Only patients suffering from a severe form of alcoholic hepatitis (Maddrey's discriminant function greater than 32) require medical treatment. Oral prednisolone for 28 days is the only treatment which has been proven to improve short-term survival over placebo in patients with severe alcoholic hepatitis. However, prednisolone alone cannot be regarded as an ideal treatment because some patients still have a bad outcome despite being treated with corticosteroids. Response to treatment can be predicted by the Lille score, a simple tool that is calculated after 7 days of prednisolone course. The ideal binary cut-off of the Lille is 0.45, responders having a Lille score < 0.45 and non-responders having a Lille score ≥0.45. In terms of treatment management, approximately 30% of patients with severe alcoholic hepatitis do not take benefit from prednisolone and are classified as null responders by a Lille score greater than 0.56. In them, there is a consensus for stopping prednisolone after a 7-day course of treatment (Lille score is calculated after 7 days) while patients with a Lille score <0.56 continue treatment for a total of 30 days.
Numerous trials have attempted to test the impact of other strategies in association with prednisolone, but none of them has shown an improvement in survival (primary endpoint) as compared to prednisolone alone. These strategies include for instance pentoxifylline, amoxicillin-clavulanic acid and enteral nutrition.
Because oxidative stress is a major driver of liver injury during alcohol-related liver disease, antioxidants, especially N-acetylcysteine, have been tested for many years to treat alcoholic hepatitis. N-acetylcysteine alone does not seem to bring a survival benefit over placebo while it may improve outcome when combined to prednisolone.
Historically in severe alcoholic hepatitis, treatment is only given for one month. However, a significant proportion of patients still disclose impaired hepatic function after treatment has been stopped (e.g. 50% of patients still have a MELD score ≥17 after 60 days in). It is thus tempting to hypothesize that a proportion of patients will recover slowly and may take benefit from a prolonged treatment. Such strategy has been proposed in some old studies with relatively limited sample size but never tested with a rigorous approach.
In the present study, for the first time in alcoholic hepatitis, we will take into account the recent recommendations of international experts by choosing an innovative primary endpoint that does not only include mortality and evaluate this endpoint at the preferred timepoint of 90 days.
After more than 30 years of negative trials in severe alcoholic hepatitis, the present study is aimed to evaluate two important new strategies to decrease both mortality and liver impairment.

开始日期2025-10-01

申办/合作机构-

NCT07052929

/ Not yet recruiting临床1/2期

A Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ASP2957 in Male Participants With Invasive Ventilator-dependent X-linked Myotubular Myopathy

X-linked myotubular myopathy (XLMTM) is a rare and serious condition present at birth where the muscles do not work properly. There are currently no therapies for XLMTM.
The protein myotubularin is needed for muscle development and movement. A gene called MTM1 tells the body to make myotubularin. XLMTM is caused by changes, or mutations, in the MTM1 gene. Changes in the MTM1 gene causes low or no levels of myotubularin to be made, so the muscles do not work properly.
Gene therapy is a way of getting a healthy copy of a gene into the body. This allows the body's cells to make a normal protein that may reduce disease symptoms. ASP2957 is an experimental gene therapy treatment that gets a healthy MTM1 gene into the body to help improve muscle development and function in young children with the disease.
In this study, ASP2957 will be given to boys for the first time. This is known as a "first in human" study. Boys 3 years or younger with XLMTM can take part.
The main aims of this study are to check the safety of ASP2957, how well the boys tolerate it, and to find the most suitable dose. The study will also check if ASP2957 reduces how long the boys spend on a ventilator.
This study has 2 parts. In Part 1, the boys will receive a single injection given slowly through a tube into a vein (infusion) of ASP2957. In Part 2, a few more boys will be given the dose of ASP2957 worked out from Part 1.
In both parts of the study, the boys will be followed-up for health checks for up to 1 year after their infusion of ASP2957.

开始日期2025-07-31

申办/合作机构

Astellas Gene Therapies, Inc.

NCT06819670

/ Recruiting临床2期IIT

A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse

After initially successful treatment, many children with infantile spasms unfortunately have a relapse, and relapse is linked to poor long-term outcomes such as autism and other forms of epilepsy. The aim of this study is to determine if treatment with low-dose prednisolone is safe, well tolerated, and effective in reducing the risk of relapse.

开始日期2025-05-05

申办/合作机构

University of California, Los Angeles

100 项与泼尼松龙相关的临床结果

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100 项与泼尼松龙相关的转化医学

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100 项与泼尼松龙相关的专利（医药）

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39,378

项与泼尼松龙相关的文献（医药）

2025-12-31·Emerging Microbes & Infections

Prevalence and treatment outcomes of latent tuberculosis infection among older patients with chronic obstructive pulmonary disease in an area with intermediate tuberculosis burden

Article

作者: Sheu, Chau-Chyun ; Lee, Meng-Rui ; Chien, Jung-Yien ; Cheng, Meng-Hsuan ; Huang, Hung-Ling ; Wang, Jann-Yuan ; Huang, Wei-Chang ; Chong, Inn-Wen ; Yang, Jinn-Moon ; Lu, Po-Liang

ABSTRACTChronic obstructive pulmonary disease (COPD) and aging both increase the risk of tuberculosis (TB), an important infectious disease in human. Exploring the burden and predictors of latent tuberculosis infection (LTBI) and treatment outcomes for older individuals with COPD is essential to guide LTBI intervention policy. We enrolled patients aged over 60 years with COPD between January 2021 and June 2023 for LTBI screening using interferon-gamma release assay (IGRA). LTBI treatment options included all World Health Organization (WHO)-recommended regimens. The final regimen was selected through shared decision-making between patients and their COPD physicians, leveraging the long-standing rapport being established. We investigated the prevalence of LTBI in this population, identified risk factors using logistic regression analysis, and evaluated treatment outcomes. A total of 810 COPD patients (mean: 72.8-years) underwent LTBI screening, with an IGRA-positive rate of 23.8%. IGRA positivity was correlated with smoking pack-years (adjusted odds ratio [aOR]: 1.02, p < 0.001), current smoking status (aOR 1.40, p = 0.030), COPD duration (aOR 1.10, p = 0.03), inhaled corticosteroid use (aOR 3.06, p < 0.001), and a cumulative equivalent dose of prednisolone exceeding 210 mg over 2 years (aOR 3.13, p < 0.001). Treatment was initiated in 150 patients (77.7%), predominantly with weekly rifapentine plus isoniazid (3HP) (60.7%). The overall completion rate was 82.0%, with adverse reactions being the primary reason for discontinuation. Our findings support that the LTBI intervention is recommended for older patients with COPD, especially those at higher risk, as nearly 25% of them have tuberculosis infection. The high treatment completion rate highlights the safety and feasibility of the WHO-recommended regimens.

2025-12-31·ANNALS OF MEDICINE

High-dose glucocorticoid treatment vs. glucocorticoid replacement in immune checkpoint inhibitor associated hypophysitis (CORTICI): an open, randomised controlled trial

Article

作者: Theiler-Schwetz, Verena ; Obermayer-Pietsch, Barbara ; Pilz, Stefan ; Schmitt, Lisa ; Trummer, Christian ; Richtig, Erika ; Terbuch, Angelika

OBJECTIVE:

One of the most severe endocrine side effects of immune checkpoint inhibitors (ICI) is hypophysitis leading to adrenal insufficiency. Recovery is rare, although it has been reported after high-dose glucocorticoid treatment. This is the first randomised study to evaluate whether hormonal recovery differs in patients treated with high-dose glucocorticoids versus glucocorticoid replacement therapy.

DESIGN/METHODS:

In this single-centre, open, randomised controlled study, patients with ICI associated hypophysitis were randomised 1:1 to high-dose glucocorticoid treatment (1 mg/kg of prednisolone for two weeks, followed by tapering until week 7 and a switch to hydrocortisone 20 mg total daily dose in week 8) or glucocorticoid replacement therapy (hydrocortisone 20 mg total daily dose) over 8 weeks. The primary outcome was the frequency of hormonal axes recovery.

RESULTS:

Between 17th April 2019 and 16th September 2022, 18 out of the 20 randomised patients finished the trial; eight completed high-dose, 10 glucocorticoid replacement. Nine patients presented with hyponatraemia, two had typical changes on MRI, 12 had isolated adrenal insufficiency, and six had an additional hormone deficiency. None of the patients in neither group experienced a recovery in adrenal function. One patient in each group showed amelioration of hypogonadism. There was a significant, unfavourable treatment effect of high-dose treatment on HbA1c (mean treatment effect 5.16, 95% confidence interval 0.31 to 10.02, p = 0.039).

CONCLUSIONS:

High-dose glucocorticoid treatment was not effective in restoring adrenal function and leads to adverse effects on glucose metabolism. We therefore do not recommend its use for the treatment of ICI associated hypophysitis, except for compressive symptoms.

2025-12-31·Hematology

Dose adjusted EPOCH-R is superior to RCHOP in frontline treatment of mediastinal large B cell lymphoma

Article

作者: Shahin, Omar ; Abufara, Alaa ; Al-Rwashdeh, Mohammad ; Muqbel, Ro’a ; Halahleh, Khalid ; Al-rabi, Kamal ; Al-Ibraheem, Akram ; Abed, Nebras Abu ; Farfoura, Heba ; Abdel-Razeq, Hikmat ; Ma'koseh, Mohammad ; Yaseen, Abeer ; Rahman, Zaid Abdel

INTRODUCTION:

Primary Mediastinal Large B Cell Lymphoma (PMLBCL) is a rare but aggressive B-cell lymphoma. This study compares the outcomes and toxicities of DA-EPOCH-R (Dose-adjusted etoposide, prednisolone, vincristine, cyclophosphamide, and doxorubicin in combination with rituximab) and RCHOP-21 (rituximab, cyclophosphamide, doxorubicin, and vincristine, every 21 days) in the treatment of newly diagnosed PMLBCL.

METHODS:

We retrospectively reviewed the medical records of adults (>18 years) diagnosed with PMLBCL and treated at our center from 2010 to 2023. Baseline characteristics were compared using chi-square and Mann Whitney U-tests. Survival outcomes were analysed using Kaplan Meier and log-rank tests.

RESULTS:

Eighty-seven patients were included, with a median age of 30 years (range: 18-55), 48 patients (55.2%) received RCHOP-21, and 39 patients (44.8%) received DA-EPOCH-R. Radiotherapy was more frequent in the RCHOP-21 group (66.6% vs 15%, p < 0.001). DA-EPOCH-R achieved a higher complete metabolic response (CMR) (92% vs 69%, p = 0.007). After a median follow-up of 47.4 months, patients treated with DA-EPOCH-R had superior overall survival (OS) and progression free survival (PFS); 3-year OS rates were 94.4% vs 69.8% (p = 0.01) and the 3-year PFS rates were 86.7% vs 62.2% (p = 0.016), particularly in patients with aa-IPI >1. Post-chemotherapy delta SUV max <0.75, and <0.7 correlated with relapse and mortality, respectively. Grade III-IV anemia and non-hematological toxicities were more frequent in the DA-EPOCH-R, but no therapy-related deaths occurred.

CONCLUSIONS:

DA-EPOCH-R improves CMR, PFS, and OS compared to R-CHOP-21 with radiotherapy in PMLBCL, particularly in high-risk patients. Longer follow-up is needed to assess long-term toxicities.

164

项与泼尼松龙相关的新闻（医药）

2025-08-23

·CPHI制药在线

4个创新药国内获批上市；荣昌生物眼科创新药授权参天制药，总交易额12.95亿元 | 制药在线一周药闻复盘

点击蓝字关注我们 *展会预登记火热进行中，👆扫描二维码免费领票！本周，最值得关注的就是5个创新药获批上市。首先是审评审批方面，放眼国内，值得一说的就是，诺华的阿曲生坦、第一三共与阿斯利康的德达博妥单抗、轩竹生物/先声药业的地罗阿克以及武汉生物制品研究所申报的口服六价重配轮状病毒减毒活疫苗（Vero细胞）均获批上市。此外，Ionis的Donidalorsen也在美国获批；其次是研发方面，多个药临床有进展，其中，普米斯PD-L1/VEGF-A双抗首个全球Ⅱ期数据公布，ORR高达95%；再次是交易及投融资方面，荣昌生物眼科创新药授权参天制药，总交易额12.95亿元；最后是财报方面，中国生物制药公布2025半年度业绩报告，营收175.7亿元，归母净利润33.9亿元，同比分别增长10.7%和140.2%。本周盘点包括审评审批、研发、交易及投融资以及财报五大板块，统计时间为2025.8.18-8.22，包含29条信息。审评审批 NMPA 上市批准 1、8月20日，NMPA官网显示，诺华的阿曲生坦（商品名：诺锐达）获批上市，用于降低有疾病快速进展风险的原发性免疫球蛋白A肾病（IgA肾病）成人患者的蛋白尿。该药是中国首个获批治疗IgA肾病的非免疫性疗法，是国内首个且目前唯一针对该适应症的高选择性内皮素A（ETA）受体拮抗剂。 2、8月22日，NMPA官网显示，第一三共与阿斯利康联合开发的靶向TROP-2ADC药物德达博妥单抗（Datopotamab deruxtecan，Dato-DXd）获批上市，用于治疗既往接受过内分泌治疗且在晚期疾病阶段接受过至少一线化疗的不可切除或转移性的激素受体（HR）阳性、人类表皮生长因子受体2（HER2）阴性（IHC0、IHC1+或IHC2+/ISH-）乳腺癌成人患者。 3、8月22日，NMPA官网显示，轩竹生物/先声药业1类新药地罗阿克片获批上市，单药适用于未经过间变性淋巴瘤激酶（ALK）抑制剂治疗的ALK阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的治疗。地罗阿克（XZP-3621）是轩竹生物开发的新一代ALK抑制剂。 4、8月22日，NMPA官网显示，武汉生物制品研究所申报的口服六价重配轮状病毒减毒活疫苗（Vero细胞）获批上市，适用于预防轮状病毒血清型G1、G2、G3、G4、G8、G9引起的婴幼儿急性胃肠炎。轮状病毒是引起世界范围内5岁以下儿童重症腹泻的主要病原体之一。申请 5、8月20日，CDE官网显示，阿斯利康的阿伏利尤单抗注射液申报上市，用于治疗系统性红斑狼疮（SLE）。阿伏利尤单抗是一款first-in-class全人源单克隆抗体，靶向I型干扰素受体1（IFNAR1），2021年8月，首次获得FDA批准，用于治疗正在接受标准治疗的中度至重度系统性红斑狼疮成人患者。 6、8月20号，CDE官网显示，恩华药业的NH600001乳状注射液申报上市，推测此次适应症为用于胃镜和结肠镜诊疗镇静/麻醉。NH600001分子结构与依托咪酯相似，拟开发成与依托咪酯相比具有明显优势的短效静脉麻醉1类新药。 7、8月20号，CDE官网显示，爱科百发的齐瑞索韦肠溶胶囊申报上市，推测其适应症为：用于由呼吸道合胞病毒（RSV）引起的2岁及以下儿童呼吸道感染的治疗。齐瑞索韦是一款全新的靶向RSV融合蛋白小分子抑制剂，它通过与病毒的F蛋白结合从而阻止病毒侵入人体细胞。 8、8月22日，CDE官网显示，强生的尼拉帕利阿比特龙片新适应症申报上市，推断用于治疗激素依赖性前列腺癌。尼拉帕利阿比特龙是强生推出的复方制剂，于2023年在欧盟、美国获批上市，用于联合泼尼松或泼尼松龙治疗BRCA1/2突变的转移性去势抵抗性前列腺癌成人患者（mCRPC）一线治疗。2024年10月，该药首次在国内获批上市。临床批准 9、8月22日，CDE官网显示，信达生物的1类新药IBI3032获批临床，拟用于成人超重或肥胖患者的长期体重控制。这是信达生物研发的创新口服小分子GLP-1R激动剂，已经于2025年8月初在美国获批IND。IBI3032的Ⅰ期临床试验将在中美同步推进，将于2025年下半年开始在健康受试者及超重或肥胖人群中给药。优先审评 10、8月18日，CDE官网显示，华奥泰生物的瑞西奇拜单抗（研发代号：HB0034）注射液拟纳入优先审评，用于治疗成人泛发性脓疱型银屑病（GPP）发作。HB0034为一款创新抗IL-36R抗体，可通过抑制IL-36通路发挥抗炎的生物学效应。 11、8月20日，CDE官网显示，石药集团的HER2双抗安尼妥单抗（KN026，anbenitamab）拟纳入优先审评，用于联合化疗治疗至少接受过一种系统性治疗（必须包含曲妥珠单抗联合化疗）失败的HER2阳性局部晚期、复发或转移性胃/胃-食管结合部腺癌。 12、8月21日，CDE官网显示，艾伯维的艾可瑞妥单抗注射液（epcoritamab）拟纳入优先审评，用于与利妥昔单抗和来那度胺联合治疗复发或难治性滤泡性淋巴瘤（FL）成人患者。艾可瑞妥单抗是Genmab利用其专有的DuoBody技术开发的一款IgG1双特异性抗体，2020年6月，艾伯维与Genmab达成协议，共同开发和商业化包括该产品在内的3款双抗。 FDA 上市批准 13、8月20日，FDA官网显示，再生元的两份阿柏西普（商品名：EYLEAHD）注射液8mg监管申请的目标行动日期延长至2025年第四季度。这两份申请包括：一份EYLEAHD预充式注射器的化学、生产和控制(CMC)预先批准补充文件(PAS)；以及一份用于治疗视网膜静脉阻塞(RVO)后黄斑水肿患者的补充生物制品许可申请(sBLA)，该申请原PDUFA日期为8月19日。 14、8月21日，FDA官网显示，Ionis Pharmaceuticals的first-in-class RNA靶向药物Donidalorsen获批上市，用于预防成人和12岁及以上的儿童患者遗传性血管性水肿（HAE）发作。本次获批也使Donidalorsen成为全球首个针对HAE的RNA靶向药物。临床批准 15、8月18日，FDA官网显示，亚盛医药自主研发的Bcl-2选择性抑制剂利沙托克拉（商品名：利生妥、研发代码：APG-2575）获批开展全球注册Ⅲ期临床研究（GLORA-4），联合阿扎胞苷（AZA）治疗新诊断的中高危骨髓增生异常综合征（HR-MDS）患者。突破性疗法 16、8月18日，FDA官网显示，第一三共和默沙东合作开发的Ifinatamab deruxtecan（I-DXd）被授予突破性疗法认定（BTD），用于治疗在铂类化疗时或化疗后出现疾病进展的广泛期小细胞肺癌成人患者。Ifinatamab deruxtecan是一款试验用潜在首款靶向B7-H3的ADC。 17、8月18日，FDA官网显示，BMS及百利天恒子公司SysImmune的伦康依隆妥单抗（Izalontamab Brengitecan）被授予突破性疗法资格，用于治疗携带EGFR外显子19缺失或外显子21L858R替换突变且既往接受过EGFR-TKI和含铂化疗治疗的局部晚期或转移性非小细胞肺癌（NSCLC）患者。这是伦康依隆妥单抗在美国获得的第一个突破性疗法资格。快速通道资格 18、8月18日，FDA官网显示，睿健毅联医药科技自主研发的NouvNeu001注射液被授予快速通道资格（FastTrack Designation，FTD）资格认定，并获准拓展适用范围。NouvNeu001是一款通用型iPSC衍生帕金森细胞治疗产品。研发临床状态 19、8月19日，药物临床试验登记与信息公示平台显示，应世生物登记了一项评估IN10018（Ifebemtinib）联合D-1553（格索雷塞）对比标准治疗在一线KRASG12C突变阳性的局部晚期或转移性非鳞状非小细胞肺癌中的随机、对照、开放性、多中心Ⅲ期研究（IN10018-023）。这是IN10018启动的首个Ⅲ期临床。 20、8月21日，药物临床试验登记与信息公示平台官网显示，齐鲁制药登记了一项注射用QLS32015用于复发/难治性多发性骨髓瘤（RRMM）的Ⅲ期试验。这是该药启动的首个Ⅲ期试验。QLS32015是齐鲁制药自主研发的一款靶向GPRC5D和CD3的新型人源化IgG1 T细胞重定向双特异性抗体。临床数据 21、8月19日，BioNTech公布了一项PD-L1/VEGF-A双抗BNT327随机、开放标签、全球性Ⅱ期临床试验（NCT06449209）结果。结果显示：在38例疗效可评估的患者中，未确认的客观缓解率（uORR）达到了86.8%（33/38，均为部分缓解），余下5例达到疾病稳定（SD）状态，疾病控制率（DCR）为100%。20mg/kg和30mg/kg剂量组患者的ORR分别为95.0%和77.8%。肿瘤体积的平均最佳百分比变化为-47.3%，89.5%的患者在早期即实现肿瘤缩小。 22、8月21日，康方生物公布了其自主研发的新型人源化抗IL-17A单克隆抗体古莫奇（AK111），在治疗活动性强直性脊柱炎（AS）的关键注册性Ⅲ期临床研究结果，主要疗效终点ASAS20及亚组分析、关键次要终点ASAS40，及其他预先选定的多个次要终点均获得成功，具有统计学显著性和临床意义的改善。交易及投融资 23、8月19日，荣昌生物宣布，与参天制药全资子公司参天中国达成协议，参天中国将获得RC28-E在大中华区及韩国、泰国、越南、新加坡、菲律宾、印度尼西亚及马来西亚的独家开发、生产和商业化权利，总交易额约12.95亿元。RC28-E注射液是由荣昌生物自主研发的针对眼部新生血管性疾病的VEGF/FGF双靶标融合蛋白药物。 24、8月19日，复宏汉霖宣布，与启德医药达成战略合作，复宏汉霖将获得由启德医药开发的创新HER2靶向抗体偶联药物（ADC）GQ1005在中国及特定海外国家和地区开发和独家商业化权益。目前，该药物处于Ⅲ期临床，拟用于治疗HER2阳性乳腺癌。临床前研究显示，GQ1005在多个肿瘤细胞系异种移植模型中展现出与德曲妥珠单抗相当的抗肿瘤活性。 25、8月21日，百奥泰宣布，与STADAArzneimittel AG就BAT1806（托珠单抗生物类似药）签署授权许可及商业化协议。STADA将拥有BAT1806在欧盟、瑞士、英国、其它部分欧洲国家，部分中东与北非地区（MENA）和部分独立国家联合体（CIS）国家市场的独占的商业化权益。总交易额超11亿元。财报 26、8月18日，翰森制药发布2025年上半年业绩，总营收约74.34亿元，较去年同期增长约14.3%；创新药与合作产品销售收入约61.45亿元（+22.1%），占总收入比例约为82.7%。抗肿瘤药、抗感染药、中枢神经系统药物、代谢及其他疾病药物分别收入人民币45.31亿元、7.35亿元、7.68亿元、14.00亿元，分别占总收入60.9%、9.9%、10.4%、18.8%。 27、8月18日，中国生物制药发布2025半年度业绩，实现营收175.7亿元，归母净利润33.9亿元，同比分别增长10.7%和140.2%，创新产品营收78亿元，同比强劲增长27.2%。2025至2027年，公司预计将获批19个创新产品，包括TQB3616（CDK2/4/6抑制剂）与TQB2102（HER2双抗ADC）、TQC3721（PDE3/4抑制剂）、Lanifibranor（泛PPAR激动剂）等。 28、8月20日，乐普生物发布2025年中期业绩，总收入约为人民币4.66亿元，同比增长约3.5倍，首次实现盈利。其中BD业务收入3.09亿元，来自与ArriventBioPharma就MRG007项目的授权合作；普特利单抗销售收入1.51亿元，同比增长58.8%。 29、8月22日，迪哲医药发布2025半年报，实现营业收入3.55亿元，较上年度同比增长74%，首度实现商业化盈利。旗下舒沃替尼片（商品名：舒沃哲）和戈利昔替尼胶囊（商品名：高瑞哲），销售保持高速增长。 END 智药研习社近期直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

上市批准财报疫苗免疫疗法临床2期

2025-08-14

·EINPresswire

Steroid Induced Glaucoma Market Set to Surge Global Value to Reach USD 2.1 Billion by 2035

Manufacturers poised for growth as drug innovation and rising awareness drive a 6.1% CAGR in a specialized ophthalmology segment. The future of glaucoma care will be won by manufacturers who innovate for precision, safety, and accessibility.” — Sabyasachi Ghosh NEW YORK, DE, UNITED STATES, August 14, 2025 / EINPresswire.com / -- The Steroid Induced Glaucoma Market , a specialized but steadily expanding niche within ophthalmology, is projected to grow from USD 1.2 billion in 2025 to USD 2.1 billion by 2035, reflecting a robust CAGR of 6.1%. This upward trajectory is driven by growing global awareness of the condition, advancements in drug development, and increasing adoption of proactive eye care practices. Within the broader ophthalmology market, steroid-induced glaucoma accounts for only 2–4%, yet it plays a critical role in targeted patient care—particularly for individuals using corticosteroids for inflammatory and post-surgical recovery. Industry leaders are seizing the opportunity to serve this high-need patient group by innovating treatments that improve efficacy, minimize side effects, and enhance patient adherence. Dr. Rebecca Chen, MD, underscores the urgency of timely intervention: “Elevated eye pressure does not always lead to steroid-induced glaucoma if it is diagnosed and treated in time.” Her statement reflects the industry’s shared mission—protecting vision through earlier detection and advanced therapies. Drug Treatments Take the Lead in Market Share In 2025, drug treatments are expected to capture 68.7% of the industry’s total share, dominating as the preferred approach for managing intraocular pressure (IOP) and preventing optic nerve damage. Pharmaceutical giants such as Allergan and Novartis are driving this dominance through continuous R&D investment in prostaglandin analogs, beta-blockers, and carbonic anhydrase inhibitors. The rise in steroid-induced glaucoma cases is closely tied to the global increase in corticosteroid use for chronic conditions like asthma, arthritis, and autoimmune diseases. As these conditions become more prevalent, manufacturers who can deliver safer, more effective drugs will gain a decisive competitive advantage. Click Here for More Information:- https://www.futuremarketinsights.com/reports/steroid-induced-glaucoma-market Steroid Use and Treatment Innovation Topical ocular steroids—projected to hold 70% of the steroid-type segment share in 2025—are essential for treating inflammation and swelling in eye care. However, they remain a double-edged sword, as their IOP-raising side effects can trigger glaucoma in susceptible patients. Common prescriptions such as prednisolone and dexamethasone will remain widely used, but the focus is shifting toward formulations and delivery systems designed to reduce the risk of glaucoma without compromising anti-inflammatory benefits. This innovation race presents a unique growth avenue for manufacturers investing in targeted formulations and sustained-release delivery methods. Companies advancing in this space are not only mitigating adverse effects but also building brand trust in a cautious prescribing environment. Hospitals as Central Hubs for Market Demand Hospitals are expected to lead sales channels with 46.3% market share in 2025, solidifying their position as the primary centers for diagnosis, treatment, and surgical intervention. These facilities play a crucial role in managing complex glaucoma cases and ensuring patient adherence to long-term care plans. For manufacturers, hospitals represent both a distribution priority and a feedback loop for product performance in real-world clinical settings. Partnering with hospital networks, offering training for ophthalmologists, and providing patient education materials will be key to sustained market penetration. Global Growth Hotspots and Market Dynamics While OECD nations show steady growth, the industry’s most dynamic expansion will occur in emerging markets—particularly India and China. India is set to lead with a 9.1% CAGR, driven by rapid healthcare infrastructure growth and heightened public awareness of eye health. China follows closely with an 8.2% CAGR, supported by government-led eye care initiatives and an expanding middle class with access to advanced treatments. Germany and the United States remain important markets, with strong healthcare systems and ongoing adoption of new glaucoma therapies. Japan, while growing more slowly at 3.8%, continues to focus on personalized treatment strategies for its aging population. The combination of increased diagnosis rates, innovation in delivery technologies, and emerging market adoption is expected to redefine the competitive landscape over the next decade. Competitive Landscape and Strategic Moves Dominant industry players such as Novartis AG, AbbVie Inc., and Bausch & Lomb, Inc. lead with extensive product portfolios, advanced R&D capabilities, and broad distribution networks. Key players including Pfizer, Thea Pharma Inc., and Sun Pharmaceutical Industries are delivering specialized formulations that cater to both global and regional needs. Emerging innovators like Ocular Therapeutix, Inc. and Glaukos are differentiating themselves through novel drug delivery systems, such as biodegradable implants that provide sustained IOP control without frequent dosing. Glaukos’s FDA-approved iDose ® TR implant, for example, promises long-term treatment adherence and reduced patient burden. Recent partnerships, including AbbVie’s collaboration with Ripple Therapeutics to develop RTC-620—a fully biodegradable sustained-release implant—signal the industry’s commitment to next-generation solutions. These strategic alliances will help manufacturers address current limitations in treatment effectiveness and patient compliance. Get Sample Report: - https://www.futuremarketinsights.com/reports/sample/rep-gb-22386 Manufacturer Opportunities for the Next Decade The projected 6.1% CAGR through 2035 offers a clear message to manufacturers: the combination of early diagnosis, advanced drug delivery, and emerging market penetration will determine market leadership. Success will depend on the ability to: Deliver treatment options that effectively manage steroid-induced IOP elevation without compromising the patient’s primary condition treatment. Innovate sustained-release and precision delivery technologies that enhance adherence. Align with hospitals and healthcare providers to increase early detection rates. Build trust in high-growth markets through affordability, accessibility, and targeted education campaigns. Manufacturers who strategically position themselves now—leveraging R&D, forging clinical partnerships, and securing footholds in Asia-Pacific—stand to capture significant value as awareness and diagnosis rates climb. The Steroid Induced Glaucoma Market is no longer an overlooked niche; it is an emerging battleground where innovation meets urgent patient need. As prevalence rises, the demand for better, safer, and longer-lasting treatments will intensify, rewarding those who act decisively in this pivotal growth phase. Editor’s Note: This press release contains forward-looking statements based on industry projections. Actual outcomes may differ due to unforeseen market dynamics. Discover Related Research:- Food Allergy Immunotherapy Market https://www.futuremarketinsights.com/reports/food-allergy-immunotherapy-market Seasonal Influenza Vaccines Therapeutics Market https://www.futuremarketinsights.com/reports/seasonal-influenza-vaccines-therapeutics-market Cold Pain Therapy Market https://www.futuremarketinsights.com/reports/cold-pain-therapy-market Rahul Singh Future Market Insights Inc. +1 347-918-3531 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

2025-07-31

·GBIHealth

逾20亿美元！Madrigal获石药集团SYH2086全球独家权益

药械追踪No.1 / 逾20亿美元！Madrigal获石药集团SYH2086全球独家权益2025年7月30日，石药集团（1093.HK）发布公告称，已与Madrigal Pharmaceuticals, Inc.（Madrigal，NASDAQ：MDGL）就公司的口服小分子激活胰高血糖素样肽-1（GLP-1）受体激动剂SYH2086在全球的开发、生产及商业化订立独家授权协议。根据协议条款，石药集团同意授予Madrigal在全球范围内开发、生产及商业化SYH2086的独家授权，同时保留本集团在中国开发和销售其他口服小分子GLP-1受体激动剂产品的权益。本集团有权收取最高可达20.75亿美元的总代价，包括1.2亿美元的预付款、最高可达19.55亿美元的潜在开发、监管及商业里程碑付款，以及基于SYH2086年度净销售额的高达双位数销售提成。SYH2086是本集团开发的具有完全自主知识产权的临床前候选药物，属于一种新型口服小分子GLP-1受体激动剂。临床前数据显示，SYH2086具有优异的体外激动活性和体内降糖、减重效果，并在不同动物种属上具有宽剂量范围线性化的药物动力学（PK）行为，且无明显安全性风险。->点击文末阅读原文，解锁完整双语新闻No.2 / 赛诺菲GPRC5D靶向抗体SAR446523获FDA孤儿药资格，用于复发/难治性多发性骨髓瘤2025年7月30日，赛诺菲（EURONEXT: SAN，NASDAQ: SNY）宣布，其在研GPRC5D靶向抗体SAR446523获得美国FDA授予的“孤儿药资格认定”，拟用于治疗复发或难治性多发性骨髓瘤（R/R MM）患者。SAR446523是一种IgG1亚型单克隆抗体，具备增强的抗体依赖性细胞毒性（ADCC）活性，靶向在骨髓瘤患者浆细胞中高表达、而在健康组织中低表达的GPRC5D受体。该药物目前正在开展I期首次人体试验，评估SAR446523的皮下注射给药方案。其安全性和有效性尚未经过任何监管机构的评估，仍在调查中。赛诺菲表示，尽管目前已有多种骨髓瘤治疗手段，但疾病难以治愈，大多数患者最终会复发且对现有疗法产生耐药，亟需新的一线治疗方案，因为后续治疗的流失率很高。SAR446523的开发目标是提供更有效的靶向治疗选择，特别是用于治疗对既有疗法不再响应的患者。->点击文末阅读原文，解锁完整双语新闻No.3 / 基于礼新医药对外授权协议，中生制药获默沙东3亿美元里程碑款中国生物制药有限公司（中生制药，1177.HK）宣布，全资附属公司礼新医药科技（上海）有限公司（简称“礼新医药”）与默沙东就LM-299/MK-2010的对外授权合作进展顺利，集团将于近期收到3亿美元的技术转移里程碑付款。LM-299/MK-2010是一款PD-1/VEGF双抗。2024年，礼新医药与默沙东就LM-299达成全球独家授权协议。根据协议条款，默沙东将获得LM299的全球开发、生产和商业化独家许可。礼新医药将获得5.88亿美元的首付款，以及最高27亿美元的里程碑付款。2025年7月，中生制药收购礼新医药并囊获其管线。->点击文末阅读原文，解锁完整双语新闻No.4 / 阿斯利康利普卓联合疗法在华获批治疗BRCA突变mCRPC患者2025年7月31日，阿斯利康（LSE/STO/Nasdaq: AZN）与默沙东（NYSE: MRK）联合宣布，其PARP抑制剂利普卓（英文商品名：Lynparza，中文通用名：奥拉帕利片）已获得中国国家药品监督管理局批准新适应证，联合阿比特龙及泼尼松或泼尼松龙用于治疗携带胚系或体细胞BRCA突变的转移性去势抵抗性前列腺癌（mCRPC）成年患者。此次批准基于III期PROpel研究的BRCA亚组分析数据。研究结果显示全球队列携带BRCA突变亚组患者的分析结果显示，奥拉帕利联合阿比特龙将疾病进展或死亡风险降低76%（风险比[HR]为0.24；95% 置信区间[CI], 0.12-0.45），降低死亡风险70%（HR 0.30；95% CI, 0.15-0.59）。奥拉帕利联合阿比特龙组的中位rPFS和中位总生存期（OS）尚未达到。奥拉帕利是全球首创的PARP抑制剂，也是首个阻断同源重组修复（HRR）缺陷的细胞/肿瘤中DNA损伤修复通路 (DDR) 的靶向治疗，例如 BRCA1和/或BRCA2突变。奥拉帕利还可能通过增强免疫原性，进一步提高抗肿瘤免疫反应的效果。该药目前已在多个国家获得批准，可用于多个肿瘤类型，包括卵巢癌、乳腺癌、胰腺癌和前列腺癌。->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

引进/卖出孤儿药抗体药物偶联物临床1期快速通道

100 项与泼尼松龙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00472	泼尼松龙	D07XA02 D07AA03 S02BA03	DB00860

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
粘膜皮肤淋巴结综合征	日本	Asahi Kasei Corp.	2013-09-13
粘膜皮肤淋巴结综合征	日本	Shionogi Pharma Co., Ltd.	2013-09-13
多发性骨髓瘤	日本	Shionogi Pharma Co., Ltd.	2011-09-16
多发性骨髓瘤	日本	Asahi Kasei Corp.	2011-09-16
子痫前症	日本	Shionogi Pharma Co., Ltd.	1985-07-23
湿疹	日本	Tatsumi Kagaku Co., Ltd.	1967-07-01
肾上腺皮质功能不全	美国	Pharmacia & Upjohn, Inc.	1955-06-21
关节炎	美国	Pharmacia & Upjohn, Inc.	1955-06-21
自身免疫性疾病	美国	Pharmacia & Upjohn, Inc.	1955-06-21
乳糜泻	美国	Pharmacia & Upjohn, Inc.	1955-06-21
溃疡性结肠炎	美国	Pharmacia & Upjohn, Inc.	1955-06-21
胰岛素抵抗	美国	Pharmacia & Upjohn, Inc.	1955-06-21
白血病	美国	Pharmacia & Upjohn, Inc.	1955-06-21
淋巴瘤	美国	Pharmacia & Upjohn, Inc.	1955-06-21
系统性红斑狼疮	美国	Pharmacia & Upjohn, Inc.	1955-06-21

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
过敏性鼻炎	临床3期	-	EMS SA (Brazil)	2013-11-01
浆细胞白血病	临床3期	美国	Janssen Scientific Affairs LLC	2012-01-13
浆细胞白血病	临床3期	中国	Janssen Scientific Affairs LLC	2012-01-13
浆细胞白血病	临床3期	澳大利亚	Janssen Scientific Affairs LLC	2012-01-13
高危妊娠	临床2期	爱尔兰	Janssen LP	2015-07-09
局限性前列腺癌	临床2期	爱尔兰	Janssen LP	2015-07-09
晚期前列腺癌	临床2期	美国	Janssen Research & Development LLC	2011-08-30
晚期前列腺癌	临床2期	中国台湾	Janssen Research & Development LLC	2011-08-30
类风湿关节炎	临床2期	澳大利亚	GSK Plc	2005-06-21
类风湿关节炎	临床2期	法国	GSK Plc	2005-06-21

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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


1142Steroid Pre-Busulfan (ASH2024)	N/A	镰状细胞血症	115	Steroid Pre-Busulfan (HLA-identical sibling HSCT)	醖鹹艱繭衊積繭觸膚艱(艱膚鏇網艱蓋糧顧簾構) = 衊網鹽顧廠選遞繭願醖膚窪淵願積鏇構膚網獵 (遞鹹艱選廠膚構艱鑰顧 ) 更多	积极	2024-12-07
UEGW2024	N/A	活动性中度溃疡性结肠炎	-	Oral prednisone 60mg/day	簾壓襯鏇淵選獵艱鬱鑰(蓋淵糧獵鏇製簾淵鹹鑰) = 壓鬱獵繭網糧廠餘鬱觸築醖顧顧網醖壓構艱艱 (憲鏇糧鹽選獵壓壓網窪 )	-	2024-10-13
				Oral prednisone 60mg/day + 500mg intravenous bolus of methyl-prednisolone for three days	簾壓襯鏇淵選獵艱鬱鑰(蓋淵糧獵鏇製簾淵鹹鑰) = 觸淵齋鏇製窪築願廠範築醖顧顧網醖壓構艱艱 (憲鏇糧鹽選獵壓壓網窪 )
NCT05768282 (Pubmed \| Gastrointest Endosc) 人工标引	临床4期	食管癌	48	Oral prednisolone	積齋衊蓋襯網醖繭糧遞(餘繭獵鹽鑰選願廠網艱) = 構網鏇觸觸夢構獵鹹餘齋夢餘夢齋糧選蓋鏇鏇 (衊願繭鏇網壓遞鏇獵醖 ) 更多	积极	2024-04-05
NCT00945724 (IELSG30, Pubmed) 人工标引	临床2期	弥漫性大B细胞淋巴瘤一线	54	R-CHOP regimen + IT liposomal cytarabinmethotrexatedose methotrexate	衊鬱壓觸選簾壓獵齋築(觸願齋選襯糧鑰醖艱鹽) = 構顧艱衊選窪構蓋餘網鏇鑰獵衊鬱顧齋網築醖 (顧窪構醖遞顧鹹淵鹹構, 81 ~ 97) 更多	积极	2024-03-26
BFM 2009 (EHA2023)	N/A	急性淋巴细胞白血病	74	Dexamethasone	壓艱蓋願顧餘網鏇簾糧(餘築襯醖獵鏇艱簾築顧) = Dexa group had higher incidence of lymphopenia 艱艱鏇簾憲鹽憲窪齋鹽 (糧鬱鹽鬱窪齋蓋憲廠廠 ) 更多	-	2023-06-08
				Prednisolone
EULAR2023	N/A	系统性红斑狼疮维持	117	Prednisolone withdrawal	夢願築衊憲網淵鏇糧糧(襯積糧淵網遞淵壓觸顧) = 構蓋鹽齋鹽膚網夢繭廠觸壓醖餘觸憲艱積糧簾 (膚糧觸廠夢衊簾糧繭觸 ) 更多	-	2023-05-31
				Immunosuppressant withdrawal	夢願築衊憲網淵鏇糧糧(襯積糧淵網遞淵壓觸顧) = 觸糧鹹選鏇齋窪鹹遞淵觸壓醖餘觸憲艱積糧簾 (膚糧觸廠夢衊簾糧繭觸 ) 更多
NCT04498260 (DDW2023)	临床4期	食管狭窄	30	Intralesional Corticosteroid Injection	製膚鑰範願餘製範窪鏇(選鹹醖製夢鹹糧淵糧網) = 鏇窪鹽膚鹽夢選艱廠鹽齋衊鏇蓋襯遞鹹糧築窪 (網構襯構獵鹹繭襯糧衊, 9) 更多	不佳	2023-05-06
				Oral Prednisolone	製膚鑰範願餘製範窪鏇(選鹹醖製夢鹹糧淵糧網) = 觸鬱願廠艱顧觸廠齋艱齋衊鏇蓋襯遞鹹糧築窪 (網構襯構獵鹹繭襯糧衊, 1) 更多
NCT02160353 (CTRIAL-IE (ICORG) 13-23, ASCO_GU2023) 人工标引	临床2期	局限性前列腺癌新辅助	45	abiraterone acetate+prednisolone+gonadotrophin-releasing hormone agonist	夢觸壓窪鹹艱糧選膚膚(憲選選願衊獵廠壓網襯) = 憲鏇糧繭襯艱簾觸顧齋遞壓齋壓鹽醖窪齋膚鏇 (憲鏇鏇鏇襯積餘餘廠窪 ) 更多	积极	2023-02-21
MO257 (ERA2022)	N/A	抗中性粒细胞胞质抗体相关性血管炎	-	High dose GC induction treatment	範襯築蓋鏇遞艱築願鹽(鏇餘築衊選襯願鑰夢積) = 艱廠餘膚齋夢觸選範範製觸艱窪襯齋繭夢糧鬱 (製構醖構範鹽選糧廠膚 ) 更多	积极	2022-05-03
				Low dose GC induction treatment	範襯築蓋鏇遞艱築願鹽(鏇餘築衊選襯願鑰夢積) = 遞衊獵艱淵鏇鏇簾遞襯製觸艱窪襯齋繭夢糧鬱 (製構醖構範鹽選糧廠膚 ) 更多
JCOG1105 (IMS2021)	N/A	多发性骨髓瘤 LDH \| CRP \| b[ED]2MG	88	Melphalan, Prednisolone, and Bortezomib	鹽製淵獵衊鹹齋鬱餘簾(襯鏇積鏇鏇願膚蓋膚齋) = 顧築鹽積壓簾網餘憲製膚觸淵鏇鏇蓋願鏇壓選 (簾廠夢鏇鏇觸鹹壓艱餘 ) 更多	-	2021-09-08