预约演示

更新于：2025-09-19

Naltrexone

纳曲酮

更新于：2025-09-19

概要

基本信息

简介纳曲酮是一种阿片受体拮抗剂，常用于治疗酒精和药物依赖症。VIVITROL是含有纳曲酮的药物，适用于在门诊环境下能够戒酒的酒精依赖症患者。在使用VIVITROL前，患者不应饮酒。此外，VIVITROL也适用于戒除阿片类药物后预防复发。使用VIVITROL时应该搭配心理社会支持一起实施。纳曲酮的作用机制为拮抗阿片受体中的μ、κ和δ受体。

药物类型

小分子化药

别名

DBR-LDN、Naltrexone implant、naltrexone implant(Drug Delivery Company)

+ [11]

靶点

Opioid receptors

作用方式

拮抗剂

作用机制

Opioid receptors拮抗剂(阿片样受体拮抗剂)

治疗领域

其他疾病消化系统疾病内分泌与代谢疾病+ [3]

在研适应症

鸦片依赖酗酒甲基苯丙胺滥用+ [11]

非在研适应症

获得性免疫缺陷综合征肢端雀斑恶性黑色素瘤酒精相关疾病+ [32]

原研机构

Alkermes, Inc.

在研机构

Yale University

Neurelis, Inc.

University of California, Los Angeles

+ [11]

非在研机构

The New York State Psychiatric Institute

Dana-Farber Cancer Institute, Inc.Hershey Medical Center

+ [12]

权益机构

Statera Biopharma, Inc.

Aardvark Therapeutics, Inc.

Scilex Pharmaceuticals, Inc.

+ [9]

最高研发阶段批准上市

首次获批日期

美国 (2006-04-13),

酗酒

最高研发阶段(中国)终止

特殊审评孤儿药 (美国)、优先审评 (中国)

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结构/序列

分子式C20H23NO4

InChIKeyDQCKKXVULJGBQN-XFWGSAIBSA-N

CAS号16590-41-3

关联

160

项与纳曲酮相关的临床试验

NCT07064564

/ Not yet recruiting临床1期

A Randomized, Comparator-Controlled, Multiple Dose-Level Study Evaluating the Pharmacokinetics and Safety of BIOPIN (Naltrexone) Implants Compared to Monthly Vivitrol Injections in Healthy Adults Over a 12-Month Period

This is a Phase 1b clinical study testing a new extended-release implant that delivers naltrexone, a medication used to treat opioid use disorder (OUD). The investigational product is called BIOPIN. It is a small implant that is inserted just under the skin of the thigh and slowly releases medication over many months. The goal of the study is to see what the blood levels of naltrexone are from two different doses of the BIOPIN implant over time and to compare it to blood levels of naltrexone from Vivitrol®, an FDA-approved injectable form of extended-release naltrexone given once a month.
This study will enroll healthy adults between the ages of 18 and 55. Participants will be randomly assigned to receive either a low dose BIOPIN implant, a high dose BIOPIN implant, or monthly Vivitrol injections. All participants will be followed closely for 12 months to monitor medication levels in their blood and assess for any side effects or health changes. The study will help determine if the BIOPIN implant can deliver naltrexone levels that are equal to or higher than those seen with monthly Vivitrol injections, particularly during the times when patients are most vulnerable to relapse.
Participants receiving the BIOPIN implant will have the option of having the implant removed at the end of the study or choosing to continue being observed until the implant fully dissolves, which may take up to two years. Participants who choose extended follow-up will be enrolled in a separate observational study.
This study is sponsored by Drug Delivery Company, LLC, with support from the National Institute on Drug Abuse (NIDA). The clinical research is being overseen by Fast-Track Research, Inc. and reviewed by Advarra IRB. All participants will undergo screening exams to ensure they are healthy and eligible, and they will be closely monitored throughout the study.
The results of this study will help researchers determine the best dose of BIOPIN to move forward into later-stage clinical trials and may support further development of long-acting treatments for opioid use disorder that do not require monthly injections or surgical removal.

开始日期2026-02-01

申办/合作机构

Drug Delivery Co. LLC

[+3]

NCT06845124

/ Not yet recruiting临床2期IIT

ICONICplus - Randomized, Double-blind, Placebo-controlled Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Cue-Induced Alcohol Craving in Alcohol Dependence

Alcohol addiction (AD) is a chronic relapsing disorder with currently limited pharmacological treatment options. Alcohol craving, a hallmark symptom of AD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound for the treatment of alcohol craving in AD is Cannabidiol (CBD), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, CBD seems to be a particularly promising candidate for enhancing the effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist, which is approved for AD treatment, due to the synergistic effects of the combination of Cannabidiol plus Naltrexone on alcohol consumption that were shown by preclinical studies. The proposed three-armed, 1:1:1 randomized, double-blind, placebo-controlled parallel group, multicentric phase II trial seeks to test the putative synergistic effects of combined CBD (800mg) + oral NTX (50mg) against CBD (1200mg) + oral NTX (50mg) against Placebo + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AD that suffer from high alcohol craving. The trial seeks to test the effects of the innovative combination of CBD plus NTX against Placebo plus NTX on alcohol craving over a 14-day treatment period, which is embedded in a standardized addiction treatment program according to current treatment guidelines, in order to estimate the added value of treatment with CBD on alcohol craving. Quality of life and neurobiological and biochemical markers for craving will serve as secondary outcomes, because they show strong associations to treatment outcome and relapse risk. Collection and analysis of follow-up data (28 days, 42 days, 105 days, 196 days) will be performed to determine whether treatment effects relate to patient outcome.

开始日期2025-07-01

申办/合作机构

Zentralinstitut für Seelische Gesundheit

[+2]

NCT06633900

/ Recruiting临床2/3期IIT

Extended-Release Naltrexone as Opioid Overdose Pre-Exposure Prophylaxis (PrEP) in People Using Stimulants Living With or At Risk of HIV

The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine). The main questions it aims to answer are:
What are the challenges for implementing naltrexone as an overdose prevention strategy?
Are injections of naltrexone effective for opioid overdose prevention among people who use stimulants?
How often are people who use stimulants and do not intentionally use opioids unintentionally exposed to opioids?
Researchers will compare participants to receive the study medication to the usual care group to see if one group experiences fewer opioid overdose events than the other.
Participants will be randomized to either receive a monthly injection of naltrexone over six months, or receive usual care. Usual care includes harm reduction supplies. Laboratory procedures will include the collection of urine, blood, and hair samples for various safety and outcome measure testing.

开始日期2025-04-10

申办/合作机构

The University of California, San Francisco

[+1]

100 项与纳曲酮相关的临床结果

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100 项与纳曲酮相关的转化医学

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100 项与纳曲酮相关的专利（医药）

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9,320

项与纳曲酮相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Hailey-Hailey disease successfully treated with naloxone: 2 case reports and Review of the literature on efficacy of opioid receptor antagonist in Hailey-Hailey disease patients

Review

作者: Sheng, Nan ; Wu, Jianbing ; Fang, Fang ; Duan, Zhimin ; Li, Chengrang ; Xu, Beilei ; Song, Hao ; Zheng, Junyou

BACKGROUND:

Hailey-Hailey disease (HHD), a genetic blistering disease, is caused by a mutation in a calcium transporter protein in the Golgi apparatus encoded by the ATP2C1 gene. Clinically, HHD is characterized by flaccid vesicles, blisters, erosions, fissures, and maceration mainly in intertriginous regions. Some patients remain refractory to conventional treatments. Previously, a series of reports have confirmed naltrexone as an effective option for those patients. However, in China, naltrexone is unavailable in some hospitals and unaffordable for some patients.

OBJECTIVE:

To confirm naloxone as a treatment option for HHD, and assess the efficacy rate and safety of naltrexone for patients with HHD.

METHODS:

Two patients with biopsy-proven HHD received naloxone (2 mg/d, via intravenous infusion). We followed up with the two patients, assessing the change of skin lesions and obtaining photographs. We searched the PubMed databases using the keywords 'Hailey-Hailey disease' or 'benign familial pemphigus', and 'naltrexone' or 'naloxone', and reviewed English publications of reports and analyzed the efficacy and safety of naltrexone.

RESULTS:

Two patients prescribed naloxone showed completely remission in two weeks without any adverse reactions. The total remission rate of naltrexone for HHD is approximately 80%, without severe adverse effects.

CONCLUSION:

Naltrexone is effective and safe in the treatment of HHD. Naloxone, an analog of naltrexone, can also effectively and safely treat HHD, potentially offering a new therapeutic option for patients with refractory HHD.

2025-12-01·Current Pain and Headache Reports

Low Dose Naltrexone In The Management Of Chronic Pain Syndrome: A Meta-Analysis Of Randomized Controlled Clinical Trials

Article

作者: Srinivasan, Anand ; V, Divya ; Hegde, Naveen Chandrashekar ; Hota, Debasish ; Mishra, Archana ; Maiti, Rituparna

OBJECTIVE:

Chronic pain conditions are among the leading causes of years lost to disability. Low Dose Naltrexone (LDN) has anti-inflammatory and immunomodulatory properties. LDN, by blocking Toll-Like Receptors (TLR), prevents central sensitization and conversion of acute pain state to a state of chronic pain. This meta-analysis compared LDN's effectiveness in chronic pain syndromes based on published randomized trials.

METHOD:

Seven studies were included after a systematic search and screening from PubMed, Embase, Scopus, Cochrane, and clinical trial registries. The efficacy outcome analyzed was the standardized mean difference (SMD), the Cohen's d, of change in pain scores between LDN and the comparator drugs using the random-effect model. Subgroup analyses by condition type and comparator were performed to analyze the effect of LDN. Adverse events were evaluated using incidence rate ratio(IRR), publication bias by funnel plot, risk of bias by Cochrane Risk of Bias tool version 2.0, and certainty of evidence by GRADE evaluation.

RESULTS:

LDN did not show a significant difference in pain response compared to control groups [d = -0.11 (95%CI -0.96 to 0.74); P = 0.31]. In fibromyalgia, LDN had improvement compared to placebo [d = -0.34 (95%CI -0.62 to -0.06); P = 0.0186]. Against active comparators, LDN had no difference [d = 0.67 (95% CI -4.69 to 6.02); P = 0.35]. Adverse events were increased with LDN compared to placebo [IRR = 1.4 (95% CI 1.12 to 1.75); P = 0.0026] but comparable to active comparators [IRR = 0.55 (95% CI 0.04 to 7.31); P = 0.65].

CONCLUSION:

LDN is better than placebo in fibromyalgia pain management, and LDN is similar to active controls in chronic pain management.

PROSPERO REGISTRATION NUMBER:

CRD42024511451.

2025-11-01·NEUROPHARMACOLOGY

Effects of orally self-administered furanyl fentanyl and acryl fentanyl in mice: antinociception, dependence and withdrawal, and defense of consumption

Article

作者: Wolf, Kayla J ; Pressley, Justin M ; Fantegrossi, William E ; Moran, Jeffery H ; Gannon, Brenda M ; Shaw, Hannah E ; Shepard, Mary E ; Avram, Marina

Oral use of illicit fentanyl formulations is common, and these preparations may be contaminated with fentanyl analogs (FAs) with unknown pharmacological and toxicological properties. Route of administration impacts pharmacological effects, and pharmacokinetic or pharmacodynamic properties of oral fentanyl and FAs could influence aspects of opioid use disorder that are not necessarily present in animal models involving other routes of administration. We established oral consumption of water, or solutions of the FAs furanyl fentanyl and acryl fentanyl in C57 B l/6N mice. Consumption of pharmacologically-relevant concentrations of the FAs was reliably engendered, verified by induction of opioid-mediated antinociceptive effects in a warm-water tail withdrawal procedure, hypothermic effects, and observation of antagonist-precipitated withdrawal. When maintenance solutions were adulterated with the bitter tastant quinine, water control mice decreased their consumption, but mice consuming FA solutions defended their consumption, even at quinine concentrations that suppressed water drinking. Brief access to supplemental water, injection of the μ-opioid antagonist naltrexone, or administration of the μ-opioid agonist morphine all attenuated the defense of FA consumption. In all cases, the abuse-related effects of acryl fentanyl were greater than those of furanyl fentanyl. Consumption of acryl fentanyl also abolished weight gain across the study, and disrupted nest-building. The results of these experiments suggest that mice drinking furanyl fentanyl or acryl fentanyl experience opioid-mediated effects including antinociception, dependence and withdrawal, and abuse-related subjective effects, and provide proof of concept for use of this model to assess pharmacological and non-pharmacological manipulations which may attenuate the reinforcing effects of oral fentanyl and FAs.

326

项与纳曲酮相关的新闻（医药）

2025-09-04

·GlobeNewswire-Health Care

Semnur Pharmaceuticals, Inc. (“Semnur”), a Majority-Owned Subsidiary of Scilex Holding Company (Nasdaq: SCLX, “Scilex”), and Denali Capital Acquisition Corp. Announce Approval from Denali’s Shareholders of the Previously Announced Business Combination

PALO ALTO, Calif, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Semnur Pharmaceuticals, Inc. (“Semnur”), a majority-owned subsidiary of Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, today announced that the shareholders of Denali Capital Acquisition Corp (“Denali”) approved the previously announced business combination with Semnur (the "Business Combination"). The Business Combination was approved by Denali’s shareholders at its Extraordinary General Meeting held on September 3, 2025 (the “Meeting”), along with all other proposals presented at the Meeting, each of which were set forth in the definitive proxy statement/prospectus filed by Denali with the U.S. Securities and Exchange Commission (the “SEC”) on August 13, 2025. The combined company will operate as Semnur Pharmaceuticals, Inc. upon consummation of the Business Combination, which is expected to close in September 2025, subject to satisfaction of customary closing conditions. Denali has filed a Current Report on Form 8-K with the SEC to disclose the full voting results of the Meeting. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), which is owned by Semnur and is a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia. Scilex is headquartered in Palo Alto, California. About Semnur Pharmaceuticals, Inc. Semnur is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica. Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California About Denali Capital Acquisition Corp. Denali is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts and may be accompanied by words that convey projected future events or outcomes, such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” or variations of such words or by expressions of similar meaning. These forward-looking statements include, but are not limited to, statements regarding future events, the Business Combination between Semnur and Denali, the estimated or anticipated future results and benefits of the combined company following the Business Combination, including the likelihood and ability of the parties to successfully consummate the Business Combination, future opportunities for the combined company, and other statements that are not historical facts. These statements are based on the current expectations of management of the Company, Semnur and Denali and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of the Company, Semnur and Denali. These statements are subject to a number of risks and uncertainties regarding the Company’s, Semnur’s and Denali’s businesses and the Business Combination, and actual results may differ materially. These risks and uncertainties include, but are not limited to, general economic, political and business conditions; the inability of the parties to consummate the Business Combination or the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement for the Business Combination; the outcome of any legal proceedings that may be instituted against the parties following the announcement of the Business Combination; the receipt of an unsolicited offer from another party for an alternative business transaction that could interfere with the Business Combination; failure to realize the anticipated benefits of the Business Combination, including as a result of a delay in consummating the potential transaction or difficulty in integrating the businesses of Semnur or Denali; the risk that the Business Combination disrupts current plans and operations as a result of the announcement and consummation of the Business Combination; the ability of the combined company to develop and successfully market SP-102 or other products; the ability of the combined company to grow and manage growth profitably and retain its key employees; the inability to obtain or maintain the listing or trading of the post-acquisition company’s securities on The Nasdaq Stock Market LLC or the over-the-counter markets, as applicable, following the Business Combination; and costs related to the Business Combination. There may be additional risks that Semnur and the Company presently do not know or that Semnur or the Company currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Semnur’s, the Company’s and Denali’s expectations, plans or forecasts of future events and views as of the date of the communication. Semnur and the Company anticipate that subsequent events and developments will cause such assessments to change. However, while Semnur and the Company may elect to update these forward-looking statements at some point in the future, each of Semnur and the Company specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing Semnur’s or the Company’s assessments as of any date subsequent to the date of this communication. Accordingly, investors are cautioned not to place undue reliance on these forward-looking statements. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a majority-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. Scilex Bio™ is a trademark owned by Scilex Holding Company, Inc. All other trademarks are the property of their respective owners. © 2025 Scilex Holding Company All Rights Reserved.

上市批准临床2期快速通道临床3期

2025-08-29

·EINPresswire

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

2025-08-26

·国际糖尿病idiabetes

ESC肥胖与心血管疾病临床共识声明：十大要点一文汇总

点击“蓝字”关注我们编者按：全球肥胖的患病率在过去四十年中翻了一倍多，目前有10亿人受累。肥胖不仅是众多慢病的高危因素，其本身也被定义为一种疾病，显著降低生活质量与寿命。尽管肥胖与动脉粥样硬化、心力衰竭、血栓栓塞性疾病、心律失常及猝死等密切相关，但受重视程度却远不及其他可干预危险因素。欧洲心脏病学会（ESC）发布的《肥胖与心血管疾病临床共识声明》基于最新循证，系统阐述了肥胖的流行病学、病因及与心血管风险交互作用，并就生活方式、内镜/外科及药物减重策略提出管理路径，旨在将肥胖纳入心血管一级与二级预防的核心环节。欧洲心脏病学会（ESC）关于肥胖与心血管疾病（CVD）的临床共识声明讨论了肥胖、心血管危险因素和CVD之间的相互作用，并为心脏病和肥胖患者的临床管理提供了指导，特别关注减重策略对心脏代谢风险和心血管结局的影响（图1）。共识指出，肥胖不仅与多种CVD的发生相关，还与死亡风险，尤其是心血管死亡风险增加相关。以下为声明的十大要点。图1. （A）肥胖的主要心血管结局，（B）各种干预措施对体重的平均影响 01 肥胖流行形势严峻全球范围内，肥胖的患病率在过去数十年中已翻了一倍以上。在ESC成员国中，约五分之一的成年人患有肥胖，全球范围内这一比例约为八分之一。 02 肥胖评估需综合多项指标目前，肥胖诊断和分类的金标准仍是基于体重指数（BMI）。然而，BMI无法反映肌肉质量与体脂含量及分布。因此，结合腹部肥胖指标，如腰围、腰高比和腰臀比，有助于在BMI基础上进一步优化个体的心血管代谢风险分层。 03 肥胖病因复杂，受多因素影响肥胖的病因具有高度复杂性和多因素性。尽管遗传与生物学因素在个体易感性中发挥重要作用，但全球肥胖流行主要由环境与社会因素驱动。 04 生活方式干预是基础生活方式干预是体重管理的基础。饮食干预通常建议每日实现500~750 kcal的能量负平衡，可实现5%~10%的体重下降。体力活动对体重减轻的直接作用相对有限，但在维持减重成果和降低总体心血管风险方面至关重要。尽管结合营养与运动的强化生活方式干预可改善心血管代谢危险因素，但对心血管结局的影响尚未在随机对照试验中得到证实。 05 药物干预显示新希望在药物干预方面，奥利司他和安非他酮/纳曲酮对体重的影响有限，长期心血管安全性证据不足。胰高糖素样肽-1受体激动剂（GLP-1RA）可有效减重并改善心血管危险因素。司美格鲁肽（2.4 mg，每周一次）在合并CVD且超重或肥胖（BMI≥27 kg/m2）但无糖尿病的患者中，显示出明确的心血管获益。 06 胃内介入与手术干预效果显著内镜下干预（如胃内球囊、内镜下袖状胃成形术）可实现7%~13%的体重下降，减重代谢手术可达25%~30%。这些干预措施适用于经过严格筛选的个体。观察性研究表明，减重手术与心血管结局改善相关，但目前尚缺乏随机对照试验数据。 07 减重是控制合并症的基石肥胖几乎对所有可干预的心血管危险因素均可产生不利影响。对于合并2型糖尿病、高血压、血脂异常或阻塞性睡眠呼吸暂停的肥胖患者，减重是治疗的基石。 08 肥胖显著增加心力衰竭风险肥胖显著增加新发心力衰竭的风险，尤其是射血分数保留的心力衰竭（HFpEF）。通过饮食、运动或药物干预减重，可改善肥胖HFpEF患者的运动能力和临床症状。对于合并射血分数降低的心力衰竭（HFrEF）的肥胖患者，生活方式干预减重可能改善症状和运动能力，但非意愿性体重下降则与死亡风险升高相关。 09 肥胖与房颤风险密切相关肥胖者发生房颤及进展为永久性房颤的风险更高，且血栓栓塞风险也增加。对于肥胖个体，应鼓励减重以进行房颤的一级预防。对于已确诊房颤的肥胖患者，减重结合其他危险因素管理，有助于降低房颤相关症状负担。 10 肥胖治疗需兼顾成本效益与可及性对部分CVD患者而言，个体化的肥胖治疗可能具有成本效益，但目前因个人和社会经济负担，多数患者仍难以获得有效治疗。从医学和成本效益的角度来看，预防才是应对肥胖流行的最优策略，应从儿童期开始推动终身健康体重维持，并在政策层面实施多维度干预，以抵消当前“致肥胖环境”的影响。参考文献：Koskinas KC, Van Craenenbroeck EM, Prescott EB. European Society of Cardiology clinical consensus statement on obesity and cardiovascular disease: 10 key points. Eur Heart J. 2025 Aug 21:ehaf177. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《心肾代谢时讯》编辑部）

AHA会议

100 项与纳曲酮相关的药物交易

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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
鸦片依赖	美国	Alkermes, Inc.	2010-10-12
酗酒	美国	Alkermes, Inc.	2006-04-13

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适应症	最高研发状态	国家/地区	公司	日期
阿片类药物过量	临床3期	美国	The University of California, San Francisco	2025-04-10
甲基苯丙胺滥用	临床3期	美国	National Institute on Drug Abuse	2024-07-01
甲基苯丙胺依赖	临床3期	美国	National Institute on Drug Abuse	2024-07-01
大便失禁	临床3期	美国	Yale University	2021-06-29
慢性盆腔疼痛综合征	临床3期	美国	Hershey Medical Center	2020-01-16
子宫内膜异位症	临床3期	美国	Hershey Medical Center	2020-01-16
暴食症	临床3期	美国	Yale University	2019-08-07
肥胖	临床3期	美国	Yale University	2019-08-07
阿片滥用	临床3期	美国	Alkermes, Inc.	2016-04-01
获得性免疫缺陷综合征	临床3期	美国	Yale University	2011-04-01

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临床结果

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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


NCT02330419 (SayWhen, CTgov)	临床2期	HIV感染	120	Behavioral survey measurements: (Placebo)	夢遞艱積構繭簾壓餘觸(衊製糧繭膚淵衊窪醖窪) = 蓋淵膚憲餘積遞夢壓蓋遞獵壓築壓廠艱糧齋鹹 (遞艱選鹽積餘憲鏇積齋, 鬱製壓艱齋襯糧糧鹹繭 ~ 鑰廠願繭襯積餘醖鏇糧) 更多	-	2025-04-20
				Behavioral survey measurements:+Naltrexone (Naltrexone)	夢遞艱積構繭簾壓餘觸(衊製糧繭膚淵衊窪醖窪) = 餘夢構夢窪積淵鏇築衊遞獵壓築壓廠艱糧齋鹹 (遞艱選鹽積餘憲鏇積齋, 選鬱餘齋糧夢窪鏇積鏇 ~ 糧構夢願顧構鬱壓繭夢) 更多
NCT01587196 (fMRI CURE, CTgov)	临床2期	-	72	Vivitrol	選繭衊築憲糧願構廠醖 = 築鏇遞壓壓艱鑰鹹膚鏇網製廠範築鹽夢遞憲鹽 (淵醖醖齋醖鑰遞醖鏇鹽, 廠獵蓋艱鬱積築鬱鹹獵 ~ 糧鏇繭醖鏇鹽鹹鹹齋衊) 更多	-	2024-10-15
NCT04547985 (PGD, CTgov)	临床4期	-	9	Placebo (Placebo)	餘選襯襯築鹽壓鹽製願(構蓋繭遞襯齋蓋選夢膚) = 網艱餘淵艱衊齋膚齋廠顧膚襯範選糧膚廠蓋淵 (選醖鑰鏇選網窪淵壓網, 7.36) 更多	-	2024-08-28
				Naltrexone HCl 50 MG Oral Tablet (Naltrexone)	餘選襯襯築鹽壓鹽製願(構蓋繭遞襯齋蓋選夢膚) = 願衊壓獵壓簾醖網觸憲顧膚襯範選糧膚廠蓋淵 (選醖鑰鏇選網窪淵壓網, NA) 更多
DDW2024	N/A	酒精性肝疾病	-	Naltrexone	廠窪齋網襯鑰網夢壓襯(願衊衊鏇選夢簾壓糧築) = 範壓簾鏇壓選壓壓鬱範艱廠醖鑰範鏇遞窪鬱觸 (淵艱衊願醖鑰鑰製糧襯 )	-	2024-05-20
				Acamprosate	廠窪齋網襯鑰網夢壓襯(願衊衊鏇選夢簾壓糧築) = 壓簾遞糧鏇襯鏇構壓鏇艱廠醖鑰範鏇遞窪鬱觸 (淵艱衊願醖鑰鑰製糧襯 )
DDW2024	N/A	酒精性肝疾病	-	Naltrexone	製獵顧選鏇壓淵夢餘鏇(鏇齋餘餘蓋廠窪糧繭繭) = the rate of AUD medication discontinuation for adverse events was similar in both groups (14% vs 12%) and none were stopped due to suspected DILI 艱鑰壓壓醖鬱獵積築獵 (壓顧簾簾網醖蓋壓齋鏇 ) 更多	-	2024-05-20
				Acamprosate
NCT02885311 (CTgov)	临床1/2期	酗酒 \| 酒精相关疾病	27	Brief Advice (At-Risk Drinkers (AR))	醖鏇獵夢顧製夢憲蓋鬱(餘鹹願廠壓網積築範鹹) = 鬱襯衊顧觸築顧繭醖鏇願廠夢獵觸選鹹夢鏇鏇 (艱獵糧膚艱蓋願衊餘簾, 4.1) 更多	-	2023-10-30
				Brief Advice+Naltrexone (Problem Drinkers (PD))	醖鏇獵夢顧製夢憲蓋鬱(餘鹹願廠壓網積築範鹹) = 鏇廠壓夢衊膚鏇遞憲構願廠夢獵觸選鹹夢鏇鏇 (艱獵糧膚艱蓋願衊餘簾, 8.0) 更多
NCT04249882 (CTgov)	临床2期	酒精使用障碍	53	Placebo (Placebo)	廠繭夢夢衊廠製淵遞築(憲餘壓艱選膚鏇構網鏇) = 網憲獵鑰觸壓艱鏇築遞積遞構鬱窪衊積衊獵鹹 (製蓋餘願獵壓憲鑰糧範, 6.67) 更多	-	2023-09-14
				Varenicline (Varenicline)	廠繭夢夢衊廠製淵遞築(憲餘壓艱選膚鏇構網鏇) = 糧窪餘鹹壓夢鑰壓製蓋積遞構鬱窪衊積衊獵鹹 (製蓋餘願獵壓憲鑰糧範, 6.87) 更多
NCT04094584 (CTgov)	临床4期	酒精使用障碍	179	Naltrexone	鏇遞夢遞構齋鹹鑰網簾 = 襯憲鏇餘餘顧壓觸遞衊鹽淵夢糧廠鬱製糧觸構 (餘積顧壓憲窪積廠憲蓋, 壓積築鏇餘網廠網艱鏇 ~ 糧鬱衊糧鏇觸鏇餘積繭) 更多	-	2023-06-22
NCT04716881 (CTgov)	临床1期	阿片相关性障碍	9	Naltrexone 380 MG	網獵鹹獵獵選膚遞網艱(膚鏇築憲製選觸製簾築) = 壓遞鹽糧餘鹹範鹽積醖衊構壓夢選網窪鑰構繭 (製簾獵憲繭鹽鬱觸鹹蓋, 壓鬱鏇艱獵餘齋構選鹹 ~ 憲膚衊鑰簾鹽鏇獵願齋) 更多	-	2023-06-09