更新于：2024-11-04
Amitriptyline Hydrochloride
盐酸阿米替林
更新于：2024-11-04
概要
基本信息
简介盐酸阿米替林是一种小分子药物，主要作用于MATs，通过单胺再摄取抑制作用产生镇痛和抗抑郁作用。其主要用于神经痛、抑郁症和夜尿症等领域。盐酸阿米替林由默克公司开发，于1961年4月7日首次获批上市。盐酸阿米替林广泛应用于精神科和神经科疾病的治疗。然而，阿米替林也具有许多不良反应，包括嗜睡、口干、便秘、体重增加等。严重的不良反应还包括心脏问题、肝损伤和药物滥用。 |
药物类型 小分子化药 |
别名 10,11-dihydro-5-(γ-dimethylaminopropylidene)-5H-dibenzo(a,d)cycloheptene、10,11-dihydro-N,N-dimethyl-5H-dibenzo(a,d)heptalene-Δ5,γ-propylamine、3-(10,11-dihydro-5H-dibenzo(a,d)cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine + [25] |
作用机制 NET抑制剂(去甲肾上腺素转运蛋白抑制剂)、5-羟色胺重摄取抑制剂 |
非在研适应症 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |
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结构
分子式C20H24ClN |
InChIKeyKFYRPLNVJVHZGT-UHFFFAOYSA-N |
CAS号549-18-8 |
关联
180
项与 盐酸阿米替林 相关的临床试验Evaluation of the association of Amitriptyline or Acmella Oleracea with Lidocaine and Prilocaine nanocapsules in topical anesthesia: randomized, crossover clinical trial
开始日期2024-10-05 |
申办/合作机构- |
Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]
This study, which is aimed at comparing the effectiveness of the most frequently used drugs in the first line in primary care for the preventive treatment of migraine (amitriptyline, flunarizine, topiramate and propranolol), is a multicentre, pragmatic, parallel group, open randomised trial. Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial, will be randomised to one of the 4 groups. Sample: 460 patients. The primary outcome will be the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.
开始日期2024-10-01 |
Single center, double-blind, placebo-controlled clinical efficacy of amitriptyline spray in patients with neuropathic pain
开始日期2024-09-14 |
申办/合作机构- |
100 项与 盐酸阿米替林 相关的临床结果
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100 项与 盐酸阿米替林 相关的转化医学
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100 项与 盐酸阿米替林 相关的专利（医药）
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7,714
项与 盐酸阿米替林 相关的文献（医药）2025-01-01·ARCHIVES OF GERONTOLOGY AND GERIATRICS
Prevalence of strong anticholinergic use in residents with and without cognitive impairment and frailty: Analysis from 106 nursing homes in 12 Asia-Pacific and European countries
Article
作者: Visvanathan, Renuka ; Aalto, Ulla ; Martínez-Velilla, Nicolás ; Liau, Shin J ; Ll, Li ; Onder, Graziano ; Roitto, Hanna M ; Zhang, Tiange G ; Saarela, Riitta ; Li, Li ; Gutiérrez-Valencia, Marta ; Cross, Amanda J ; Bell, J Simon ; Zhao, Meng ; Roncal-Belzunce, Victoria ; Petrie, Kate ; Dowd, Laura A ; Hamada, Shota ; Jadczak, Agathe D ; Ooi, Choon Ean ; Liperoti, Rosa ; Villani, Emanuele R ; Pitkälä, Kaisu ; Sakata, Nobuo
PURPOSE:
There is a need to balance the benefits and risks associated with strong anticholinergic medications in older adults, particularly among those with frailty and cognitive impairment. This study explored the international prevalence of strong anticholinergic medication use in residents of nursing homes with and without cognitive impairment and frailty.
METHODS:
Secondary, cross-sectional analyses of data from 5,800 residents of 106 nursing homes in Australia, China, Czech Republic, England, Finland, France, Germany, Israel, Italy, Japan, Netherlands, and Spain were conducted. Strong anticholinergic medications were defined as medications with a score of 2 or 3 on the Anticholinergic Cognitive Burden scale. Dementia or cognitive impairment was defined as a documented diagnosis or using a validated scale. Frailty was defined using the FRAIL-NH scale as 0-2 (non-frail), 3-6 (frail) and 7-14 (most-frail). Data were analyzed using descriptive statistics.
RESULTS:
Overall, 17.4 % (n = 1010) residents used ≥1 strong anticholinergic medication, ranging from 1.3 % (n = 2) in China to 27.1 % (n = 147) in Italy. The most prevalent strong anticholinergics were quetiapine (n = 290, 5.0 % of all residents), olanzapine (132, 2.3 %), carbamazepine (102, 1.8 %), paroxetine (88, 1.5 %) and amitriptyline (87, 1.5 %). Prevalence was higher among residents with cognitive impairment (n = 602, 17.9 %) compared to those without (n = 408, 16.8 %), and among residents who were most frail (n = 553, 17.9 %) compared to those who were frail (n = 286, 16.5 %) or non-frail (n = 171, 17.5 %).
CONCLUSIONS:
One in six residents who were most frail and living with cognitive impairment used a strong anticholinergic. However, there was a 20-fold variation in prevalence across the 12 countries. Targeted deprescribing interventions may reduce potentially avoidable medication-harm.
2024-12-01·BIOCHEMICAL PHARMACOLOGY
Non-additivity of the functional properties of individual P450 species and its manifestation in the effects of alcohol consumption on the metabolism of ketamine and amitriptyline
Article
作者: Lazarus, Phillip ; Gaither, Kari A ; Luo, Shaman ; Prasad, Bhagwat ; Kumar Singh, Dilip ; Zhao, Mengqi ; Davydov, Dmitri R ; Davydova, Nadezhda ; Ponraj, Kannapiran
To explore functional interconnections between multiple P450 enzymes and their manifestation in alcohol-induced changes in drug metabolism, we implemented a high-throughput study of correlations between the composition of the P450 pool and the substrate saturation profiles (SSP) of amitriptyline and ketamine demethylation in a series of 23 individual human liver microsomes preparations from donors with a known history of alcohol consumption. The SSPs were approximated with linear combinations of three Michaelis-Menten equations with globally optimized KM (substrate affinity) values. This analysis revealed a strong correlation between the rate of ketamine metabolism and alcohol exposure. For both substrates, alcohol consumption caused a significant increase in the role of the low-affinity enzymes. The amplitudes of the kinetic components and the total rate were further analyzed for correlations with the abundance of 11 major P450 enzymes assessed by global proteomics. The maximal rate of metabolism of both substrates correlated with the abundance of CYP3A4, their predicted principal metabolizer. However, except for CYP2D6 and CYP2E1, responsible for the low-affinity metabolism of ketamine and amitriptyline, respectively, none of the other potent metabolizers of the drugs revealed a positive correlation. Instead, in the case of ketamine, we observed negative correlations with the abundances of CYP1A2, CYP2C9, and CYP3A5. For amitriptyline, the data suggest inhibitory effects of CYP1A2 and CYP2A6. Our results demonstrate the importance of functional interactions between multiple P450 species and their decisive role in the effects of alcohol exposure on drug metabolism.
2024-11-01·JOURNAL OF SURGICAL RESEARCH
Amitriptyline Decreases Mouse Lung Endothelial Cell Inflammatory Responses to Packed Red Blood Cell Microparticles
Article
作者: Nguyen, Christopher ; Wattley, Lindsey ; Schuster, Rebecca ; Lentsch, Alex ; Goodman, Michael ; Pritts, Timothy A ; Chae, Ryan ; Caldwell, Charles
INTRODUCTION:
Large-volume packed red blood cell (pRBC) transfusion is associated with lung injury and worsened outcomes. Amitriptyline reduces lung injury and inflammation in a murine sepsis model. We hypothesized that red cell microparticles (MP) activate endothelial cells, leading to lung injury and that treatment with amitriptyline would blunt the inflammatory response MPs through inhibition of acid sphingomyelinase (ASM).
METHODS:
Murine pRBCs were obtained from C57Bl/6 mice and stored in AS3 for 14 d. The MPs were isolated from pRBCs by serial centrifugation. Mouse lung endothelial cells (MLECs) were pretreated with amitriptyline (0, 2.5, 25, 27 μM, n = 5) for 30 min prior to MP treatment. Chemokine secretion and adhesion molecule shedding was assessed. ASM activity was measured from cell lysates.
RESULTS:
MPs increased the secretion of chemokines and shedding of adhesion molecules in MLECs at both four and 24 h. Amitriptyline treatment of MLECs decreased ASM activity in the setting of MPs. Amitriptyline pretreatment decreased the secretion of chemokines and shedding of adhesion molecules in response to MPs at 4 h but did not decrease adhesion molecule shedding at 24 h CONCLUSIONS: Endothelial cell treatment with MPs induces secretion of chemokines responsible for chemotaxis (keratinocyte chemoattractant, regulated upon activation normal T cell expressed and presumably secreted, and G-granulocyte colony-stimulating factor) as well as many downstream proinflammatory effects (interleukin-6). Additionally, MPs induce adhesion molecule shedding (vascular cell adhesion molecule-1, intracellular adhesion molecule-1, P-selectin, and E-selectin), which has been shown to be associated with endothelial cell activation. Amitriptyline pretreatment decreases MLEC inflammatory response and ASM activity is decreased. These data suggest that ASM inhibition in MLECs is a potential strategy to blunt the inflammatory response to the red blood cell storage lesion.
54
项与 盐酸阿米替林 相关的新闻（医药）2024-09-24
PARIS, Sept. 24, 2024 (GLOBE NEWSWIRE) -- AlgoTherapeutix (AlgoTx), a clinical stage biotechnology company developing a first-in-class therapeutic for peripheral neuropathic pain, ATX01, announced today the completion of the Last Patient Last Visit (LPLV) in its 276 patient Phase II trial known as 'ACT (ATX01 in ChemoTherapy-induced peripheral neuropathy)’. Conducted under the guidance of Professor Guido Cavaletti (Univ of Milano-Bicocca, Italy), ACT is an international, double-blind, placebo-controlled evaluation of ATX01’s efficacy and safety in patients suffering from CIPN, a common side effect of neurotoxic cancer treatments caused by nerve degeneration (1). AlgoTx’s Founder, President & CEO, Stéphane Thiroloix said, “We’re delighted with the solid progress of our ACT clinical trial and commend the patients, investigators and AlgoTx clinical team for their dedication in achieving this major milestone. The trial involved over 40 sites in the US, Belgium, Czechia, France, Italy, Poland and Spain, which is a significant undertaking, and commitment to making a difference, for any biotech company.” AlgoTx’s Chief Development Officer, Philippe Picaut added, “CIPN affects two thirds of chemotherapy patients, representing a high unmet need without any approved treatments. Any progress in this field is therefore very gratifying. We look forward to sharing the ACT data and progressing to the next stage.” The company’s high-concentration, non-opioid ATX01 selectively targets specific nociceptive sodium channels in the peripheral nervous system involved in pain signaling. Its twice-daily local application provides sufficient concentrations to alleviate extreme pain whilst minimizing toxicity through limited systemic exposure. Reference: (1) “Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) (ACT)”. The purpose of this clinical trial is to compare the efficacy of twice daily applications of ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating CIPN in adult cancer survivor patients. Full details here: [link] ENDS Media Contacts AlgoTxCEO Stéphane Thiroloixstephane@algotx.com Scius CommunicationsKatja StoutKatja@sciuscommunications.com+44 778 943 5990 Daniel Goochdaniel@sciuscommunications.com +44 774 787 5479 About AlgoTherapeutix (AlgoTx) AlgoTherapeutix (AlgoTx) is a clinical stage biotechnology company developing a targeted, first in class therapeutic for peripheral neuropathic pain. Its lead asset, ATX01, is a proprietary topical formulation of amitriptyline for use in chemotherapy-induced peripheral neuropathy (CIPN), an area of high unmet need associated with unbearable pain in patients’ extremities and for which there is currently no viable treatment options. ATX01 targets the signaling pathways involved in the regulation of pain by inhibiting specific nociceptive sodium channel receptors. Its topical administration provides targeted relief from the excruciating pain in patients’ extremities from CIPN, which is caused by nerve degeneration and is a common side effect of cancer treatment, occurring in 68% of patients. ATX01 was granted FDA fast track development status in CIPN. The company has completed recruitment into an international Phase II clinical trial of 276 patients with CIPN (the ‘ACT’ study). This trial is due to provide its final data read early in 2025, and the company is making plans to expedite a Phase 3 trial. The company has seasoned leadership, with experience of bringing global products successfully to market, and is backed by an international board. AlgoTx raised a Series B round of EUR 20 million in 2023 and has raised EUR 35 million to date. AlgoTx has a consortium of investors including Relyens Innovation Santé / Turenne Capital, who led the Series B fund raise, along with UI Investissement, and angel investors. Historical investors include Bpifrance through its Innobio 2 fund and Omnes Capital. In 2023, the company won France Biotech’s prestigious ESG HealthTech Trophy in recognition of its early commitment to ESG initiatives. For more information, see the company’s website and follow AlgoTx on LinkedIn.
临床2期快速通道
2024-09-20
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最新最热的医药健康新闻政策
前九批国家组织药品集中采购品种可替代药品参考监测范围
第一批国家组织药品集中采购中选品种监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
阿托伐他汀钙口服常释剂型
★辛伐他汀、★匹伐他汀、
普伐他汀、氟伐他汀、洛伐他汀
★瑞舒伐他汀
2
瑞舒伐他汀钙口服常释剂型
★辛伐他汀、★匹伐他汀、
普伐他汀、氟伐他汀、洛伐他汀
★阿托伐他汀
3
氯吡格雷口服常释剂型
噻氯匹定
★替格瑞洛
4
厄贝沙坦口服常释剂型
★奥美沙坦酯、★坎地沙坦酯、★缬沙坦、★替米沙坦、
★氯沙坦、阿利沙坦酯、
阿齐沙坦、美阿沙坦
★赖诺普利、★贝那普利、★依那普利、
★培哚普利、雷米普利、喹那普利、
咪达普利
5
氨氯地平口服常释剂型
★左氨氯地平
★硝苯地平、★非洛地平、拉西地平、
尼群地平、贝尼地平、西尼地平、
马尼地平、尼卡地平、★乐卡地平
6
恩替卡韦口服常释剂型
拉米夫定、★阿德福韦酯、替比夫定
★替诺福韦二吡呋酯、★丙酚替诺福韦、艾米替诺福韦
7
艾司西酞普兰口服常释剂型
★西酞普兰
多塞平、氯米帕明、噻奈普汀、吗氯贝胺、马普替林、
米安色林、瑞波西汀
★氟西汀、★帕罗西汀、伏硫西汀、
★度洛西汀、★舍曲林、氟伏沙明、
安非他酮、曲唑酮、★文拉法辛、
米那普仑、★米氮平、阿戈美拉汀、
阿米替林、圣约翰草提取物
8
帕罗西汀口服常释剂型
多塞平、氯米帕明、噻奈普汀、吗氯贝胺、马普替林、
米安色林、瑞波西汀
★西酞普兰、★艾司西酞普兰、
★氟西汀、伏硫西汀、★度洛西汀、
★舍曲林、氟伏沙明、安非他酮、
曲唑酮、★文拉法辛、米那普仑、
★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
9
奥氮平口服常释剂型
三氟拉嗪、三氟哌多、
五氟利多、洛沙平、硫利达嗪、哌泊塞嗪、氟哌利多
★氨磺必利、★阿立哌唑、★利培酮、
帕利哌酮、★氯氮平、★喹硫平、
布南色林、★鲁拉西酮、齐拉西酮、
舒必利、氯丙嗪、氟哌啶醇、
氟奋乃静、奋乃静、癸氟奋乃静、
硫必利、氯普噻吨
10
头孢呋辛酯口服常释剂型
★头孢克洛、★头孢丙烯
★头孢拉定、★头孢氨苄、头孢羟氨苄、
★头孢克肟、★头孢地尼、头孢他美酯、
头孢妥仑匹酯、头孢泊肟酯
11
利培酮口服常释剂型
三氟拉嗪、三氟哌多、
五氟利多、洛沙平、硫利达嗪、
哌泊塞嗪、氟哌利多
★氨磺必利、★阿立哌唑、★奥氮平、
帕利哌酮、★氯氮平、★喹硫平、
布南色林、★鲁拉西酮、齐拉西酮、
舒必利、氯丙嗪、氟哌啶醇、
氟奋乃静、奋乃静、癸氟奋乃静、
硫必利、氯普噻吨
12
吉非替尼口服常释剂型
埃克替尼、★厄洛替尼
★阿法替尼、达可替尼、奥希替尼、
伏美替尼、阿美替尼
13
福辛普利口服常释剂型
★赖诺普利、★贝那普利、
★依那普利、★培哚普利、
雷米普利、喹那普利、咪达普利
★奥美沙坦酯、★坎地沙坦酯、
★缬沙坦、★替米沙坦、★氯沙坦、
阿利沙坦酯、阿齐沙坦、美阿沙坦
14
厄贝沙坦氢氯噻嗪口服常释剂型
奥美沙坦酯氢氯噻嗪、
★氯沙坦氢氯噻嗪、
替米沙坦氢氯噻嗪、
★缬沙坦氢氯噻嗪、坎地氢噻
15
赖诺普利口服常释剂型
★贝那普利、★依那普利、
★培哚普利、雷米普利、
喹那普利、咪达普利
★福辛普利
16
替诺福韦二吡呋酯口服常释剂型
拉米夫定、★阿德福韦酯、替比夫定
★丙酚替诺福韦、艾米替诺福韦
★恩替卡韦
17
氯沙坦口服常释剂型
阿齐沙坦、美阿沙坦、
★奥美沙坦酯、★坎地沙坦酯、
★缬沙坦、★替米沙坦、
★厄贝沙坦、阿利沙坦酯
★赖诺普利、★贝那普利、★依那普利、
★培哚普利、雷米普利、喹那普利、
咪达普利
18
依那普利口服常释剂型
★贝那普利、★赖诺普利、
★培哚普利、雷米普利、
喹那普利、咪达普利
★福辛普利、★奥美沙坦酯、★缬沙坦、
★坎地沙坦酯、★替米沙坦、★氯沙坦、
阿利沙坦酯、阿齐沙坦、美阿沙坦
19
左乙拉西坦口服常释剂型
奥卡西平、丙戊酸镁、丙戊酸钠、
卡马西平、拉莫三嗪、托吡酯
20
伊马替尼口服常释剂型
氟马替尼
尼洛替尼、达沙替尼
21
孟鲁司特口服常释剂型
普仑司特、扎鲁司特
22
蒙脱石口服散剂
23
培美曲塞注射剂
24
氟比洛芬酯注射剂
双氯芬酸、★布洛芬、★帕瑞昔布、
吡罗昔康、★酮咯酸氨丁三醇
25
右美托咪定注射剂
第二批国家组织药品集中采购中选品种监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
阿比特龙口服常释剂型
氟他胺、★比卡鲁胺、恩扎卢胺
2
阿德福韦酯口服常释剂型
拉米夫定、替比夫定
★替诺福韦二吡呋酯、★丙酚替诺福韦、艾米替诺福韦、★恩替卡韦
3
阿卡波糖口服常释剂型
伏格列波糖、★米格列醇
4
阿莫西林口服常释剂型
青霉素V、氨苄西林、
苯唑西林、氯唑西林
5
阿奇霉素口服常释剂型
红霉素、琥乙红霉素、
环酯红霉素、★罗红霉素
地红霉素、泰利霉素、依托红霉、
★克拉霉素
6
安立生坦片
波生坦
马昔腾坦、利奥西呱
7
奥美沙坦酯口服常释剂型
★氯沙坦、阿利沙坦酯
★坎地沙坦酯、★缬沙坦、★替米沙坦、★厄贝沙坦、阿齐沙坦、美阿沙坦
★福辛普利、★贝那普利、★赖诺普利、
★培哚普利、雷米普利、喹那普利、
咪达普利
8
比索洛尔口服常释剂型
★美托洛尔、卡维地洛、
贝凡洛尔、阿罗洛尔、
塞利洛尔
阿替洛尔、★普萘洛尔、尼群洛尔
9
对乙酰氨基酚口服常释剂型
★布洛芬、萘普生
双氯芬酸、★洛索洛芬、★美洛昔康、
★依托考昔、★塞来昔布、艾瑞昔布
10
多奈哌齐口服常释剂型
加兰他敏、卡巴拉汀、★美金刚
11
氟康唑口服常释剂型
★伏立康唑、伊曲康唑、泊沙康唑、
艾沙康唑
12
福多司坦口服常释剂型
羧甲司坦、乙酰半胱氨酸
厄多司坦、美司坦、★氨溴索、
★溴己新、桉柠蒎
13
格列美脲口服常释剂型
格列本脲
★格列齐特
格列喹酮、★格列吡嗪
14
甲硝唑口服常释剂型
★替硝唑、★奥硝唑、
塞克硝唑
左奥硝唑
15
聚乙二醇口服散剂
复方聚乙二醇电解质Ⅰ、
复方聚乙二醇电解质Ⅱ、
复方聚乙二醇电解质Ⅲ、
复方聚乙二醇电解质Ⅳ、硫酸镁、乳果糖
16
坎地沙坦酯口服常释剂型
★氯沙坦、阿利沙坦酯
阿齐沙坦、美阿沙坦、
★奥美沙坦酯、★缬沙坦、
★替米沙坦、
★厄贝沙坦、阿齐沙坦酯
★福辛普利、★贝那普利、★赖诺普利、
★培哚普利、雷米普利、喹那普利、
咪达普利
17
克林霉素口服常释剂型
克林霉素棕榈酸酯、
克林霉素磷酸酯、林可霉素
18
铝碳酸镁咀嚼片
铝镁加
磷酸铝凝胶、复方氢氧化铝
19
美洛昔康口服常释剂型
吡罗昔康
氯诺昔康、★塞来昔布、★依托考昔、
艾瑞昔布、双氯芬酸、★洛索洛芬
20
莫西沙星口服常释剂型
吡哌酸、氧氟沙星、
★诺氟沙星
★左氧氟沙星、
★环丙沙星、洛美沙星、
氟罗沙星、司帕沙星
吉米沙星、奈诺沙星、加诺沙星、安妥沙星
21
曲美他嗪缓释控释剂型
22
索利那新口服常释剂型
托特罗定、奥昔布宁
23
他达拉非片
★西地那非、伐地那非
24
特拉唑嗪口服常释剂型
阿夫唑嗪、多沙唑嗪
★坦索罗辛、赛洛多辛
25
替吉奥口服常释剂型
氟尿嘧啶
替加氟、★卡培他滨、曲氟尿苷替匹嘧啶
26
头孢氨苄口服常释剂型
★头孢拉定、头孢羟氨苄
★头孢呋辛酯、★头孢克洛、★头孢丙烯、★头孢克肟、★头孢地尼、头孢妥仑匹酯、头孢泊肟酯、头孢他美酯
27
头孢拉定口服常释剂型
★头孢氨苄、头孢羟氨苄
★头孢呋辛酯、★头孢克洛、★头孢丙烯、★头孢地尼、头孢妥仑匹酯、★头孢克肟、头孢泊肟酯、头孢他美酯
28
辛伐他汀口服常释剂型
★匹伐他汀、普伐他汀、
氟伐他汀、洛伐他汀
★瑞舒伐他汀、★阿托伐他汀
29
异烟肼口服常释剂型
30
吲达帕胺口服常释剂型
氢氯噻嗪、★呋塞米、
★托拉塞米
美托拉宗、螺内酯、阿米洛利、布美他尼
31
注射用紫杉醇（白蛋白结合型）
紫杉醇脂质体、
★紫杉醇
★多西他赛
32
左西替利嗪口服常释剂型
赛庚啶、氯苯那敏、
★西替利嗪
苯海拉明、★异丙嗪、★氯雷他定、
★地氯雷他定、卢帕他定、★奥洛他定、
非索非那定、阿伐斯汀、咪唑斯汀、
★依巴斯汀、★贝他斯汀、依美斯汀
第三批国家组织药品集中采购中选品种监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
阿那曲唑口服常释剂型
★来曲唑、依西美坦
2
阿哌沙班口服常释剂型
华法林
★利伐沙班、艾多沙班、★达比加群酯
3
阿扎胞苷注射剂
4
氨基葡萄糖口服常释剂型
5
氨溴索口服常释剂型
羧甲司坦、乙酰半胱氨酸
★福多司坦、厄多司坦、美司坦 、
★溴己新、桉柠蒎
6
奥氮平口腔崩解片
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★氨磺必利、★阿立哌唑、★利培酮、
帕利哌酮、★氯氮平、★喹硫平、布南色林、
★鲁拉西酮、齐拉西酮、舒必利、氯丙嗪、
氟哌啶醇、氟奋乃静、奋乃静、癸氟奋乃静、
硫必利、氯普噻吨
7
奥美拉唑口服常释剂型
★艾司奥美拉唑
★泮托拉唑、兰索拉唑、雷贝拉唑、艾普拉唑
8
布洛芬缓释控释剂型
右布洛芬、萘普生
★对乙酰氨基酚、★美洛昔康、双氯芬酸、
★塞来昔布、★依托考昔、芬布芬、洛索洛芬
9
布洛芬颗粒剂
右布洛芬、萘普生
★对乙酰氨基酚、★美洛昔康、双氯芬酸、
★塞来昔布、★依托考昔、芬布芬、洛索洛芬
10
地氯雷他定口服常释剂型
赛庚啶、
氯苯那敏、
★氯雷他定
★异丙嗪、苯海拉明、非索非那定、
卢帕他定、★奥洛他定、★西替利嗪、
★左西替利嗪、阿伐斯汀、咪唑斯汀、
★依巴斯汀、★贝他斯汀、依美斯汀
11
多潘立酮口服常释剂型
★莫沙必利、氯波必利、伊托必利
12
二甲双胍缓释控释剂型
苯乙双胍
二甲双胍常释制剂
13
二甲双胍口服常释剂型
苯乙双胍
二甲双胍缓释控释剂型
14
非布司他口服常释剂型
别嘌醇、苯溴马隆
15
非那雄胺口服常释剂型（5mg）
爱普列特
★度他雄胺
16
非那雄胺口服常释剂型（1mg）
17
氟西汀口服常释剂型
多塞平、氯米帕明、噻奈普汀、
吗氯贝胺、马普替林、米安色林、
瑞波西汀
★西酞普兰、★艾司西酞普兰、★帕罗西汀、
伏硫西汀、★度洛西汀、★舍曲林、
氟伏沙明、安非他酮、曲唑酮、★文拉法辛、
米那普仑、★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
18
枸橼酸西地那非片
★他达拉非、伐地那非
19
甲钴胺口服常释剂型
维生素B12、腺苷钴胺
20
卡培他滨口服常释剂型
氟尿嘧啶
替加氟、★替吉奥、曲氟尿苷替匹嘧啶
21
卡托普利口服常释剂型
★福辛普利、★赖诺普利、★培哚普利、
★依那普利、雷米普利、喹那普利、
★贝那普利、咪达普利
22
喹硫平口服常释剂型
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★奥氮平、★利培酮、帕利哌酮、★阿立哌唑、★氨磺必利、布南色林、★鲁拉西酮、齐拉西酮、舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、癸氟奋乃静、硫必利、氯普噻吨
23
来曲唑口服常释剂型
★阿那曲唑、依西美坦
24
氯氮平口服常释剂型
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★奥氮平、★利培酮、帕利哌酮、
★阿立哌唑、★氨磺必利、★喹硫平、
布南色林、★鲁拉西酮、齐拉西酮、舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、
癸氟奋乃静、硫必利、氯普噻吨
25
美金刚口服常释剂型
★多奈哌齐、利斯的明、加兰他敏、
卡巴拉汀、丁苯酞、甘露特钠
26
孟鲁司特咀嚼片
普仑司特、扎鲁司特
27
孟鲁司特颗粒剂
普仑司特、扎鲁司特
28
匹伐他汀口服常释剂型
★辛伐他汀
普伐他汀、氟伐他汀、洛伐他汀、
★阿托伐他汀、★瑞舒伐他汀
29
普芦卡必利口服常释剂型
30
曲美他嗪口服常释剂型
31
塞来昔布口服常释剂型
艾瑞昔布
★依托考昔、芬布芬、右布洛芬、★布洛芬、洛索洛芬
32
舍曲林口服常释剂型
多塞平、氯米帕明、噻奈普汀、
吗氯贝胺、马普替林、米安色林、
瑞波西汀
★西酞普兰、★艾司西酞普兰、★氟西汀、
★帕罗西汀、伏硫西汀、★度洛西汀、
氟伏沙明、安非他酮、曲唑酮、★文拉法辛、
米那普仑、★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
33
坦洛新（坦索罗辛） 缓释控释剂型
★特拉唑嗪、阿夫唑嗪、多沙唑嗪、赛洛多辛
34
碳酸氢钠口服常释剂型
35
替格瑞洛口服常释剂型
噻氯匹啶
★氯吡格雷
36
托法替布口服常释剂型
巴瑞替尼、乌帕替尼
37
维格列汀口服常释剂型
★沙格列汀、西格列汀、阿格列汀、利格列汀
38
维生素B6口服常释剂型
39
西酞普兰口服常释剂型
★艾司西酞普兰、多塞平、
氯米帕明、噻奈普汀、吗氯贝胺、
马普替林、米安色林、瑞波西汀
★氟西汀、★帕罗西汀、伏硫西汀、
★度洛西汀、★舍曲林、氟伏沙明、
安非他酮、曲唑酮、★文拉法辛、米那普仑、★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
40
西替利嗪口服常释剂型
赛庚啶、氯苯那敏
★左西替利嗪
苯海拉明、★异丙嗪、★氯雷他定、
★地氯雷他定、非索非那定、卢帕他定、
★奥洛他定、阿伐斯汀、咪唑斯汀、
★依巴斯汀、★贝他斯汀、依美斯汀
41
缬沙坦口服常释剂型
★氯沙坦、
阿利沙坦酯
坎地沙坦、依普沙坦、★厄贝沙坦
★奥美沙坦、★替米沙坦、阿齐沙坦、
美阿沙坦
42
盐酸达泊西汀片
43
依托考昔口服常释剂型
艾瑞昔布
★塞来昔布、芬布芬、右布洛芬
44
乙胺丁醇口服常释剂型
氨硫脲、对氨基水杨酸
45
右佐匹克隆口服常释剂型
佐匹克隆
唑吡坦、扎来普隆、艾司唑仑
46
左乙拉西坦口服液体剂
奥卡西平、丙戊酸镁、丙戊酸钠、卡马西平、拉莫三嗪、托吡酯
47
左乙拉西坦注射用浓溶液
苯巴比妥、丙戊酸钠
48
阿莫西林颗粒剂
青霉素V、氨苄西林
苯唑西林、氯唑西林
49
利奈唑胺口服常释剂型
康替唑胺
50
莫西沙星氯化钠注射剂
氧氟沙星、
诺氟沙星
环丙沙星、★左氧氟沙星、
洛美沙星、帕珠沙星、依诺沙星、
培氟沙星、氟罗沙星、加替沙星
奈诺沙星
51
左氧氟沙星滴眼剂
诺氟沙星滴眼液、氧氟沙星滴眼液、洛美沙星滴眼液、环丙沙星滴眼液
★莫西沙星滴眼液、加替沙星滴眼液
52
环丙沙星口服常释剂型
吡哌酸、
★诺氟沙星
★莫西沙星、奈诺沙星、加诺沙星、
西他沙星、依诺沙星、培氟沙星、氟罗沙星、
氧氟沙星、★左氧氟沙星、洛美沙星、
司帕沙星、加替沙星、吉米沙星、安妥沙星
53
头孢地尼口服常释剂型
★头孢克肟、头孢妥仑匹酯、
头孢泊肟酯、头孢他美酯
★头孢呋辛酯、★头孢克洛、★头孢丙烯
54
头孢克洛口服常释剂型
★头孢呋辛酯、★头孢丙烯
★头孢拉定、★头孢氨苄、头孢羟氨苄、
★头孢克肟、★头孢地尼、头孢妥仑匹酯、
头孢泊肟酯、头孢他美酯
55
克拉霉素口服常释剂型
红霉素、琥乙红霉素、环酯红霉素、依托红霉素、★罗红霉素
★阿奇霉素、地红霉素、泰利霉素
第四批国家组织药品集中采购中选品种监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
恩曲他滨替诺福韦口服常释剂型
齐多夫定、司他夫定、阿巴卡韦、
替诺福韦、奈韦拉平、依非韦伦、
茚地那韦、利托那韦、
洛匹那韦利托那韦、达芦那韦考比司他、
拉替拉韦、多替拉韦
2
多索茶碱注射剂
氨茶碱
二羟丙茶碱
3
氨溴索注射剂
乙酰半胱氨酸、★溴己新
4
沙丁胺醇吸入剂
左沙丁胺醇、★特布他林
5
氨磺必利口服常释剂型
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★奥氮平、★利培酮、帕利哌酮、
★氯氮平、★阿立哌唑、★喹硫平、
布南色林、★鲁拉西酮、齐拉西酮、
舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、
奋乃静、癸氟奋乃静、硫必利、氯普噻吨
6
度洛西汀口服常释剂型
多塞平、氯米帕明、噻奈普汀、
吗氯贝胺、马普替林、米安色林、
瑞波西汀
★西酞普兰、★艾司西酞普兰、
★氟西汀、★帕罗西汀、伏硫西汀、
★舍曲林、氟伏沙明、安非他酮、
曲唑酮、★文拉法辛、米那普仑、
★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
7
喹硫平缓释控释剂型
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★氨磺必利、★奥氮平、★利培酮、
帕利哌酮、★阿立哌唑、布南色林、
★鲁拉西酮、齐拉西酮、舒必利、
氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、
癸氟奋乃静、硫必利、氯普噻吨
8
吡嗪酰胺口服常释剂型
9
诺氟沙星口服常释剂型
部分喹诺酮、小檗碱
10
头孢丙烯口服常释剂型
★头孢呋辛酯、★头孢克洛
★头孢拉定、★头孢氨苄、头孢羟氨苄、★头孢地尼、★头孢克肟、
头孢妥仑匹酯、头孢泊肟酯、头孢他美酯
11
左氧氟沙星口服常释剂型
吡哌酸、氧氟沙星、
★诺氟沙星
★环丙沙星、洛美沙星、
依诺沙星、培氟沙星、氟罗沙星、
司帕沙星、加替沙星、吉米沙星、
安妥沙星
★莫西沙星、奈诺沙星、加诺沙星、
西他沙星
12
伏立康唑口服常释剂型
★氟康唑、伊曲康唑、泊沙康唑、
艾沙康唑
13
特比萘芬口服常释剂型
14
丙泊酚中/长链脂肪乳注射剂
丙泊酚
美索比妥、羟丁酸钠、
氯胺酮、依托咪酯、咪达唑仑、
艾司氯胺酮
15
氯雷他定口服常释剂型
赛庚啶、氯苯那敏
苯海拉明、★异丙嗪、★地氯雷他定、
★奥洛他定、卢帕他定、非索非那定、
★左西替利嗪、★西替利嗪、阿伐斯汀、
咪唑斯汀、★依巴斯汀、★贝他斯汀、
比拉斯汀
16
恩格列净口服常释剂型
达格列净、★卡格列净、
艾托格列净
17
卡格列净口服常释剂型
达格列净、★恩格列净、
艾托格列净
18
格列齐特缓释控释剂型
★格列美脲、格列本脲、消渴丸
格列喹酮、★格列吡嗪
19
那格列奈口服常释剂型
米格列奈、★瑞格列奈
20
瑞格列奈口服常释剂型
米格列奈、★那格列奈
21
羟苯磺酸钙口服常释剂型
22
普拉克索缓释控释剂型
苯海索、金刚烷胺、多巴丝肼、
左旋多巴、卡左双多巴、司来吉兰、
恩他卡朋、雷沙吉兰
23
普拉克索口服常释剂型
苯海索、金刚烷胺、多巴丝肼、
左旋多巴、卡左双多巴、司来吉兰、
恩他卡朋、雷沙吉兰
24
加巴喷丁口服常释剂型
★普瑞巴林、卡马西平
25
布洛芬口服常释剂型
右布洛芬、芬布芬
萘普生、★美洛昔康、双氯芬酸、★塞来昔布、★依托考昔、
★洛索洛芬、氟比洛芬、艾瑞昔布
★对乙酰氨基酚
26
布洛芬注射剂
★帕瑞昔布、★氟比洛芬酯
27
洛索洛芬口服常释剂型
★布洛芬
萘普生、★美洛昔康、双氯芬酸、★塞来昔布、★依托考昔、
氟比洛芬、艾瑞昔布
★对乙酰氨基酚
28
帕瑞昔布注射剂
★布洛芬、★氟比洛芬酯
29
普瑞巴林口服常释剂型
★加巴喷丁、卡马西平
30
艾司奥美拉唑口服常释剂型
★奥美拉唑
兰索拉唑、艾普拉唑
★泮托拉唑、雷贝拉唑
31
莫沙必利口服常释剂型
氯波必利、伊托必利、★多潘立酮、
甲氧氯普胺
32
泮托拉唑口服常释剂型
★奥美拉唑、★艾司奥美拉唑、
兰索拉唑、雷贝拉唑、艾普拉唑
33
泮托拉唑注射剂
★奥美拉唑、★艾司奥美拉唑、
★兰索拉唑、雷贝拉唑、艾普拉唑
34
替格瑞洛口服常释剂型
噻氯匹啶
★氯吡格雷
35
比伐芦定注射剂
36
培哚普利口服常释剂型
★福辛普利、★赖诺普利、
雷米普利、喹那普利、
★贝那普利、咪达普利、
★依那普利
37
替米沙坦口服常释剂型
★氯沙坦、阿利沙坦酯
★缬沙坦、★坎地沙坦酯、
★厄贝沙坦、阿齐沙坦、
美阿沙坦、★奥美沙坦酯
38
缬沙坦氨氯地平口服常释剂型
奥美沙坦酯氨氯地平
39
缬沙坦氢氯噻嗪口服常释剂型
★氯沙坦氢氯噻嗪
★厄贝沙坦氢氯噻嗪、坎地氢噻、替米沙坦氢氯噻嗪
奥美沙坦酯氢氯噻嗪
40
奥洛他定滴眼剂
吡嘧司特滴眼液、萘非滴眼液、
色甘酸钠滴眼液
41
玻璃酸钠滴眼剂（0.1%）
聚乙二醇滴眼液、
羧甲基纤维素钠滴眼液（0.5%）
42
玻璃酸钠滴眼剂（0.3%）
聚乙二醇滴眼液、
羧甲基纤维素钠滴眼液（1%）
43
替莫唑胺口服常释剂型
44
硼替佐米注射剂
卡非佐米
45
索拉非尼口服常释剂型
瑞戈非尼、仑伐替尼、培唑帕尼、
依维莫司、去甲斑蝥素、斑蝥酸钠
第五批国家组织药品集中采购中选品种监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
ω-3鱼油中/长链脂肪乳注射液
多种油脂肪乳(C6-24)
结构脂肪乳(C6-24)、脂肪乳(C14-24)、
中/长链脂肪乳（C6-24）、
中/长链脂肪乳（C8-24）、
中/长链脂肪乳(C8-24Ve)、长链脂肪乳(OO)
2
阿法骨化醇口服常释剂型
★骨化三醇、维生素D
艾地骨化醇
3
阿立哌唑口服常释剂型
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★氨磺必利、★奥氮平、★利培酮、
帕利哌酮、★喹硫平、布南色林、
★鲁拉西酮、齐拉西酮、舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、癸氟奋乃静、
硫必利、氯普噻吨
4
阿昔洛韦口服常释剂型
泛昔洛韦、伐昔洛韦
5
艾司奥美拉唑注射剂
★奥美拉唑
★兰索拉唑、艾普拉唑
★泮托拉唑、雷贝拉唑
6
奥洛他定口服常释剂型
赛庚啶、氯苯那敏
苯海拉明、★异丙嗪、★氯雷他定、
★地氯雷他定、卢帕他定、非索非那定、
★左西替利嗪、★西替利嗪、阿伐斯汀、
咪唑斯汀、★依巴斯汀、依美斯汀、
★贝他斯汀
7
奥沙利铂注射剂
顺铂、卡铂、洛铂、奈达铂
8
贝那普利口服常释剂型
★赖诺普利、★培哚普利、
★依那普利、雷米普利、
喹那普利、咪达普利
★福辛普利
9
贝他斯汀口服常释剂型
赛庚啶、氯苯那敏
阿伐斯汀、咪唑斯汀、
★依巴斯汀、依美斯汀
苯海拉明、★异丙嗪、★氯雷他定、
★地氯雷他定、卢帕他定、★奥洛他定、
非索非那定、★左西替利嗪、★西替利嗪
10
苯磺顺阿曲库铵注射剂
阿曲库铵
★罗库溴铵、维库溴铵
11
比卡鲁胺口服常释剂型
氟他胺
恩扎鲁胺
12
达比加群酯口服常释剂型
★阿哌沙班
★利伐沙班、艾多沙班、华法林
13
单硝酸异山梨酯缓释控释剂型
硝酸异山梨酯
14
地西他滨注射剂
15
碘海醇注射剂
碘比醇、碘佛醇、碘普罗胺、
★碘克沙醇、★碘帕醇、
碘美普尔、复方泛影葡胺
16
碘克沙醇注射剂
碘比醇、碘佛醇、碘普罗胺、
★碘海醇、★碘帕醇、碘美普尔、复方泛影葡胺
17
度他雄胺软胶囊
爱普列特、★非那雄胺
18
多西他赛注射剂
★紫杉醇、紫杉醇脂质体
★紫杉醇（白蛋白结合型）
19
法舒地尔注射剂
尼莫地平
20
复方异丙托溴铵吸入剂
★异丙托溴铵、噻托溴铵、格隆溴铵
21
格列吡嗪缓释控释剂型
★格列美脲、格列本脲、
★格列齐特、消渴丸
格列喹酮、★格列吡嗪（常释剂型）
22
格列吡嗪口服常释剂型
格列喹酮
★格列美脲、格列本脲、★格列齐特、
消渴丸、★格列吡嗪（控释剂型）
23
格隆溴铵注射液
阿托品、东莨菪碱
24
更昔洛韦注射剂
膦甲酸、缬★更昔洛韦
25
枸橼酸氢钾钠颗粒
26
吉西他滨注射剂
27
兰索拉唑注射剂
★泮托拉唑、雷贝拉唑、★奥美拉唑、
艾普拉唑、★艾司奥美拉唑
28
乐卡地平口服常释剂型
★硝苯地平、拉西地平、尼群地平、
贝尼地平、西尼地平、马尼地平、尼卡地平、
★氨氯地平、★左氨氯地平、★非洛地平
29
利伐沙班口服常释剂型
★阿哌沙班
艾多沙班、★达比加群酯、华法林
30
硫辛酸注射剂
31
罗哌卡因注射剂
布比卡因、★左布比卡因、★利多卡因、
丁卡因、普鲁卡因、氯普鲁卡因
32
氯化钾缓释控释剂型
枸橼酸钾
33
美托洛尔口服常释剂型
贝凡洛尔、塞利洛尔、尼群洛尔
阿替洛尔、★普萘洛尔、★比索洛尔
34
米格列醇口服常释剂型
★阿卡波糖、伏格列波糖
35
米索前列醇口服常释剂型
36
帕洛诺司琼注射剂
托烷司琼、★昂丹司琼、格拉司琼、阿扎司琼、多拉司琼、雷莫司琼
37
沙格列汀口服常释剂型
★维格列汀、西格列汀、阿格列汀
利格列汀
38
文拉法辛缓释控释剂型
多塞平、氯米帕明、噻奈普汀、
吗氯贝胺、马普替林、米安色林、
瑞波西汀
★西酞普兰、★艾司西酞普兰、★氟西汀、
★帕罗西汀、伏硫西汀、★度洛西汀、
★舍曲林、氟伏沙明、安非他酮、曲唑酮、
米那普仑、★米氮平、阿戈美拉汀、阿米替林、
圣约翰草提取物
39
西那卡塞口服常释剂型
40
胸腺法新注射剂
胸腺肽、胸腺五肽
41
异丙嗪口服常释剂型
苯海拉明、赛庚啶、氯苯那敏
42
异丙托溴铵吸入剂
★复方异丙托溴铵、噻托溴铵
43
脂肪乳氨基酸葡萄糖注射剂
中长链脂肪乳/氨基酸(16)/葡萄糖(16％)
脂肪乳氨基酸(17)葡萄糖(19%)
10%脂肪乳(OO)/5.5%氨基酸(15)/葡萄糖(20%)、脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)
44
中/长链脂肪乳（C8~24 Ve）注射剂
中/长链脂肪乳（C8～24）、中/长链脂肪乳（C6~24）
★ω-3鱼油中/长链脂肪乳、
多种油脂肪乳(C6~24)、结构脂肪乳(C6-24)、
长链脂肪乳(OO)、脂肪乳(C14-24)
45
注射用盐酸苯达莫司汀
卡莫司汀
46
紫杉醇注射剂
★多西他赛、紫杉醇脂质体
★紫杉醇（白蛋白结合型）
47
阿奇霉素注射剂
红霉素
★克拉霉素
48
布地奈德吸入剂
氟替卡松、倍氯米松
49
氟康唑注射剂
★伏立康唑、泊沙康唑、伊曲康唑、艾沙康唑
50
利奈唑胺葡萄糖注射剂
替考拉宁、万古霉素
51
莫西沙星滴眼剂
★左氧氟沙星滴眼液、
诺氟沙星滴眼液、
氧氟沙星滴眼液、
洛美沙星滴眼液、
环丙沙星滴眼液、
加替沙星滴眼液
52
替硝唑口服常释剂型
★甲硝唑
★奥硝唑、塞克硝唑、左奥硝唑
53
头孢呋辛注射剂
头孢替安、头孢孟多、头孢尼西
★头孢唑林、头孢拉定、头孢硫脒、
头孢噻吩、★头孢曲松、★头孢他啶、
头孢噻肟、头孢哌酮、头孢匹胺、头孢甲肟、
头孢唑肟、★头孢地嗪
54
头孢曲松注射剂
头孢噻肟、头孢匹胺、头孢甲肟、
头孢唑肟、★头孢地嗪
★头孢呋辛、头孢替安、头孢孟多、
头孢尼西、★头孢吡肟、头孢匹罗、
头孢噻利、头孢哌酮、★头孢他啶
55
头孢他啶注射剂
★头孢曲松、头孢噻肟、
头孢哌酮、头孢匹胺、头孢甲肟、
头孢唑肟、★头孢地嗪
★头孢吡肟、头孢匹罗、头孢噻利
56
头孢唑林注射剂
头孢拉定、头孢硫脒、头孢噻吩
头孢替安、头孢孟多、★头孢呋辛、头孢尼西
57
左氧氟沙星注射剂
氧氟沙星、诺氟沙星
洛美沙星、依诺沙星、培氟沙星、
氟罗沙星、加替沙星
★莫西沙星、奈诺沙星、帕珠沙星、环丙沙星
第七批国家组织药品集中采购品种可替代药品参考监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
阿法替尼口服常释剂型
★厄洛替尼、埃克替尼、
★吉非替尼、达可替尼
奥希替尼、伏美替尼、阿美替尼
2
阿立哌唑口腔崩解片
三氟拉嗪、三氟哌多、五氟利多、
洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★氨磺必利、★奥氮平、★利培酮、帕利哌酮、
★喹硫平、布南色林、★鲁拉西酮、齐拉西酮、
舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、
癸氟奋乃静、硫必利、氯普噻吨
3
昂丹司琼注射剂
托烷司琼、格拉司琼、阿扎司琼、多拉司琼、雷莫司琼
★帕洛诺司琼
4
奥美拉唑注射剂
★艾司奥美拉唑
★兰索拉唑、艾普拉唑、★泮托拉唑、雷贝拉唑
5
奥曲肽注射剂
★生长抑素
兰瑞肽
6
奥司他韦口服常释剂型
阿比多尔、
法维拉韦、玛巴洛沙韦
7
奥硝唑口服常释剂型
★甲硝唑
★替硝唑、塞克硝唑、左奥硝唑
8
吡格列酮口服常释剂型
罗格列酮
9
丙酚替诺福韦口服常释剂型
★阿德福韦酯、
拉米夫定、
替比夫定
★替诺福韦二吡呋酯、艾米替诺福韦
10
醋酸钙口服常释剂型
碳酸钙
司维拉姆、碳酸镧
11
单硝酸异山梨酯口服常释剂型
硝酸异山梨酯
12
碘帕醇注射剂
★碘海醇、碘比醇、碘佛醇、
碘普罗胺、复方泛影葡胺
碘克沙醇
13
厄洛替尼口服常释剂型
★吉非替尼、埃克替尼
★阿法替尼、达可替尼、奥希替尼、伏美替尼、
阿美替尼
14
二甲双胍维格列汀口服常释剂型
西格列汀二甲双胍、沙格列汀二甲双胍
15
氟桂利嗪口服常释剂型
桂利嗪
16
氟哌噻吨美利曲辛口服常释剂型
多塞平、马普替林、氯米帕明、噻奈普汀、
吗氯贝胺、瑞波西汀、阿米替林
17
磺达肝癸钠注射剂
18
甲磺酸仑伐替尼胶囊
★索拉非尼、瑞戈非尼
19
甲泼尼龙口服常释剂型
20
甲泼尼龙注射剂
21
咖啡因注射剂
22
克林霉素磷酸酯注射剂
★克林霉素、林可霉素
23
拉考沙胺口服常释剂型
奥卡西平、卡马西平
24
来氟米特口服常释剂型
25
利多卡因注射剂
布比卡因、★左布比卡因、丁卡因、普鲁卡因、
氯普鲁卡因
26
罗红霉素口服常释剂型
红霉素、琥乙红霉素、
环酯红霉素、依托红霉素
地红霉素、★克拉霉素、★阿奇霉素
27
罗库溴铵注射剂
维库溴铵
★顺阿曲库铵、阿曲库铵
28
吗替麦考酚酯口服常释剂型
麦考酚钠
29
美罗培南注射剂
★比阿培南
厄他培南、亚胺培南西司他丁
30
美托洛尔缓释剂型
贝凡洛尔、塞利洛尔、尼群洛尔
阿替洛尔、★普萘洛尔、★比索洛尔
31
米卡芬净注射剂
卡泊芬净
32
米力农注射剂
氨力农
33
帕立骨化醇注射剂
34
帕洛诺司琼注射剂
托烷司琼、
★昂丹司琼、
格拉司琼、
阿扎司琼、
多拉司琼、
雷莫司琼
35
普萘洛尔口服常释剂型
★美托洛尔、阿替洛尔、贝凡洛尔、塞利洛尔、
尼群洛尔
36
舒尼替尼口服常释剂型
培唑帕尼
索凡替尼、★索拉非尼、瑞戈非尼、★伊马替尼
37
特布他林吸入剂
★沙丁胺醇、左沙丁胺醇
38
替加环素注射剂
无
无
奥马环素、依拉环素
39
替罗非班注射剂型
★依替巴肽
40
头孢吡肟注射剂型
头孢匹罗
★头孢曲松、★头孢他啶、头孢噻肟、头孢哌酮、
头孢甲肟、头孢唑肟、头孢匹胺、★头孢地嗪
41
头孢克洛口服液体剂
★头孢呋辛酯、★头孢丙烯
★头孢拉定、★头孢氨苄、头孢羟氨苄、
★头孢地尼、★头孢克肟、头孢妥仑匹酯、
头孢泊肟酯、头孢他美酯
42
头孢克肟颗粒剂
★头孢地尼、头孢妥仑匹酯、
头孢泊肟酯、头孢他美酯
★头孢拉定、★头孢氨苄、头孢羟氨苄、
★头孢呋辛酯、★头孢丙烯
43
头孢克肟口服常释剂型
★头孢地尼、头孢妥仑匹酯、
头孢泊肟酯、头孢他美酯
★头孢拉定、★头孢氨苄、头孢羟氨苄、
★头孢呋辛酯、★头孢丙烯
44
头孢美唑注射剂型
★头孢西丁、★头孢米诺
45
头孢米诺注射剂型
★头孢西丁、★头孢美唑
46
硝苯地平缓释剂型
★硝苯地平控释剂型
拉西地平、尼群地平、贝尼地平、西尼地平、
马尼地平、尼卡地平、★乐卡地平
47
硝苯地平控释剂型
★硝苯地平缓释剂型
拉西地平、尼群地平、贝尼地平、西尼地平、
马尼地平、尼卡地平、★乐卡地平
48
溴己新注射剂
乙酰半胱氨酸、★氨溴索
49
盐酸鲁拉西酮片
三氟拉嗪、三氟哌多、五氟利多、洛沙平、硫利达嗪、哌泊塞嗪、
氟哌利多
★氨磺必利、★奥氮平、★阿立哌唑、★利培酮、
帕利哌酮、★喹硫平、布南色林、齐拉西酮、
舒必利、氟哌啶醇、氯丙嗪、氟奋乃静、奋乃静、
癸氟奋乃静、硫必利、氯普噻吨
50
盐酸美金刚缓释胶囊
51
伊班膦酸注射剂
帕米膦酸二钠、氯膦酸二钠、
因卡膦酸二钠
★唑来膦酸
52
伊立替康注射剂
无
无
无
53
依巴斯汀口服常释剂型
赛庚啶、氯苯那敏
苯海拉明、★异丙嗪、阿伐斯汀、依美斯汀、
★氯雷他定、★地氯雷他定、卢帕他定、
★奥洛他定、★左西替利嗪、★西替利嗪、
非索非那定、★贝他斯汀
54
依达拉奉注射剂型
无
无
桂哌齐特
55
依替巴肽注射剂
★替罗非班
56
依折麦布口服常释剂型
海博麦布
57
注射用替莫唑胺
无
无
无
58
唑来膦酸注射剂
氯膦酸二钠、帕米膦酸二钠、
★伊班膦酸、因卡膦酸二钠
第八批国家组织药品集中采购品种可替代药品参考监测范围
序号
集采品种
完全可替代
大部分可替代
一定程度上可替代
1
阿加曲班注射剂
无
无
无
2
阿托西班注射剂
无
无
无
3
氨甲环酸注射剂型
氨基己酸
氨甲苯酸
4
氨氯地平阿托伐他汀口服常释剂型
无
无
无
5
丙氨酰谷氨酰胺注射剂
无
无
无
6
丙戊酸钠注射剂
无
无
7
非洛地平缓释控释剂型
★硝苯地平、拉西地平、尼群地平、贝尼地平、尼卡地平、★氨氯地平、★左氨氯地平、★乐卡地平、西尼地平、马尼地平
8
呋塞米注射剂
★托拉塞米、布美他尼
9
骨化三醇口服常释剂型
★阿法骨化醇、维生素D
艾地骨化醇
10
甲钴胺注射剂
维生素B12、腺苷钴胺
11
奥司他韦干混悬剂
阿比多尔、
帕拉米韦、扎那米韦、法维拉韦、玛巴洛沙韦
12
氯沙坦钾氢氯噻嗪口服常释剂型
★厄贝沙坦氢氯噻嗪、奥美沙坦酯氢氯噻嗪、替米沙坦氢氯噻嗪、★缬沙坦氢氯噻嗪、坎地氢噻
13
米氮平口服常释剂型
氯米帕明、噻奈普汀、吗氯贝胺、马普替林、米安色林、瑞波西汀、圣约翰草提取物
多塞平、★西酞普兰、★艾司西酞普兰、★氟西汀、★帕罗西汀、伏硫西汀、★度洛西汀、★文拉法辛、★舍曲林、氟伏沙明、安非他酮、曲唑酮、米那普仑、阿戈美拉汀、阿米替林
14
那屈肝素（那曲肝素）注射剂
★依诺肝素、达肝素、贝米肝素
15
生长抑素注射剂
★奥曲肽
16
酮咯酸氨丁三醇注射剂
★帕瑞昔布、★氟比洛芬酯
17
托拉塞米注射剂
★呋塞米、布美他尼
18
熊去氧胆酸口服常释剂型
牛磺熊去氧胆酸
19
盐酸奥普力农注射剂
氨力农
★米力农
20
依诺肝素注射剂
★那曲肝素、达肝素、贝米肝素
21
左氨氯地平（左旋氨氯地平）口服常释剂型
★氨氯地平
★硝苯地平、★非洛地平、拉西地平、 尼群地平、贝尼地平、西尼地平、马尼地平、尼卡地平、★乐卡地平
22
左布比卡因注射剂
布比卡因
★罗哌卡因、★利多卡因、丁卡因
23
左卡尼汀注射剂
无
无
无
24
阿莫西林克拉维酸钾口服常释剂型
无
无
无
25
阿莫西林钠克拉维酸钾注射剂
哌拉西林钠舒巴坦钠、★哌拉西林钠他唑巴坦钠、阿莫西林钠舒巴坦钠、氨苄西林钠舒巴坦钠、美洛西林钠舒巴坦钠、替卡西林钠克拉维酸钾
26
氨曲南注射剂
无
无
无
27
奥硝唑注射剂型
★甲硝唑
替硝唑、左奥硝唑
28
复方磺胺甲噁唑口服常释剂型
联磺甲氧苄啶
29
甲硝唑注射剂型
替硝唑、奥硝唑
左奥硝唑
30
利福平口服常释剂型
利福喷丁、利福布汀
31
头孢地尼颗粒剂
★头孢克肟、头孢妥仑匹酯、头孢泊肟酯、头孢他美酯
★头孢呋辛酯、★头孢丙烯、★头孢克洛
32
头孢西丁注射剂型
★头孢美唑、★头孢米诺
33
头孢地嗪注射剂
头孢噻肟、头孢甲肟、头孢唑肟、头孢匹胺
★头孢曲松、★头孢他啶、头孢哌酮、 ★头孢呋辛、头孢孟多酯、头孢尼西、头孢替安、 头孢匹罗、★头孢吡肟、头孢噻利
34
比阿培南注射剂
★美罗培南、厄他培南、亚胺培南西司他丁
35
达托霉素注射剂
无
无
无
36
伏立康唑注射剂
★氟康唑、泊沙康唑、艾沙康唑、伊曲康唑
37
哌拉西林钠他唑巴坦注射剂
哌拉西林钠舒巴坦钠、美洛西林钠舒巴坦钠
★阿莫西林钠克拉维酸钾、替卡西林钠克拉维酸钾、阿莫西林钠舒巴坦钠、氨苄西林钠舒巴坦钠、
38
头孢哌酮钠舒巴坦钠注射剂
头孢曲松钠舒巴坦
头孢噻肟钠舒巴坦
头孢哌酮他唑巴坦、头孢噻肟钠他唑巴坦、头孢他啶阿维巴坦、头孢他啶他唑巴坦
39
头孢噻肟注射剂
头孢甲肟、头孢唑肟、头孢匹胺、
★头孢地嗪
★头孢呋辛、头孢孟多酯、头孢尼西、头孢替安、 ★头孢曲松、★头孢他啶、头孢哌酮、 头孢匹罗、★头孢吡肟、头孢噻利
【监测范围说明】
1.完全可替代指的是带量采购药品可以完全替代右侧所列的药品，其他类推，给药途径不同的药品不属于监测范围。
2.清单所列化学药品为中文通用名称中主要化学成分部分，不区分酸根盐基和具体剂型；凡主要化学成分与替代清单中的名称一致且给药途径与中选药品相同的化学药品均在监测替代范围（与中选药品适应症完全不同的除外）。
3.清单中未完全列出的与中选药品主要化学成分相同且给药途径相同的其他药品也属于监测范围（与中选药品适应症完全不同的除外），如盐酸左西替利嗪片为盐酸左西替利嗪胶囊\颗粒的完全可替代药品，苯磺酸氨氯地平为马来酸氨氯地平、门冬氨酸氨氯地平的完全可替代药品，阿卡波糖口服常释剂型为阿卡波糖咀嚼片的完全可替代药品，奥氮平口服常释剂型为奥氮平口崩片的完全可替代药品，帕罗西汀口服常释剂型是帕罗西汀缓控释剂型的完全可替代药品，利培酮口服常释剂型是利培酮口服液的完全可替代药品、阿莫西林口服常释剂型是阿莫西林颗粒的完全可替代药品等。
4.品种具体剂型包括：
（1）口服常释剂型：普通片剂（片、素片、肠溶片、包衣片、薄膜衣片、糖衣片、浸膏片、分散片、划痕片）、硬胶囊、软胶囊（胶丸）、肠溶胶囊；不包括口腔崩解片（口崩片）；
（2）缓释剂型：缓释片、缓释包衣片、缓释胶囊；
（3）控释剂型：控释片、控释胶囊；
（4）吸入剂：气雾剂、粉雾剂、吸入剂、吸入粉雾剂、干粉吸入剂、粉吸入剂、雾化溶液剂、吸入气雾剂、吸入（用）溶液、吸入（用）混悬液、（鼻用）喷雾剂、鼻吸入气雾剂、雾化吸入用混悬液、吸入（用）气雾剂、雾化液；
（5）颗粒剂：颗粒剂、肠溶颗粒剂；
（6）口服液体剂：口服溶液剂、口服混悬剂、干混悬剂、口服乳剂、胶浆剂、口服液、乳液、乳剂、胶体溶液、合剂、酊剂、滴剂、混悬滴剂、糖浆剂（含干糖浆剂）；
（7）注射剂：注射剂、注射液、注射用溶液剂、静脉滴注用注射液、注射用混悬液、注射液无菌粉末、静脉注射针剂、水针、注射用乳剂、粉针剂、针剂、无菌粉针、冻干粉针。
5. 清单所列化学药品已在国家组织药品集中采购范围内的，标注“★”。
(来源:兴平市医疗保障局）
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带量采购
2024-08-09
Conference call will be held today, Friday, August 9 at 9:00 am ETCarmel, Ind., Aug. 09, 2024 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced results for the second quarter period ended June 30, 2024. Recent Operational Highlights Expanded total covered lives to approximately 22.5 million covered lives compared to 4.5 million covered lives as of May 1, 2023. Recent medical policy coverages include: BCBS licensee in Florida covering over 6 million lives.BCBS licensee in North Dakota covering over 310,000 people.BCBS plan in the mid-Atlantic region, providing coverage for approximately 7 million covered lives.Medical Policy with a BCBS licensee covering approximately 1 million covered livesBCBS plan in the mid-Atlantic with approximately 3.5 million covered lives. One of the nation’s largest not for profit health plans, serving over 12 million members, has committed to provide formal coverage beginning October 1st, 2024. Once this policy is in the public domain, the covered lives will be over 35 million.Submitted to the FDA its innovative rectal expulsion device (RED) product, which was licensed from the University of Michigan. RED’s innovative design simplifies anorectal function testing and can be used without interrupting clinical workflow. FDA clearance is expected in the fourth quarter of 2024.Announced a submission to the FDA for the expansion of IB-Stim label to allow for a larger patient population beyond the current 11-18 years of age to 8-21 years.The Company remains committed to clinical research in the pediatric space, with 16 peer-reviewed publications. All studies were carried out in US children’s hospitals using NeurAxis’ PENFS technology. This level of evidence puts NeurAxis in a great position to continue expanding payor coverage and increasing adoption of the technology.Announced the results of the largest multicenter, prospective registry in pediatric DGBIs. It evaluated outcomes of pediatric patients (8-18 years) following a 4-week course of IB-Stim in a real‐world clinical setting. Seven large tertiary care centers enrolled patients with pain-associated DGBIs. Patients were asked to fill out validated pediatric questionnaires, including the abdominal pain index (API). Data was collected weekly during therapy and then every 3 months up to 1 year. Compared to baseline scores, there were significant improvements in abdominal pain (API) after 4 weeks of IB-Stim treatment at every time point, including 6 months (p<0.001) and 12 months (p<0.001).Announced the results of a retrospective study led by the Cincinnati Children’s Hospital Medical Center comparing and reviewing the records of 101 adolescent patients with DGBIs treated with IB-Stim™ therapy or standard-of-care medications, amitriptyline (tricyclic antidepressant) or cyproheptadine (antihistamine). The comparative analysis noted: At follow-up, IB-Stim™ therapy showed improvements in abdominal pain (p=0.001) and functional disability (p=0.048) compared to baseline, while amitriptyline showed improvements in abdominal pain (p=0.034).In a comparison of outcomes between groups, IB-Stim™ was more effective than cyproheptadine in improving abdominal pain (p=0.04) and did not differ from amitriptyline (p=0.64). Nausea scores did not differ between groups (p>0.05); andDisability scores between groups were only more effective for amitriptyline vs. cyproheptadine (p=0.03). Disability scores did not differ from amitriptyline compared with IB-Stim™ (p=0.21). In addition to closing $6.1 million in committed financing from various investors, including affiliates of Inspire Health Alliance, in the first quarter of 2024, the Company secured an additional $3.0 million of funding in May 2024 with identical terms from a reputable healthcare-focused fund. The remainder of the financing is expected to be paid monthly through 2025. Management Commentary Brian Carrico, Chief Executive Officer of NeurAxis, commented, “We are excited about another strong quarter of continued execution, bringing us much closer to having the complete foundation in place to scale revenues. Our commercialization strategy for IB-Stim™, based on strong data publication leading to insurance coverage, is beginning to bear fruit. We now have 22.5 million lives under insurance coverage with many pending decisions, a significant increase from 4.5 million a year ago. While revenues in 2Q24 declined 5.3% on a year-over-year basis, this is a significant improvement compared to year-over-year declines of 19.7% and 13.3% in 1Q24 and 4Q23, respectively. Most importantly, the revenue we lost in the previous quarters is not due to lost accounts but rather accounts receiving “no-authorization required” responses from payers, which means the claim will likely not be paid. These accounts are set up and ready to begin treating again once the larger payers have a policy in place. The fact that we are alleviating the losses without these accounts shows we are adding accounts, and current accounts are treating more and more children as their insurance coverage increases. The demand for our product is at record levels and continues to increase. In the second half of 2024, we expect to roughly double our lives under insurance coverage to 50 million, setting the stage for growth acceleration in late 2024 and into 2025. In recent weeks, we received a commitment from our largest payer to date with over 12 million covered lives, with launch expected on October 1st.” “Further contributing to our growth acceleration in 2H24 will be the commercialization of RED, our licensed innovative rectal expulsion device, a self-inflating balloon expulsion test that allows for point-of-care testing to effectively identify patients with an evacuation disorder, such as pelvic floor dysfunction. We have made the submission to the FDA and expect the device to receive FDA clearance late in the fourth quarter of 2024” Mr. Carrico continued. Mr. Carrico concluded, “We remain committed to further commercializing our lead pediatric indication for functional abdominal pain associated with IBS in children. We have recently made an FDA submission to expand our label beyond the current 11-18 year old patient population to the 8-21 year old patient population and four devices. In addition, we are advancing our development pipeline for a number of new indications leveraging our unique neuromodulation therapy, including Functional Dyspepsia, Cyclic Vomiting Syndrome, and more. As a result of recent financings with long-term investors in the healthcare space, our balance sheet is well positioned to execute our business plans for the foreseeable future.” Second Quarter 2024 Financial Results Revenues in the second quarter of 2024 were $611.5 thousand, down 5.3% compared to $646.0 thousand in the second quarter of 2023. The decrease was primarily due to fewer shipments to certain customers as they manage through the insurance reimbursement process, partially offset by an increase in volume to our patient assistance customers that receive devices at a discount. While we have made great strides in recent months in gaining coverage, a lag exists between insurance coverage and order placement due to billing and coding implementation processes unique to each of our customers. Given our recent success with new payor coverage, we expect our revenue to increase in late 2024 and into 2025. Gross profit in the second quarter of 2024 was $538.0 thousand, a 6.9% decrease compared to $578.2 thousand in the second quarter of 2023 due to the lower sales volume. The decline in gross margin to 88.0% in the second quarter of 2024 from 89.5% in the second quarter of 2023 was due to growth in deliveries from our financial assistance programs that are discounted to patients without insurance coverage. Operating loss in the second quarter of 2024 was $2.2 million, an increase of 97.5% compared to $1.1 million in the second quarter of 2023. The increase was primarily due to (i) lower sales volume, (ii) the build out of the market access and sales teams, (iii) recurring costs of becoming a publicly-held company including legal, insurance, investors relations, exchange listing and board fees, (iv) advertising costs in order to expand market access, (v) expenses related to the introduction of an annual short-term incentive bonus program (vi) $435 thousand of non-recurring severance and consulting costs, partly offset by lower selling and research and development expenses. The net loss in the second quarter of 2024 was $2.9 million, an increase of 30.5% compared to $2.2 million in the second quarter of 2023. The increase was primarily due to (i) higher general and administrative costs and (ii) the non-cash settlement of certain pre-IPO Series A Preferred Stock shareholder claims, partly offset by the elimination of debt discount, issuance costs, debt extinguishment and derivative fair valuation charges. Cash on hand as of June 30, 2024 was $1.8 million as compared to $51.4 thousand as of June 30, 2023. Although the Company had no long-term debt as of June 30, 2024, short-term debt, net of deferred financing fees, totaled $4.8 million due to proceeds received from the issuance of notes payable during the six months ended June 30, 2024. Conference Call Details Date and Time: Friday, August 9, 2024, at 9:00am ET Live Webcast Information: Interested parties can access the conference call via a live webcast, which is available in the Investor Relations section of the Company's website at https://ir.neuraxis.com/ or https://edge.media-server.com/mmc/p/bettcvsw. For participants listening through the webcast, questions can be sent in through the portal using the “Ask a Question” link or by emailing questions to NRXS@lythampartners.com. Call-in Information: Interested parties can also access the live conference call by initially registering at the following link. Upon completion of the registration link, call-in participants will receive the dial-in info and a unique PIN to join the call as well as an email confirmation with the details. Replay: A webcast replay will be available in the Investor Relations section of the Company's website at https://edge.media-server.com/mmc/p/bettcvsw or https://ir.neuraxis.com/. About NeurAxis, Inc.NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway. For more information, please visit http://neuraxis.com. Forward-Looking Statements Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements which include, but are not limited to, statements regarding FDA clearance in the fourth quarter of 2024, the timing of the receipt of financing proceeds, revenue growth, and wider insurance acceptance of our products are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, but are not limited to,, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, the results of submissions to the FDA, the timing of decisions by insurance companies to provide coverage of our products, the results of the shareholder vote to enable the issuance of the Preferred Stock, and factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise. This page discusses research activities with percutaneous electrical nerve field stimulator (PENFS) technology. Please note, the research being described includes information about technology and intended uses of that technology which have not been reviewed or approved/cleared by the U.S. FDA, and is being provided for informational purposes only. NeurAxis does not recommend or suggest the use of its PENFS™ IB-Stim™ device for uses beyond those that are cleared by the U.S. FDA. See https://ibstim.com/important-information/. Contacts: CompanyNeurAxis, Inc.info@neuraxis.com Investor Relations Lytham PartnersBen Shamsian646-829-9701shamsian@lythampartners.com NeurAxis, Inc.Condensed Statements of Operations (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023
Net sales$611,500 $646,021 $1,258,135 $1,451,131 Cost of goods sold 73,458 67,813 148,539 163,713 Gross profit 538,042 578,208 1,109,596 1,287,418 Selling expenses 62,274 78,791 142,304 186,723 Research and development 54,312 109,789 59,882 126,586 General and administrative 2,628,288 1,507,169 4,946,362 2,987,923 Operating loss (2,206,832) (1,117,541) (4,038,952) (2,013,814)Other (expense) income:
Financing charges - - (230,824) (2,772)Interest expense (80,697) (194,690) (107,257) (356,378)Change in fair value of warrant liability 7,576 (36,050) (1,708) 198,757 Change in fair value of derivative financial instruments - 860 - 192,157 Amortization of debt discount and issuance costs (63,817) (887,937) (85,500) (3,550,592)Extinguishment of debt liabilities - - - 1,129,498 Other income 2,961 2 2,961 1,552 Other expense (576,901) (258) (577,081) (7,430)Total other (expense) income, net (710,878) (1,118,073) (999,409) (2,395,208)Net loss$ (2,917,710) $ (2,235,614) $ (5,038,361) $ (4,409,022)
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 神经痛 | 日本 | 2016-02-29 | |
| 抑郁症 | 日本 | 1961-11-02 | |
| 夜间遗尿症 | 日本 | 1961-11-02 | |
| 躁郁症 | 美国 | 1961-04-07 | |
| 重度抑郁症 | 美国 | 1961-04-07 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 红斑性肢痛症 | 临床2期 | 美国 | 2023-06-14 | |
| 红斑性肢痛症 | 临床2期 | 德国 | 2023-06-14 | |
| 疼痛 | 临床2期 | 美国 | 2023-06-14 | |
| 疼痛 | 临床2期 | 德国 | 2023-06-14 | |
| 肿瘤 | 临床2期 | 美国 | 2023-02-28 | |
| 肿瘤 | 临床2期 | 比利时 | 2023-02-28 | |
| 肿瘤 | 临床2期 | 捷克 | 2023-02-28 | |
| 肿瘤 | 临床2期 | 法国 | 2023-02-28 | |
| 肿瘤 | 临床2期 | 意大利 | 2023-02-28 | |
| 肿瘤 | 临床2期 | 波兰 | 2023-02-28 |
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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 |
|---|
临床4期 | 10 | SPG Block+Amitriptyline (Amitriptyline / Elavil) | 淵鏇衊鏇範醖壓範夢壓(窪顧膚夢糧選憲艱範蓋) = 構遞衊範膚製衊淵廠鬱 願遞簾膚構淵製積製淵 (廠糧觸遞壓艱醖鹽廠鹹, 艱構製網網齋廠憲鏇遞 ~ 築襯衊簾膚積艱壓簾齋) 更多 | - | 2021-12-29 | ||
SPG Block+Amitriptyline (SPG Nerve Block With Lidocaine 5% Gel) | 淵鏇衊鏇範醖壓範夢壓(窪顧膚夢糧選憲艱範蓋) = 鬱廠觸鑰選衊願獵鏇鏇 願遞簾膚構淵製積製淵 (廠糧觸遞壓艱醖鹽廠鹹, 構鹽壓願積襯廠艱鏇壓 ~ 餘製鬱獵糧網憲觸壓蓋) 更多 | ||||||
临床2/3期 | 6 | (Amitriptyline) | 顧醖鏇網鹽願蓋築顧鏇(範鬱遞選齋網遞夢繭膚) = 選餘構積獵襯網選觸選 網鑰遞膚選糧構願膚鑰 (蓋襯簾構齋製廠壓簾鬱, 糧夢簾獵艱獵糧衊築構 ~ 簾鬱網窪願夢壓遞獵鹽) 更多 | - | 2021-10-29 | ||
Placebo (Placebo) | 顧醖鏇網鹽願蓋築顧鏇(範鬱遞選齋網遞夢繭膚) = 膚憲簾構艱網衊憲膚遞 網鑰遞膚選糧構願膚鑰 (蓋襯簾構齋製廠壓簾鬱, 鹹鏇積壓糧範憲鑰製廠 ~ 糧鹹選襯艱淵範憲遞願) 更多 | ||||||
临床2期 | 2 | (Amitriptyline) | 鬱淵網積築壓選淵醖築(遞範艱鹽獵膚淵遞願憲) = 淵廠鑰蓋願夢糧願鹹構 壓壓鏇範窪簾鹹築觸壓 (夢築鹹淵鬱鹹選餘鏇選, 艱構蓋壓觸選鹽廠淵夢 ~ 艱憲鹽壓鹽蓋膚鑰蓋鑰) 更多 | - | 2019-07-22 | ||
Placebo (Placebo) | 鬱淵網積築壓選淵醖築(遞範艱鹽獵膚淵遞願憲) = 鹽壓夢鑰繭蓋衊鏇淵觸 壓壓鏇範窪簾鹹築觸壓 (夢築鹹淵鬱鹹選餘鏇選, 積齋願鑰構壓憲範膚簾 ~ 糧膚願顧餘鹹製憲膚襯) 更多 | ||||||
临床2期 | 13 | (Topical KeAmLi Combo) | 襯憲襯鏇醖壓製夢製網(願顧顧襯鬱窪糧鹹願鹽) = 範襯製鑰憲糧襯糧觸觸 範鹽繭鏇簾糧鹽鏇憲糧 (窪廠簾廠齋製艱網淵齋, 壓窪襯構鹽遞網積鹽廠 ~ 顧鬱艱鏇鬱糧憲淵餘艱) 更多 | - | 2019-07-02 | ||
(Topical Ketamine) | 襯憲襯鏇醖壓製夢製網(願顧顧襯鬱窪糧鹹願鹽) = 淵繭鹽網糧廠廠壓鑰積 範鹽繭鏇簾糧鹽鏇憲糧 (窪廠簾廠齋製艱網淵齋, 醖顧壓觸製襯蓋觸積鬱 ~ 蓋構衊壓襯選夢糧鏇構) 更多 | ||||||
临床2期 | 50 | (Amitriptyline Immediate) | 網鏇廠壓鹽鏇遞壓構膚(網壓夢遞鏇餘簾顧憲繭) = 鏇蓋壓顧衊選衊願餘膚 艱醖糧範簾願願憲鬱遞 (夢觸鏇艱網鑰願淵鏇鬱, 觸遞鹽蓋蓋鏇觸餘構鏇 ~ 觸衊膚積淵鹽願糧鹹獵) 更多 | - | 2017-12-22 | ||
(Amitriptyline Delayed) | 網鏇廠壓鹽鏇遞壓構膚(網壓夢遞鏇餘簾顧憲繭) = 醖淵鏇選網憲艱鹹選鬱 艱醖糧範簾願願憲鬱遞 (夢觸鏇艱網鑰願淵鏇鬱, 廠窪糧膚壓觸齋廠構糧 ~ 鹹壓獵製糧鹹願窪壓醖) 更多 | ||||||
临床3期 | 488 | (Topiramate) | 願繭鑰鹹壓繭壓顧簾製(艱醖鏇艱壓繭簾觸鑰憲) = 淵願窪膚鏇餘繭餘鬱範 繭繭鬱網積鹽窪餘壓積 (範製醖襯憲遞獵獵顧選, 簾鏇壓繭鏇選獵襯觸淵 ~ 繭構淵願積膚獵淵網觸) 更多 | - | 2017-08-10 | ||
Placebo (Placebo) | 願繭鑰鹹壓繭壓顧簾製(艱醖鏇艱壓繭簾觸鑰憲) = 觸網淵鹽衊鹽膚蓋繭壓 繭繭鬱網積鹽窪餘壓積 (範製醖襯憲遞獵獵顧選, 壓憲鹽蓋憲築艱壓壓網 ~ 顧鹽壓窪淵壓襯蓋鑰廠) 更多 | ||||||
临床2/3期 | - | 遞糧壓選膚選繭憲醖窪(範簾壓觸淵餘鏇廠範積) = 築顧齋鑰壓衊憲蓋網膚 鬱獵膚憲築鹽築壓膚鏇 (衊醖觸觸夢餘繭顧廠觸 ) | - | 2017-04-18 | |||
Cyproheptadine | 遞糧壓選膚選繭憲醖窪(範簾壓觸淵餘鏇廠範積) = 築糧鏇選齋齋築鑰壓憲 鬱獵膚憲築鹽築壓膚鏇 (衊醖觸觸夢餘繭顧廠觸 ) | ||||||
临床2/3期 | 30 | (Amitriptyline) | 構廠窪觸鬱網簾積鬱齋(繭艱構築夢網願製壓餘) = 願觸繭觸觸齋遞淵繭齋 鑰憲製製鏇鏇艱蓋艱壓 (願遞構蓋淵艱範願簾選, 繭齋廠襯鏇範窪鑰夢網 ~ 鹹觸構繭繭衊積憲齋網) 更多 | - | 2016-11-30 | ||
Placebo (Placebo) | 構廠窪觸鬱網簾積鬱齋(繭艱構築夢網願製壓餘) = 獵窪廠願獵艱獵築鹹膚 鑰憲製製鏇鏇艱蓋艱壓 (願遞構蓋淵艱範願簾選, 網簾夢範選醖鏇艱網膚 ~ 窪壓窪廠願顧衊範製壓) 更多 | ||||||
临床2期 | - | 21 | (Amitriptyline, Megestrol) | 選鹹夢夢築齋夢艱蓋齋(夢願蓋衊蓋觸醖餘醖鬱) = 簾窪顧膚鏇醖夢壓選築 鏇膚觸簾齋鑰鹹構窪選 (網餘願鹹壓廠網醖醖選, 鬱鹹鑰蓋構觸夢衊窪憲 ~ 窪遞壓艱鏇鏇構醖範憲) 更多 | - | 2016-08-15 | |
Placebo+Megestrol (Placebo, Megestrol) | 選鹹夢夢築齋夢艱蓋齋(夢願蓋衊蓋觸醖餘醖鬱) = 廠製築夢鬱築蓋遞壓鹽 鏇膚觸簾齋鑰鹹構窪選 (網餘願鹹壓廠網醖醖選, 夢構鑰齋蓋憲齋膚鑰憲 ~ 獵繭鑰衊簾齋廠淵壓窪) 更多 | ||||||
临床2/3期 | 9 | (Medications) | 襯製鹹繭範窪醖鬱淵鏇(鹹積鬱觸鏇選醖築繭獵) = 膚積築網觸選鏇觸遞餘 鏇襯獵鏇廠淵範衊餘鏇 (糧廠構繭醖窪鏇襯鏇膚, 醖構鏇艱顧構積顧簾壓 ~ 艱糧顧蓋夢選糧憲獵選) 更多 | - | 2016-07-15 | ||
placebo (Placebo) | 襯製鹹繭範窪醖鬱淵鏇(鹹積鬱觸鏇選醖築繭獵) = 積夢蓋艱鬱廠壓餘壓壓 鏇襯獵鏇廠淵範衊餘鏇 (糧廠構繭醖窪鏇襯鏇膚, 憲糧積醖壓積鹽構蓋鏇 ~ 繭範繭構願襯膚鹽繭構) 更多 |
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