Phase II/III multicenter, randomized, double-blind, placebo-controlled trial on acetyl-L-carnitine (ALCAR) in subjects living with amyotrophic lateral sclerosis (ALS). Primary study aim: The clinical objective consists of assessing the efficacy of ALCAR (two different dosages will be tested: 1.5g/day and 3g/day) on the progression of functional disability (loss of self-sufficiency), as measured by the ALSFRS-R scale. Secondary study aims: 1. The effect of ALCAR treatment on different clinical aspects: functional decline as measured by ALSFRS-R total score; the decline of forced vital capacity (FVC); quality of life as measured by ALSAQ-40 scale; cognitive function as measured by Edinburgh Cognitive and Behavioural ALS Screen (ECAS) scale; survival (being alive and without tracheostomy). 2. To measure the effects of ALCAR treatment on disease biomarkers potentially involved in the drug's mechanisms of action. These include PGC-1 alpha, 3-nitrotyrosine (3-NT), acetyl cyclophilin A (acetyl-PPIA), neurofilament light chain (NFL), creatine kinase (CK), Musclin/osteocrin, MyomiRNA (MiR-206), Uric acid, Matrix metalloproteinase-9 (MMP-9), Monocyte Chemoattractant Protein-1 (MCP-1), 4-Hydroxynonenal (HNE). 3. The tolerability and safety of ALCAR treatment by identifying unexpected adverse events.
Study population: 246 subjects will be enrolled on one Australian and ten Italian ALS sites.
Inclusion criteria: subjects aged 18+ years with a diagnosis of ALS according to Gold Coast Criteria; disease duration <24 months; satisfactory bulbar and spinal function (self-sufficiency evaluated by a score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking); satisfactory respiratory function (FVC ≥80% of predicted); documented progression of symptoms as measured by the ALSFRS-R scale. Disease progression rate (DFS) must be>= 0.33. DFS =(48- ALSFRS-R at screening)/months from onset to screening, treatment with Riluzole in the last four weeks. Exclusion criteria: antecedent polio infection; other motor neuron disease; involvement of other systems possibly determining a functional impairment; other severe clinical conditions; unwillingness or inability to take riluzole; previous use of ALCAR for any reason; inability to understand and comply with the study requirements, and to give written informed consent personally or via their legally authorized representative.
All eligible participants will be randomized to receive ALCAR (1,5 or 3 g/day) or placebo in addition to riluzole 50 mg b.i.d. Permuted block (with a block size of 6), 1:1:1 centralized randomization scheme will be used. The overall treatment duration will be 48 weeks. After enrolment, each participant will be followed up until death. Eligible subjects will be seen after 4, 12, 24, 36 and 48 weeks. At each visit, a general assessment will be made, including vital signs, body mass index (BMI), neurological examination (including quantitative and qualitative evaluation of the motor system), comorbidity, concomitant treatments and adverse events. Blood samples will be collected at baseline -Day 1 (randomization)-, 4, 12, 24, 36 and 48 weeks to test biomarkers. Functional disability will be assessed at each visit using the ALS-FRS-R scale. The respiratory function will be assessed using a spirometer to measure FVC before starting treatment (baseline visit) and at 4, 12, 24, 36 and 48 weeks. Cognitive function will be evaluated at baseline, weeks 24 and 48, using ECAS scale. Health-related quality of life, measured by the ALSAQ-40, will be tested at baseline, 24 and 48 weeks. Compliance will be tested by the local investigators, counting unused packages at each follow-up visit. Pre-planned statistical analyses will be done on Intention-to-treat and Per-protocol (PP) populations. The statistical plan will include descriptive statistics and a comparison of the proportions of self-sufficient participants at week 48 using the chi-square or Fisher's exact test for the primary endpoint. Secondary endpoints measured by numerical scores obtained from clinical scales will be analyzed using repeated measures mixed models, while biomarkers using repeated measures ANOVA. Time-to-event endpoints, such as survival and the probability of remaining self-sufficient over 48 weeks, will be analyzed with Kaplan-Meier curves. The number of adverse events and serious adverse events after 48 weeks will be compared between treatment arms.

开始日期2025-01-01

申办/合作机构

Fightmnd

[+1]

CTRI/2024/07/070353

/ Not yet recruiting临床3期IIT

ACETYL-L-CARNITINE as augmentation therapyin Clozapine resistant Schizophrenia - NIL

开始日期2024-07-20

申办/合作机构-

NCT05653895

/ CompletedN/AIIT

Independent and Additive Effects Of Micronutrients With Metformin In Patients With PCOS:A Double Blind Randomized Placebo Controlled Trial

The investigators aim to conduct a double blind randomized clinical trial to study the independent and additive effects of micronutrients (Resveratrol, Acetyl-L Carnitine, L Arginine and COQ10 ) with Metformin in patients with PCOS .Women diagnosed with PCOS according to National Institute of Health( NIH) 2012 extension of European Society of Human Reproduction and Embryology /American Society of Reproductive Medicine ESHRE /ASRM 2003 criteria will be included according to a specific phenotype including Hyperandrogenism, Ovulatory dysfunction and Polycystic Ovarian Morphology. The investigators propose that by using combination therapy with micro supplements like Resveratrol, Acetyl-L Carnitine, L Arginine and COQ10 will produce greater improvement better than or at least comparable to Metformin in metabolic and endocrine profile of patients with PCOS.

开始日期2022-12-07

申办/合作机构

Khyber Medical University

100 项与乙酰左旋肉碱相关的临床结果

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100 项与乙酰左旋肉碱相关的转化医学

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100 项与乙酰左旋肉碱相关的专利（医药）

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项与乙酰左旋肉碱相关的文献（医药）

2025-02-01·ADDICTIVE BEHAVIORS

Mediation of beneficial effects of an alcohol-specific inhibition training on drinking of patients with alcohol use disorder: The role of cognitive demands and inhibitory performance

Article

作者: Jaeger, Joshua ; Tschuemperlin, Raphaela M ; Tschuemperlin, Raphaela M. ; Moggi, Franz ; Stein, Maria ; Wiers, Reinout W ; Batschelet, Hallie M. ; Batschelet, Hallie M ; Guarriello, Alessandra ; Wiers, Reinout W. ; Soravia, Leila M. ; Soravia, Leila M ; Fleckenstein, Tim

BACKGROUND:

A cognitively demanding, alcohol-specific inhibition training (Alc-IT) might enhance treatment success in patients with severe alcohol use disorder (AUD; Stein et al., 2023). An inhibitory working mechanism for Alc-IT has been discussed, but compelling evidence supporting this hypothesis is yet lacking. The present study investigates inhibitory performance during Alc-IT and examines whether inhibitory parameters mediate drinking outcome.

METHODS:

Patients with AUD (N = 232) completed six sessions of either a standard or improved Alc-IT, differing in their inhibitory demands determined by Go/NoGo-ratios in a modified Go-NoGo-task, or a control training. During these training sessions, data on inhibitory performance was collected. To assess differences in inhibitory performance and its improvement, alcohol-related errors of commission and relative performance, integrating accuracy and speed, were analyzed with hierarchical linear contrast models. Mediation analyses tested whether inhibitory performance predicted drinking outcome (percent days abstinent at 3-month follow-up).

RESULTS:

Patients in improved Alc-IT started with higher errors of commission (γ_01(standard) = -2.74, p < 0.001, R² = 0.885) and a lower relative performance in the first training session compared to standard Alc-IT (γ_01(standard) = 0.51, p = 0.004). They showed a steeper increase in relative performance until the final sixth session (γ_{1(s6),(standard)} = -0.37, p = 0.024, R² = 0.882). The effect of improved Alc-IT on drinking outcome was mediated by relative performance increase (bootstrap-CI [0.15, 7.11]).

CONCLUSION:

Higher inhibitory demands enable larger improvements across sessions. Mediation analysis supports an inhibitory working mechanism. Tailoring inhibitory demands to individual performance capacity could optimize future Alc-IT.

2025-02-01·FOOD CHEMISTRY

Structural characteristics determining starch digestibility in cooked rice complexed with an emulsion formulation

Article

作者: Mikami, Akifumi ; Saito, Takahiro ; Fujimoto, Akira ; Kobayashi, Hideaki ; Tamura, Masatsugu ; Susaki, Kenta ; Kitamura, Rika

To evaluate the effects of structural characteristics on amylose-lipid complex (ALC) formation and the starch digestibility of cooked rice grains with the addition of 0, 5, 10, and 20 % emulsification formulation (EMF), both cooked rice (CR) grains with intact structural characteristics and CR slurries with their structural characteristics destroyed were examined. When EMF was added, the surface firmness, adhesiveness and adhesion of the CR grain changed. Depressions associated with ALC formation were observed on the surface of CR grains. The addition of more than 10 % EMF significantly suppressed starch hydrolysis in CR grains, while there was no significant difference in the starch digestibility of CR slurries, regardless of the amount of EMF. These results revealed that the structural characteristics of a layer like ALC on the CR grains suppressed starch digestibility and that once the structural characteristics were destroyed, the inhibitory effect of ALC on starch digestibility was lost.

2025-01-01·JOURNAL OF PHARMACEUTICAL SCIENCES

Bioavailability improvement by atomic layer coating: Fenofibrate a case study

Article

作者: Wang, Fei ; Redasani, Vijayendra ; Narwankar, Pravin ; Gupta, Neha ; Ganapathy, Balaji ; Kadam, Ankur ; Debnath, Sujit

Biopharmaceutical Classification Systems (BCS) class II drugs show poor solubility and high permeability in the body. Fenofibrate (FF) is a classic example of a BCS class II drug, used to treat high cholesterol and triglyceride (fat-like substances) levels in the blood. Atomic layer coating (ALC) is a surface engineering technology adapted from the semiconductor industry, where metal oxides are coated one atomic layer at a time over the active pharmaceutical ingredients (API) particles. ALC coating was proven to improve the processability, alter the hydrophilicity, improve the stability, and fine-tune the release of drugs. Herein, we report the intervention of ALC coating in enhancing the bioavailability of a poorly water-soluble drug (fenofibrate) in the animal model. The physical properties of uncoated fenofibrate were compared with those of zinc oxide-coated and silicon oxide-coated fenofibrate. Following the application of the coatings, the structural integrity (both chemical stability and solid-state stability) of the active pharmaceutical ingredient (API) remained uncompromised, as corroborated by ¹H NMR and powder X-ray diffraction analyses. Notably, zinc oxide-coated fenofibrate exhibited favorable flow characteristics, whereas no discernible enhancement in flow behavior was observed for silicon oxide-coated fenofibrate. The results from contact angle measurements suggest that the silicon oxide-coated fenofibrate exhibits superior wetting behavior, as indicated by a contact angle nearing 0°. The application of ALC demonstrates an enhanced dissolution rate when compared to the uncoated active pharmaceutical ingredient (API) while leaving its equilibrium solubility unaffected. Coating the API with silicon oxide improves particle hydrophilicity and wetting properties, whereas zinc oxide coating aids in particle de-agglomeration, thereby enhancing their interaction with an aqueous medium. In vivo bioavailability studies conducted on rodents and larger animal (dog) models indicate a substantial increase in bioavailability (approximately 2 times) for the silicon oxide-coated API in comparison to the uncoated API, as determined by the area under the curve (AUC). Furthermore, the C_max values for the silicon oxide-coated API also demonstrate a significant increase (approximately 3 times) over the uncoated API. Notably, an oral subacute toxicity study of ALC silicon-coated fenofibrate revealed no toxic effects attributable to the coating. This study underscores the potential of ALC in augmenting the bioavailability of BCS(II) drugs.

项与乙酰左旋肉碱相关的新闻（医药）

2024-07-29

·梅斯医学

世界肝炎日，关注药物性肝损伤

7月28日是“世界肝炎日”，今年的宣传主题是“消除肝炎，积极行动”。近年来，我国病毒性肝炎发病率呈下降趋势，但非病毒性肝炎发病率明显升高，主要包括脂肪型肝炎、酒精性肝炎、药物性肝损伤（DILI）等。其中，药物性肝损伤是当前急性肝损伤最为常见的病因之一，正成为全球急性肝衰竭的主要病因，其占比正在逐渐增加。根据2014年发布的国内迄今最大规模的药物性肝损伤流行病学研究成果——《中国大陆药物性肝损伤发生率及病因学》显示，我国药物性肝损伤的年发病率为23.8/10万人，远高于法国、美国、西班牙、瑞士等欧美国家，其中急性药物性肝损伤占87%。目前已知全球有超出1100种上市药物具有潜在肝毒性。在欧美国家，非甾体抗炎药、抗感染药物是引起药物性肝损伤的常见药物。在我国，传统中草药和膳食补充剂、抗结核药、抗肿瘤药、免疫调节剂是引起肝损伤的主要可疑药物。在亚洲，传统治疗药物具有悠久的应用历史并广泛用于各类疾病的预防和治疗。由于很多患者存在草药“天然无毒”的错误认识，对草药的肝损伤风险常缺乏警惕，我国多数研究报道的 DILI 患者由草药引起占比约为 20% ～ 30% 。在我国，据报道可能引起肝损伤的有何首乌、雷公藤、黄药子、补骨脂、千里光、淫羊藿、菊三七等 HMs 及其汤剂或成药。 1、根据发病机制，DILI 分为固有型、特异质型和间接型： 2、根据生物化学异常模式，DILI分为肝细胞损伤型、胆汁淤积型和混合型：（1）肝细胞损伤型：R ≥ 5；轻者可无任何症状；重者则可出现黄疸，如全身皮肤和 / 或巩膜黄染、尿色加深等，伴或不伴不同程度的乏力、食欲减退、厌油、肝区胀痛及上腹不适等非特异性消化道症状。（2）胆汁淤积型：R ≤ 2；明显者可出现黄疸、大便颜色变浅和瘙痒等表现。进展为 ALF/SALF 者则可出现黄疸、凝血功能障碍、腹水、肝性脑病等相关症状。（3）混合型：2 ＜ R ＜ 5。 R 值＝ [ 丙氨酸转氨酶（ALT）实测值 /ALT 的正常值上限（ULN）] / [ 碱性磷酸酶（ALP）实测值/ALP的ULN]。ALT缺失时，可用天冬氨酸转氨酶（AST）取代进行计算。 R值计算通常是基于首次可获得的异常肝脏生物化学检查结果，可大致反映肝损伤时的生物化学异常模式。发病起始时的 R 值可随着肝损伤的演变而发生变化，病程中动态监测 R 值，有助于更全面地了解和判断肝损伤的演变过程。 3、特殊表型 7% ～ 13% 的患者在急性 DILI 事件后的 6 个月或 1 年，肝脏生物化学指标仍未恢复至正常或基线水平，提示急性肝损伤可能转化为慢性或肝损伤延迟恢复。 1、病史采集：详细、完整的包括可疑药物应用史在内的病史采集对评估因果关系，最终建立 DILI 诊断至关重要。疑似 DILI 患者，建立诊断或进行因果关系评估至少需采集的病史信息包括：（1）可疑药物信息及开始和停止用药时间；（2）可疑药物和/或同类药物的既往暴露史及反应；（3）其他合并用药信息及反应；（4）疑似 DILI 事件的起病时间、预后、去激发的反应等；（5）伴随疾病和基础肝病或既往肝损伤史；（6）排除肝损伤其他病因。 2、实验室检查：诊断急性 DILI 时肝脏生物化学阈值需达到下述标准之一：（1）ALT ≥ 5×ULN ；（2）ALP ≥ 2×ULN（尤其是伴随 GGT 升高且排除骨骼疾病引起的 ALP 水平升高）；（3）ALT ≥ 3×ULN 同时 TBil ≥ 2×ULN。未达上述阈值标准而因果关系评估为药物引起者，可界定为药物性肝脏生物化学异常。需提醒的是，上述肝脏生物化学阈值标准仅适用于急性 DILI 时的诊断，不适用于慢性和特殊表型 DILI 的临床诊断。 3、组织学检查 DILI 的组织学表现复杂多样，几乎涵盖了肝脏病理改变的全部范畴。由于缺乏特异性的诊断生物标志物，DILI 的诊断目前仍是基于详细病史采集、临床症状和体征、血清生物化学、影像学和组织学等的排他性策略。根据药品不良反应 / 事件关联性评价的原则，建立诊断最终很大程度上依赖于：（1）药物暴露或停药与肝脏生物化学的改变有明确、合理的时效关系；（2）肝损伤的临床和/或病理表现（型）与可疑药物已知的肝毒性一致；（3）停药或减少剂量后肝损伤显著改善或恢复正常；（4）再次用药后肝损伤再次出现；（5）排除了肝损伤的其他病因和基础肝病的活动或复发，且无法用其他合并用药/治疗手段、原发疾病进展来解释。急性 DILI 诊断建立后，需对其严重程度进行评估，可按以下国际 DILI 专家工作组标准： 1级（轻度）：ALT ≥ 5×ULN 或 ALP ≥ 2×ULN 且 TBil ＜ 2×ULN； 2级（中度）：ALT ≥ 5×ULN 或 ALP ≥ 2×ULN 且 TBil ≥ 2×ULN，或有症状性肝炎； 3级（重度）：ALT ≥ 5×ULN 或 ALP ≥ 2×ULN 且 TBil ≥ 2×ULN，或有症状性肝炎并达到下述任何 1 项： ①INR ≥ 1.5， ②腹水和/或肝性脑病，病程 < 26 周，且无肝硬化， ③DILI 导致的其他器官功能衰竭； 4级（致命）：因 DILI 死亡，或需接受肝移植才能生存。除了及时停用可疑肝损伤药物，尽量避免再次使用可疑或同类药物外，还可以结合目前循证医学证据，合理选择治疗药物。除了上述比较常用的药物外，临床可以根据患者的具体情况酌情使用多烯磷脂酰胆碱、熊去氧胆酸、腺苷蛋氨酸、左旋肉碱和谷胱甘肽等。 1、鹅膏毒素引起的 DILI——水飞蓟素（宾）类多项临床研究证实水飞蓟素（宾）类能够有效治疗鹅膏毒素中毒所致肝损伤。一项收集20年2000例毒蕈导致肝损伤患者的回顾性研究发现，应用水飞蓟素（宾）类的病死率为5.8%，而未使用水飞蓟素（宾）类的病死率高达14.1%。此外，还有临床研究证实水飞蓟素（宾）类治疗毒蕈中毒时安全性良好，可用于中位数年龄为5岁的儿童患者。 2、胆汁淤积型DILI——熊去氧胆酸/S-腺苷蛋氨酸：胆汁淤积型DILI患者，尤其是严重或恢复缓慢的胆汁淤积型或混合型DILI患者中可使用熊去氧胆酸或S-腺苷蛋氨酸，用以降低ALP水平。 3、对乙酰氨基酚（APAP）引起的固有型DILI——N-乙酰半胱氨酸（NAC）： NAC是被FDA批准用来治疗APAP引起的固有型DILI的唯一解毒药物。 4、急性DILI——异甘草酸镁：异甘草酸镁是目前唯一具有急性DILI适应证的药物。 5、DRESS综合征、DI-ALH、ICIs肝毒性——糖皮质激素：对于伴随超敏或自身免疫征象的免疫介导的DILI是糖皮质激素应用的指征，如DRESS综合征、DI-ALH、ICIs肝毒性。参考文献： [1]中国医药生物技术协会药物性肝损伤防治技术专业委员会, 中华医学会肝病学分会药物性肝病学组. 中国药物性肝损伤诊治指南（2023 年版）[J]. 中华肝脏病杂志,2023,31(4):355-384. [3]水飞蓟制剂肝病临床应用专家委员会. 水飞蓟制剂肝病临床应用专家共识 [J]. 中华实验和临床感染病杂志（电子版）,2016,10(5):517-521. 内容来源于网络，如有侵权，请联系删除。

2024-02-06

·PRNewswire

Recognize National Senior Independence Month by Supporting Your Vitality With Gundry MD Energy Renew

A Dietary Supplement That Helps Recharge Your Energy and Fight Visible Signs of Aging LOS ANGELES, Feb. 6, 2024 /PRNewswire/ -- February is National Senior Independence Month. It is dedicated to empowering our senior community with the tools and knowledge to achieve well-being and vitality. Dr. Steven Gundry, a cardiothoracic surgeon and renowned expert in health and nutrition, provides invaluable tips to help maintain independence and vitality at any age. Continue Reading Gundry MD Energy Renew is a dietary supplement crafted with the delightful flavors of passionfruit and hibiscus. This specially crafted supplement is designed to help bolster your body's cell vitality, enabling the generation of energy. Formulated with the finest ingredients, including an exclusive polyphenol blend, Gundry MD Energy Renew cannot only support healthy energy levels but also help promote sustained wakefulness and mental clarity, aiding in your daily recovery. Navigating the natural changes that come with aging, like pains and decreased energy, can be challenging. But, Dr. Gundry teaches that aging does not have to equate to this. His motto is to help people 'die young at a ripe old age.' Dr. Gundry emphasizes three key tips to support longevity and vitality: Exercise Snacking: Incorporating short bursts of physical activity throughout the day, or as he likes to call it, "exercise snacking" Exercise snacking is a powerful way to boost energy levels and enhance overall well-being. Simple, quick exercises can make a significant difference in maintaining mobility and vitality, such as doing squats while brushing your teeth, dancing in your living room to an entire song, or leg or calf raises while you're watching TV Gut-Buddy Friendly Diet: Dr. Gundry advocates for a diet that feeds your good gut bacteria and starves the bad bacteria. Eat foods with soluble fiber, like asparagus and pressure-cooked beans. Incorporate fermented foods, like sauerkraut and sugar-free coconut yogurt, daily. And avoid sugary, highly processed foods. Take Supplements: To further support your energy levels and vitality, Dr. Gundry recommends using Gundry MD Energy Renew. This unique supplement features a robust blend of superfruits and hibiscus, combined with D-Ribose and Acetyl L-Carnitine. These ingredients work synergistically to support your energy stores and combat the unpleasant discomfort that comes with aging.†* Energy Renew also boasts a distinctive blend of superfruit extracts, delivering a mega-boost of polyphenols. These compounds act as powerful antioxidants and help "rewind the clock" and offer support to tired, aging cells. By incorporating Gundry MD Energy Renew into your daily routine, you can take proactive steps towards maintaining independence and embracing the joys of aging with vitality.†* What is Gundry MD Energy Renew? Gundry MD Energy Renew is a passion fruit-flavored dietary supplement designed to unleash the benefits of its unique blend of ingredients, promoting youthful energy and vitality. This powerful formula includes superfruits and hibiscus, coupled with D-Ribose and Acetyl L-Carnitine, working harmoniously to help boost cellular energy without the risk of crashing. Within Gundry MD Energy Renew, superfruits flood your body with antioxidants, supporting the immune system and facilitating easier weight management. Meanwhile, the combination of D-Ribose and Acetyl L-Carnitine enhances alertness throughout the day, promoting a youthful feeling and contributing to healthy-looking skin. This well-balanced blend of potent energy boosters and superfruits serves as an ideal pick-me-up for those grappling with exhaustion, weakness, or premature visible aging. Gundry MD Energy Renew also features healthy compounds capable of virtually support aging cells. This unique aspect of the supplement can help foster independence and mobility as you age, making it a comprehensive solution for your overall well-being.†* Where to Purchase Gundry MD Energy Renew Gundry MD Energy Renew can be purchased on the Gundry MD website for the cost of $74.95 for a 30-day supply with a 90-day purchase price guarantee. Suggested Use of Gundry MD Energy Renew Gundry MD Energy Renew can be effortlessly prepared by mixing one scoop of the passionfruit-hibiscus flavored powder with 8 oz. of water. You can incorporate this supplement into your routine at any time of day. Simply mix, sip, and experience the revitalizing benefits of Gundry MD Energy Renew. About Gundry MD Founded in 2015, Gundry MD is dedicated to providing cutting-edge solutions to its users by using science-backed ingredients that can offer a boost in metabolism, all-day energy, smooth, easy digestion, and a youthful-feeling mind and body. These amazing results all begin with feeding your body powerful health-boosting nutrients like polyphenols. Based on his many years of nutrition research, Dr. Gundry helps create every Gundry MD product. Best-selling Gundry MD products include Total Restore, Energy Renew, and Polyphenol-Rich Olive Oil. All Gundry MD products come with a 90-day purchase price guarantee if you are not satisfied. For more information, visit or @gundrymd on Instagram and Facebook.† About Dr. Gundry Founder of Gundry MD, Dr. Steven Gundry was one of the world's top cardiothoracic surgeons and is currently the medical director at The International Heart and Lung Institute and The Centers for Restorative Medicine in Palm Springs, Beverly Hills, and Santa Barbara, California. He has spent the past 25 years helping people restore their health by optimizing nutrition and lifestyle choices. Steven Gundry, MD is also the host of the top-ranked health podcast, The Dr. Gundry Podcast, and author of four New York Times best-selling books including The Plant Paradox™ which details his famous lectin-free Plant Paradox Diet. His new book Gut Check provides the keys to unlocking our gut health, allowing our bodies, and their microbiome, to function at their highest potential. For more information, visit drgundry.com and the Dr. Gundry YouTube channel, and follow @drstevengundry on Instagram and TikTok. *All individuals are unique. Your results can and will vary. Media Contact: Ashley Beenen [email protected] SOURCE Gundry MD

2024-01-30

·药研发

【药研发0131】齐鲁创新药ALK/ ROS1抑制剂肺癌III期临床见刊 | 浙江普洛终止索法地尔脑卒中III期临床...

「本文共：16条资讯，阅读时长约：3分钟」今日头条齐鲁ALK/ROS1抑制剂肺癌III期临床见刊。齐鲁制药新型口服ALK/ROS1抑制剂伊鲁阿克（WX-0593）在《胸部肿瘤学杂志》上公布一线治疗局部晚期或转移性ALK阳性、非小细胞肺癌（NSCLC）的III期INSPIRE研究积极结果。IRC评估的结果显示，与克唑替尼相比，WX-0593显著提高患者无进展生存期（中位PFS：27.7个月vs14.6个月），使疾病进展或者死亡风险降低了66％。两组重度不良反应的发生率相当（51.7%vs49.7%）。国内药讯1.恒瑞「他克莫司缓释胶囊」获FDA批准上市。恒瑞医药宣布「他克莫司缓释胶囊」的简略新药申请（ANDA）已获得FDA批准。他克莫司是一种强效的免疫抑制剂，能够抑制造成移植排斥反应之细胞毒淋巴细胞的生成、T细胞活化及T辅助细胞依赖型B细胞的增殖、淋巴因子的生成（如白细胞介素2、白细胞介素3及γ干扰素）以及白细胞介素2受体的表达。该产品原研产品由安斯泰来开发，美国商品名为Astagraf XL。2.亘喜双靶点FasTCAR-T获批新临床。亘喜生物靶向BCMA/CD19双靶点自体FasTCAR-T产品GC012F获FDA临床许可，即将在美国开展早线治疗多发性骨髓瘤(ELMM)Ⅰ期临床。去年2月和11月，FDA已批准GC012F在美国针对复发/难治性多发性骨髓瘤（R/R MM）和难治性系统性红斑狼疮（SLE）开展Ⅰ/Ⅱ期临床试验。在治疗R/R MM的临床试验（IIT）中，GC012F的总体应答率（ORR）达到100%。3.恒瑞PD-L1+CTLA-4单抗联合用药获批临床。恒瑞医药PD-L1单抗阿得贝利单抗注射液获国家药监局临床试验默示许可，拟联合CTLA-4单抗SHR-8068及含铂双药用于携带丝氨酸-苏氨酸激酶11（STK11）基因突变，或Kelch样环氧氯丙烷相关蛋白1（KEAP1）基因突变，或鼠类肉瘤病毒癌基因（KRAS）突变的晚期或转移性非鳞状非小细胞肺癌患者的一线治疗。4.浙江普洛终止索法地尔脑卒中III期临床。普洛药业宣布终止其1类化药注射用索法地尔治疗急性缺血性脑卒中的III期临床试验。临床试验终止后，已入组的受试者将继续按照临床试验方案进行随访。2009年，普洛药业旗下家园药业通过韩国Neurotech（GNT Pharma）授权，获得该产品在大中华区的自主知识产权。截至目前，索法地尔研发投入共计1.22亿元（未经审计）。5.疫苗研发公司康乐卫士申请港交所IPO。1月29日，康乐卫士在港交所递交IPO申请并获得受理。招股书显示，该公司拥有丰富的HPV疫苗产品组合。核心产品三价HPV疫苗将于2024年递交上市申请，九价HPV疫苗将于2025年递交上市申请，十五价HPV疫苗将于2024年启动Ⅰ期临床。康乐卫士还正在开发RSV疫苗、带状疱疹疫苗、七价诺如病毒疫苗、HFMD疫苗、脊髓灰质炎疫苗和二价治疗性HPV疫苗。国际药讯1.FDA发布基因编辑疗法和CAR-T开发指南。FDA日前针对使用基因组编辑的基因疗法和体外制造的CAR-T产品发布最终行业指南。FDA支持对基因组编辑产品使用加速批准通道，并鼓励开发商尽早讨论在研产品使用这一途径的可能性，包括在临床开发早期进行讨论，提供替代终点或中间临床终点。CAR-T开发指南除了提供关于CMC、药理学和毒理学以及临床试验设计的具体建议外，还新增了对癌症适应症的关注。2.Celltrion托珠单抗生物类似药在美报BLA。Celltrion旗下Celltrion USA公司开发的托珠单抗生物类似药CT-P47已向FDA递交生物制品许可申请（BLA）。托珠单抗原研产品（商品名：Actemra）是罗氏子公司中外制药开发的一款抗白介素-6受体（IL-6R）单抗，目前已获批用于治疗类风湿关节炎、活动性多关节幼年特发性关节炎、巨细胞动脉炎、细胞因子释放综合征、系统性硬化症相关间质性肺疾病（SSc-ILD）和新型冠状病毒感染等6项适应症。3.K药辅助治疗肾癌最新III期临床积极。默沙东PD-1抑制剂Keytruda辅助治疗肾切除术后或肾切除术联合转移灶切除术后有中高/高复发风险的肾细胞癌（RCC）患者的III期KEYNOTE-564研究结果积极。中位随访为57.2个月时，K药辅助治疗可使疾病复发或死亡风险降低28%（HR=0.72 [95% CI, 0.59-0.87]）；显著改善患者总生存期，死亡风险降低38%；研究中未出现新的安全性信号。4.Locus公司CRISPR噬菌体疗法上Ⅱ/Ⅲ期临床。Locus公司宣布获得美国生物医学高级研究与发展管理局（BARDA）2390万美元资助，将启动一项Ⅱ/Ⅲ期临床试验，评估CRISPR增强型噬菌体疗法LBP-EC01用于治疗由耐药性大肠杆菌引起的尿路感染（UTIs）患者的潜力。LBP-EC01具有独特的双重作用机制：噬菌体的天然裂解活性和CRISPR-Cas3的DNA靶向活性。该产品在杀死致病菌的同时保留有益细菌。5.体内RNA编辑疗法获批眼科Ⅰ/Ⅱ期临床。Ascidian公司RNA外显子编辑疗法ACDN-01获FDA批准开展Ⅰ/Ⅱ期临床STELLAR，评估一次性经视网膜下注射ACDN-01在患有Stargardt病和其他ABCA4相关视网膜病变的受试者中的安全性与初步疗效。Stargardt病是由ABCA4基因变异导致的一种遗传性黄斑变性。ACDN-01能够重新编辑RNA序列，将导致疾病的RNA序列替换为功能正常的RNA序列。6.吉利德与Arcus公司修订合作协议。吉利德宣布修订与Arcus公司的合作协议，并向Arcus公司追加3.2亿美元投资，将持股比例提高至33%。根据修订协议，两家公司重新确定了TIGIT抗体多凡纳利单抗（Domvanalimab）联合开发项目的优先次序，专注于推进并可能加速STAR-121（肺癌）和STAR-221（胃肠道癌）的Ⅲ期研究；注册启动一项Ⅲ期肺癌研究STAR-131（包括domvanalimab和PD-1抗体zimberelimab方案）。2020年，吉利德已与Arcus达成为期10年的合作。医药热点1.马斯克称已完成首例人类大脑设备植入手术。当地时间29日，马斯克在社交媒体上表示，其脑机接口公司Neuralink已完成首例人类大脑设备植入手术，接入者“恢复良好”。Neuralink公司的首款产品被命名为Telepathy(心灵感应)。马斯克表示，“只需要思考，就可以控制手机或电脑，并通过它们控制几乎任何设备”。首批使用者将是失去肢体功能的人。2.山东省立医院临床心理科成立。1月26日，山东第一医科大学附属省立医院（山东省立医院）临床心理科正式揭牌成立。临床心理学科在心理咨询门诊的基础上增设了病房服务。临床心理科病房的成立将助力增强专业科室的临床诊疗和科研教学水平，进一步提升医院综合服务能力和水平。3.去年跨省异地就医直接结算1.29亿人次。国家医保局29日公布2023年全国医疗保障跨省异地就医直接结算公共服务信息，信息显示，2023年1—12月，跨省异地就医直接结算运行基本平稳，跨省异地就医直接结算1.29亿人次，减少参保群众垫付1536.74亿元，分别较2022年增长238.67%、89.91%。截至2023年12月底，全国住院费用跨省联网定点医疗机构达8.23万家，较2022年底增加1.96万家。2023年1—12月，全国住院费用跨省直接结算1125.48万人次，减少个人垫付1351.26亿元，分别较2022年增长97.87%、77.25%。评审动态 1. CDE新药受理情况（01月30日) 2. FDA新药获批情况（北美01月29日）股市资讯上个交易日 A 股医药板块 -2.79%涨幅前三跌幅前三广誉远 +9.98% 常山药业-11.67%通化东宝+4.78% 金凯生科-11.00%安图生物+4.21% 华熙生物-10.63%【透景生命]全资子公司上海透最申报的乙酷左旋肉碱、氯化胆碱、y-丁基甜菜碱、左旋肉碱和氧化三甲胺质控品、乙酰左旋肉碱、氯化胆碱、y-丁基甜菜碱、左旋肉碱和氧化三甲胺校准品医疗器械注册申请于近期获得了上海市药品监督管理局的受理。【明德生物]发布业绩预告，预计2023年年度实现归属于上市公司股东的净利润盈利5500万元--7500万元，同比增长98.69%至-98.22%;扣除非经常性损益后的净利润盈利-1.2亿元至-9000亿元。【君实生物]发布业绩预告，预计2023年年度实现营业收入15.41亿元左右。同比增长6.02%左右;归属于母公司所有者的净利润-22.5亿元左右，同比亏损减少5.78%左右;归属于母公司所有者扣除非经常性损益后的净利润-22.79亿元左右，同比亏损减少6.99%左右。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

临床3期临床2期疫苗IPO上市批准

100 项与乙酰左旋肉碱相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	乙酰左旋肉碱	N06BX12	DB08842

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
周围神经系统疾病	意大利	Sigma-Tau Industrie Farmaceutiche Riunite SpA	1997-01-05
痴呆	意大利	Sigma-Tau Industrie Farmaceutiche Riunite SpA	1996-12-31
糖尿病性神经病变	意大利	Sigma-Tau Industrie Farmaceutiche Riunite SpA	1995-02-23
阿尔茨海默症	意大利	Sigma-Tau Industrie Farmaceutiche Riunite SpA	1995-01-28

未上市

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适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	临床3期	意大利	Leadiant Biosciences, Inc.	2008-04-01
高血压	临床3期	意大利	Leadiant Biosciences, Inc.	2008-04-01
乳腺癌	临床2期	美国	Alfasigma SpA	2007-03-01
糖尿病并发症	临床2期	日本	Mitsubishi Tanabe Pharma Corp.	-
疲劳	临床2期	美国	Sigma-Tau Industrie Farmaceutiche Riunite SpA	-
肌萎缩侧索硬化	药物发现	美国	Leadiant Biosciences, Inc.	-
Leber氏遗传性视神经萎缩	药物发现	美国	Leadiant Biosciences, Inc.	-

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临床结果

适应症

分期

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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


NCT01695317 (EUDRACT (2012-001624-36) \| ALCAR, CTgov)	临床4期	偏头痛	72	Acetyl-L-carnitine (Acetyl-L-carnitine)	簾構夢顧繭遞製觸遞繭(蓋壓窪遞齋窪艱鹽壓糧) = 衊鏇網選鏇觸廠觸鑰簾膚鑰壓獵衊遞廠觸憲餘 (齋鬱壓蓋構積簾壓鬱夢, 醖鬱鑰淵顧構顧範膚淵 ~ 構範鬱衊衊遞構艱鑰簾) 更多	-	2022-04-13
				Acetyl-L-carnitine (Sugar Pills)	簾構夢顧繭遞製觸遞繭(蓋壓窪遞齋窪艱鹽壓糧) = 築襯鹹憲淵選夢遞齋夢膚鑰壓獵衊遞廠觸憲餘 (齋鬱壓蓋構積簾壓鬱夢, 夢窪膚簾夢鬱獵簾鬱膚 ~ 鹹憲蓋膚膚廠餘鬱窪壓) 更多
NCT01054768 (CTgov)	临床2期	炎症 \| 镰状细胞血症	37	alpha-lipoic acid+acetyl-L-carnitine (Alpha-lipoic Acid and Acetyl-L-carnitine)	窪壓壓構糧鑰壓顧鹽願(築鑰積淵餘顧繭衊鬱願) = 衊顧顧顧壓顧夢窪憲鏇網鏇顧廠遞鬱築淵壓鏇 (淵築獵衊艱衊網醖願鑰, 餘窪範鹽夢築築獵觸鑰 ~ 網獵夢願繭窪繭鏇糧膚) 更多	-	2021-08-03
				Control (Placebo)	窪壓壓構糧鑰壓顧鹽願(築鑰積淵餘顧繭衊鬱願) = 願繭顧鹹齋淵鹹範糧構網鏇顧廠遞鬱築淵壓鏇 (淵築獵衊艱衊網醖願鑰, 積壓獵顧製簾範壓鏇製 ~ 鑰壓鬱衊鑰糧襯淵範願) 更多
NCT05601479 (Pubmed \| Exp Ther Med)	临床2期	化疗引起的损伤	239	Acetyl-L-carnitine	夢窪淵壓鬱簾獵蓋膚範(網衊鹽窪範衊蓋範壓餘) = 壓獵夢繭範蓋窪簾願鬱齋獵醖壓遞淵顧鑰獵獵 (繭壓製壓選鹹蓋選淵憲 )	积极	2016-12-01
				Placebo	夢窪淵壓鬱簾獵蓋膚範(網衊鹽窪範衊蓋範壓餘) = 繭選獵廠鬱鹹廠獵遞鹽齋獵醖壓遞淵顧鑰獵獵 (繭壓製壓選鹹蓋選淵憲 )
NCT02485158 (TDS, CTgov)	N/A	-	28	placebo+d-amphetamine+amphetamine+THC (AMP Arm)	糧衊願衊餘蓋獵鬱襯繭(鑰壓鹹遞艱憲製觸築簾) = 壓鏇襯糧繭壓夢製製簾鹹簾製糧鏇願餘獵壓獵 (窪艱積製淵範襯鬱膚鹹, 淵艱鬱憲顧遞選襯夢簾 ~ 膚遞鏇鑰艱簾膚齋顧網) 更多	-	2016-11-29
				placebo+d-amphetamine+THC (ALC Arm)	糧衊願衊餘蓋獵鬱襯繭(鑰壓鹹遞艱憲製觸築簾) = 壓餘膚選鹹淵觸憲襯艱鹹簾製糧鏇願餘獵壓獵 (窪艱積製淵範襯鬱膚鹹, 衊願製齋襯醖餘膚襯顧 ~ 顧觸襯鑰鏇鑰淵願獵窪) 更多
NCT01695317 (EUDRACT (2012-001624-36), Pubmed \| Cephalalgia)	临床4期	偏头痛	72	Acetyl-l-carnitine	壓選築鬱鏇鹹鏇範遞獵(選觸壓顧憲製壓繭窪簾) = 選繭糧餘構鏇廠壓鏇鹽廠選餘襯簾齋鹹顧餘獵 (襯鑰製壓顧艱淵衊壓積 )	不佳	2015-10-01
				Placebo	壓選築鬱鏇鹹鏇範遞獵(選觸壓顧憲製壓繭窪簾) = 鹽網鏇膚鬱繭窪鏇壓觸廠選餘襯簾齋鹹顧餘獵 (襯鑰製壓顧艱淵衊壓積 )
SNMMI2014	N/A	-	-	Acetyl-L-Carnitine (ALC)	繭製鬱選簾夢積選構獵(襯蓋淵憲醖廠網觸壓襯) = 淵網夢選醖範願築齋獵願憲選積鏇遞顧獵淵鹹 (鬱繭襯壓積餘築醖範糧 )	-	2014-11-05
				Methamphetamine (METH)	願憲鹽夢鏇醖構築鹽鬱(繭鹹積觸襯鑰窪範鬱願) = 鹹遞蓋繭積夢夢餘膚醖鑰簾鏇顧鹽艱鹹醖繭蓋 (膚鏇願鏇網壓製窪製鹹 )
Pubmed \| Amyotroph Lateral Scler Frontotemporal Degener	N/A	肌萎缩侧索硬化	-	Acetyl-L-carnitine 3g/day	製齋築衊憲網範簾積繭(鬱顧蓋鑰襯齋窪鬱鏇夢) = 醖築廠膚簾築積鹹淵淵壓鬱糧淵鹹蓋鹹築積獵 (選選齋窪鹽襯蓋顧鏇選, 10.4) 更多	积极	2013-09-01
				Placebo	製齋築衊憲網範簾積繭(鬱顧蓋鑰襯齋窪鬱鏇夢) = 壓壓糧積積衊鏇鑰壓顧壓鬱糧淵鹹蓋鹹築積獵 (選選齋窪鹽襯蓋顧鏇選, 9.9) 更多
NCT00719706 (CTgov)	临床2期	躁郁症	40	alpha-lipoic acid+acetyl-l-carnitine (ALCAR/ALA)	繭窪鏇壓醖築製鬱獵顧(齋顧齋築襯鹹淵鹽網積) = 願齋憲糧獵壓鑰願廠襯顧艱願願淵構觸膚餘鏇 (鏇鹽衊願襯艱餘鹽淵繭, 廠願製夢襯夢憲鹽膚築 ~ 願鬱顧餘鑰壓觸鏇獵窪) 更多	-	2012-07-18
				placebo (Placebo)	繭窪鏇壓醖築製鬱獵顧(齋顧齋築襯鹹淵鹽網積) = 艱壓獵壓齋醖顧窪鹹夢顧艱願願淵構觸膚餘鏇 (鏇鹽衊願襯艱餘鹽淵繭, 顧繭獵鹹鹹鹹膚淵鏇範 ~ 夢衊鹹艱觸膚餘鹽製顧) 更多
P04.151 (AAN2012)	N/A	肌萎缩侧索硬化	-	Acetyl-L-Carnitine 3g/day + Riluzole 100mg/day	鹽鑰網選遞鏇夢築膚壓(壓襯繭構繭繭糧顧簾蓋) = 膚築襯壓網鹹廠遞襯窪網選憲遞鹹鹹壓襯鏇獵 (顧選鹽構觸築積積選餘 ) 更多	积极	2012-04-23
				Placebo + Riluzole 100mg/day	鹽鑰網選遞鏇夢築膚壓(壓襯繭構繭繭糧顧簾蓋) = 醖範繭艱範餘範醖繭鏇網選憲遞鹹鹹壓襯鏇獵 (顧選鹽構觸築積積選餘 ) 更多
NCT00592488 (ALC, CTgov)	临床1/2期	脓毒性休克	13	Acetyl-L-Carnitine (ALC) (Acetyl-L-Carnitine (ALC) Then Placebo)	壓簾選製衊網網觸餘餘(願選獵願鑰醖艱遞繭獵) = 壓廠齋鏇齋簾顧鹹鏇膚鹹襯齋觸壓鬱簾顧構膚 (顧願鹹憲顧繭鏇積觸構, 遞衊鏇獵窪鏇廠壓膚餘 ~ 構簾獵壓艱鹽製憲醖遞)	-	2011-06-08
				Placebo (Placebo Then Acetyl-L-Carnitine (ALC))	壓簾選製衊網網觸餘餘(願選獵願鑰醖艱遞繭獵) = 遞蓋壓餘簾醖鑰鏇簾窪鹹襯齋觸壓鬱簾顧構膚 (顧願鹹憲顧繭鏇積觸構, 憲願範餘觸鑰鑰鏇憲築 ~ 襯鹹觸觸醖鹽繭餘遞齋)