更新于：2024-06-21

Luliconazole

卢立康唑

更新于：2024-06-21

概要

概要

基本信息

药物类型

小分子化药

别名

Luconac Solution、Luliconazole (JAN/USAN/INN)、Lulifin

+ [12]

靶点

fungal CYP51A1

作用机制

fungal CYP51A1抑制剂(真菌细胞色素P450家族成员51抑制剂)

治疗领域

感染皮肤和肌肉骨骼疾病

在研适应症

手癣甲癣皮肤念珠菌病+ [7]

非在研适应症

慢性皮肤黏膜念珠菌病

原研机构

Nihon Nohyaku Co., Ltd.

在研机构

Sato Pharmaceutical Co., Ltd.

海南海灵化学制药有限公司Bausch Health US LLC

+ [6]

非在研机构

Topica Pharmaceuticals, Inc.

Medicis Pharmaceutical Corp.

Janus Pharmaceuticals, Inc.

最高研发阶段批准上市

首次获批日期

日本 (2005-04-11),

念珠菌病花斑癣癣

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C14H9Cl2N3S2

InChIKeyYTAOBBFIOAEMLL-REQDGWNSSA-N

CAS号187164-19-8

关联

项与卢立康唑相关的临床试验

CTRI/2024/03/063613 / Not yet recruiting临床4期

A Comparative study to evaluate the efficacy and safety of topical Luliconazole versus topical Ciclopirox olamine among patients with Tinea corporis/cruris - NIL

开始日期2024-03-16

申办/合作机构

Pradeep Trading Co.

CTRI/2023/01/049161 / Active, not recruiting临床3期

A randomized study to evaluate and compare the efficacy of emollient versus topical luliconazole in the maintenance of remission of recurrent dermatophytosis after adequate systemic treatment.

开始日期2023-01-26

申办/合作机构-

CTRI/2022/03/041348 / Not yet recruiting临床4期IIT

COMPARISION OF EFFICACY OF LULICONAZOLE 1% W/W Vs AMOROLFINE 0.25% W/W IN THE TREATMENT OF TINEA CRURIS.A SINGLE CENTRE , RANDOMISED , DOUBLE BLIND , NON INFERIORITY STUDY.

开始日期2022-03-31

申办/合作机构-

100 项与卢立康唑相关的临床结果

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100 项与卢立康唑相关的转化医学

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100 项与卢立康唑相关的专利（医药）

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184

项与卢立康唑相关的文献（医药）

2024-03-01·International journal of biological macromolecules

Fabrication of gelatin coated polycaprolactone nanofiber scaffolds co-loaded with luliconazole and naringenin for treatment of Candida infected diabetic wounds

Article

作者: Manjit, Manjit ; Jha, Abhishek ; Kumar, Krishan ; Tiwari, Punit ; Koch, Biplob ; Singh, Virendra ; Mishra, Brahmeshwar ; Bharti, Kanchan ; Tilak, Ragini ; Kumar, Manish

The current study focuses on the development of gelatin-coated polycaprolactone (PCL) nanofibers co-loaded with luliconazole and naringenin for accelerated healing of infected diabetic wounds. Inherently, PCL nanofibers have excellent biocompatibility and biodegradation profiles but lack bioadhesion characteristics, which limits their use as dressing materials. So, coating them with a biocompatible and hydrophilic material like gelatin can improve bioadhesion. The preparation of nanofibers was done with the electrospinning technique. The solid state characterization and in-vitro performance assessment of nanofibers indicate the formation of uniformly interconnected nanofibers of 200-400 nm in diameter with smooth surface topography, excellent drug entrapment, and a surface pH of 5.6-6.8. The antifungal study showed that the nanofiber matrix exhibits excellent biofilm inhibition activity against several strains of Candida. Further, in-vivo assessment of nanofiber performance on C. albicans infected wounds in diabetic rats indicated accelerated wound healing efficacy in comparison to gauge-treated groups. Additionally, a higher blood flow and rapid re-epithelialization of wound tissue in the treatment group corroborated with the results obtained in the wound closure study. Overall, the developed dual-drug-loaded electrospun nanofiber mats have good compatibility, surface properties, and excellent wound healing potential, which can provide an extra edge in the management of complex diabetic wounds.

2024-02-01·Colloids and surfaces. B, Biointerfaces

Development of microemulgel formulations with varied permeation enhancers for transungual delivery of luliconazole in onychomycosis management

Article

作者: Dixit, Pradyumna Kumar ; Behera, Amulyaratna ; Habibullah, Sk ; Giri, Yashwant ; Mahalik, Gyanranjan ; Mohanty, Biswaranjan

Luliconazole-loaded microemulgels containing different permeation enhancers were formulated for transungual drug delivery for the management of onychomycosis, onychomycosis, which affects nails. The physicochemical properties like droplet size, zeta potential, pH, viscosity, spreadability, extrudability, oil binding capacity, drug content, and microscopic study were evaluated. The Pseudo-ternary phase diagram was constructed for the formulation of microemulsions (MEs) by keeping the K_m ratio constant at 3:1 and characterized for clarity, mean droplet size, zeta potential, viscosity, pH, transmittance, refractive index, and stability. The ME mean droplet size and zeta potential were found in the range of 38.78 to 171.4 nm, and 0.00 to - 6.6 mV, respectively. Prepared MEs were converted into microemulgel by adding a 2.5% gelling agent (Carbapol 934) in the external phase, and a drug release study was conducted. Formulation E3 showed better drug release and was chosen as the control. Four different penetration enhancers were added separately within E3 and further evaluated for pH, viscosity, spreadability, extrudability, oil binding capacity, drug content, microscopic study, Compatibility study, XRD, and DSC. A favorable docking score was observed between luliconazole and Lanosterol 14-alpha-demethylase. In-vitro cumulative drug release at the end of 24 h from E3-SS, containing sodium sulfide as a penetration enhancer, was found to be 94.70% and was 2 times more than the control formulation. Ex-vivo transungual permeation studies through cutting nail clippings were found to be in the range of 28.18 - 36.52 µg/mm². The microemulgels tagged as E3, E3-SS, and E3-SL showed a significant zone of inhibition against Candida albicans and Aspergillus fumigatus as compared to the marketed formulation.

2024-02-01·International journal of biological macromolecules

Formulation and characterization of polyvinyl alcohol/chitosan composite nanofiber co-loaded with silver nanoparticle & luliconazole encapsulated poly lactic-co-glycolic acid nanoparticle for treatment of diabetic foot ulcer

Article

作者: Manjit, Manjit ; Tiwari, Punit ; Koch, Biplob ; Singh, Virendra ; Mishra, Brahmeshwar ; Tilak, Ragini ; Bharti, Kanchan ; Kumar, Krishan ; Jha, Abhishek ; Kumar, Manish

Chronic wounds are prone to fungal infections, possess a significant challenge, and result in substantial mortality. Diabetic wounds infected with Candida strains are extremely common. It can create biofilm at the wound site, which can lead to antibiotic resistance. As a result, developing innovative dressing materials that combat fungal infections while also providing wound healing is a viable strategy to treat infected wounds and address the issue of antibiotic resistance. Present work proposed anti-infective dressing material for the treatment of fungal strains Candida-infected diabetic foot ulcer (DFU). The nanofiber was fabricated using polyvinyl Alcohol/chitosan as hydrogel base and co-loaded with silver nanoparticles (AgNP) and luliconazole-nanoparticles (LZNP) nanoparticles, prepared using PLGA. Fabricated nanofibers had pH close to target area and exhibited hydrophilic surface suitable for adhesion to wound area. The nanofibers showed strong antifungal and antibiofilm properties against different strains of Candida; mainly C. albicans, C. auris, C. krusei, C. parapsilosis and C. tropicalis. Nanofibers exhibited excellent water retention potential and water vapour transmission rate. The nanofibers had sufficient payload capacity towards AgNP and LZNP, and provided controlled release of payload, which was also confirmed by in-vivo imaging. In-vitro studies confirmed the biocompatibility and enhanced proliferation of Human keratinocytes cells (HaCaT). In-vivo studies showed accelerated wound closure by providing ant-infective action, supporting cellular proliferation and improving blood flow, all collectively contributing in expedited wound healing.

项与卢立康唑相关的新闻（医药）

2024-05-26

·药明康德

不用吃药，自身免疫疾病患者实现长期缓解；总生存率100%的细胞疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点1. Dyne Therapeutics公司治疗杜氏肌营养不良（DMD）等肌肉疾病的潜在“first-in-class”抗体偶联反义寡核苷酸（ASO）疗法的早期临床试验数据积极，可改善患者的肌肉功能。2. 在Orca Bio公司的在研同种异体T细胞免疫疗法Orca-T治疗急性髓系白血病（AML）的1期研究中，患者的一年总生存率达100%。3. iCell Gene Therapeutics公司的BCMA与CD19靶向复合嵌合抗原受体-T（BCMA-CD19 cCAR-T）细胞免疫疗法在早期临床试验中使系统性红斑狼疮（SLE）患者实现了长期无药物缓解。药明康德内容团队整理DYNE-101、DYNE-251：公布1/2期临床试验数据Dyne Therapeutics公司公布了分别用于治疗强直性肌营养不良1型（DM1）和DMD的抗体偶联ASO疗法DYNE-101和DYNE-251的积极1/2期临床试验结果。DYNE-101由与片段抗体（Fab）偶联的反义寡核苷酸组成，Fab与肌肉上高表达的转铁蛋白受体1（TfR1）结合。它旨在实现靶向肌肉组织递送，目的是减少细胞核中的有毒DMPK RNA、释放剪接蛋白、允许正常mRNA处理和正常蛋白翻译，并有可能阻止或逆转疾病进展。在1/2期临床试验ACHIEVE中，DYNE-101（5.4 mg/kg）在第3个月时表现出剂量依赖性剪接校正，剪接校正比例达到27%。此外，DYNE-101改善了患者的肌肉强直、肌肉力量以及多种患者报告的功能性和疲惫指标。DYNE-251由Fab偶联的磷酸二酰胺吗啉寡聚物（PMO）组成。它旨在实现靶向肌肉组织递送，促进外显子51跳跃，使肌肉细胞产生截短、功能性的抗肌萎缩蛋白（dystrophin），目标是停止或逆转疾病进展。在1/2期临床试验DELIVER中，DYNE-251（10 mg/kg）在6个月时将抗肌萎缩蛋白的表达水平提高到接受标准治疗患者的10倍。多种功能性检测也显示出接受DYNE-251治疗患者的功能改善。Orca-T：公布1b期临床试验数据 Orca Bio公司公布了其在研同种异体T细胞免疫疗法Orca-T用于治疗AML患者的1b期临床试验的积极结果。这款细胞疗法由富集的CD34+干细胞，以及通过高精度平台纯化、取材自单倍体匹配供体的特定T细胞亚群组合而成。Orca-Q有潜力改善患者的预后和降低移植物抗宿主疾病（GvHD）风险，并且无需对无法找到人类白细胞抗原（HLA）匹配的患者进行移植后环磷酰胺（PTCy）治疗。此次公布的结果显示，接受Orca-T治疗的37例AML患者中，12个月的无复发生存率和总生存率分别为82.5%和100%，12个月的非复发死亡率为0%。Orca-T在该亚组中的安全性与更大范围的1b期人群一致，没有发现新的安全性信号。Orca-T目前正在美国各大治疗中心进行关键性的3期临床试验评估。BCMA-CD19 cCAR-T：公布1期临床试验数据 iCell Gene Therapeutics宣布其BCMA-CD19 cCAR-T细胞免疫疗法的研究者发起临床试验（IIT）的积极结果。这款由iCell所设计的cCAR-T细胞免疫疗法，在单一结构中表达两种不同且功能齐全的CAR分子，一种靶向B细胞上的CD19分子，另一种靶向浆细胞上的BCMA。鉴于B细胞和长寿浆细胞具有独立的记忆，因此需要同时靶向B细胞和长寿浆细胞以消除所有升高的自身抗体。分析显示，所有接受足量初始剂量cCAR-T治疗的SLE/狼疮性肾炎（LN）患者，在治疗3个月后体内自身抗体呈现阴性，并在随访46个月时，均达到无症状和无药物缓解。ARO-RAGE：公布1/2期临床试验数据Arrowhead Pharmaceuticals公司公布了其用于治疗哮喘等肺部炎症性疾病的RNA干扰（RNAi）疗法ARO-RAGE的最新中期临床数据。高级糖化终产物受体（RAGE）是2型和非2型炎症级联的上游介质，与哮喘和多种炎症疾病的发病机制有关。ARO-RAGE通过RNAi抑制RAGE表达，旨在减少肺上皮细胞中RAGE蛋白的表达，从而有望减少RAGE依赖性炎症通路，以达到降低哮喘患者病情恶化的频率并改善其通气的目的。此次公布的中期结果表明，使用ARO-RAGE治疗后，正常健康受试者（NHV）和轻中度哮喘患者支气管肺泡灌洗液（BALF）和血清中的可溶性RAGE浓度呈剂量依赖性降低。轻度至中度哮喘患者使用两剂ARO-RAGE后，血清中的可溶性RAGE降低了88%，平均最大降幅达77%。此外，该候选疗法的安全性良好，药效学效应持续时间长，有望支持每两个月一次的给药频率。FG-3246：公布1期临床试验的新数据 FibroGen公布了其与Fortis Therapeutics联合开发的潜在“first-in-class”抗体偶联药物（ADC）FG-3246的1期临床试验的新数据。FG-3246旨在治疗转移性去势抵抗性前列腺癌和其他肿瘤类型，其靶向的CD46是一种细胞受体靶点，在前列腺癌和其他肿瘤类型中高度表达，并在大多数正常组织中表达非常有限。FG-3246由抗CD46抗体与抗有丝分裂剂MMAE连接而成，MMAE是一种已经过临床验证的ADC有效载荷。此次公布的结果显示，FG-3246联用恩杂鲁胺使未经生物标志物筛选的患者的中位放射学无进展生存期（PFS）达到10.2个月。此外，FG-3246具有可接受的安全性，不良事件与其他包含细胞毒性药物MMAE作为载荷的ADC一致。TTX-080：公布1b期临床试验数据 Tizona Therapeutics公司公布了其HLA-G靶向抗体TTX-080在转移性结直肠癌（mCRC）和局部晚期/转移性头颈部鳞状细胞癌（mHNSCC）患者中的1b期临床试验数据。TTX-080联用西妥昔单抗对野生型RAS、BRAF、HER2阴性mCRC患者具有抗肿瘤活性，这些患者之前接受过的中位治疗线数为2线（范围为1-5）。患者的中位PFS为24.4周，36周时的无进展生存率为47%。在14例可评估的患者中，4例患者（29%）获得部分缓解（PR），6例患者（43%）保持疾病稳定（SD），这10例（71%）患者的疾病控制了超过90天。TTX-080联用西妥昔单抗可在人乳头瘤病毒（HPV）阴性mHNSCC患者中产生抗肿瘤活性。这些患者之前接受过的中位治疗线数为1线（范围为1-2），所有患者之前都接受过免疫疗法。患者的中位PFS为23.9周，24周时的无进展生存率为43%。在7例可评估的患者中，1例（14%）患者达到了完全缓解（CR），3例（43%）患者达到了PR，1例（14%）患者达到了SD，这5例（71%）患者的疾病控制了超过90天。SON-1010：公布两项1期临床试验的新数据 Sonnet BioTherapeutics公司公布了其在研免疫调节重组蛋白SON-1010的两项1期临床试验的新数据。SON-1010为一重组蛋白，由单链人类IL-12蛋白与和白蛋白结合的抗体单链片段组合而成，具潜力通过刺激产生干扰素γ将像是非小细胞肺癌、黑色素瘤等肿瘤微环境由“冷”转“热”，活化先天免疫与适应性免疫细胞。这些肿瘤的肿瘤微环境中表达SPARC与GP60蛋白。目前，SON-1010研究共招募了61名受试者，患者已接受了25个周期的SON-1010单药治疗或10个周期的SON-1010联用Tecentriq治疗，在任何剂量水平上都未出现剂量限制性毒性。细胞因子数据显示，与重组人IL-12相比，SON-1010的半衰期延长了约10倍，可诱导长时间和可控的干扰素γ反应，且任何剂量下均未发现细胞因子释放综合征的证据。可评估的晚期实体瘤患者中有35%（8/23）在开始给药后的第四个月出现临床获益。Azenosertib：公布1期临床试验数据Zentalis Pharmaceuticals公司公布了新型、选择性口服生物可利用的WEE1抑制剂azenosertib联用吉西他滨治疗复发性或难治性骨肉瘤1期试验的最终结果。WEE1是G1-S和G2-M细胞周期检查点的主调控因子，通过对CDK1和CDK2的负调控来阻止DNA受损细胞的复制。通过抑制WEE1，azenosertib可使细胞周期在存在高水平DNA损伤的情况下继续进行，从而使癌细胞积累DNA损伤并最终死亡。此次公布的结果显示，azenosertib联用吉西他滨的耐受性良好，与过去类似患者人群的队列相比，接受该组合疗法的患者的无事件生存率（EFS）的提高具有临床意义。前者16周的EFS大约为12%，后者18周时的EFS为39%（11/28）。NDI-101150：公布1/2期临床试验数据 Nimbus Therapeutics公司公布了其小分子HPK1抑制剂NDI-101150的早期临床试验的新数据。临床前研究发现，NDI-101150对HPK1的选择性是MAP4K家族相关蛋白的300多倍，这有望减少脱靶效应。此次公布的结果显示，NDI-101150的单药治疗为30例可评估患者中的5例（16.7%）带来了临床获益，包括1例CR（肾细胞癌）、1例PR（肾细胞癌）和3例SD。3名患有胰腺癌、肾细胞癌或子宫内膜癌的患者表现出了长时间（>6个月）的SD，肾细胞癌患者已保持疾病稳定21个月。此外，NDI-101150的耐受性良好，整体安全性可接受。KN-002：公布1b期临床试验数据 Kinaset Therapeutic公司公布了其口腔吸入式泛JAK抑制剂KN-002的1b期研究的积极结果。KN-002是一种对所有JAK亚型（即JAK1、JAK2、JAK3和TYK2）均有效的均衡抑制剂，目前正作为一种非侵入性抗炎治疗药物进行开发，适用于所有接受中高剂量吸入型糖皮质激素（ICS）或长效β2受体激动剂（LABA）维持治疗但病情控制不佳的嗜酸性粒细胞性和非嗜酸性粒细胞性哮喘患者以及慢性阻塞性肺病患者。KN-002配制成干粉，具有出色的递送效率和化学/物理稳定性。通过吸入进行局部给药，KN-002能够在肺部炎症部位达到治疗浓度，同时最大限度地降低全身暴露水平。这项随机、双盲、安慰剂对照研究报告称，在为未接受过吸入皮质类固醇治疗的轻度哮喘患者进行为期10天、每天剂量≤16 mg的治疗后，未发现安全性或耐受性问题。此外，每天使用一次和两次KN-002可在临床上显著降低部分呼出一氧化氮（FeNO）水平。▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] GC Biopharma/Novel Pharma's Sanfilippo Syndrome Treatment Obtains FDA IND Approval. Retrieved May 24, 2024, from https://www.prnewswire.com/news-releases/gc-biopharmanovel-pharmas-sanfilippo-syndrome-treatment-obtains-fda-ind-approval-302149872.html[2] GigaGen Doses First Patient in Phase 1 Trial of Anti-CTLA-4 Oncology Drug Candidate GIGA-564 in Advanced Solid Tumors. Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/20/2884820/0/en/GigaGen-Doses-First-Patient-in-Phase-1-Trial-of-Anti-CTLA-4-Oncology-Drug-Candidate-GIGA-564-in-Advanced-Solid-Tumors.html[3] Rila Therapeutics Announces Dosing of First Cohort in Phase 1 Clinical Trial of RLA-23174, a First-In-Class HIPK2 Allosteric Inhibitor, For Treatment of Chronic Kidney Disease and Fibrosis. Retrieved May 24, 2024, from https://www.prnewswire.com/news-releases/rila-therapeutics-announces-dosing-of-first-cohort-in-phase-1-clinical-trial-of-rla-23174-a-first-in-class-hipk2-allosteric-inhibitor-for-treatment-of-chronic-kidney-disease-and-fibrosis-302150159.html[4] FDA Provides Clearance to IND Application for Type 1 Diabetes Therapy SAB-142 by SAB Biotherapeutics. Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/21/2885460/0/en/FDA-Provides-Clearance-to-IND-Application-for-Type-1-Diabetes-Therapy-SAB-142-by-SAB-Biotherapeutics.html[5] Abdera Therapeutics Announces FDA Clearance of IND Application for ABD-147. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240522691994/en[6] Anokion Announces New Clinical Data from the Phase 1b/2 ACeD-it Trial Supporting KAN-101 as a Potential Disease-Modifying Treatment for Celiac Disease. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240520638624/en/[7] Kinaset Therapeutics Debuts Positive Outcomes Data from Phase 1b Study of KN-002 at the 2024 American Thoracic Society (ATS) International Conference. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240521531651/en[8] Inipharm to Present Pharmacokinetic Data From a Phase 1 Clinical Trial of INI-822, a Small Molecule Inhibitor of HSD17B13. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240522608190/en[9] Sonnet BioTherapeutics Announces Updated Clinical Data for SON-1010 as Monotherapy or Combined with an anti-PD-L1, along with an Increase in the Dose-Escalation Target. Retrieved May 24, 2024, from https://www.sonnetbio.com/news-media/press-releases/detail/88/sonnet-biotherapeutics-announces-updated-clinical-data-for[10] Arrowhead Pharmaceuticals Presents New Clinical Data Showing ARO-RAGE Achieves High Level of Gene Knockdown in Patients with Asthma. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240520575548/en[11] Dyne Therapeutics Announces New Clinical Data from ACHIEVE Trial of DYNE-101 in DM1 and DELIVER Trial of DYNE-251 in DMD Demonstrating Compelling Impact on Key Disease Biomarkers and Improvement in Multiple Functional Endpoints. Retrieved May 24, 2024, from https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-announces-new-clinical-data-achieve-trial-dyne[12] iCell Gene Therapeutics Announces Positive Clinical Data from Investigator Initiated Phase 1 Trial Evaluating BCMA-CD19 Compound CAR in Patients with Systemic Lupus Erythematosus/Lupus Nephritis Published in Annals of the Rheumatic Diseases. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523089601/en[13] Biomica Presents Positive Clinical Data Update from Ongoing Phase 1 Trial of Microbiome-Based Therapeutic, BMC128, for Refractory RCC, NSCLC & Melanoma. Retrieved May 24, 2024, from https://www.prnewswire.com/news-releases/biomica-presents-positive-clinical-data-update-from-ongoing-phase-1-trial-of-microbiome-based-therapeutic-bmc128-for-refractory-rcc-nsclc--melanoma-302154259.html[14] NKGen Biotech Publishes Phase 1 Interim Analysis Results of SNK02 Allogeneic NK Cell Therapy in Advanced Solid Tumors at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887701/0/en/NKGen-Biotech-Publishes-Phase-1-Interim-Analysis-Results-of-SNK02-Allogeneic-NK-Cell-Therapy-in-Advanced-Solid-Tumors-at-the-2024-American-Society-of-Clinical-Oncology-ASCO-Annual-.html[15] FibroGen Announces Presentation of Positive Interim Data from the Phase 1b Study of FG-3246 (FOR46) in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) at the 2024 American Society of Clinical Oncology Annual Meeting. Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887699/33525/en/FibroGen-Announces-Presentation-of-Positive-Interim-Data-from-the-Phase-1b-Study-of-FG-3246-FOR46-in-Combination-with-Enzalutamide-in-Patients-with-Metastatic-Castration-Resistant-.html[16] IN8bio Announces INB-200 Phase 1 Study Data in Newly Diagnosed Glioblastoma to be Presented at the 2024 ASCO Annual Meeting. Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887674/0/en/IN8bio-Announces-INB-200-Phase-1-Study-Data-in-Newly-Diagnosed-Glioblastoma-to-be-Presented-at-the-2024-ASCO-Annual-Meeting.html[17] BioAtla Presenting Phase 1 Evalstotug Clinical Trial Data Demonstrating Clinical Benefit at the Upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887704/0/en/BioAtla-Presenting-Phase-1-Evalstotug-Clinical-Trial-Data-Demonstrating-Clinical-Benefit-at-the-Upcoming-2024-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting.html[18] Nimbus Therapeutics Presents New Positive Monotherapy Phase 1/2 Clinical Data of HPK1 Inhibitor in Treatment of Advanced Solid Tumors at 2024 ASCO Annual Meeting. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523128342/en[19] Sensei Biotherapeutics Presents Promising Clinical Data from Phase 1 Dose Escalation Study of SNS-101. Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887708/0/en/Sensei-Biotherapeutics-Presents-Promising-Clinical-Data-from-Phase-1-Dose-Escalation-Study-of-SNS-101.html[20] Elicio Therapeutics Announces Preliminary Data from the Ongoing AMPLIFY-7P Phase 1a Study of ELI-002 7P in Patients with mKRAS-driven Solid Tumors at the 2024 ASCO Annual Meeting. Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887722/0/en/Elicio-Therapeutics-Announces-Preliminary-Data-from-the-Ongoing-AMPLIFY-7P-Phase-1a-Study-of-ELI-002-7P-in-Patients-with-mKRAS-driven-Solid-Tumors-at-the-2024-ASCO-Annual-Meeting.html[21] Zentalis Pharmaceuticals to Present Promising Results from Phase 1 Trial of Azenosertib and Gemcitabine in Relapsed or Refractory Osteosarcoma at 2024 American Society of Clinical Oncology Annual Meeting. Retrieved May 24, 2024, from https://ir.zentalis.com/news-releases/news-release-details/zentalis-pharmaceuticals-present-promising-results-phase-1-trial[22] Orca Bio to Present Positive Clinical Outcomes with Orca-T in Patients with AML at 2024 ASCO Annual Meeting. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523266449/en/[23] Aulos Bioscience Provides Positive Interim Phase 1/2 Data From AU-007 at 2024 ASCO Annual Meeting. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523489073/en/[24] Bicycle Therapeutics to Present Pharmacokinetic and Safety Evaluation of Lead BTC Molecules in Phase 1/2 Trials at the 2024 ASCO Annual Meeting. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523534475/en/[25] Coherus Presents Preliminary Results from Phase I Dose Escalation Study of its Anti-chemokine receptor 8 (CCR8) Antibody, CHS-114, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved May 24, 2024, from https://www.globenewswire.com/news-release/2024/05/23/2887728/33333/en/Coherus-Presents-Preliminary-Results-from-Phase-I-Dose-Escalation-Study-of-its-Anti-chemokine-receptor-8-CCR8-Antibody-CHS-114-at-the-2024-American-Society-of-Clinical-Oncology-ASC.html[26] AffyImmune Announces Confirmed Complete Response in Patient with Anaplastic Thyroid Cancer. Retrieved May 24, 2024, from https://www.businesswire.com/news/home/20240523653892/en免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

细胞疗法免疫疗法临床结果临床1期信使RNA

2024-04-07

·药明康德

开辟mRNA新应用的蛋白替代疗法；使截肢率降低6倍的糖尿病辅助治疗…… | 一周盘点

▎药明康德内容团队编辑本期看点1. Moderna公司公布了其开发的mRNA蛋白替代疗法mRNA-3927的首个临床试验结果，将mRNA的应用范围扩展到疫苗之外。2. 中度或重度糖尿病足溃疡感染的外用辅助治疗pravibismane在早期临床试验中能够加速缩小溃疡面积，同时使患者与糖尿病溃疡相关的下肢截肢发生率降低了约6倍。药明康德内容团队整理mRNA-3927：公布1/2期临床试验数据Moderna公司在《自然》杂志上发表了其用于治疗丙酸血症（PA）的在研mRNA疗法mRNA-3927的积极早期临床数据。PA是由丙酰辅酶A羧化酶（PCC）的α或β亚基（分别由PCCA和PCCB基因编码）的致病变异引起的，这些变异会导致PCC缺乏，并使有毒的代谢物积累。该病的特点是反复出现的危及生命的代谢失代偿事件（MDE）和多系统并发症。目前，没有针对PA的根本原因的有效治疗方法。mRNA-3927是一种通过静脉给药、由脂质纳米颗粒（LNP）包裹的双mRNA疗法，该疗法编码PCCA和PCCB亚基蛋白以恢复肝脏中功能性PCC酶活性。通过编码细胞内蛋白，mRNA疗法可能在预防和治疗急性代谢失代偿中起作用。此次公布的中期分析显示，mRNA-3927表现出良好的安全性和耐受性，接受mRNA-3927治疗的患者的发病风险降低了70%。研究人员指出，这是首个在罕见疾病患者中，使用mRNA表达细胞内蛋白，作为蛋白替代疗法的临床试验。▲mRNA-3927降低患者出现危及生命的代谢失代偿事件的次数（图片来源：参考资料[16]）Pravibismane：公布1b期临床试验数据Microbion公司公布了其外用候选疗法pravibismane作为中度或重度糖尿病足溃疡感染的辅助治疗的1b期研究结果。Pravibismane具有独特的三重新型作用模式，包括强效广谱抗感染性、抗生物膜活性和免疫调节活性。此次公布的结果显示，pravibismane的耐受性良好，全身吸收率极低，没有出现任何治疗引发的不良反应或严重不良事件。与安慰剂组相比，接受pravibismane治疗的受试者溃疡面积缩小了约3倍（85%对比30%），与糖尿病溃疡相关的下肢截肢发生率降低了约6倍（2.6%对比15.4%）。这些结果表明，局部使用pravibismane有望满足糖尿病溃疡患者的未竟药物需求，这种新疗法可以同时治疗细菌生物膜相关感染并加速缩小溃疡面积，并有可能导致伤口完全再上皮化和闭合，同时降低患者再感染和截肢的风险。Deltacel（KB-GDT-01）：公布1期临床试验中第三例患者的数据Kiromic BioPharma公司公布了其在研γ-δ T细胞（GDT）疗法Deltacel（KB-GDT-01）用于治疗IV期转移性非小细胞肺癌（NSCLC）患者的1期临床试验的积极早期疗效数据。Deltacel是一种同种异体细胞治疗产品，由未经修饰的供体来源GDT组成。Deltacel旨在利用GDT的天然效力靶向实体瘤，最初的临床开发重点是NSCLC（约占肺癌病例的80%至85%）。两项临床前研究的数据表明，Deltacel与低剂量放射治疗相结合具有良好的安全性和有效性。从治疗开始六周后获得的初步结果显示，Deltacel在控制肿瘤生长方面具有有效性，以及良好的安全性和耐受性。此前公布的首例患者在治疗前三天被确诊为病情进展活跃。接受Deltacel治疗六周后，计算机断层扫描（CT）扫描证实了此患者的病情稳定，初步的无进展生存期为一个半月。第二例患者在治疗开始前进行了核磁共振（MRI）扫描，发现了新的转移灶，这些新病灶在治疗后第六周的MRI复查中被发现已完全消退。此次公布的第三例患者在入组时疾病处于活动期，接受治疗后的第六周时，PET/CT、诊断CT和MRI扫描结果均显示患者的疾病正趋于稳定，没有出现新的转移性疾病。cNeT：公布1/2a期临床试验的中期数据Achilles Therapeutics公司公布了关于克隆性新抗原反应性T细胞（cNeT）在晚期不可切除或转移性NSCLC患者中、以及在复发性或转移性恶性黑色素瘤患者中的早期临床试验的中期数据。此次公布的数据显示，25%（3/12）的高剂量组患者达到疾病稳定（SD）状态，肿瘤体积有所缩小。而因为与IL-2相关的毒性更少，cNeT的安全性和耐受性与标准的肿瘤浸润淋巴细胞疗法相比更有优势。FG-3246：公布1期临床试验数据FibroGen公布了其与Fortis Therapeutics联合开发的潜在“first-in-class”抗体偶联药物（ADC）FG-3246（亦称FOR46）在1期临床试验中获得积极顶线数据。FG-3246旨在治疗转移性去势抵抗性前列腺癌和其他肿瘤类型，其靶向的CD46是一种细胞受体靶点，在前列腺癌和其他肿瘤类型中高度表达，并在大多数正常组织中表达非常有限。FG-3246由抗CD46抗体与抗有丝分裂剂MMAE连接而成，MMAE是一种已经过临床验证的ADC有效载荷。此次公布的结果显示，36%可评估前列腺特异性抗原（PSA）的患者被观察到PSA减少超过50%（PSA50）。对于可根据RECIST评估的患者，20%达到部分缓解（PR），定义为肿瘤缩小超过30%，中位缓解持续时间为7.5个月。在这批接受大量前期治疗的患者中，中位放射学无进展生存期（rPFS）为8.7个月。最常见的不良事件与其他包含细胞毒性药物MMAE作为载荷的ADCs一致，包括输液相关反应、疲劳、体重减轻、中性粒细胞减少和周围神经病变。Itolizumab：公布1b期临床试验数据Equillium公司公布了其在研单克隆抗体itolizumab治疗狼疮性肾炎的1b期临床试验的积极顶线数据。Itolizumab是一种潜在“first-in-class”的CD6靶向单克隆抗体，可选择性靶向CD6-ALCAM信号通路，选择性抑制致病性效应T细胞，同时保留对维持平衡免疫反应至关重要的调节T细胞。T细胞可驱动多种免疫炎症疾病，该通路在调节T细胞的活性和运输方面发挥着核心作用。此次公布的结果显示，当itolizumab联合吗替麦考酚酯/霉酚酸（MMF/MPA）和皮质类固醇使用时，与标准治疗方法相比，患者达成完全缓解（CR）和PR的比例更高，且尿蛋白肌酐比值（UPCR）的降低更为迅速和显著。大多数治疗伴发不良反应（TEAE）的严重程度被评估为轻度（1级）或中度（2级），其中两种最常见的TEAE是淋巴细胞减少和外周水肿。CONV01-α：公布1/2期临床试验数据Convergent Therapeutics的主打在研疗法CONV01-α是一种与锕-225（Ac-225）结合的单克隆抗体，靶向前列腺特异性膜抗原（PSMA）。锕-225是一种放射性α粒子发射器。CONV01-α的一个关键功能特性是，一旦与PSMA结合，它就会被内化，将其强大的放射性有效成分直接送入前列腺癌细胞，同时将对周围健康组织的损害降至最低。新闻稿指出，CONV01-α有望成为首个获批用于前列腺癌治疗的Ac-225放射性抗体。在一项针对晚期前列腺癌患者的多剂量、剂量递增研究中，患者对CONV01-α的耐受性良好，67%的患者达到了PSA50，27%的患者被观察到PSA减少超过90%（PSA90）。正在进行的研究表明，CONV01-α在单独使用或与其他癌症疗法联合使用时可能非常有效。TPST-1120：公布1期临床试验数据Tempest Therapeutics公司公布了其在研疗法TPST-1120单药或联用纳武利尤单抗治疗晚期实体瘤的1期试验的积极结果。TPST-1120是一种口服、选择性PPARα小分子拮抗剂。临床前数据显示，TPST-1120可直接杀死肿瘤细胞，并靶向肿瘤微环境中的抑制性免疫通路。这两种类型中的靶向细胞皆依赖脂肪酸代谢，该代谢过程由PPARα转录因子调节。在一项针对接受过多次治疗的晚期实体瘤患者的1期临床试验中，TPST-1120单药治疗和与PD-1抑制剂纳武利尤单抗联合应用均导致肿瘤缩小及生物标志物的变化。此次公布的临床数据显示，TPST-1120单药或联用纳武利尤单抗的耐受性良好，最大耐受剂量尚未确定。在接受单药治疗的患者中，53%（10/19）可评估患者的最佳缓解是SD，其中5名患者的治疗时间超过5个月。21%的患者（4例）在接受治疗后靶病灶缩小，另有3例患者的最佳缓解是靶病灶无生长。在此前接受过多线治疗的胆管癌（CCA）、肝细胞癌（HCC）和肾细胞癌（RCC）患者的联合治疗队列中，所有剂量水平的客观缓解率（ORR）为23%（3/13，均为PR）。在曾接受过抗PD-1治疗并疾病进展的RCC和CCA患者中，ORR为50%（2/4）。全血标本分析显示，PPARα相关免疫基因的表达与TPST-1120的剂量水平有关。其中一些变化仅在部分获得缓解的患者中观察到，这说明TPST-1120的生物活性与患者的临床结局有关。SZN-043：公布1a期临床试验数据Surrozen公司公布了SZN-043在健康受试者和肝硬化患者中进行的1a期临床试验的最新进展。SZN-043是采用Surrozen的SWEETS技术开发的首个候选药物，旨在治疗严重肝病。在这项研究中，SZN-043在所有受试者中均表现出了可接受的安全性和耐受性。在有肝病史的肝硬化患者中，SZN-043能够呈剂量依赖性地激活Wnt信号转导，并改善患者的肝功能。ELI-002：公布1期临床试验的新数据Elicio Therapeutics公司公布了其在研治疗性癌症免疫疗法ELI-002治疗具高复发风险胰腺癌和结直肠癌患者的新临床试验数据，这些患者携带KRAS G12D和G12R突变。ELI-002由AMP修饰的KRAS突变体（mKRAS）肽段，和一种AMP修饰的免疫刺激寡核苷酸佐剂ELI-004组成，经皮下给药靶向淋巴结。它能产生RAS特异性杀伤性T细胞，以攻击术后残留肿瘤细胞，有望延长癌症患者缓解并可预防未来复发。此次公布的结果显示，68%接受ELI-002治疗的患者产生了细胞毒性mKRAS特异性CD4+T细胞；84%的患者产生了细胞毒性mKRAS特异性CD8+T细胞；大多数接受ELI-002治疗的患者都出现了抗原扩散，诱导的T细胞靶向mKRAS以外的其他患者特异性肿瘤突变；在大多数接受ELI-002加强剂量治疗的患者中观察到持久的mKRAS特异性T细胞应答，记忆T细胞表型增加。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] Hanmi Pharm submits IND to US FDA for obesity drug HM15275 phase 1 trial. Retrieved April 7, 2024, from https://www.koreabiomed.com/news/articleView.html?idxno=23719[2] Equillium Announces Positive Topline Data from the Type B Portion of the Phase 1b EQUALISE Study of Itolizumab in Lupus Nephritis. Retrieved April 7, 2024, from https://www.businesswire.com/news/home/20240401373328/en[3] Context Therapeutics Submits IND Application to Evaluate CTIM-76 in Claudin 6-Positive Cancers. Retrieved April 7, 2024, from https://www.globenewswire.com/news-release/2024/04/01/2855097/0/en/Context-Therapeutics-Submits-IND-Application-to-Evaluate-CTIM-76-in-Claudin-6-Positive-Cancers.html[4] FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer. Retrieved April 7, 2024, from https://www.globenewswire.com/news-release/2024/04/02/2856521/33525/en/FibroGen-Announces-Topline-Results-from-Phase-1-Monotherapy-Study-of-FG-3246-in-Patients-with-Metastatic-Castration-Resistant-Prostate-Cancer.html[5] Convergent Therapeutics Announces FDA Clearance of IND Application for CONV01-α, a Best-in-Class Radioantibody Targeting Prostate-Specific Membrane Antigen. Retrieved April 7, 2024, from https://www.prnewswire.com/news-releases/convergent-therapeutics-announces-fda-clearance-of-ind-application-for-conv01--a-best-in-class-radioantibody-targeting-prostate-specific-membrane-antigen-302106271.html[6] Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus. Retrieved April 7, 2024, from https://www.globenewswire.com/news-release/2024/04/04/2858178/0/en/Caribou-Biosciences-Expands-Clinical-Development-of-CB-010-with-FDA-Clearance-of-IND-in-Lupus.html[7] iECURE Announces FDA Clearance of Investigational New Drug Application for ECUR-506 to Initiate OTC-HOPE Trial for Treatment of Neonatal Onset Ornithine Transcarbamylase Deficiency in the U.S. Retrieved April 7, 2024, from https://www.businesswire.com/news/home/20240404289854/en[8] Tempest Announces Publication of Positive Data from Phase 1 Trial of TPST-1120 in Patients with Advanced Solid Tumors in Journal of Cancer Research Communications. Retrieved April 7, 2024, from https://www.globenewswire.com/news-release/2024/04/04/2857718/0/en/Tempest-Announces-Publication-of-Positive-Data-from-Phase-1-Trial-of-TPST-1120-in-Patients-with-Advanced-Solid-Tumors-in-Journal-of-Cancer-Research-Communications.html[9] Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR™-310 in Relapsed/Refractory B-cell NHL. Retrieved April 7, 2024, from https://www.prnewswire.com/news-releases/verismo-therapeutics-announces-submission-of-ind-application-to-the-fda-for-synkir-310-in-relapsedrefractory-b-cell-nhl-302106584.html[10] EILEAN THERAPEUTICS RECEIVES CLEARANCE TO INITIATE R/R AML TRIAL WITH LOMONITINIB, A SELECTIVE PAN-FLT3/IRAK4 INHIBITOR. Retrieved April 7, 2024, from https://www.prnewswire.com/news-releases/eilean-therapeutics-receives-clearance-to-initiate-rr-aml-trial-with-lomonitinib-a-selective-pan-flt3irak4-inhibitor-302108790.html[11] Microbion's Topical Pravibismane Phase 1b Moderate or Severe Diabetic Foot Ulcer Infection Study is Published in International Wound Journal. Retrieved April 7, 2024, from https://www.prnewswire.com/news-releases/microbions-topical-pravibismane-phase-1b-moderate-or-severe-diabetic-foot-ulcer-infection-study-is-published-in-international-wound-journal-302107893.html[12] Elicio Therapeutics to Present Updated Clinical T Cell and Antigen Spreading Response Data from the Ongoing AMPLIFY-201 Phase 1 Study of ELI-002 and Preclinical Data on ELI-007 and ELI-008 at the AACR Annual Meeting. Retrieved April 7, 2024, from https://elicio.com/press_releases/elicio-therapeutics-to-present-updated-clinical-t-cell-and-antigen-spreading-response-data-from-the-ongoing-amplify-201-phase-1-study-of-eli-002-and-preclinical-data-on-eli-007-and-eli-008-at-the-aacr/[13] Achilles Therapeutics Provides Interim Phase I/IIa Update on Clonal Neoantigen Reactive T Cells in Advanced NSCLC and Melanoma Including First Patients Dosed with Enhanced Host Conditioning. Retrieved April 7, 2024, from https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-provides-interim-phase-iiia-update-clonal[14] Kiromic BioPharma Reports Favorable Safety, Tolerability, and Early Efficacy from Third Patient in Deltacel-01 Clinical Trial. Retrieved April 7, 2024, from https://www.businesswire.com/news/home/20240402903280/en[15] Surrozen Announces Safety, Pharmacodynamic and Liver Function Data for SZN-043. Retrieved April 7, 2024, from https://investors.surrozen.com/news-releases/news-release-details/surrozen-announces-safety-pharmacodynamic-and-liver-function[16] Koeberl et al., (2024). Interim analyses of a first-in-human phase 1/2 mRNA trial for propionic acidaemia. Nature, https://doi-org.libproxy1.nus.edu.sg/10.1038/s41586-024-07266-7免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

信使RNA临床结果临床2期临床1期疫苗

2024-02-26

·药融圈

东亚药业年产厄多司坦、非布司他等73吨原料药技术改造项目

▲3月7-8日成都生物医药创新者峰会 · 点击立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。【原料药情报局】获悉：近日，关于浙江东亚药业股份有限公司年产厄多司坦、非布司他等73吨原料药技术改造项目在相关网站公示。项目基本情况项目名称：年产厄多司坦、非布司他等73吨原料药技术改造项目企业名称：浙江东亚药业股份有限公司企业地址：三门县浦坝港镇沿海工业城投资概况：项目总投资人民币2250万元建设性质：技改项目用地：利用现有厂区建设规模：年产50吨厄多司坦、10吨非布司他、7吨枸橼酸莫沙必利、3吨盐酸西那卡塞、3吨卢立康唑。同时通过产品结构调整，将现有已建500t/a氧氟沙星产能削减至300t/a，30t/a盐酸多奈哌齐产能削减至15t/a。技改产品方案技改后全厂项目情况浙江东亚药业股份有限公司创建于1998年，位于三门县沿海工业城，是一家主要生产医药原料药、医药中间体的医化企业，是国家高新技术企业。来源：公开资讯整理版权声明：本文转自原料药情报局，如不希望被转载的媒体或个人可与我们联系，我们将立即删除活动推荐 3月 • NDC x 2024新药创新者峰会关键词： ADC，改良型新药，小分子新药，GLP-1药物（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

抗体药物偶联物

100 项与卢立康唑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01980	卢立康唑	D01AC18	DB08933

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
手癣	美国	Bausch Health US LLC	2018-02-20
甲癣	日本	Sato Pharmaceutical Co., Ltd.	2016-01-22
皮肤念珠菌病	中国	海南海灵化学制药有限公司	2012-06-27
真菌病	韩国	Dream Pharma Corp.	2010-02-01
体癣	日本	Nihon Nohyaku Co., Ltd.	2005-07-31
股癣	日本	Nihon Nohyaku Co., Ltd.	2005-07-31
足癣	日本	Nihon Nohyaku Co., Ltd.	2005-07-31
念珠菌病	日本	Sun Pharma Japan Ltd.	2005-04-11
癣	日本	Sun Pharma Japan Ltd.	2005-04-11
花斑癣	日本	Sun Pharma Japan Ltd.	2005-04-11

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
慢性皮肤黏膜念珠菌病	药物发现	美国	Topica Pharmaceuticals, Inc.	2011-01-11

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02767271 (CTgov)	临床4期	足癣 \| 股癣	30	Luliconazole Cream 1% (Tinea Pedis)	艱願範觸築衊廠淵蓋窪(醖廠憲鑰顧鏇網網鏇鏇) = 醖顧淵壓繭醖蓋繭範廠顧觸窪繭廠壓選構蓋餘 (蓋鑰壓衊夢糧夢鹹網醖, 醖繭顧積窪襯遞範製夢 ~ 艱衊衊鏇壓鏇壓鏇夢廠) 更多	-	2019-11-27
				Luliconazole Cream 1% (Tinea Cruris)	繭選膚構醖襯襯積淵築(鬱蓋鑰鑰廠窪製餘選廠) = 齋鑰網壓積醖範鹽艱築蓋獵鹽築構鏇繭築鏇窪 (蓋觸鏇鹽選壓遞網醖廠, 構衊鑰糧構遞淵醖獵鏇 ~ 築觸餘壓衊網構鑰醖繭) 更多
NCT02767947 (CTgov)	临床4期	体癣	75	Luliconazole Cream 1% (Luliconazole Cream 1%)	網壓鬱簾製構願鹽構顧(築衊壓壓構簾窪憲顧壓) = 襯醖鹹選窪膚壓壓構憲鏇顧顧憲膚夢選觸製鑰 (衊夢窪襯壓觸繭醖鏇顧, 顧築鏇鬱艱壓蓋築夢築 ~ 膚築淵簾鑰願膚壓網齋) 更多	-	2019-11-27
				Vehicle Cream (Vehicle Cream)	網壓鬱簾製構願鹽構顧(築衊壓壓構簾窪憲顧壓) = 廠憲壓窪範憲鹹範襯築鏇顧顧憲膚夢選觸製鑰 (衊夢窪襯壓觸繭醖鏇顧, 蓋憲範築艱鏇願選餘艱 ~ 簾顧鏇顧願構顧餘範壓) 更多
NCT02394340 (CTgov)	临床4期	足癣 \| 股癣	20	Omeprazole 40 mg+Luliconazole Cream 1%	繭淵廠鹹築構獵膚壓醖(窪獵鏇夢夢鑰繭築憲鹽) = 壓網淵餘窪鹹壓襯廠廠壓餘築觸齋憲簾鹹構顧 (願廠鹽襯觸艱鏇齋廠醖, 艱願願觸糧壓廠築衊艱 ~ 壓範築網廠顧構夢鑰積) 更多	-	2019-11-27