盐酸度洛西汀(Duloxetine Hydrochloride) - 药物靶点：NET x SERT_在研适应症：骨关节炎，腰痛，糖尿病周围神经病变_专利_临床

概要

基本信息

简介CYMBALTA®（盐酸度洛西汀）是口服药物，属于选择性5-羟色胺和去甲肾上腺素再摄取抑制剂（SNRI）类。它由礼来公司于2004年首次获得美国批准使用。CYMBALTA®适用于重度抑郁症、成人和7岁及以上的小儿的广泛性焦虑障碍、成人糖尿病周围神经病性疼痛、成人和13岁及以上的小儿纤维肌痛、成人慢性肌肉骨骼疼痛的治疗。其化学名称为(+)-(S)-N-甲基-γ-(1-萘氧基)-2-噻吩丙胺盐酸盐，分子式为C18H19NOS•HCl，分子量为333.88。它通过抑制5-羟色胺和去甲肾上腺素的再摄取发挥作用。

药物类型

小分子化药

别名

(3S)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine、(S)-duloxetine、Ariclaim

+ [15]

靶点

NET x SERT

作用机制

NET抑制剂(去甲肾上腺素转运蛋白抑制剂)、SERT抑制剂(5-羟色胺转运体抑制剂)

治疗领域

免疫系统疾病神经系统疾病内分泌与代谢疾病+ [3]

在研适应症

骨关节炎腰痛糖尿病周围神经病变+ [10]

非在研适应症

创伤性脑损伤慢性骨关节炎慢性疼痛+ [9]

原研机构

Eli Lilly & Co.

在研机构

Zentiva ks

Eli Lilly & Co.Eli Lilly Nederland BV

+ [3]

非在研机构

Esteve Pharmaceuticals S.A.

Boehringer Ingelheim GmbHShionogi, Inc.

+ [2]

最高研发阶段批准上市

首次获批日期

美国 (2004-08-03),

重度抑郁症

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)

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结构

分子式C18H20ClNOS

InChIKeyBFFSMCNJSOPUAY-LMOVPXPDSA-N

CAS号136434-34-9

关联

541

项与盐酸度洛西汀相关的临床试验

NCT06614322 / Not yet recruiting临床2期IIT

Sensory Phenotyping to Enhance Neuropathic Pain Drug Development (SPENDD): a Randomized, Double-blinded Cross-over Clinical Trial Aimed At Investigating Whether Bedside Quantitative Sensory Testing Can Predict Response to Analgesics.

The goal of this clinical trial is to determine whether quantitative sensory testing (QST) can be used to classify participants into pain sub-groups and predict who will respond best to certain pain treatments in participants with painful peripheral neuropathy.
The analgesic effect is evaluated by measuring pain intensity and Patient Global Impression of Change (PGIC).
This study is a 3-period cross-over trial. This means researchers will compare 3 different drugs (pregabalin, duloxetine, and placebo) over a period of 19 weeks.
Participants will:
* Undergo a quantitative sensory testing (QST) exam.
* Provide a blood sample.
* Complete questionnaires on the computer.
* Take the study drug as instructed.

开始日期2025-09-01

申办/合作机构

University of Rochester

[+1]

NCT05976347 / Not yet recruiting临床4期IIT

Identifying and Treating Depression in the Orthopaedic Trauma Population

The goal of this trial is to pilot a way for orthopaedic surgeons to safely screen for depression and provide treatment for depression with medication. The main questions it aims to answer are:
1. What are the outcomes of patients who screen positive for depressive symptoms and are prescribed either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI).
2. What are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?

开始日期2025-01-01

申办/合作机构

Wake Forest School of Medicine

NCT06711978 / Not yet recruitingN/AIIT

Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors

To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN).
There will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN).
Participants will:
* Take drug duloxetine or a mirogabalin every day for 4 weeks.
* Visit the clinic once every 2 weeks for checkups and tests

开始日期2024-12-01

申办/合作机构-

100 项与盐酸度洛西汀相关的临床结果

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100 项与盐酸度洛西汀相关的转化医学

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100 项与盐酸度洛西汀相关的专利（医药）

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3,216

项与盐酸度洛西汀相关的文献（医药）

2025-01-01·JOURNAL OF CLINICAL DENSITOMETRY

Comparison of the Effect of Selective Serotonin and Norepinephrine Reuptake Inhibitors on Bone Mineral Density with Selective Serotonin Reuptake Inhibitors and Healthy Controls

Article

作者: AYGÜN, Emine AK ; BULUT, Serdar ; AK Aygün, Emine ; Zengin İspir, Gamze ; Bulut, Serdar ; ZENGİN İSPİR, Gamze ; BULUT, Süheyla DOĞAN ; Doğan Bulut, Süheyla ; Ak Aygün, Emine

PURPOSE:

This study investigated the association between selective serotonin reuptake inhibitor (SSRI) and selective serotonin and norepinephrine reuptake inhibitor (SNRI) use and the risk of decreased bone mineral density in postmenopausal women.

METHODS:

Sixty-three patients diagnosed with GAD (Generalized Anxiety Disorder) were treated with venlafaxine or duloxetine from the SNRI group, and sixty patients treated with SSRIs were enrolled. Social demographic features, the Hamilton Anxiety Scale (HAS) results, and the Hamilton Depression Scale (HDS) scores of all the patients were assessed. The BMD (bone mineral density) of the patients was measured by dual-energy X-ray absorptiometry (DXA) at the femoral and lumbar regions. The BMD of the patients was compared with that of 40 healthy controls.

RESULTS:

Bone measurements in the SNRI and SSRI users were similar to those of the healthy controls. However, osteopenic values were observed in the SSRI users, while normal bone density was found in the SNRI users. Also, the bone mineral densities were compared between patients using duloxetine and venlafaxine with healthy controls, showing similar T-score and Z-score values with no significant differences compared to the control group. However, while the lumbar region T-scores of those using duloxetine were within normal values, they were within the osteopenia range of venlafaxine and healthy controls.

CONCLUSION:

SNRIs may have a lower risk of developing osteoporosis than SSRIs. Of the SNRIs, duloxetine appears to be safer than venlafaxine. Further randomized controlled studies are warranted to determine whether SNRI use is risky.

2024-12-01·BRITISH JOURNAL OF PHARMACOLOGY

Vortioxetine reduces the development of pain‐related behaviour in a knee osteoarthritis model in rats: Involvement of nerve growth factor (NGF) down‐regulation

Article

作者: Jovanović, Aleksandar ; Pecikoza, Uroš ; Tomić, Maja ; Stepanović‐Petrović, Radica ; Brdarić, Emilija ; Pavićević, David ; Milenković, Danijela ; Kotur‐Stevuljević, Jelena ; Dinić, Miroslav ; Nastić, Katarina ; Micov, Ana

Abstract:

Background and Purpose:

Vortioxetine, a multimodal‐acting antidepressant, has recently shown analgesic properties. We aimed to investigate its prophylactic effect in the osteoarthritis (OA) model and gain insights into the underlying molecular mechanisms. Duloxetine was studied as a reference.

Experimental Approach:

In the monoiodoacetate (MIA)‐induced rat model of knee OA, pain‐related behaviour was assessed in weight‐bearing and Von Frey tests. Antidepressants were administered orally once daily for 28 days. Gene expression of pain‐related mediators (Ngf, Il‐1β, Tnf‐α, Bdnf, and Tac1 encoding substance P) and oxidative stress parameters were determined after completion of the treatment/behavioural testing protocol.

Key Results:

Vortioxetine and duloxetine dose dependently reduced weight‐bearing asymmetry and mechanical hyperalgesia of the paw ipsilateral to the MIA‐injected knee. Vortioxetine reduced the increased Ngf mRNA expression in the MIA‐injected knees to the level in sham‐injected counterparts. It reduced oxidative stress parameters in the affected knees, more effectively in females than males. Duloxetine showed no effect on Ngf mRNA expression and oxidative stress. Both antidepressants decreased mRNA expression of pain‐related mediators in the lumbar L3–L5 ipsilateral DRGs and spinal cords, which were up‐regulated in MIA‐injected rats. This effect was male‐specific.

Conclusion and Implications:

Vortioxetine may be effective against the development of chronic pain in OA. Its antihyperalgesic effect may be mediated, at least in part, by normalization of NGF expression in the affected joint. Decrease of localized oxidative stress and of expression of pain‐related mediators that contribute to central sensitization are also involved in vortioxetine's antihyperalgesic effect, in a sex‐specific pattern.

2024-12-01·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Efficacy and safety of antidepressants for pain in older adults: A systematic review and meta‐analysis

Review

作者: Underwood, Martin ; Vizza, Lisa ; Ivers, Rowena ; McLachlan, Andrew J. ; Xi, Xiao ; Zhou, Linyi ; Abdel Shaheed, Christina ; Tao, Shunyu ; Naganathan, Vasi ; Narayan, Sujita W. ; Singh, Ramnik

Aims:

In many countries, pain is the most common indication for use of antidepressants in older adults. We reviewed the evidence from randomized controlled trials on the efficacy and safety of antidepressants, compared to all alternatives for pain in older adults (aged ≥65 years).

Methods:

Trials published from inception to 1 February 2024, were retrieved from 13 databases. Two independent reviewers extracted data on study and participant characteristics, primary efficacy (pain scores, converted to 0–100 scale) and harms. Estimates for efficacy were pooled using a random effects model and reported as difference in means and 95% CI. Quality of included trials was assessed using the Cochrane risk of bias tool.

Results:

Fifteen studies (n = 1369 participants) met the inclusion criteria. The most frequently studied antidepressants were duloxetine and amitriptyline (6/15 studies each). Pain related to knee osteoarthritis was the most studied (6/15 studies). For knee osteoarthritis, antidepressants did not provide a statistically significant effect for the immediate term (0–2 weeks), (−5.6, 95% confidence interval [CI]: −11.5 to 0.3), but duloxetine provided a statistically significant, albeit a very small effect in the intermediate term, (≥6 weeks and <12 months), (−9.1, 95% CI: −11.8 to −6.4). Almost half (7/15) of the studies reported increased withdrawal of participants in the antidepressant treatment group vs. the comparator group due to adverse events.

Conclusions:

For most chronic painful conditions, the benefits and harms of antidepressant medicines are unclear. This evidence is predominantly from trials with sample sizes of <100, have disclosed industry ties and classified as having unclear or high risk of bias.

159

项与盐酸度洛西汀相关的新闻（医药）

2024-12-04

·米内网

抗抑郁药TOP20！1类新药暴涨469%，10亿大品种领跑，倍特、京卫备战第十批集采

精彩内容第十批集采将于12月12日开标，氢溴酸伏硫西汀片在列。米内网数据显示，2024H1中国公立医疗机构终端抗抑郁药销售额同比增长3.89%，豪森、丹麦、晖致领跑市场。产品TOP20中，草酸艾司西酞普兰片稳居榜一，9个产品销售额涨逾10%；品牌TOP20中，豪森药业的阿戈美拉汀片蝉联榜一，辉瑞、灵北、科伦、华海各有2个产品上榜。抗抑郁药市场企稳回升，豪森、灵北领跑经过一番调整，抗抑郁药市场呈现出止跌回升的局面。米内网数据显示，抗抑郁药2023年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额接近86亿元，同比增长4.12%；2024年上半年销售额超过46亿元，同比增长3.89%。中国公立医疗机构终端抗抑郁药销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局目前国内已上市的抗抑郁药制剂包括片剂、胶囊剂、溶液剂三种剂型。其中，片剂抗抑郁药销售额领跑，占据的市场份额超过85%；胶囊剂抗抑郁药销售额排名第二，占比超过14%；溶液剂抗抑郁药占比不足1%，存在巨大的增长空间。抗抑郁药集团销售额排名中，TOP10企业上榜门槛是上半年销售额超过1.5亿元，6家企业销售额增幅均超过11%。其中，豪森药业、丹麦灵北、晖致位列前三，市场份额均超过9%；山东京卫制药位列第四，销售额接近4亿元；华海药业位列第五，销售额超过3亿元。 2024H1中国公立医疗机构终端抗抑郁药销售额TOP10集团来源：米内网中国公立医疗机构药品终端竞争格局抗抑郁药TOP20洗牌，1类新药暴涨468.76% 抗抑郁药产品TOP20中，草酸艾司西酞普兰片自2015年以来持续稳居榜首，上半年以超过10亿元的销售额与第二名拉开差距；盐酸舍曲林片、阿戈美拉汀片分别位列第二、第三，市场份额均超过10%。 2024H1中国公立医疗机构终端抗抑郁药产品TOP20来源：米内网中国公立医疗机构药品终端竞争格局 9个产品销售额涨逾10%，其中国产1类新药盐酸托鲁地文拉法辛缓释片暴涨468.76%，其上半年销售额已超过去年全年，盐酸米那普仑片大涨64.94%，盐酸文拉法辛胶囊增长17.81%。4个产品销售额出现负增长，其中第八批集采品种米氮平片大跌49.38%，盐酸度洛西汀肠溶片大跌34.84%。抗抑郁药品牌TOP20中，豪森药业的阿戈美拉汀片继2023年首次登顶榜首后，2024年上半年再次位列第一；山东京卫制药的草酸艾司西酞普兰片位列第二，销售额接近4亿元；灵北的草酸艾司西酞普兰片位列第三，销售额超过3亿元；辉瑞的盐酸舍曲林片位列第四，丽珠集团的马来酸氟伏沙明片位列第五。 2024H1中国公立医疗机构终端抗抑郁药品牌TOP20来源：米内网中国公立医疗机构药品终端竞争格局第一批集采品种草酸艾司西酞普兰片有4家企业上榜，包括山东京卫制药、灵北、科伦药业、湖南洞庭药业；第三批集采品种盐酸舍曲林片、第五批集采品种盐酸文拉法辛缓释胶囊、马来酸氟伏沙明片、盐酸曲唑酮片各有2家企业上榜。目前马来酸氟伏沙明片已有13家企业过评，尚未被纳入集采，盐酸曲唑酮片尚未有企业过评。从企业层面上看，辉瑞、灵北、科伦药业、华海药业各有2个产品上榜。集采促进国产替代，科伦药业上榜的2个产品草酸艾司西酞普兰片、氢溴酸西酞普兰片，以及华海药业上榜的2个产品盐酸帕罗西汀片、盐酸舍曲林片均为国家集采中标品种。过亿大品种将集采，京卫、倍特、石药发力截至目前，抗抑郁药已有26个品种通过或视同通过一致性评价。7个品种草酸艾司西酞普兰片、氢溴酸伏硫西汀片、盐酸度洛西汀肠溶胶囊、马来酸氟伏沙明片、盐酸文拉法辛缓释胶囊、盐酸舍曲林片、阿戈美拉汀片过评企业达10家及以上，其中马来酸氟伏沙明片、阿戈美拉汀片尚未被纳入集采。抗抑郁药过评与集采情况在已落地执行的八批化药集采中，抗抑郁药合计有9个通用名药品被纳入，其中7个为口服常释剂型，2个为缓释控释剂型。 11月22日，国家组织药品联合采购办公室发布《全国药品集中采购文件（GY-YD2024-2）》，标志着第十批集采进入企业申报阶段，62个品种（135个品规）被纳入，将于12月12日在上海开标。62个品种中，抗抑郁药氢溴酸伏硫西汀片赫然在列。中国公立医疗机构终端氢溴酸伏硫西汀片销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局氢溴酸伏硫西汀片是一款多靶点作用机制的新型抗抑郁药，尚未进入国家医保药品目录。米内网数据显示，氢溴酸伏硫西汀片在国内上市后销售额一路上涨，2023年在中国公立医疗机构终端销售额超过1.5亿元，同比增长6.52%；2024年上半年销售额超过8000万元，同比增长0.12%。氢溴酸伏硫西汀片过评企业来源：米内网一致性评价进度数据库氢溴酸伏硫西汀片原为第八批拟集采品种，后在正式目录中被剔除，直到本次第十批集采才被正式纳入。该品种集采的延期，为未过评企业争取了时间，目前过评企业增加至14家，包括豪森药业、正大天晴、石药集团、扬子江药业、倍特药业、山东京卫制药、康弘药业等。资料来源：米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

带量采购核酸药物申请上市

2024-11-29

·GlobeNewswire-Health Care

Lexicon Announces Completion of Enrollment in Phase 2B PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)

Strong Interest in Trial Participation Resulted in Enrollment Exceeding Target by 20 Percent and Completion Ahead of Schedule Top-line Data Expected in Q1 2025 Nov. 26, 2024 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the completion of patient enrollment in the PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) study evaluating LX9211, a novel, orally-delivered, selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), for the treatment of diabetic peripheral neuropathic pain (DPNP). The study successfully enrolled 494 patients, approximately 20 percent more than originally targeted, marking a significant milestone in the trial and increasing study power. Top-line data from PROGRESS is expected to be announced in Q1 2025. "We are pleased to have completed enrollment for the PROGRESS study of LX9211 in DPNP, a condition for which there is significant need for new, non-opioid treatment options," said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. "The strong interest in this study resulted in enrollment significantly exceeding the target and completion of enrollment eight weeks ahead of schedule, underscoring the urgent demand in DPNP. We are confident that the greater-than-expected enrolled patient population will lead to critical insights, inform our Phase 3 design and add to the body of evidence supporting the use of LX911 in treating neuropathic pain and we look forward to sharing top-line findings from the study early next year." PROGRESS commenced in December of 2023 with the goal of enrolling adult patients with a diagnosis of diabetes (type 1 or type 2) with moderate to severe DPNP. The study is placebo-controlled with a primary endpoint of reduction of Average Daily Pain Score (ADPS) at 8 weeks. Secondary endpoints include change from baseline in burning pain and pain interference with sleep. Study design permitted patients to maintain one stable-dose DPNP therapy (gabapentin, pregabalin or duloxetine) without being forced to withdraw from therapies that, although inadequate, may be providing benefit – aligning with how new DPNP drugs are likely to be used in practice. DPNP is a type of nerve damage caused by chronically high blood sugar and is a major disabling and devastating consequence of long-term diabetes. It can result in pain, numbness, and other symptoms in the hands, feet, legs, and arms. There are approximately 20 million patients in the U.S. who are suffering with some type of neuropathic pain, of which about 5 million have DPNP. Discovered using Lexicon’s unique approach to gene science, LX9211 is a potent, orally delivered, selective, investigational small molecule inhibitor of AAK1. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. LX9211 received Fast Track designation from the U.S. Food and Drug Administration for development in DPNP. Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com. The content above comes from the network. if any infringement, please contact us to modify.

快速通道临床结果

2024-11-24

·米内网

重庆药友制药爆发了！22个新品获批，领跑5大百亿市场，1类新药、4个首仿药在路上

精彩内容近日，重庆药友制药拿下了硫酸异帕米星注射液的国产第3家获批，公司今年已累计获批22个新品，创出新高。米内网数据显示，在中国公立医疗机构终端，重庆药友制药已成功挤进5个百亿市场的TOP20集团名单，市场优势明显。公司手握8个独家产品，盐酸依匹斯汀胶囊惊现“4连涨”，47个高端仿制药冲刺上市，其中4个将争夺国内首仿，1类新药YP01001胶囊剑指300亿市场，值得期待。今年已拿下22个重磅新品，250亿市场大突破 11月21日国家药监局发布最新药品获批信息，重庆药友制药子公司北京吉洛华制药的硫酸异帕米星注射液获批上市，公司为该产品的国产第三家。近三年，重庆药友制药（含子公司）不断有新品面世，2024年至今已获批了22个新品，数量远超前两年全年。表1：重庆药友制药及子公司近三年获批的新品来源：米内网中国申报进度（MED）数据库米内网数据显示，2022年重庆药友制药拿下了4个新品，涉及精神兴奋药（1个）、糖尿病用药（1个）、治疗与胃酸分泌相关疾病的药物（1个）、抗血栓形成药（1个）。 2023年重庆药友制药拿下了10个新品，涉及治疗与胃酸分泌相关疾病的药物（3个）、精神安定药（2个）、全身用抗病毒药（1个）、止痛药（1个）、全身用抗细菌药（1个）、抗肿瘤药（1个）、其它所有治疗用药品（1个）。 2024年至今重庆药友制药已拿下了22个新品，主要涉及抗肿瘤药（4个）、精神安定药（4个）、全身用抗细菌药（2个）、精神兴奋药（2个）、免疫抑制剂（1个）、高血压用药（1个）、胃肠解痉药及抗胆碱药和胃动力药（1个）、抗血栓形成药（1个）、心脏病治疗用药（1个）、抗分枝杆菌药（1个）、抗癫痫药（1个）、影响骨结构及其矿化的药物（1个）、血脂调节剂（1个）、治疗与胃酸分泌相关疾病的药物（1个）。无论是数量的增加还是亚类的拓展，重庆药友制药在2024年都迎来了丰收期。值得注意的是，重庆药友制药2024年以前在免疫抑制剂、影响骨结构及其矿化的药物两大亚类市场尚无产品获批，枸橼酸托法替布片是公司首款获批的免疫抑制剂，阿仑膦酸钠片是公司首款获批的影响骨结构及其矿化的药物，具有积极意义。在中国公立医疗机构终端，免疫抑制剂（化+生）2023年的销售规模已升至250亿元以上，重庆药友制药在2024年正式入局这个百亿市场。领跑5大百亿市场，独家产品惊现“4连涨” 在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端，重庆药友制药的畅销产品分布在20多亚类市场，目前公司已成功挤进了7个品类的TOP20集团（二级，下同）榜单，成绩亮眼。 2023年在中国公立医疗机构终端全身用抗组胺化药的市场规模超过47亿元，2024上半年重庆药友制药以1.2亿元的销售额排在TOP3集团，市场份额升至4.89%。盐酸依匹斯汀胶囊是公司的独家产品，适用于成人所患的过敏性鼻炎、荨麻疹、湿疹、皮炎、皮肤瘙痒症、痒疹、伴有瘙痒的寻常性银屑病及过敏性支气管哮喘的防治，该产品2021-2024上半年在中国公立医疗机构终端持续大涨，销售额增长率分别为20.50%、10.08%、10.05%、15.95%。图1：盐酸依匹斯汀胶囊的销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局 2023年在中国公立医疗机构终端胆和肝疾病治疗药（化+生）的市场规模超过180亿元，2024上半年重庆药友制药以4.5亿元的销售额排在TOP4集团，市场份额达5.16%。谷胱甘肽片是公司的独家产品（按集团统计），用于慢性乙肝的保肝治疗，该产品2021-2022年在中国公立医疗机构终端的销售额保持在6.5亿元左右，2024上半年销售额超过2.3亿元。公司该类别畅销的产品还有注射用谷胱甘肽、注射用二氯醋酸二异丙胺葡萄糖酸钠等。 2023年在中国公立医疗机构终端精神安定化药的市场规模超过150亿元，2024上半年重庆药友制药以2.3亿元的销售额排在TOP10集团，市场份额达2.99%。公司该类别畅销的产品包括了富马酸喹硫平片、劳拉西泮片、氟哌啶醇注射液、阿普唑仑片等。 2023年在中国公立医疗机构终端维生素类化药的市场规模超过150亿元，2024上半年重庆药友制药以1.3亿元的销售额排在TOP14集团，市场份额升至1.81%。公司该类别畅销的产品包括了阿法骨化醇片、注射用水溶性维生素等。 2023年在中国公立医疗机构终端精神兴奋化药的市场规模超过140亿元，2024上半年重庆药友制药以1.7亿元的销售额排在TOP15集团，市场份额升至2.21%。公司该类别畅销的产品包括了草酸艾司西酞普兰片、盐酸度洛西汀肠溶胶囊、盐酸美金刚片、盐酸文拉法辛片等。 2023年在中国公立医疗机构终端矿物质补充剂化药的市场规模超过100亿元，2024上半年重庆药友制药以1.1亿元的销售额排在TOP15集团，市场份额达1.96%。公司该类别畅销的产品有氯化钾颗粒。 2023年在中国公立医疗机构终端其它所有治疗用药品（化+生）的市场规模超过59亿元，2024上半年重庆药友制药排在TOP20集团，市场份额达1.37%。公司该类别畅销的产品包括了盐酸纳洛酮注射液、硫代硫酸钠注射液、注射用盐酸纳洛酮、亚硝酸钠注射液等。表2：重庆药友制药的独家产品（按集团统计）来源：米内网中国上市药品（MID）数据库 47个高端仿制药在路上，1类新药掘金300亿市场 2023年至今，重庆药友制药不断拓展产品线，目前报产在审的高端仿制药有47个，其中4个新品有望争夺国内首仿。卡非佐米、布瑞哌唑（又名依匹哌唑）、诺西那生钠2023年全球销售额均超过10亿美元，目前在国内市场仅有原研的注射用卡非佐米、布瑞哌唑片、诺西那生钠注射液获批进口。阿糖胞苷2023年在中国公立医疗机构终端的销售额在3亿元级别，目前注射用阿糖胞苷、注射用盐酸阿糖胞苷已有国内药企获得生产批文，阿糖胞苷注射液暂无国产仿制药获批。从目前的审评情况来看，诺西那生钠注射液和阿糖胞苷注射液仅有重庆药友制药的仿制上市申请在审评审批中，公司大概率能拿下国内首仿（含剂型首仿）。表3：2023年至今重庆药友制药报产在审的仿制药新品来源：米内网中国申报进度（MED）数据库随着新品陆续获批，将进一步丰富公司的产品矩阵，47个报产在审的新品涉及9个大类（20个亚类），其中全身用抗细菌药占了10个、抗肿瘤药占了9个、精神安定药占了4个、精神兴奋药和高血压用药各占了3个。早前，重庆药友制药在抗帕金森氏病药、全身用抗真菌药、造影剂3大亚类市场暂无产品获批，多巴丝肼片或将成为公司首款抗帕金森氏病药，注射用伏立康唑或将成为公司首款全身用抗真菌药，碘佛醇注射液和碘克沙醇注射液也将为公司打开造影剂市场大门。图2：重庆药友制药1类新药临床进展来源：米内网中国临床试验数据库 YP01001胶囊是重庆药友制药在2021年获批临床的化药1类新药，该新药是一款创新型小分子化学药物，据悉，在国内已上市的该新药同类型药品有甲磺酸仑伐替尼胶囊等。甲磺酸仑伐替尼胶囊是蛋白激酶抑制剂畅销产品，2021-2022年在中国公立医疗机构终端销售额在10亿元级别。近几年，蛋白激酶抑制剂在中国公立医疗机构终端的销售规模持续上涨，2024年有望突破300亿元，市场潜力可期。 69个过评产品亮眼，11个产品抢攻第十批国采 11月22日国家药监局发布最新药品获批信息，重庆药友制药的注射用赖氨匹林通过一致性评价，截至目前重庆药友制药及子公司已过评（含视同过评）的产品达69个（按产品名统计），12个产品中标前九批国采。表4：重庆药友制药国采中标产品的最新市场情况来源：米内网中国公立医疗机构药品终端竞争格局随着各批次国采落地，重庆药友制药的中标产品市场地位逐步提升，2024上半年在中国公立医疗机构终端，公司已成为阿法骨化醇片、注射用头孢美唑钠的龙头企业，已成为盐酸克林霉素胶囊、富马酸喹硫平片、盐酸美金刚片、甲苯磺酸索拉非尼片、盐酸度洛西汀肠溶胶囊、注射用头孢米诺钠的TOP2企业。 11月22日第十批国采文件正式对外公布，重庆药友制药有11个产品将参与竞标，“老产品”包括了盐酸格拉司琼注射液、阿司匹林肠溶片和氯化钾颗粒，也有近几年获批的新产品注射用拉氧头孢钠、哌柏西利胶囊、舒更葡糖钠注射液、氟尿嘧啶注射液、间苯三酚注射液、注射用尼可地尔、注射用盐酸罗沙替丁醋酸酯、瑞戈非尼片，“光脚产品”若顺利中标有望快速占领市场，助力公司提升竞争力。资料来源：国家药监局官网、上海阳光医药采购网、米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至11月22日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准

100 项与盐酸度洛西汀相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01179	盐酸度洛西汀	N06AX21	DB00476

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
骨关节炎	日本	Shionogi & Co., Ltd.	2016-12-19
腰痛	日本	Shionogi & Co., Ltd.	2016-03-18
糖尿病周围神经病变	美国	Eli Lilly & Co.	2014-10-16
糖尿病性神经病变	日本	Shionogi & Co., Ltd.	2012-02-22
慢性肌肉骨骼疼痛	美国	Eli Lilly & Co.	2010-11-04
纤维肌痛	美国	Eli Lilly & Co.	2008-06-13
焦虑症	澳大利亚	Eli Lilly & Co.	2007-03-14
神经痛	澳大利亚	Eli Lilly & Co.	2007-03-14
抑郁症	中国	Eli Lilly & Co.	2006-07-28
广泛性焦虑障碍	欧盟	Esteve Pharmaceuticals S.A.	2004-12-17
广泛性焦虑障碍	欧盟	Eli Lilly Nederland BV	2004-12-17
广泛性焦虑障碍	冰岛	Esteve Pharmaceuticals S.A.	2004-12-17
广泛性焦虑障碍	冰岛	Eli Lilly Nederland BV	2004-12-17
广泛性焦虑障碍	列支敦士登	Eli Lilly Nederland BV	2004-12-17
广泛性焦虑障碍	列支敦士登	Esteve Pharmaceuticals S.A.	2004-12-17
广泛性焦虑障碍	挪威	Esteve Pharmaceuticals S.A.	2004-12-17
广泛性焦虑障碍	挪威	Eli Lilly Nederland BV	2004-12-17
糖尿病周围神经性疼痛	欧盟	Eli Lilly Nederland BV	2004-08-11
糖尿病周围神经性疼痛	冰岛	Eli Lilly Nederland BV	2004-08-11
糖尿病周围神经性疼痛	列支敦士登	Eli Lilly Nederland BV	2004-08-11

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
慢性骨关节炎	临床3期	日本	Eli Lilly & Co.	2014-10-01
慢性骨关节炎	临床3期	日本	Shionogi, Inc.	2014-10-01
慢性疼痛	临床3期	中国	Eli Lilly & Co.	2013-09-01
髌骨股骨疼痛综合征	临床3期	美国	Eli Lilly & Co.	2009-11-01
髌骨股骨疼痛综合征	临床3期	波多黎各	Eli Lilly & Co.	2009-11-01
肥胖	临床3期	美国	Eli Lilly & Co.	2009-09-01
多发性硬化症	临床3期	美国	Eli Lilly & Co.	2008-10-01
多发性硬化症	临床3期	比利时	Eli Lilly & Co.	2008-10-01
多发性硬化症	临床3期	加拿大	Eli Lilly & Co.	2008-10-01
多发性硬化症	临床3期	波兰	Eli Lilly & Co.	2008-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03249558 (Duloxetine, CTgov)	临床4期	腰痛 \| 慢性疼痛 \| 颈部疼痛	81	Duloxetine+Morphine (Morphine, Duloxetine)	網網鬱餘鹽壓淵艱遞選(壓簾壓艱壓製鹽憲齋範) = 糧範糧淵製鏇憲鬱膚壓鏇膚網鏇願簾窪廠網憲 (糧觸淵膚網鬱艱鹽衊製, 範構鹽憲糧繭製衊鏇鬱 ~ 壓壓醖鹽鹹膚衊築顧範) 更多	-	2024-11-14
				Placebo+Morphine (Morphine, Placebo Duloxetine)	網網鬱餘鹽壓淵艱遞選(壓簾壓艱壓製鹽憲齋範) = 糧繭積繭淵製積廠衊製鏇膚網鏇願簾窪廠網憲 (糧觸淵膚網鬱艱鹽衊製, 製鹹齋遞範襯範網艱蓋 ~ 鹹鬱蓋糧製衊齋膚獵窪) 更多
NCT04313335 (PROCESS Trial, Pubmed \| Clin Infect Dis)	N/A	疱疹后神经痛 \| 带状疱疹	-	Duloxetine	醖遞鑰鏇廠鑰蓋夢願願(觸積糧鏇醖壓憲鹽餘襯) = 簾鹽鑰願積築憲鏇觸鬱餘衊獵構鑰遞鑰糧獵範 (鬱遞壓顧構鬱鏇簾鬱簾 )	-	2024-04-10
				Duloxetine (Control)	醖遞鑰鏇廠鑰蓋夢願願(觸積糧鏇醖壓憲鹽餘襯) = 鏇鑰築糧廠鹹鹽鹽壓淵餘衊獵構鑰遞鑰糧獵範 (鬱遞壓顧構鬱鏇簾鬱簾 )
NCT02229825 (CTgov)	临床4期	重度抑郁症	339	Duloxetine (60 mg Duloxetine)	艱壓醖鹽淵蓋願餘糧遞(願鬱顧膚餘壓艱夢鑰蓋) = 餘製鬱製鏇鹹鬱艱憲壓構鏇壓艱鏇鏇壓鬱膚衊 (齋糧築範顧艱範繭憲糧, 鬱膚齋鑰鏇鬱鑰遞窪糧 ~ 築壓廠積構繭夢膚鹹簾) 更多	-	2023-10-23
				Duloxetine (120 mg Duloxetine)	艱壓醖鹽淵蓋願餘糧遞(願鬱顧膚餘壓艱夢鑰蓋) = 鬱簾壓積構襯襯願鑰壓構鏇壓艱鏇鏇壓鬱膚衊 (齋糧築範顧艱範繭憲糧, 網鬱膚鑰憲積夢醖鬱餘 ~ 鹹淵壓膚淵繭艱夢範壓) 更多
NCT03395353 (Pubmed \| Drug Metab Pharmacokinet)	临床3期	重度抑郁症	151	duloxetine (Japanese pediatric patients with major depressive disorder)	鏇醖醖衊簾窪遞鑰範構(夢願齋積鏇觸壓襯遞淵) = 鹽齋壓蓋鏇襯齋糧積鑰糧築鬱鹽鬱糧鑰願願鑰 (鹽壓淵願製簾醖蓋餘鹽 ) 更多	-	2023-02-15
NCT04178993 (CTgov)	临床1期	甲基苯丙胺依赖	8	Placebo oral capsule+Methylphenidate+Methamphetamine (Placebo Comparator: Placebo)	壓醖襯獵選憲範憲憲構(蓋簾簾夢簾憲積築製繭) = 觸蓋鑰簾觸廠鑰遞淵願簾壓範淵觸蓋鹹獵廠願 (鹽餘膚艱鏇顧遞壓糧簾, 製襯築夢醖鬱憲窪顧願 ~ 廠醖窪淵構齋壓築膚淵) 更多	-	2023-01-09
				Placebo oral capsule+Methylphenidate+Duloxetine+Methamphetamine (Active Comparator: Duloxetine)	鑰積餘餘構襯膚鑰廠願(夢齋獵淵獵鏇襯獵鹽遞) = 衊鏇選範蓋製齋膚餘獵構繭簾範廠選積衊遞艱 (淵壓廠願廠衊觸觸遞齋, 壓窪鑰遞夢壓製願膚願 ~ 鏇範選築簾範醖窪選觸) 更多
Pubmed \| Pain Med	N/A	疼痛	82	Duloxetine	鏇願糧壓獵觸廠糧艱觸(選網鏇鏇鑰積獵鬱鹹製) = 蓋顧構糧構繭淵鑰網網遞築鹹獵鬱齋顧鑰獵鬱 (淵艱構齋築獵鹹鬱膚蓋 )	积极	2022-11-21
				Placebo	鏇願糧壓獵觸廠糧艱觸(選網鏇鏇鑰積獵鬱鹹製) = 顧製繭憲網製築壓廠製遞築鹹獵鬱齋顧鑰獵鬱 (淵艱構齋築獵鹹鬱膚蓋 )
NCT03271151 (CTgov)	临床4期	关节疾病 \| 急性疼痛 \| 慢性疼痛	160	Cymbalta (Duloxetine ("Cymbalta"))	壓鬱夢願獵鬱願膚窪餘(糧鏇膚鑰獵窪構構獵糧) = 齋鬱簾範顧蓋淵築網衊鹹憲鹹觸觸製製壓積糧 (簾築衊築齋鏇鹹觸淵壓, 鏇簾夢衊窪夢製願餘築 ~ 製蓋襯築獵夢艱積選獵) 更多	-	2022-04-26
				Placebo (Placebo)	壓鬱夢願獵鬱願膚窪餘(糧鏇膚鑰獵窪構構獵糧) = 夢餘鑰餘網夢糧鑰鹹遞鹹憲鹹觸觸製製壓積糧 (簾築衊築齋鏇鹹觸淵壓, 糧襯廠蓋廠夢窪糧醖觸 ~ 簾衊選遞構鏇獵簾繭繭) 更多
NCT04697693 (CTgov)	临床4期	重度抑郁症 \| 创伤后应激障碍	1	Escitalopram+Duloxetine	窪簾鹹襯構窪築願築鏇(餘鑰鹹選構願醖遞艱獵) = 蓋襯廠鹹獵衊艱夢觸遞淵餘餘鹽繭觸壓廠齋範 (網顧鏇夢築壓願齋築範, 顧蓋鹹廠膚齋窪糧壓衊 ~ 鹹襯餘網衊醖蓋鹹壓簾) 更多	-	2022-03-28
NCT03321006 (CTgov)	临床4期	认知功能障碍 \| 抑郁症 \| 老年性耳聋	25	escitalopram+Audeo B-R 90 hearing aid device (Sham)+Duloxetine (Antidepressant (AD) + Low Amplification (Sham) Hearing Aids)	窪鹹繭顧餘獵蓋鏇鏇築(構夢衊廠餘顧鏇顧鬱範) = 鑰範齋製艱蓋鑰獵衊遞膚蓋獵製築廠鬱齋範壓 (齋願艱壓糧選鹽繭繭網, 積膚積築製網襯構選淵 ~ 範願鏇鬱糧壓膚築鹹獵) 更多	-	2021-08-19
				escitalopram+Phonak Audeo B-R 90 hearing aid device (Active)+Duloxetine (Antidepressant (AD) + Full Amplification Hearing Aids)	窪鹹繭顧餘獵蓋鏇鏇築(構夢衊廠餘顧鏇顧鬱範) = 齋壓夢憲壓窪範餘襯遞膚蓋獵製築廠鬱齋範壓 (齋願艱壓糧選鹽繭繭網, 衊築鏇製襯顧顧簾艱構 ~ 製觸糧襯築齋襯衊鏇築) 更多
NCT03395353 (CTgov)	临床3期	抑郁症	151	Duloxetine (Duloxetine)	蓋顧構衊構鹹襯網觸簾(鏇網鏇鑰艱鹽壓窪鏇簾) = 簾簾構簾鏇顧遞網艱鹹襯襯鹽鬱遞齋鹽憲鹹範 (積壓構鑰繭廠簾壓膚獵, 獵範糧範鏇鬱製鬱願築 ~ 構鏇觸蓋選壓壓鑰憲構) 更多	-	2021-06-18
				Duloxetine (Duloxetine 40 mg (9 to 11 Years Old))	築遞網築憲製鑰壓鑰築(廠糧衊選糧構廠製窪餘) = 鹽構憲壓廠憲蓋鬱繭齋襯艱夢淵齋簾鹽襯壓壓 (顧餘鏇廠醖艱憲積願壓, 積鏇積鹽構簾襯鑰積壓 ~ 艱築鬱鬱淵鹹範窪夢鑰)