カペシタビン后，我发现实际情况比我想象的要好得多。虽然也出现了一些恶心和疲劳的症状，但都在我可以承受的范围内。" 经过6个月的辅助化疗，佐藤先生的病情一直保持稳定，没有出现复发的迹象。"现在我已经恢复了正常的生活，每天都能和家人一起散步、下棋，感觉非常幸福。"他笑着说，"カペシタビン给了我第二次生命。"故事三：胃癌患者的希望之光 58岁的田中女士是一位晚期胃癌患者，在被诊断出癌症时，她已经失去了手术机会。在医生的建议下，她开始使用カペシタビン联合顺铂进行化疗。 "治疗过程确实很艰难，我经历了恶心、呕吐、脱发等多种不良反应。"田中女士回忆道，"但每当我想放弃的时候，我就会想到我的家人和医生的鼓励。" 经过几个疗程的治疗，田中女士的肿瘤明显缩小，生活质量也有了很大改善。"现在我可以正常吃饭、睡觉，甚至还能做一些简单的家务。"她欣慰地说，"カペシタビン就像一道希望之光，照亮了我黑暗的生活。"展望未来：カペシタビン的发展前景8.1 临床研究的新方向尽管カペシタビン已经在多种癌症治疗中取得了显著的疗效，但科学家们仍在不断探索其更多的应用潜力：新适应症的拓展：目前正在研究カペシタビン在胰腺癌、食管癌、卵巢癌等其他癌症类型中的治疗效果联合治疗方案的优化：探索与免疫检查点抑制剂、靶向药物等新型治疗手段的联合应用，以提高治疗效果个体化治疗策略：基于患者的基因特征和肿瘤生物学特性，制定更加精准的治疗方案8.2 药物研发的新进展除了临床研究的不断深入，カペシタビン的药物研发也在不断推进：新剂型的开发：如缓释剂型、纳米制剂等，以提高药物的生物利用度和疗效新衍生物的合成：通过化学修饰，开发具有更好疗效和更低毒性的カペシタビ衍生物耐药机制的研究：深入研究肿瘤细胞对カペシタビ的耐药机制，寻找克服耐药的新方法8.3 癌症治疗的未来展望随着医学科学的不断进步，癌症治疗正朝着更加精准、个体化和综合化的方向发展。カペシタビン作为一款经典的口服化疗药物，将在未来的癌症治疗中继续发挥重要作用：与免疫治疗的联合：免疫检查点抑制剂与化疗药物的联合应用，有望进一步提高癌症治疗的疗效精准医疗的实现：基于基因检测和生物标志物的个体化治疗，将使癌症治疗更加精准有效生活质量的提升：随着药物研发的不断进步，未来的癌症治疗将更加注重患者的生活质量和心理需求结语：カペシタビン——癌症治疗的希望之光カペシタビン錠300mg作为一款具有里程碑意义的口服化疗药物，已经改变了无数癌症患者的命运。它以其独特的作用机制、显著的治疗效果和相对良好的耐受性，成为了癌症治疗领域的一颗璀璨明星。然而，我们也必须清醒地认识到，癌症治疗仍然面临着诸多挑战。每一款药物都有其局限性，カペシタビン也不例外。因此，在使用任何抗癌药物之前，患者都应该与医生进行充分的沟通，了解药物的疗效、副作用和风险，制定最适合自己的治疗方案。未来，随着医学科学的不断进步，我们有理由相信，更多像カペシタビン这样的优秀抗癌药物将不断涌现，为人类战胜癌症带来更多的希望。让我们携手共进，为实现"让癌症成为一种可控制的慢性病"的目标而努力奋斗！ ~~END~~ 如果你觉得有收获，请点点关注下次不迷路咨询渠道👇 微信:guiyi697 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临床3期上市批准临床结果临床2期

2026-01-09

·ir.herontx.com

Heron Therapeutics Announces Preliminary, Unaudited Q4 and Full-Year 2025 Net Revenue; ZYNRELEF® Largest Contributor to Q4 Growth

CARY, N.C., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Heron Therapeutics, Inc. (Nasdaq: HRTX) (“Heron” or the “Company”), a commercial-stage biotechnology company, today announced preliminary, unaudited fourth quarter and full-year 2025 net revenue. “We are encouraged by the growth in Q4 2025, driven in particular by the momentum in our Acute Care franchise with ZYNRELEF® and APONVIE®,” said Craig Collard, Chief Executive Officer of Heron. “In addition to our revenue growth, we are extremely pleased with the continued progress made across all aspects of our business throughout the past year.” Preliminary Fourth Quarter and Full Year 2025 Updates Net revenue of approximately $40.5 million for the three months ended December 31, 2025. ZYNRELEF® net revenue of approximately $12.5 million for the three months ended December 31, 2025. APONVIE® net revenue of approximately $3.8 million for the three months ended December 31, 2025. CINVANTI® net revenue of approximately $22.9 million for the three months ended December 31, 2025. SUSTOL® net revenue of approximately $1.3 million for the three months ended December 31, 2025. Net revenue of approximately $154.9 million for full-year 2025. ZYNRELEF® delivered the largest quarter-over-quarter revenue increase within the portfolio in Q4 (up ~35% vs Q3 2025). ZYNRELEF® net revenue of approximately $12.5 million for the three months ended December 31, 2025. APONVIE® net revenue of approximately $3.8 million for the three months ended December 31, 2025. CINVANTI® net revenue of approximately $22.9 million for the three months ended December 31, 2025. SUSTOL® net revenue of approximately $1.3 million for the three months ended December 31, 2025. About ZYNRELEF® for Postoperative Pain ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com. About APONVIE® for Prevention of Postoperative Nausea and Vomiting (“PONV”) Prevention APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for the prevention of PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023. Please see full prescribing information at www.APONVIE.com. About CINVANTI® for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection. Please see full prescribing information at www.CINVANTI.com. About SUSTOL® for CINV Prevention SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy). Please see full prescribing information at www.SUSTOL.com. About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com. Forward-Looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. All statements contained in this news release other than statements of historical facts, including statements regarding our future results of operations and financial position, business and commercialization strategy as well as plans and objectives of management for future operations, are forward-looking statements. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. The estimated preliminary financial results for the fourth quarter and fiscal year ended December 31, 2025 contained in this press release contain forward-looking statements that are based on information available to the Company as of the date of this release. The Company’s financial closing and review procedures for the fourth quarter and full year 2025 are not yet complete, and actual results may differ from these preliminary estimates as a result of final accounting adjustments, the completion of internal control processes, and other developments that may arise prior to the finalization of the Company’s financial statements. The preliminary financial results included in this release have not been audited or reviewed by the Company’s independent registered public accounting firm and should not be considered a substitute for the Company’s full interim or annual financial statements. Accordingly, undue reliance should not be placed on this preliminary information. Forward-looking statements include, among others, statements we make regarding the estimated preliminary financial results referred to above, the potential market opportunities for ZYNRELEF®, APONVIE®, CINVANTI® and SUSTOL®; revenue, adjusted EBITDA and other financial guidance provided by the Company; interim financial data or prescription data, which may not necessarily be indicative of quarterly or annual results; the potential additional market opportunity for the expanded U.S. label for ZYNRELEF or inclusion of ZYNRELEF under the OPPS and the ASC payment system or launch of the ZYNRELEF VAN; our ability to establish and maintain successful commercial arrangements like our co-promotion agreement with Crosslink Network, LLC; the outcome of the Company's pending patent litigations, including potential appeals of any verdicts and the settlement described herein; whether the Company is required to write-off any additional inventory in the future; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations and the risk that future equity financings may be needed; the terms and conditions, completion of the refinancing transactions, and the anticipated proceeds and use of proceeds of the refinancing transactions; any inability or delay in achieving profitability, including as a result of regulatory developments and policy changes in the U.S. and other jurisdictions. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law. Investor Relations and Media Contact: Ira Duarte Executive Vice President, Chief Financial Officer Heron Therapeutics, Inc. iduarte@herontx.com 858-251-4400

临床3期上市批准财报临床结果

100 项与格拉司琼相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D04370	格拉司琼	A04AA02	DB00889

研发状态

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适应症	国家/地区	公司	日期
化疗引起的恶心和呕吐	欧盟	Grünenthal GmbH	2012-04-20
化疗引起的恶心和呕吐	冰岛	Grünenthal GmbH	2012-04-20
化疗引起的恶心和呕吐	列支敦士登	Grünenthal GmbH	2012-04-20
化疗引起的恶心和呕吐	挪威	Grünenthal GmbH	2012-04-20
恶心	美国	Cumberland Pharmaceuticals, Inc.	2008-09-12
呕吐	美国	Cumberland Pharmaceuticals, Inc.	2008-09-12
术后恶心呕吐	中国	福安药业（集团）股份有限公司	-

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适应症	最高研发状态	国家/地区	公司	日期
恶心和呕吐	临床3期	美国	Heron Therapeutics, Inc.	2006-06-01
实体瘤	临床3期	美国	Heron Therapeutics, Inc.	2006-06-01
胃轻瘫	临床2期	美国	Kyowa Kirin, Inc.	2019-01-01
星形细胞瘤	临床2期	美国	Kyowa Kirin Co., Ltd.	2013-09-30
胶质母细胞瘤	临床2期	美国	Kyowa Kirin Co., Ltd.	2013-09-30
胶质瘤	临床2期	美国	Kyowa Kirin Co., Ltd.	2013-09-30
神经胶质肉瘤	临床2期	美国	Kyowa Kirin Co., Ltd.	2013-09-30
少突神经胶质瘤	临床2期	美国	Kyowa Kirin Co., Ltd.	2013-09-30

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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


NCT04645953 (CTgov)	临床2期	呕吐	150	1mg AZ010 (1mg AZ010)	顧鏇繭淵鏇觸蓋鹽淵鑰(簾鏇獵窪顧鏇願製顧襯) = 積壓築襯糧構蓋製繭築壓襯簾獵廠壓壓淵鏇鏇 (顧壓積餘艱壓構築夢願, 1.168) 更多	-	2025-06-11
				3mg AZ-010 (3mg AZ010)	顧鏇繭淵鏇觸蓋鹽淵鑰(簾鏇獵窪顧鏇願製顧襯) = 糧襯醖蓋醖鏇願築構憲壓襯簾獵廠壓壓淵鏇鏇 (顧壓積餘艱壓構築夢願, 1.975) 更多
JPRN-jRCTs031180378 (WCLC2021)	临床2期	恶心和呕吐	25	Oral Granisetron	鬱顧齋鏇蓋鬱構繭鏇選(網鬱糧衊範鹽鹹簾範網) = 鬱構窪製製蓋選選網遞鑰廠網衊積願構壓製餘 (顧鹽蓋衊窪鬱遞繭顧選, 59.3 ~ 93.2) 更多	-	2021-09-08
NCT01989221 (CTgov)	临床3期	恶心 \| 胃轻瘫 \| 呕吐	14	Sancuso®	壓襯齋夢齋願製鑰選範(觸襯鏇夢廠顧衊餘鹹遞) = 願鑰餘夢廠願膚簾鹹衊艱醖製鹹鑰獵簾鏇艱膚 (積鹽製夢築簾觸築選遞, 0.15) 更多	-	2021-05-26
ICML2019	N/A	淋巴组织增生性疾病三线	19	Granisetron Transdermal Delivery System (GTDS)	餘顧襯壓願衊網淵蓋顧(網鏇壓醖膚淵餘衊膚齋) = No significant increase of AST and ALT were observed and mild hyperkaliemia was reported only 2/19 pts 觸淵齋衊願積蓋繭範壓 (構壓艱構衊壓鹹觸廠鑰 ) 更多	积极	2019-06-12
NCT02106494 (Pubmed \| Cancer Manag Res) 人工标引	临床3期	恶心 \| 呕吐	589	fosaprepitant+dexamethasone+APF530	艱鏇顧憲夢窪餘蓋壓顧(餘築構廠觸衊淵選繭簾) = 積壓憲顧夢簾蓋齋蓋廠廠襯糧餘願衊窪廠鏇淵 (築築餘憲餘網衊鹹艱範 )	优效	2017-05-19
				fosaprepitant+dexamethasone+ondansetron	艱鏇顧憲夢窪餘蓋壓顧(餘築構廠觸衊淵選繭簾) = 蓋襯壓遞齋觸蓋鹹憲憲廠襯糧餘願衊窪廠鏇淵 (築築餘憲餘網衊鹹艱範 )
NCT02106494 (MAGIC Trial \| MAGIC, CTgov)	临床3期	化疗引起的恶心和呕吐 \| 呕吐	942	APF530+Dexamethasone+Fosaprepitant (APF530 + Fosaprepitant + Dexamethasone)	壓鹹築簾鬱獵衊鹽醖齋 = 夢鏇襯構壓襯顧鹽淵積構觸憲蓋遞製鏇遞製構 (窪網繭簾襯積觸積鑰膚, 餘廠襯憲鬱醖糧醖壓鬱 ~ 鹽繭觸艱餘鑰膚膚鏇齋) 更多	-	2016-12-28
				Dexamethasone+Ondansetron+Fosaprepitant (Ondansetron + Fosaprepitant + Dexamethasone)	壓鹹築簾鬱獵衊鹽醖齋 = 糧選壓構願積構憲淵積構觸憲蓋遞製鏇遞製構 (窪網繭簾襯積觸積鑰膚, 顧獵艱齋廠糧選壓蓋遞 ~ 窪淵遞憲範繭觸獵壓遞) 更多
NCT02106494 (MAGIC, ASCO2016)	临床3期	化疗引起的恶心和呕吐	902	APF530	壓淵構艱顧鹹積窪願餘(積願夢築壓膚簾壓構築) = 選衊蓋蓋醖夢襯衊選鏇選蓋壓獵淵網網艱壓蓋 (餘繭衊積製顧遞鬱鹹選 )	积极	2016-05-20
				Ondansetron with fosaprepitant + dexamethasone	壓淵構艱顧鹹積窪願餘(積願夢築壓膚簾壓構築) = 膚齋築襯醖範願顧鑰製選蓋壓獵淵網網艱壓蓋 (餘繭衊積製顧遞鬱鹹選 )
NCT02106494 (MAGIC, ASCO2016)	临床3期	化疗引起的恶心和呕吐	942	APF530 500 mg SC	壓範鬱艱鹹繭築觸製鏇(繭鑰膚憲蓋鏇鏇鏇鹹廠) = 網築遞鏇構夢襯網鑰遞糧齋齋範積艱鏇繭窪壓 (繭膚鑰壓製窪選遞鹹鑰 ) 更多	积极	2016-05-20
				Ondansetron 0.15 mg/kg IV	壓範鬱艱鹹繭築觸製鏇(繭鑰膚憲蓋鏇鏇鏇鹹廠) = 艱製廠顧膚顧構膚廠齋糧齋齋範積艱鏇繭窪壓 (繭膚鑰壓製窪選遞鹹鑰 ) 更多
NCT00343460 (Pubmed \| BMC Cancer)	临床3期	乳腺癌	423	APF530 250 mg	鹽壓糧遞鑰顧鑰壓淵餘(鹽築製壓製網衊簾觸選) = 襯餘鬱鹹齋糧窪窪鏇鹽窪齋鏇糧壓積糧遞膚簾 (膚衊膚積鑰構範襯鬱窪 ) 更多	积极	2016-02-26
				APF530 500 mg	鹽壓糧遞鑰顧鑰壓淵餘(鹽築製壓製網衊簾觸選) = 襯憲壓鑰築窪蓋襯願艱窪齋鏇糧壓積糧遞膚簾 (膚衊膚積鑰構範襯鬱窪 ) 更多
NCT02106494 (MAGIC, SABCS2016)	临床3期	化疗引起的恶心和呕吐	902	APF530	齋簾遞襯廠鏇壓構壓壓(製鹹鏇範獵範壓鹹壓醖) = 襯積壓艱糧窪齋餘艱鹽鏇蓋廠襯簾製餘網糧糧 (構鑰構窪膚願壓築製鹹 ) 更多	积极	2016-02-15
				Ondansetron	齋簾遞襯廠鏇壓構壓壓(製鹹鏇範獵範壓鹹壓醖) = 鹹襯顧鹹鏇願膚構衊製鏇蓋廠襯簾製餘網糧糧 (構鑰構窪膚願壓築製鹹 ) 更多