阿法诺肽(Afamelanotide Acetate) - 药物靶点：MC1R_在研适应症：红细胞生成性原卟啉症，红细胞生成性卟啉病，多样性卟啉病_专利_临床

概要

基本信息

药物类型

合成多肽

别名

Melanotan 1、Melanotan I、Melanotan-1

+ [4]

靶点

MC1R

作用机制

MC1R激动剂(黑素皮质素受体1激动剂)

治疗领域

遗传病与畸形消化系统疾病内分泌与代谢疾病+ [4]

在研适应症

红细胞生成性原卟啉症红细胞生成性卟啉病多样性卟啉病+ [5]

非在研适应症

寻常痤疮光化性角化病光化性痒疹+ [7]

原研机构

Clinuvel Pharmaceuticals Ltd.

在研机构

Clinuvel (UK) Ltd.

Clinuvel Pharmaceuticals Ltd.Clinuvel Europe Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2014-12-22),

红细胞生成性卟啉病

最高研发阶段(中国)-

特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)

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结构

分子式C80H115N21O21

InChIKeyLBIUKNXYUXOWFF-CRYSLBJVSA-N

CAS号1566590-77-9

序列信息

Sequence Code 440960

来源: *****

关联

54

项与阿法诺肽相关的临床试验

NCT06388642 / Recruiting临床1/2期

A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)

The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.

开始日期2024-03-07

申办/合作机构

Clinuvel Europe Ltd.

CTIS2023-507311-35-00 / Recruiting

A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients with Erythropoietic Protoporphyria (EPP). - CUV052

开始日期2024-03-07

申办/合作机构

Clinuvel Europe Ltd.

PACTR202405869934666 / Suspended临床3期

A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE® and Narrow-Band Ultraviolet B (NB-UVB) Light versus NB-UVB Light Alone in the Treatment of Vitiligo

开始日期2023-10-31

申办/合作机构

Clinuvel (UK) Ltd.

100 项与阿法诺肽相关的临床结果

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100 项与阿法诺肽相关的转化医学

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100 项与阿法诺肽相关的专利（医药）

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160

项与阿法诺肽相关的文献（医药）

2024-08-14·The British journal of dermatology

The effects of cholecalciferol and afamelanotide on vitamin D levels in erythropoietic protoporphyria: a multicentre cohort study

Article

作者: Wagenmakers, Margreet A E M ; Nekouei Shahraki, Mitra ; Kuerten, Viola ; Homey, Bernhard ; Kluijver, Louisa G ; Langendonk, Janneke G ; Schelonke, Kathrin ; Hanssen, Bettina E

Abstract:

Background:

Patients with erythropoietic protoporphyria experience lifelong painful photosensitivity resulting in a lack of sunlight exposure. Previous studies have shown that 47–63% of patients with EPP suffer from vitamin D deficiency and a high prevalence of osteoporosis. An effective treatment for EPP has been available since 2016: the α-melanocyte stimulating hormone analogue afamelanotide. So far, studies on vitamin D levels in EPP have only investigated patients who have not been treated with afamelanotide.

Objectives:

To investigate the effects of afamelanotide treatment on vitamin D levels in EPP.

Methods:

A multicentre observational cohort study in adults with EPP from the Erasmus Medical Centre, the Netherlands, and the University Hospital Düsseldorf, Germany, was carried out. Routinely collected vitamin D levels between 2005 and 2021 were used for analysis. Patient exposure to cholecalciferol or afamelanotide was categorized into four treatment groups: untreated, cholecalciferol, afamelanotide and combined treatment. A linear mixed model for longitudinal data was applied to measure the effect of the treatment groups compared with the untreated groups on vitamin D levels.

Results:

A total of 230 patients and 1774 vitamin D measurements were included. The prevalence of vitamin D deficiency and severe deficiency remained high despite afamelanotide treatment (< 50 nmol L–1 in 71.8% of patients and < 30 nmol L–1 in 48.1%, respectively). Afamelanotide treatment alone did not lead to a significant average increase in vitamin D levels [β = 0.5, 95% confidence interval (CI) –3.2 to 4.2]. In contrast, cholecalciferol and combined therapy with afamelanotide led to a significant increase in vitamin D levels [β = 11.6 (95% CI 7.2–15.9) and β = 15.2 (95% CI 12.3–18.1), respectively].

Conclusions:

Cholecalciferol remains essential for the treatment of vitamin D deficiency in EPP, irrespective of new treatment options like afamelanotide. Afamelanotide treatment did not affect vitamin D levels. We suggest that future guidelines include continuous monitoring of vitamin D and a prescription for cholecalciferol in all patients with EPP, including those treated with afamelanotide.

2024-08-14·BRITISH JOURNAL OF DERMATOLOGY

Vitamin D status in patients with erythropoietic protoporphyria taking the systemic photoprotective agent afamelanotide

Letter

作者: Rhodes, Lesley E

2024-08-01·Chinese Clinical Oncology

AB080. High-dose methotrexate with and without intra-thecal methotrexate and whole-brain radiotherapy for primary central nervous system lymphoma: a systematic review

Review

作者: July, Julius ; Dharmaraja, Fernando ; Angelica, Vanessa ; Wijovi, Felix ; Kirana, Denny Handoyo

BACKGROUND:

Primary central nervous system lymphoma (PCNSL) requires effective & well-tolerated treatment strategies. The use of high-dose methotrexate (HD-MT) with or without intra-thecal methotrexate (IT-MT) and whole-brain radiotherapy (WBRT) has emerged as a prominent approach for PCNSL. This systematic review aims to assess the efficacy and safety of these treatment modalities.

METHODS:

A comprehensive search strategy identified relevant studies from PubMed, EMBASE, and Cochrane Library. The following search terms were used: "high-dose methotrexate", "primary central nervous system lymphoma", "intra-thecal methotrexate", and "whole-brain radiotherapy". We included randomized controlled trials (RCTs), cohort studies & case-controlled studies evaluating the use of HD-MT with or without IT-MT and whole-brain radiotherapy in the treatment of confirmed PCNSL. Data extraction & quality assessment was conducted by two independent reviewers. Primary outcomes include overall survival (OS), progression-free survival (PFS) & treatment-related adverse events (TRAEs). Secondary outcomes were neurological function and quality of life (QOL) assessments. The risk of bias in individual studies was assessed using the Cochrane Risk of Bias Tool for randomized trials and the Newcastle-Ottawa Scale for observational studies.

RESULTS:

We identified 5 studies, consisting of 1 RCT, 3 cohort studies, and 1 case-controlled study. Pooled analysis revealed that HD-MT with or without IT-MT and whole-brain radiotherapy significantly improved both OS and PFS compared to other treatment modalities but we found no significant difference between patients who received HD-MT with or without IT-MT. Combination therapy was generally well-tolerated, with manageable TRAE. Subgroup analyses stratified by age, disease stage, and other relevant factors demonstrated consistent efficacy and safety profiles across different patient populations. The risk of bias assessment indicated that the majority of the included studies had low-moderate risk of bias.

CONCLUSIONS:

There was no significant difference between patients who received HD-MT with or without IT-MT plus radiotherapy, emphasizing the comparable efficacy of these treatment modalities. Combination therapy was generally well-tolerated, with manageable TRAE. This highlights the favourable safety profile of HD-MT with fewer side effects compared with the combination of IT-MT.

26

项与阿法诺肽相关的新闻（医药）

2024-10-30

·Pharmaceutical Technology

How a patient helped shape a treatment for a rare skin disorder

Dr Jasmin Barman-Aksӧzen speaking at the Outsourcing in Clinical Trials (OCT) DACH 2024 conference in Zurich, Switzerland. Credit: Jenna Philpott / GlobalData. When Dr Jasmin Barman-Aksӧzen began experiencing painful, unexplained burns on her skin, she turned to Wikipedia for answers. After discovering a possible diagnosis, she proposed it to her physician who confirmed that she had erythropoietic protoporphyria (EPP). This ultra-rare genetic disorder causes a phototoxic heme precursor to build up in the red blood cells, resulting in severe burn injuries on the skin after as little as ten minutes of exposure to visible light. At the time of her diagnosis, no treatment existed to alleviate or prevent the symptoms of EPP. “There was no cure, there was no therapy for the pain, and there were no preventive possibilities for this phototoxic reaction, so the only thing we could do was avoid visible light. As you can imagine, that’s socially very isolating, and it’s not compatible with a normal life, and having to avoid light also leads to depression. We sometimes see suicidal ideations,” she explained. Around the same time, Australia-based biotech Clinuvel Pharmaceuticals was in the process of developing afamelanotide – a slow-release treatment now known as Scenesse. The drug increases skin pigmentation and has anti-inflammatory properties, offering protection against light-induced skin damage. Speaking at the Outsourcing in Clinical Trials (OCT) DACH 2024 conference, taking place in Zurich, Switzerland, between 29 and 30 October, Barman-Aksӧzen explained that she joined a University of Zurich research group working on Scenesse as a PhD student. The treatment was already in Phase III trials, and she provided insights on clinical trial design and quality of life (QoL) measures for patients with EPP. See Also: Matinas BioPharma mulls wind-down as antifungal therapy deal falls through Amgen earns higher revenues in Q3 2024, puts rare diseases in the spotlight The results from the pivotal trial (NCT01605136) showed that patients receiving Scenesse could spend, on average, an additional 20 minutes in sunlight daily without experiencing pain, compared to those on a placebo. Maximally, the patients can spend up to three hours a day in sunlight while using the treatment. They also experienced fewer phototoxic reactions, with symptoms that were less intense and shorter in duration, leading to an overall improvement in quality of life. Though an additional 20 minutes of sun exposure a day may sound minimal, Barman-Aksӧzen highlighted how significant this can be for patients with EPP. Recalling a trip to Berlin, she shared that, without treatment, she wouldn’t have been able to take a taxi with a sunroof without risking a severe phototoxic reaction. “Those are the moments when we are really happy to have the treatment,” she explained. Data from this clinical trial led to Scenesse receiving European approval in 2014. Notably, Barman-Aksӧzen became the first patient to present directly to the European Medicines Agency (EMA) committee before its approval vote, offering insights that clarified both the condition and the treatment’s impact. The EMA subsequently announced that Scenesse was the first drug approved through a European pilot programme that incorporated patient and physician clinical experiences in regulatory decisions – an approach now more widely adopted. In 2019, the US Food and Drug Administration (FDA) followed with its own approval of the drug. Barman-Aksӧzen continues her work advocating for EPP patients and co-founded the International Porphyria Patient Network (IPPN) alongside other patient advocates. While Scenesse brought a treatment option to EPP patients, Barman-Aksӧzen underscored its limitations; it’s a fixed-dose implant for symptomatic relief, which is not scalable and cannot be used for children. Two new candidates, Mitsubishi’s dersimelagon and Disc Medicine’s bitopertin, are being evaluated in clinical trials. These trials present ethical challenges such as the potential for phototoxic burns in control groups, and the risk of a bias in patient selection, as more severely affected patients may hesitate to participate. Barman-Aksӧzen added: “As patients, we’ve requested head-to-head studies. Besides the ethical aspects, I, as a patient, want to know how a new substance compares not only to placebo but also to the existing therapy.”

临床3期上市批准临床结果寡核苷酸

2024-10-01

·凯莱英药闻

2024年9月国内生物医药投融资汇总

欢迎关注凯莱英药闻 2024年9月，国内共有7家生物医药企业完成融资。在细分赛道上，包括专注于基因编辑疗法的贝斯生物；专注于小分子药物开发的盛世泰科；专注于抗体药物研发的天辰生物；专注于小核酸药物研发的赫吉亚生物；专注于膜蛋白创新药开发的晶蛋生物；专注于内分泌和代谢领域创新药开发的君合盟；专注于改良型新药研发的惠永药研。一基因编辑疗法贝斯生物成立于2021年，是一家专注于基因编辑领域基础创新的技术驱动型创新企业。公司致力于开发世界首创的细胞疗法和基因编辑产品，尤其在癌症和遗传疾病治疗方面显示出巨大潜力。贝斯生物在基因编辑领域开发了一系列核心技术，包括ePE引导编辑、AccuBase®基因编辑系统、CasH基因编辑技术、BEAT-CART技术以及体内靶向递送技术；其中，AccuBase®基因编辑系统具有全球自由实施（FTO）的特点，能够在体外和体内进行高效且零脱靶的基因编辑；该系统也是世界上首个使用碱基编辑赋予NK细胞靶向特异性的疗法。在对外合作方面，贝斯生物已将其AccuBase®基因编辑技术非独家授权给了国际领先的CAR-T细胞治疗公司，并与农业企业合作，利用碱基编辑技术开发无刺鱼，探索其在作物改良和家畜遗传改造方面的应用。二小分子药物盛世泰科是一家处于商业化阶段的生物科技公司，核心团队拥有几十年国际化药品全生命周期的从业经验，致力于优质化与差异化的小分子创新药研发与产业化。公司凭借集成化药物研发技术平台和多元化的商业视野，搭建了覆盖降糖、抗癌和自身免疫等丰富的创新药管线。目前，公司新一代高选择性DPP-4抑制剂森格列汀处于NDA阶段，用于治疗2型糖尿病；此外，公司还开发了多款进入临床阶段的抗肿瘤药物，其中高选择性CXCR4拮抗剂CGT-1881，以及FGFR/VEGFR双靶点抑制剂CGT-6321，有望成为实体瘤领域潜在的first in class药物。三抗体药物天辰生物成立于2020年10月26日，是研发大分子创新药的生物技术公司，拥有三大创新生物药技术平台：Sundoma、InCibitor 和NeXine均具有完整自主知识产权。公司研发管线围绕“过敏和补体”双赛道，覆盖呼吸、皮肤、肾科、血液科、罕见病等自身免疫疾病；其中，新一代抗IgE抗体LP-003正在开发用于过敏、慢性荨麻疹、哮喘等多个适应症；此外，全球首创的补体双功能抗体LP-005有望在肾科（IgA肾等）、眼科及神经科等领域开辟全新治疗路径。据悉，天辰生物将在近期完成LP-003和LP-005的美国IND申报，并动海外桥接临床研究，这是公司海外布局的首个重大里程碑，为公司实现全球化发展的战略目标奠定坚实基础。四小核酸药物赫吉亚生物致力于siRNA领域递送技术平台的构建及药物研发，目前拥有多个自主知识产权的siRNA递送技术平台，其中MVIP递送平台为全球首创的siRNA双位点偶联GalNAc递送技术，不仅提高了siRNA在体内的稳定性，而且展现出更优的siRNA递送效率。DDP是公司打造的二代肝源性疾病siRNAs递送技术平台，可以同步递送两条或多条siRNAs，可用来开发针对多靶点、多机制介导的复杂或难治性疾病。NSDP是公司针对神经系统疾病开发的siRNA递送技术平台，不仅可以靶向中枢神经系统（CNS），也可以靶向外周神经（PNS）。基于上述平台，公司管线主要聚焦在肝源性疾病、心脑血管及代谢性疾病、补体介导相关疾病、神经系统疾病等疾病领域。五膜蛋白创新药晶蛋生物成立于2019年8月，致力于神经精神类疾病、慢性肾病及心血管疾病的药物研发，公司建立了全球独特离子通道靶点小分子和蛋白药物技术平台IonFire平台（小分子药物）和BigC平台（大分子药物），并配套四大工具平台：离子通道新靶点发现、活性测试、蛋白结构解析和大分子药物开发，构筑了强大的技术壁垒，解决了药物发现成功率低和副作用大等行业瓶颈。六内分泌及代谢领域药物君合盟成立于2020年11月，是一家专注于重组蛋白创新药物及合成生物学领域创新产品开发的生物科技公司。公司研发管线布局围绕严肃医疗、消费医疗、代谢等拥有广阔市场的前沿蛋白药物领域，已实现包括重组I/III型人胶原蛋白原液及制剂、重组A型肉毒毒素等在内的高端重组蛋白产品的规模化放大。七改良型新药惠永药研成立于2018年5月，拥有多个高端制剂关键技术研究平台；公司专注于改良性新药研发，产品涵盖靶向多肽偶联药物、长效注射制剂、纳米晶、纳米胶束、新型吸入制剂、缓控释制剂等各种高端制剂，其自主开发的纳米胶束技术、靶向多肽偶联药物技术、新型吸入给药技术均属国际领先。目前，公司研究领域聚焦于抗肿瘤药、镇痛药、心脑血管药和儿童用药，已有1个一类新药、4个二类新药处于临床阶段，1个仿制药获得生产批件。参考资料 1、各公司官网 2、投资界感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

细胞疗法临床申请基因疗法免疫疗法核酸药物

2024-09-30

·GlobeNewswire-Health Care

CLINUVEL files Canadian New Drug Submission for SCENESSE® in EPP

Patient Special Access Program continues during Health Canada reviewMELBOURNE, Australia, Oct. 01, 2024 (GLOBE NEWSWIRE) -- CLINUVEL has filed a New Drug Submission (NDS) to Health Canada, seeking approval for its novel photoprotective therapy SCENESSE® (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). If approved, SCENESSE® would be the first treatment for Canadian EPP patients. Health Canada review process Health Canada’s Health Products and Food Branch (HPFB) reviews and approves medications for use in Canada, assessing the safety and efficacy of the products in the proposed indication, as well as the drug’s quality. Following a formal dossier validation period, the HPFB may complete the review of a new drug candidate within 300 days. Canadian Special Access Program ongoing In 2023 CLINUVEL announced that the first Canadian EPP patient had received treatment with SCENESSE® under Canada’s Special Access Program (SAP). The SAP allows individual physicians to facilitate access to treatment for patients who have serious or life-threatening conditions and lack therapeutic alternatives. Patient treatment under the SAP continued without interruption prior to Health Canada’s review of the NDS. All Canadian patients treated under the SAP have received insurance coverage to support their treatment access. Two Canadian Specialty Centers have been trained and accredited to treat EPP patients with SCENESSE®. Further potential Canadian treatment centres have been identified to enable prompt treatment access pending regulatory and pricing approvals. To date, CLINUVEL has trained and accredited 85 Specialty Centers across North America. EPP affects approximately 1:140,000 individuals, with an estimated 280 EPP patients in Canada. Commentary “The SAP has provided an important bridge for Canadian patients to access treatment and helped us understand the Canadian therapeutic landscape,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “A formal authorisation will enable more Canadian patients to receive SCENESSE® and is a logical next step. “The dossier submitted contains both data which led to the FDA’s approval, as well as long-term data collected during the follow up of EPP patients worldwide,” Dr Wright concluded. SCENESSE® in EPP: systemic photoprotection EPP is a rare genetic disorder which causes phototoxicity, debilitating reactions and burns following light exposure. CLINUVEL has spent nearly two decades developing SCENESSE® as the first treatment for EPP. The drug, administered as a controlled-release injectable implant every 60 days, stimulates the production of melanin in skin, protecting skin cells from visible and ultraviolet light (photoprotection) and acting as a strong antioxidant. Clinical and long-term post-marketing studies of SCENESSE® have shown that it can prevent and reduce the severity of phototoxic reactions, as well as improving patients’ quality of life. The drug has been approved for adults by the European Medicines Agency, US Food and Drug Administration (FDA), and regulatory authorities in Australia and Israel. To date, over 16,000 doses of SCENESSE® have been administered to EPP patients worldwide. References Ceresnie, M. S., et al. (2022). Association of quality of life measures with afamelanotide treatment in patients with erythropoietic protoporphyria and x-linked protoporphyria: A retrospective cohort study. Journal of the American Academy of Dermatology, S0190962222028729. Elder, G., et al. (2013). The incidence of inherited porphyrias in Europe. Journal of Inherited Metabolic Disease, 36(5), 849–857. Langendonk, J., et al. (2015). Afamelanotide for Erythropoietic Protoporphyria. The New England Journal of Medicine, 373(1), 48–59. Wensink, D., Wagenmakers, M. A. E. M., & Langendonk, J. G. (2021). Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria. Expert Review of Clinical Pharmacology, 14(2), 151–160. About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL (ASX: CUV; ADR LEVEL 1: CLVLY; Börse Frankfurt: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives. CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information, please go to https://www.clinuvel.com. Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD. Head of Investor RelationsMr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD Investor Enquirieshttps://www.clinuvel.com/investors/contact-us Forward-Looking Statements This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Please see CLINUVEL’s website for the full Forward-Looking Statements disclaimer. Contact:Tel: +61 3 9660 4900Fax: +61 3 9660 4909Email: mail@clinuvel.comAustralia (Head Office), Level 22, 535 Bourke Street, Melbourne, Victoria, 3000, Australia CLINUVEL on InstagramCLINUVEL on XCLINUVEL on LinkedInCLINUVEL on FacebookCLINUVEL on YouTube

上市批准寡核苷酸临床研究

100 项与阿法诺肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10511 D11334	阿法诺肽	D02BB02	DB04931

研发状态

批准上市

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适应症	国家/地区	公司	日期
红细胞生成性原卟啉症	澳大利亚	Clinuvel Pharmaceuticals Ltd.	2020-11-18
红细胞生成性卟啉病	欧盟	Clinuvel Europe Ltd.	2014-12-22
红细胞生成性卟啉病	冰岛	Clinuvel Europe Ltd.	2014-12-22
红细胞生成性卟啉病	列支敦士登	Clinuvel Europe Ltd.	2014-12-22
红细胞生成性卟啉病	挪威	Clinuvel Europe Ltd.	2014-12-22

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适应症	最高研发状态	国家/地区	公司	日期
光化性痒疹	临床3期	-	Clinuvel Pharmaceuticals Ltd.	2010-05-05
多样性卟啉病	临床2期	荷兰	Clinuvel (UK) Ltd.	2023-03-28
白癜风	临床2期	美国	Clinuvel Pharmaceuticals Ltd.	2022-10-11
补充组C着色性干皮症	临床2期	比利时	Clinuvel Europe Ltd.	2022-03-28
补充组C着色性干皮症	临床2期	西班牙	Clinuvel Europe Ltd.	2022-03-28
补充组E着色性干皮症	临床2期	比利时	Clinuvel Europe Ltd.	2022-03-28
补充组E着色性干皮症	临床2期	西班牙	Clinuvel Europe Ltd.	2022-03-28
色素性干皮症	临床2期	德国	Clinuvel Europe Ltd.	2021-10-19
雄激素不敏感综合征	临床2期	澳大利亚	Clinuvel Pharmaceuticals Ltd.	2021-06-03
缺血性卒中	临床2期	澳大利亚	Clinuvel Pharmaceuticals Ltd.	2021-06-03

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适应症

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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


NCT04962503 (Pubmed)	临床2期	脑卒中	6	Afamelanotide 16 mg	範選網築鬱鹹鹽鬱網願(蓋遞築網壓鏇鏇製夢壓) = One patient (who received 2 doses), suffered a fatal recurrent stroke on D9 due to a known complete acute internal carotid artery occlusion, assessed as unrelated to the study drug 網膚鬱繭鹹網遞醖夢範 (窪醖膚鏇衊範獵願憲膚 )	-	2023-07-26
NCT04962503 (CTgov)	临床2期	雄激素不敏感综合征 \| 动脉闭塞 \| 缺血性卒中 ... 更多	6	Afamelanotide	觸齋築衊襯艱觸蓋選廠(膚糧膚遞餘鑰齋憲鑰繭) = 觸簾繭淵艱鑰鬱顧製廠淵壓蓋獵遞願願構廠糧 (餘積餘選醖獵簾醖觸選, 襯簾壓繭積窪遞範範範 ~ 窪廠簾鏇壓鬱餘鑰醖壓) 更多	-	2023-04-11
NCT04943159 (CTgov)	临床2期	寻常痤疮	3	Afamelanotide	網築醖廠襯夢鬱積糧膚(窪憲壓夢夢壓鑰製壓夢) = 淵壓衊選壓齋壓積遞壓淵衊製壓蓋積遞夢憲醖 (選憲衊膚膚壓製鬱憲齋, 獵簾窪網遞願憲構積構 ~ 膚顧壓鏇簾淵願窪憲餘) 更多	-	2021-10-26
NCT00979745 (CTgov)	临床3期	红细胞生成性原卟啉症	74	Placebo	餘選襯範淵鹹餘夢願繭(襯壓製獵襯簾願鏇鏇餘) = 窪餘齋廠築糧憲築艱憲鑰夢鏇願壓鹽鑰衊醖構 (壓壓選憲鏇製窪範遞構, 衊顧襯鹽窪鑰餘齋獵襯 ~ 網範餘願憲構構餘簾鬱) 更多	-	2021-10-12
NCT04425746 (CTgov)	临床2期	-	16	Afamelanotide (Afamelanotide)	淵餘衊鬱積製艱憲構繭(鹹糧築繭糧蓋簾願廠艱) = 願壓壓膚簾淵壓獵廠鹹築製鑰簾襯齋觸鹽夢簾 (鬱簾積衊廠網夢製鹽範, 構鑰膚膚艱遞衊淵襯淵 ~ 膚齋構簾壓獵網鹹鑰壓) 更多	-	2021-10-01
NCT04425746 (CTgov)	临床2期	-	16	Placebo (Placebo)	淵餘衊鬱積製艱憲構繭(鹹糧築繭糧蓋簾願廠艱) = 鬱淵糧鬱艱顧壓壓網鹹築製鑰簾襯齋觸鹽夢簾 (鬱簾積衊廠網夢製鹽範, 鹹遞願範繭繭壓鬱蓋壓 ~ 窪窪構構簾夢選淵窪淵) 更多	-	2021-10-01
NCT04525157 (CTgov)	临床2期	非节段型白癜风	21	Afamelanotide	繭鏇襯顧膚鏇醖製鹽艱(獵遞獵膚觸構築鹽網醖) = 襯鏇憲製窪獵簾顧獵範願廠積膚構鑰鬱鏇壓淵 (鬱製壓蓋醖蓋觸齋壓齋, 蓋淵淵艱積衊鑰觸齋鹹 ~ 衊齋簾範繭醖願積觸糧) 更多	-	2021-05-21
NCT04704713 (CTgov)	临床3期	光化性痒疹	31	Afamelanotide (Afamelanotide)	製獵膚窪遞鹹醖顧鬱獵(範願繭餘積鹽鏇壓顧積) = 願衊觸範製齋鹹淵衊壓壓壓構網蓋鬱鹹鏇襯淵 (觸鬱膚鏇願鬱衊蓋構廠, 餘廠構鬱簾願壓壓鹹鹹 ~ 築簾夢壓鬱製蓋鹹構齋) 更多	-	2021-03-19
NCT04704713 (CTgov)	临床3期	光化性痒疹	31	Placebo (Placebo)	製獵膚窪遞鹹醖顧鬱獵(範願繭餘積鹽鏇壓顧積) = 鹽築襯鹹網憲醖鹽鏇獵壓壓構網蓋鬱鹹鏇襯淵 (觸鬱膚鏇願鬱衊蓋構廠, 遞築鹽構網簾鑰餘鑰鏇 ~ 廠淵簾顧範鹹遞願襯糧) 更多	-	2021-03-19
NCT04578496 (CTgov)	临床3期	红细胞生成性原卟啉症	16	Afamelanotide	餘鏇繭網積築鑰夢遞繭(膚鬱鬱餘夢壓膚鏇製糧) = 醖鹽襯網襯獵構選構蓋鏇鹽簾襯網淵壓願網鬱 (餘範鹹鹹鏇鏇選廠鏇簾, 衊蓋鏇鏇醖夢淵憲積齋 ~ 簾願範艱鏇築襯遞鑰構) 更多	-	2020-11-02
NCT04053270 (CTgov)	临床3期	红细胞生成性原卟啉症	100	Placebo+Afamelanotide (Group A)	觸範範艱鏇糧餘製顧鑰(繭膚願窪鬱築鹹壓醖鹹) = 壓衊壓蓋網願鏇積築齋廠夢廠築艱廠網齋願構 (觸範鹽窪餘蓋獵製獵齋, 壓壓鏇齋範遞蓋襯顧夢 ~ 壓艱衊顧鹽構願鬱夢範) 更多	-	2019-10-10
NCT04053270 (CTgov)	临床3期	红细胞生成性原卟啉症	100	Placebo+Afamelanotide (Group B)	觸範範艱鏇糧餘製顧鑰(繭膚願窪鬱築鹹壓醖鹹) = 糧壓選積鏇鏇鹽膚糧範廠夢廠築艱廠網齋願構 (觸範鹽窪餘蓋獵製獵齋, 鏇觸選鏇觸衊構壓製衊 ~ 鬱齋鹹醖餘淵齋齋網蓋) 更多	-	2019-10-10
NCT01097044 (CTgov)	临床2期	红细胞生成性原卟啉症	77	Afamelanotide (Afamelanotide)	蓋選餘鹹憲範衊製鏇淵(簾艱鬱鹹醖餘蓋範夢遞) = 獵鏇糧鏇糧構遞廠顧膚鏇築醖襯膚鏇蓋鹹簾網 (廠積觸範遞鑰廠網鹽鬱, 構願觸鑰選獵鏇獵顧製 ~ 壓鬱選憲構鏇選遞窪鏇) 更多	-	2019-09-17
NCT01097044 (CTgov)	临床2期	红细胞生成性原卟啉症	77	Placebo (Placebo)	蓋選餘鹹憲範衊製鏇淵(簾艱鬱鹹醖餘蓋範夢遞) = 壓鬱鬱構壓觸選築選憲鏇築醖襯膚鏇蓋鹹簾網 (廠積觸範遞鑰廠網鹽鬱, 選遞鬱網淵窪淵憲繭構 ~ 鬱淵製構繭鹽壓憲繭築) 更多	-	2019-09-17