预约演示

更新于：2026-09-24

Fentanyl

芬太尼

更新于：2026-09-24

概要

基本信息

简介芬太尼是一种合成阿片类药物，非常有效地用于治疗严重的疼痛，特别是癌症患者。它通过结合中枢神经系统中的阿片受体来产生镇痛作用。芬太尼有多种剂型，包括贴片、含片和注射溶液。但由于其强效性，芬太尼具有高度的成瘾性、呼吸抑制和过量的风险。因此，它在美国被归类为II级受控物质。目前的研究重点是开发更安全和更有效的芬太尼给药途径，如抗滥用制剂和新颖的给药途径。

药物类型

小分子化药

别名

AeroLEF、AVERSA Fentanyl、Fentany Transdermal System

+ [39]

靶点

Opioid receptors

作用方式

激动剂

作用机制

Opioid receptors激动剂(阿片样受体激动剂)

治疗领域

神经系统疾病其他疾病肿瘤

在研适应症

癌症疼痛疼痛肝转移+ [5]

非在研适应症

急性疼痛晚期癌症突出痛+ [11]

原研机构

Janssen Global Services LLC

在研机构

兆科药业（广州）有限公司Janssen Pharmaceutical KK

北京可诺医药科技有限公司

+ [7]

非在研机构

INSYS Therapeutics, Inc.

Janssen Pharmaceuticals, Inc.

Janssen Pharmaceutica NV

+ [5]

权益机构

Terumo Corp. /Hemodialyzer Marketing Operations/

Nutriband, Inc.

Kindeva Drug Delivery LP

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (1990-08-07),

通气不足术后疼痛

最高研发阶段(中国)临床2期

特殊审评-

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结构/序列

分子式C22H28N2O

InChIKeyPJMPHNIQZUBGLI-UHFFFAOYSA-N

CAS号437-38-7

关联

782

项与芬太尼相关的临床试验

CTRI/2026/05/109969

/ Not yet recruitingN/AIIT

Incidence, risk factors and pattern of distribution of pruritis in patients receiving intrathecal fentanyl vs intrathecal buprenorphine as an adjuvant to spinal anaesthesia with bupivacaine - a prospective observational study - NIL

开始日期2027-04-08

申办/合作机构-

NCT07748884

/ Not yet recruiting临床4期IIT

A Comparative Study on the Incidence of Respiratory Adverse Events Between Esketamine Combined With Remazolam and Traditional Propofol in Pediatric Gastroscopy

Gastroscopy is important for diagnosing and treating upper gastrointestinal diseases in children. To ensure the procedure is safe and smooth, most children require sedation. Compared to adults, children have more fragile airways, lower lung capacity, and poorer oxygen reserves, making them more prone to breathing difficulties and low oxygen levels during sedation.
Esketamine, a stronger form of ketamine, helps maintain heart rate and blood pressure and may reduce breathing-related risks. Remimazolam, a new short-acting sedative, acts quickly, allows faster recovery, and has a better safety profile than propofol-it doesn't cause breathing problems or injection pain.
The safety and effectiveness of combining remimazolam with esketamine for pediatric gastroscopy have not been well studied. This research will compare this new combination with the traditional propofol-based approach to evaluate its potential benefits and safety in children.

开始日期2026-08-01

申办/合作机构

温州医科大学附属第二医院（温州医科大学附属育英儿童医院）

ACTRN12621000850875

/ Not yet recruiting临床4期IIT

The effect of fentanyl co-administration on sneezing during nasal local anaesthetic injection for adults undergoing plastic surgery under propofol-based intravenous sedation: Randomised-Controlled Blinded Trial

开始日期2026-07-01

申办/合作机构

Portland District Health

[+1]

100 项与芬太尼相关的临床结果

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100 项与芬太尼相关的转化医学

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100 项与芬太尼相关的专利（医药）

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24,291

项与芬太尼相关的文献（医药）

2026-12-31·Canadian Journal of Pain-Revue Canadienne de la Douleur

A Survey of Knowledge, Attitudes, and Behaviours of Canadian Family Physicians in Response to the Canadian Guideline on Prescribing Opioids for Chronic Non-cancer Pain

Article

作者: Selby, Peter ; Mian, Najam ; Hatcher, Lydia ; Bootsman, Nicole ; Saberian, Lillian ; Dale, Craig M ; Carol, Angela ; Parmar, Nagina ; Lau, Jenny ; Sud, Abhimanyu ; Furlan, Andrea D

Background:

Chronic non-cancer pain (CNCP) is widespread in Canada, with Family Physicians (FPs) playing a crucial role in patient care and opioid stewardship amidst high prescribing rates. Two national surveys conducted in 2010 and 2018 revealed notable knowledge gaps and poor adherence to safe opioid prescribing practices among Canadian FPs.

Aims:

To provide an update on Canadian FPs' knowledge, attitudes, and behavior regarding opioid prescribing for CNCP.

Methods:

This study is the third national cross-sectional online survey of Canadian FPs. The results are presented narratively, and only descriptive statistics are offered.

Results:

A total of 529 responses were collected from July 2023 to June 2024, primarily from female participants (52%) and Ontario (50%). Eighteen percent of respondents did not prescribe opioids for CNCP, and 17% prescribed only weak opioids. Wait time for a pain specialist and for a non-urgent referral to an addiction specialist were less than one month among 23% and 25% of respondents, respectively. Only 27% of respondents were able to correctly identify the minimum daily dose of morphine equivalents to start prescribing a transdermal fentanyl patch. Respondents' adherence to recommended practices before starting opioids varied from 16% for "providing written information about opioid therapy" to 93% for "explaining potential harms of long-term opioid therapy."

Conclusion:

Several knowledge gaps and a lack of adherence to certain guideline-recommended practices were observed among respondents, along with reduced wait times for consultations with pain specialists.

2026-12-31·Journal of Maternal-Fetal & Neonatal Medicine

Exploration of the relationship between miR-146a rs2910164 polymorphisms and the efficacy of epidural fentanyl in labor analgesia among pregnant women

Article

作者: Liu, Jie ; Wang, Bei ; Shen, Yiyi

BACKGROUND:

miR-146a influences an individual's pain sensitivity through the regulation of inflammation-related pathways, and its genetic polymorphism may play a role in labor analgesia.

OBJECTIVES:

This study aimed to investigate the impact of the miR-146a rs2910164 polymorphism on the efficacy of epidural fentanyl in labor analgesia.

MATERIALS AND METHODS:

In this study, a total of 142 primiparas who received epidural fentanyl analgesia were enrolled. Genotyping was conducted using the SNPscan^™ Kit, and the miR-146a expression was measured by RT-qPCR. The 24-hour Visual Analogue Scale (VAS) score was utilized as an indicator to assess analgesic efficacy, and a logistic regression was employed to analyze the association between different genotypes and the effectiveness of pain relief.

RESULTS:

At the rs2910164 locus, the miR-146a expression in individuals with the CC genotype was significantly lower than that in those with the GG and GC genotypes, whereas no significant difference was observed between the GG and GC genotypes. Regarding clinical characteristics, the 24-hour VAS pain score was significantly higher in the CC genotype group compared to the GG and GC genotype groups. When the GG and GC genotypes were combined and compared against the CC genotype, the difference in VAS scores remained statistically significant. Logistic regression analysis revealed a significant association between the rs2910164 polymorphism and the 24-hour VAS score (OR = 3.189, 95% CI: 1.142-8.901, p = 0.027).

CONCLUSION:

The CC genotype at the rs2910164 locus served as an independent risk factor associated with decreased efficacy of epidural fentanyl analgesia. However, further validation in larger multicenter studies is required before any clinical application can be considered.

2026-12-31·JOURNAL OF INVESTIGATIVE SURGERY

Influence of Oliceridine on the Incidence of Postoperative Nausea and Vomiting in High-Risk Patients Stratified Using Apfel Score After General Anesthesia: A Prospective, Randomized Controlled Clinical Study

Article

作者: Xu, Aina ; Heng, Xinyang ; Ding, Rumei ; Xiong, Yajing ; Zhao, Jiangfeng

BACKGROUND:

As a typical complication, postoperative nausea and vomiting (PONV) usually occurs among patients undergoing general anesthesia surgery, diminishing postoperative satisfaction and recovery.

OBJECTIVE:

Herein, we applied a new G-protein-biased μ-opioid receptor agonist, oliceridine, to compare its management with fentanyl on PONV among high-risk patients receiving general anesthesia with transversus abdominis plane block (TAP).

METHODS:

In this prospective, double-blind, randomized controlled study, a total of 280 patients were enrolled for general anesthesia surgery, including laparoscopic cholecystectomy and laparoscopic gynecological surgery. Participants were randomly divided into either the oliceridine group or the fentanyl group at a 1: 1 ratio. Afterwards, the primary outcome was the rate of nausea and vomiting on postoperative day 2. The secondary outcomes comprised the visual analogue scale (VAS) score of PONV, intraoperative analgesic effect, rescue antiemetic treatment, hemodynamic parameters during T1-T5, postoperative pain assessment, hospitalization period, gut function, time of drink and food intake, drainage tube removal, hospitalizations, and perioperative complications.

RESULTS:

Among the enrolled 279 patients, oliceridine effectively reduced the occurrence of nausea (26.4% versus 12.9%, p = 0.005) and vomiting (24.3% versus 6.5%, p < 0.001). In addition, the postoperative nausea VAS score showed significantly lower in the oliceridine group compared with the fentanyl group (1.40 ± 1.31 versus 2.01 ± 1.79, p = 0.013), accompanied by reduced rescue antiemetic rate (17.1% versus 7.2%, p = 0.011), with stable hemodynamic condition and comparable postoperative recovery.

DISCUSSION:

According to our study, oliceridine may be a viable substitute for general anesthesia to ameliorate postoperative incidence of PONV, along with its impressive pain control during anesthesia induction and maintenance.

CLINICAL TRIAL REGISTRATION:

Chinese Clinical Trial Registry (ChiCTR2400089121).

989

项与芬太尼相关的新闻（医药）

2026-09-22

·行舟Drug

癌症疼痛诊疗上海专家共识（2026年版）

点击上方的行舟Drug ▲ 添加关注疼痛是癌症患者常见的症状之一，未能有效缓解的疼痛会使患者痛苦，严重影响患者的身体机能、社会心理健康及生活质量。急性癌痛是指因诊断性操作、癌症治疗或肿瘤快速生长累及周围组织/器官所直接引起的突发性疼痛。表现为剧烈疼痛，通常持续时间较短，随着潜在病因的治疗或消退，疼痛可在3个月内缓解。慢性癌痛是一种持续时间超过3个月的持续性或复发性疼痛，由癌症本身、转移或抗肿瘤治疗引起。虽然随着新型抗肿瘤疗法的应用，癌痛的发生率和严重程度均有所下降，但癌症患者疼痛的总体发生率仍然较高（44.5%），31%的患者遭受中重度疼痛的困扰，超过40%的患者出现过爆发痛。疼痛可能出现于癌症患者疾病全程的任何阶段，初诊患者的癌痛发生率为40%，抗肿瘤治疗过程中癌痛发生率为50%，姑息治疗患者的癌痛发生率可达56%，而在癌症生存者中疼痛发生率仍有36%。图1：癌痛规范化全程管理流程图推荐意见汇总表推荐意见1：医护人员应对癌症患者进行疼痛筛查；对主诉疼痛症状不典型者，需注意甄别疼痛风险（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见2：疼痛具有主观性和多维性，医护人员应指导患者准确主动报告疼痛并正确使用常用评估工具（证据质量：中；推荐强度：强；专家赞同率：96.2%）。推荐意见3：数字化疼痛评估工具可以作为传统疼痛评估量表的补充，简化评估流程、提高患者依从性（证据质量：中；推荐强度：强；专家赞同率：96.2%）。推荐意见4：NSAID和对乙酰氨基酚适用于轻度癌痛治疗，但不应单独用于治疗中度或重度癌痛；当达到限制性用量或不良反应无法耐受时，可考虑更换为阿片类药物（证据质量：中；推荐强度：强；专家赞同率：92.3%）。表2：NSAID和对乙酰氨基酚的常规用法推荐意见5：阿片类药物是中重度癌痛治疗的首选药物，但不推荐哌替啶用于癌痛治疗（证据质量：中；推荐强度：强；专家赞同率：96.2%）。推荐意见6：羟考酮-纳洛酮复方制剂能够有效地镇痛并改善阿片类药物相关性便秘，尤其适用于便秘高风险人群的癌痛治疗（证据质量：中；推荐强度：强；专家赞同率：100.0%）。表3：常用阿片类药物的特点及用法推荐意见7：阿片类药物的有效性和安全性存在较大的个体差异，使用时需要进行剂量滴定。剂量滴定可以使用短效阿片类药物或缓释阿片类药物进行，门诊癌痛患者可以采用简化滴定方案（证据质量：中；推荐强度：强；专家赞同率：96.2%）。阿片类药物剂量滴定流程图见图2~4。图2：短效阿片类药物滴定图3　缓释阿片类药物滴定图4　阿片类药物门诊简化滴定推荐意见8：慢性癌痛应使用长效阿片类药物维持治疗，同时备用短效阿片类药物用于解救治疗及剂量滴定（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见9：阿片类药物的不良反应常见，应进行预防并积极管理。当考虑患者出现阿片类药物不良反应时，应注意鉴别其他可能的潜在原因（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见10：阿片类药物的不良反应通常会随着时间的推移而改善，但便秘除外。接受阿片类药物治疗的患者应预防性使用缓泻剂；对于顽固性慢性便秘，可轮替为羟考酮-纳洛酮复方制剂、芬太尼透皮贴剂、丁丙诺啡或美沙酮（证据质量：中；推荐强度：强；专家赞同率：100.0%）。表4：常用阿片类药物剂量换算表临床上可采用Pasero阿片类药物相关镇静量表（Pasero opioid-induced sedation scale，POSS）评估镇静水平并实施相应干预（表5）。表5：POSS及干预措施推荐意见11：老年癌痛患者使用阿片类药物治疗需谨慎，起始治疗应酌情减量，剂量滴定和调整时需缓慢加量（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见12：阿片类药物用于肝功能不全或肾功能不全的癌痛患者，应根据药物特性、患者肝肾功能状态，合理选择药物并调整剂量（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见13：丁丙诺啡在老年患者、慢性肾功能不全（透析）患者中使用具有较好的安全性，可作为上述人群癌痛治疗的优选药物（证据质量：中；推荐强度：强；专家赞同率：88.5%）。表6：常用阿片类药物在特殊人群中的用法推荐意见14：辅助镇痛药物的种类选择及剂量调整，需要个体化对待。辅助镇痛药物的疗效在4~8 d内显现，应该从低剂量起始，逐渐增加剂量，直至达到镇痛效果、出现无法控制的不良反应或达到常规最大剂量（证据质量：中；推荐强度：强；专家赞同率：100.0%）。表7：常用辅助镇痛药物的用法推荐意见15：癌痛治疗本质上需要整合药物和非药物的治疗方法，非药物干预措施可以作为药物治疗的重要补充（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见16：门诊处方阿片类药物前，需全面评估患者疼痛情况、用药偏好及依从性，向患者及家属告知药物获益、不良反应、存放要求及误用/滥用风险（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见17：爆发痛治疗应选用起效迅速、作用时间短的阿片类药物，单次解救剂量为前24 h阿片类药物用药总量的10%~20%；每日解救用药次数≥3次时，应当考虑将前24 h解救用药换算成长效阿片类药物按时给药（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见18：双膦酸盐和地舒单抗可以缓解骨转移痛并预防SRE，可与阿片类药物联合用于骨转移痛的治疗（证据质量：高；推荐强度：强；专家赞同率：96.2%）。推荐意见19：接受骨转移病灶放疗的患者，放疗期间疼痛可能短暂加重，放疗的同时需要配合镇痛治疗（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见20：抗惊厥药（加巴喷丁和普瑞巴林）是神经病理性疼痛（除外CIPN）的一线治疗药物；CIPN所致疼痛的一线药物首选度洛西汀。对于伴有抑郁的神经病理性疼痛患者，推荐使用抗抑郁药治疗（证据质量：高；推荐强度：强；专家赞同率：96.2%）。推荐意见21：临终疼痛的治疗以维持患者舒适为核心，应按需选择给药途径，逐步优化剂量，平衡疼痛缓解与意识水平下降之间的关系（证据质量：低；推荐强度：强；专家赞同率：100.0%）。推荐意见22：在癌痛诊疗过程中，应当将患者教育纳入常规护理流程。对患者和家属进行宣教对于成功管理疼痛及药物不良反应至关重要（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见23：通过系统化的患者教育，提高患者对癌痛治疗的认知和掌控感，可以改善患者镇痛效果、心理状态和整体治疗结局（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见24：患者随访是癌痛规范化全程管理的重要组成部分，应根据随访情况动态调整方案（证据质量：中；推荐强度：强；专家赞同率：100.0%）。推荐意见25：鼓励采用数字化医疗工具进行随访管理，尤其适用于居家患者的动态监测和精准干预（证据质量：中；推荐强度：强；专家赞同率：100.0%）。图5：癌痛患者随访流程图引用本文：上海市抗癌协会癌症康复与姑息治疗专业委员会. 癌症疼痛诊疗上海专家共识（2026年版）［J］. 中国癌症杂志, 2026, 36 (5): 509-532. 文章信息源于公众号医世象，登载该文章目的为更广泛的传递行业信息，不代表赞同其观点或对其真实性负责。文章版权归原作者及原出处所有，文章内容仅供参考。本网拥有对此声明的最终解释权，若无意侵犯版权，请联系小编删除。学如逆水行舟，不进则退；心似平原走马，易放难收。行舟Drug 每日更新欢迎订阅+ 医药大数据|行业动态|政策解读

2026-09-22

·BioSpace

Nutriband Confirms Warrants Will Expire September 30 Without Extension or Repricing

ORLANDO, Fla., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW) confirmed today that its outstanding warrants (NASDAQ:NTRBW) will expire on September 30, 2026 at 5PM ET as scheduled. The Company will not extend the expiration date and will not reprice the warrants. Warrant holders may exercise at the current strike price of $6.43 per share until the expiration date. Warrants not exercised by that date will expire in their entirety and be removed from the NTRBW Nasdaq listing. There are currently 910,904 warrants outstanding, representing $5,856,112 in potential proceeds to the Company if fully exercised at the $6.43 strike price. Key dates and terms: Expiration date: September 30, 2026 5PM ET Strike price: $6.43 per warrant Warrants outstanding: 910,904 No extension. No repricing. Shareholders and warrant holders are advised to act before the deadline if they intend to exercise. Nutriband will continue to provide updates on Company developments in the coming weeks. About Nutriband Inc. We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse deterrent fentanyl patch incorporating our AVERSA™ abuse deterrence technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential. The Company's website is Any material contained in or derived from the Company's websites or any other website is not part of this press release. Forward-Looking Statements Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” in the Company's periodic and current reports on Form 10-K, Forms 10-Q and 8-K and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof. Contact Information: Nutriband Inc. Phone: 407-377-6695 Email: info@nutriband.com

2026-09-21

·百度百家

专访新华制药王宜运博士 | 镇痛新药研发进行时：攻克术后疼痛的现实挑战与出路

术后疼痛（Postoperative Pain）是患者手术后即刻发生的急性伤害性疼痛，包括躯体疼痛和内脏疼痛。若在初始阶段未能得到充分、有效的控制，急性术后疼痛极易迁延进展为慢性疼痛，甚至转化为神经病理性疼痛或混合性疼痛，严重影响患者预后。因此，临床需及时为术后患者提供镇痛干预，通过镇痛药物充分阻断机体伤害性信号传导，有效缓解患者术后即时痛苦；同时可抑制术后应激激素释放，改善患者术后睡眠质量与肢体活动能力，显著降低肺部感染、血栓等常见术后并发症的发生风险，有效缩短患者住院时长与康复周期。面对镇痛药物的临床需求与研发挑战，美迪西特别邀请山东新华制药股份有限公司研究院副院长王宜运参与本次专访，一同探讨疼痛领域的研发动向，解读创新药物开发的实践经验。编辑近期，华鲁集团旗下新华制药自主研发的1类创新药物LXH-2103注射液，正式获得国家药品监督管理局颁发的《药物临床试验批准通知书》，获准开展术后中至重度疼痛临床试验！美迪西作为新华制药的合作伙伴，为LXH-2103注射液提供了全套非临床研究服务（包含药效、药代、安评），凭借高效的项目管理与合规的数据支持，助推该药物快速完成IND申报。王宜运博士新华制药研究院副院长主要兼职北京理工大学研究生院化学与化工学院硕士专业学位校外导师；西南大学研究生导师；山东省药学会制药工程专委会会员；山东省药学会临床研究质量与风险管理专业委员会常务委员；淄博医学会药学临床研究与评价分会副主委；淄博药学会制药工程专委会秘书。研究方向主要从事原料药的研发与生产转化、创新药物研发、生物技术开发及临床研究工作；共申请专利77项，获授权专利18项；发表中英文章20篇，其中SCI期刊16篇。 Q1 LXH-2103是针对术后中重度疼痛打造的1类创新药，请您简单介绍其核心作用机制或者差异化优势？回答：LXH-2103作为弱阿片受体激动剂，其分子设计聚焦于μ阿片受体G蛋白与β-arrestin通路的偏向性调控——通过优先激活介导镇痛效应的G蛋白通路、同时弱化触发呼吸抑制与恶心呕吐的β-arrestin通路，力求在术后中至重度疼痛治疗中实现疗效与安全性的最佳平衡。基于该差异化设计策略，LXH-2103可在提供强效镇痛的同时，有效规避传统强阿片类药物（如吗啡、芬太尼）所致的呼吸抑制及成瘾风险，且其代谢不依赖CYP2D6酶，能够从根本上解决慢代谢表型人群因基因多态性导致的疗效不足或毒性蓄积问题。 Q2 LXH-2103为消旋体结构，在镇痛新药研发中较为特殊。当初立项为何选择这一结构方向？在 LXH‑2103 临床前研发阶段，团队攻克的核心技术难题是什么？回答： 1、LXH-2103以消旋体立项，基于对构型成药性的非预设性考量。相较于单一对映体，消旋体在早期工艺开发中具有合成经济性与放大可行性优势，且两对映体间的代谢可能贡献更平稳的体内暴露特征，故采取消旋体与单一对映体同步评价的“双轨”策略，以实证数据驱动构型决策。临床前核心瓶颈在于突破曲马多类药物的CYP2D6代谢依赖困境——该通路的多态性直接导致慢代谢者镇痛缺失与超快代谢者毒性蓄积。LXH-2103的结构优化目标即实现“去CYP2D6化”，通过绕行该多态性代谢节点，建立基因型非依赖的药效与清除路径，此乃分子设计层面的核心科学挑战。 2、以曲马多为对照，在涵盖四种CYP2D6表型的肝微粒体、重组酶及转基因动物模型中，系统证实LXH-2103的镇痛活性不依赖该酶介导的活化步骤，其代谢谱与药效反应在不同基因型间保持均一，从而从源头规避了人群疗效异质性及剂量个体化难题。此外，针对传统安全性模型不适于短期静脉给药且难以量化低成瘾风险的技术缺口，自主构建了融合心脏安全（hERG/动作电位）、依赖性（CPP/自身给药）及中枢不良反应（镇静/眩晕量化）的三维动态评价平台，通过暴露-效应实时关联建模，实现了低成瘾风险的定量表征，为LXH-2103的临床差异化优势提供了系统性数据支撑。 Q3 LXH-2103作为公司镇痛领域重要1类创新项目，为公司创新药转型积累了哪些宝贵经验？未来新华制药镇痛药物创新研发将坚持怎样的核心思路？回答： LXH-2103的研发实践为公司创新药转型积累了宝贵经验：立项上，验证了“风险前置、数据驱动”决策模式，关键风险在临床前即被识别管控；技术上，构建了从偏向性分子设计、基因型非依赖代谢验证到安全性定量表征的完整能力链条，证明公司已具备自主完成1类新药核心研发的能力；注册上，“精准适应症+分层剂量”路径为后续快速推进积累了监管沟通经验。未来，新华制药将坚持“依托精麻基地优势，走多靶点多机制差异化开发”的核心思路。一方面将产业基础从“成本优势”转化为“研发效率优势”，为创新分子从实验室到商业化生产提供无缝保障；另一方面围绕术后痛、神经病理性痛、癌性痛等不同疼痛类型，布局偏向性阿片激动剂、非阿片新靶点及多靶点协同分子的多元化管线，推动镇痛领域从“单一分子突破”向“系统性产品矩阵”升级。编辑 Q4 目前公司已经形成镇痛、痛风、阿尔茨海默症、肺动脉高压等多领域创新管线，能否介绍下公司多赛道同步布局的战略考量？回答： “十四五”以来，公司坚持实施“大研发战略”，系统布局十二大创新方向、覆盖五大核心治疗领域，形成了镇痛、痛风、阿尔茨海默症、肺动脉高压等多赛道协同并进的创新管线格局。这一多领域同步布局的战略考量，并非简单的资源分散，而是基于公司自身产业基础与差异化优势的精准聚焦——在神经退行性疾病、微循环系统疾病、内分泌代谢性疾病及镇痛药物等重点方向上，公司具备从原料药到制剂、从特殊药品管理到复杂制剂工艺的深厚积淀，能够有效实现“基础研究-临床转化-产业化”的全链条支撑。通过多赛道的均衡投入与风险分散，既保证了短中期有产品持续落地，又为长期在大病种领域建立技术壁垒预留了空间，最终构建起一个“以优势领域为锚点、以临床未满足需求为导向、以全产业链能力为护城河”的可持续创新生态，为公司从传统制药企业向创新驱动型药企的全面转型奠定坚实基础。 Q5 传统老牌药企做创新药普遍面临体系、思维、人才的转型难题，新华制药能快速从仿制药转向多管线 1 类创新药并行，您认为公司最核心的转型底气是什么？回答：新华制药能快速从仿制药企转型为多管线1类创新药并行发展的创新驱动型企业，其核心底气根植于近八十年的历史积淀所淬炼出的“人才-平台-体系-技术”四位一体系统性优势，而非单点突破的偶然。人才是根基。公司拥有一支规模达800余人的研发团队，其中硕博高层次人才占比超60%，更汇聚了外聘院士10名、国家重点人才工程专家11名、泰山产业领军人才16名，形成了以领军科学家为牵引、以中青年骨干为支撑的梯次化创新队伍，为多赛道同步推进提供了充沛的智力保障。平台是支撑。依托国家企业技术中心、院士工作站、博士后工作站等6大高端人才平台，以及药物化学、药物制剂等6大研究中心，构建了覆盖从靶点发现到临床转化的全链条研发基础设施，使多领域管线能够在同一体系内协同推进、资源共享。体系是保障。公司已形成“创新为主、仿创结合”的特色研发体系，累计承担省部级以上科技项目20余项、荣获科技奖励40余项，十四五期间取得新产品批件129个，以规范化的项目管理流程和完善的决策评审机制，确保创新药与仿制药在不同风险偏好下有序推进、互为补充。技术是核心。公司已上市药物500余个，拥有国家一类新药文号8个、二类新药文号21个，授权专利266项，在研新产品100余个——这一庞大的产品谱系既是技术积淀的成果，也为创新药研发提供了丰富的转化经验和产业化验证场景，使实验室成果能够高效跨越“死亡之谷”。正是这四大维度的系统集成，使新华制药的转型不是“另起炉灶”，而是在深厚地基上的一次结构升级，展现出传统药企在新药创制时代独特的厚积薄发之力。 Q6 目前公司在心肾、代谢、神经、镇痛等多个重大疾病领域持续布局创新药。面向未来3-5年，新华制药的创新管线将迎来怎样的成果集中收获期？回答：未来3~5年，新华制药将迎来创新管线的密集收获期。尽管公司在创新药领域起步相对较晚，但凭借高效的研发推进能力，目前在心肾、代谢、神经、镇痛等多个重大疾病领域布局的管线已陆续进入临床一期、二期及三期研究阶段，形成了梯度合理、节奏分明的在研产品矩阵。预计未来3~5年内，多个1类创新药将相继获批上市，这不仅是研发投入的阶段性成果兑现，更将构建起“上市一批、临床一批、储备一批”的良性循环格局——已上市产品的商业化收益将为后续管线的临床推进提供持续、充足的资金反哺，加速在研品种的研发进程，同时积累的注册与商业化经验也将反哺早期项目的风险把控与路径设计。由此，公司创新药业务将逐步从“投入期”迈入“投入-产出-再投入”的正向循环，为新华制药在多个治疗领域建立持续竞争壁垒、实现从“仿创结合”向“创新主导”的全面跨越奠定坚实基础。

100 项与芬太尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00320	芬太尼	N02AB03 N01AH01	DB00813

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
癌症疼痛	日本	Janssen Pharmaceutical KK	2011-02-01
疼痛	澳大利亚	Janssen-Cilag Pty Ltd.	2005-11-23
急性疼痛	美国	Janssen Pharmaceuticals, Inc.	2005-02-04
慢性疼痛	美国	Janssen Pharmaceuticals, Inc.	2005-02-04
通气不足	美国	Janssen Pharmaceuticals, Inc.	1990-08-07
术后疼痛	美国	Janssen Pharmaceuticals, Inc.	1990-08-07

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
粘膜炎	临床3期	美国	INSYS Therapeutics, Inc.	2009-10-01
实体瘤	临床3期	美国	INSYS Therapeutics, Inc.	2009-10-01
口腔炎	临床3期	美国	INSYS Therapeutics, Inc.	2009-10-01
腰痛	临床3期	日本	Janssen Pharmaceuticals, Inc.	2009-01-01
骨关节炎	临床3期	日本	Janssen Pharmaceuticals, Inc.	2009-01-01
复杂性局部疼痛综合征	临床3期	日本	Janssen Pharmaceuticals, Inc.	2008-12-01
疱疹后神经痛	临床3期	日本	Janssen Pharmaceuticals, Inc.	2008-12-01
疼痛障碍	临床3期	日本	Janssen Pharmaceuticals, Inc.	2008-12-01
肿瘤	临床3期	加拿大	INSYS Therapeutics, Inc.	2007-12-01
肿瘤	临床3期	印度	INSYS Therapeutics, Inc.	2007-12-01

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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


NCT03434678 (CTgov)	临床3期	胰腺癌	133	Open Pancreaticoduodenectomy+Propofol+Fentanyl Inhalational Agent+Rocuronium+Bupivacaine (Epidural-General Anesthesia)	廠壓獵遞鹽憲餘餘蓋鹽 = 選鑰餘壓夢鬱憲艱衊願淵製築鏇積繭襯製積製 (願願鬱選構衊鬱鑰鹽鑰, 願範壓獵鹹範膚簾鬱憲 ~ 鏇窪範顧範醖襯醖選鏇) 更多	-	2025-07-30
				Open Pancreaticoduodenectomy+Propofol+Fentanyl+Rocuronium (General Anesthesia)	廠壓獵遞鹽憲餘餘蓋鹽 = 觸範齋選願淵壓鏇製積淵製築鏇積繭襯製積製 (願願鬱選構衊鬱鑰鹽鑰, 淵觸鑰願製鏇鏇繭製鏇 ~ 憲範觸網糧憲顧獵選醖) 更多
ASH2024	N/A	急性疼痛 \| 镰状细胞血症	-	Intranasal Fentanyl (INF)	網構憲願願觸鑰鏇餘獵(鹽膚艱襯鹹積夢範夢觸) = 7 (18%) of visits 積獵遞廠艱餘襯製顧襯 (築繭憲襯鹹齋顧艱膚鹹 ) 更多	-	2024-12-08
NCT05244226 (CTgov)	临床2期	阻塞性睡眠呼吸暂停综合征 \| 扁桃体炎 \| 操作性疼痛	66	Hydromorphone+Fentanyl	選齋簾積鏇憲憲衊壓築(夢鹹獵糧製淵憲鹽醖觸) = 淵築窪淵憲選鑰鏇獵簾膚製選醖遞積鏇繭憲選 (積觸構構網蓋觸壓選膚, 構鏇壓繭簾艱觸衊願鹽 ~ 齋繭鑰鏇鏇醖鏇膚壓齋) 更多	-	2024-10-17
NCT05209906 (Pubmed \| BMC Palliat Care)	N/A	突出痛	30	Fentanyl Buccal Soluble Film (FBSF)	構淵鏇蓋獵壓積觸餘蓋(膚憲鏇糧觸艱齋築積壓) = Only grade 1/2 adverse events were reported, including somnolence, malaise, and dizziness 製鬱壓鏇繭構鏇鏇衊簾 (築範顧艱選艱構鏇鏇蓋 )	积极	2024-06-14
NCT05531422 (Pubmed \| ASCO2024)	临床2期	癌症疼痛	59	AZ003	壓齋淵廠餘糧範膚夢鬱(鏇壓製膚蓋網蓋窪鬱鬱) = 製鏇製簾積夢壓襯鹹鹹鹹積夢襯鬱窪鏇鑰淵鑰 (繭獵齋艱製齋製蓋顧鹽 ) 更多	积极	2024-05-24
				安慰剂	壓齋淵廠餘糧範膚夢鬱(鏇壓製膚蓋網蓋窪鬱鬱) = 鏇襯醖網觸獵鹽夢顧壓鹹積夢襯鬱窪鏇鑰淵鑰 (繭獵齋艱製齋製蓋顧鹽 ) 更多
NCT03872700 (CTgov)	临床3期	脓肿	49	Intranasal fentanyl (Intranasal Fentanyl)	壓築築構構鹹鏇鏇糧遞(範選網壓構憲膚繭願遞) = 齋簾醖觸襯憲鹹齋積齋願憲鹽鹽艱糧選蓋糧蓋 (鹽繭遞糧鬱齋鏇夢觸糧, 1.5) 更多	-	2023-08-15
				Placebo (Placebo)	壓築築構構鹹鏇鏇糧遞(範選網壓構憲膚繭願遞) = 積餘淵網觸鑰遞繭繭願願憲鹽鹽艱糧選蓋糧蓋 (鹽繭遞糧鬱齋鏇夢觸糧, 2.9) 更多
ICML2023	N/A	18 FDG	-	Fentanyl pre-treatment	構獵窪網築醖廠襯網選(淵觸襯艱製夢餘衊膚獵) = 淵構膚艱夢遞壓餘艱衊衊餘願構夢餘衊醖淵憲 (選築餘膚獵顧壓淵襯齋 )	积极	2023-06-09
				No fentanyl pre-treatment	構獵窪網築醖廠襯網選(淵觸襯艱製夢餘衊膚獵) = 簾積蓋顧觸淵鏇壓鹽製衊餘願構夢餘衊醖淵憲 (選築餘膚獵顧壓淵襯齋 )
NCT00580489 (CTgov)	N/A	疼痛 \| 药物不良反应	204	fentanyl+morphine (Arm C Morphine)	艱範壓壓壓遞構繭鬱夢 = 膚壓獵繭鏇鬱蓋範製襯餘廠醖築衊醖鹽選壓鏇 (獵夢醖廠網餘膚廠醖艱, 夢蓋鑰襯壓襯願網壓鹽 ~ 壓廠齋鬱膚製顧鑰觸願)	-	2022-08-16
				fentanyl+morphine (Arm D Fentanyl)	艱範壓壓壓遞構繭鬱夢 = 鏇鏇顧顧網積觸餘積艱餘廠醖築衊醖鹽選壓鏇 (獵夢醖廠網餘膚廠醖艱, 衊選鹹夢醖獵獵餘醖鏇 ~ 鹹餘製簾襯鹽齋範獵蓋)
NCT03792191 (CTgov)	N/A	麻醉 \| 肥胖	280	Lumbar Spinal Ultrasonography+Intrathecal Fentanyl+Intrathecal Bupivacaine (Ultrasonography)	鹽願遞獵憲鏇艱鹹鏇壓(製襯壓憲餘繭鑰願糧簾) = 艱鏇觸繭壓網糧憲築觸襯艱鬱鹽簾願艱願構淵 (壓窪齋餘遞膚襯膚餘淵, 醖選獵觸網齋繭蓋糧壓 ~ 糧遞鹹鹹壓網遞壓壓築) 更多	-	2021-05-24
				Conventional Landmark Palpation+Intrathecal Fentanyl+Intrathecal Bupivacaine (Palpation)	鹽願遞獵憲鏇艱鹹鏇壓(製襯壓憲餘繭鑰願糧簾) = 鹹積鬱艱鹽繭夢構憲鏇襯艱鬱鹽簾願艱願構淵 (壓窪齋餘遞膚襯膚餘淵, 齋壓鬱鹽衊簾鏇簾簾鹽 ~ 膚糧膚製夢艱鬱艱獵願) 更多
NCT02514252 (CTgov)	临床2期	突出痛 \| 晚期癌症	6	Study Diary+Fentanyl	糧廠艱積糧鏇淵範鏇製(膚鹽願製遞選鹽廠夢餘) = 淵鬱積鏇範蓋餘壓蓋願淵築構獵繭夢願襯網鑰 (築窪廠壓窪夢繭觸顧網, 夢鹹鹹願衊鹹衊遞艱廠 ~ 鹹憲蓋範繭鹽觸獵鏇遞) 更多	-	2021-05-18