异维A酸(Isotretinoin) - 药物靶点：RARs_在研适应症：寻常痤疮，痤疮样疹，囊性痤疮_专利_临床

概要

基本信息

药物类型

小分子化药

别名

13 cis retinoic acid、Isotretinoin (USP)、异维甲酸

+ [26]

靶点

RARs

作用机制

RARs激动剂(维甲酸受体家族激动剂)

治疗领域

皮肤和肌肉骨骼疾病遗传病与畸形内分泌与代谢疾病+ [1]

在研适应症

寻常痤疮痤疮样疹囊性痤疮+ [3]

非在研适应症

板层状鳞癣

原研机构

F. Hoffmann-La Roche Ltd.

在研机构

Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries, Inc.Roche Products Pty Ltd.

+ [1]

非在研机构

Cipher Pharmaceuticals, Inc.Hoffmann-La Roche, Inc.

最高研发阶段批准上市

首次获批日期

美国 (1982-05-07),

痤疮样疹

最高研发阶段(中国)-

特殊审评快速通道 (美国)、孤儿药 (欧盟)、突破性疗法 (美国)

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结构

分子式C20H28O2

InChIKeySHGAZHPCJJPHSC-XFYACQKRSA-N

CAS号4759-48-2

关联

200

项与异维A酸相关的临床试验

NCT06225570 / Not yet recruiting早期临床1期IIT

Randomized Controlled Trial of Weekly Oral Isotretinoin Vs. Oral Tetracyclines for the Treatment of Moderate Acne Vulgaris

In the effort to find better treatments for Moderate Acne, which often relies on long-term antibiotic use, researchers are exploring alternative options. While Isotretinoin, a Vitamin A derivative, is highly effective for severe acne, its side effects limit its use for milder cases. A recent study from our institution investigated a new approach: weekly Isotretinoin dosing. The results were promising, with acne improvement and no major side effects. This suggests that weekly Isotretinoin could be a successful alternative for moderate acne in both males and females. To validate these findings, investigators propose a randomized controlled trial comparing weekly Isotretinoin to daily Doxycycline over four months. This study could confirm the safety and effectiveness of weekly Isotretinoin, as well as shed light on patient satisfaction, and long-term results compared to standard antibiotics. This research may offer a breakthrough in treating moderate acne while addressing concerns about antibiotic overuse.

开始日期2025-01-01

申办/合作机构

Medical University of South Carolina

NCT06447480 / Not yet recruiting临床3期IIT

Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study

In Dermatology, assessment of people of color remains underrepresented in RCTs (<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. In darker skin type patients, i.e., Fitzpatrick phototypes IV-VI, acne-related pigmentation (ARP) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. Whatever is the mechanism, ARP (number, size, importance of dyschromia) impacts the quality of life in such patients. In moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially ARP). However, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in ARP. Moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. Isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.The main objective: To assess the superiority at M6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of ARP.Multicenter randomized controlled trial - open study. The number of subjects required for the trial = 420

开始日期2024-12-01

申办/合作机构

Centre Hospitalier Universitaire de Nice

KCT0009913 / RecruitingN/AIIT

Effectiveness of Isotretinoin in Patients with Systemic Lupus Erythematosus Accompanied by Skin Symptoms

开始日期2024-11-25

申办/合作机构-

100 项与异维A酸相关的临床结果

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100 项与异维A酸相关的转化医学

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100 项与异维A酸相关的专利（医药）

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5,554

项与异维A酸相关的文献（医药）

2025-01-01·Brazilian Journal of Otorhinolaryngology

Importance of psychological follow-up in rhinoplasty

Review

作者: Espósito, Mário Pinheiro ; Ferreira, Thales Victor Fernandes ; Fernandes, Ana Luíza Cézar

OBJECTIVETo comprehensively analyze the benefits and harms associated with the use of isotretinoin as a skin preparation agent for rhinoplasty.METHODA systematic review of the literature was carried out, conducted through a comprehensive search in scientific databases: LILACS and PUBMED.RESULTSAlthough isotretinoin has beneficial effects on skin preparation, some studies indicate that its continuous use before rhinoplasty may interfere with healing, suggesting the need for a period of suspension prior to the procedure. Other concerns include the impact on blood levels, increasing the risk of hematological changes, highlighting the importance of regular hematological monitoring during treatment. The decision to use isotretinoin as preparation for rhinoplasty must take into account the surgeon's experience and the specific characteristics of the patient, seeking to balance the aesthetic benefits with the potential risks.CONCLUSIONThe decision to use isotretinoin as part of skin preparation for rhinoplasty must be individualized, taking into account the specific characteristics of the patient, their aesthetic objectives and the assessment of risks and benefits. A collaborative approach between the plastic surgeon, dermatologist and patient is essential to ensure safe and effective use of isotretinoin, maximizing its benefits while minimizing the potential harm associated with this therapy.

2025-01-01·Dermatologic Clinics

Innovations in Acne

Review

作者: Barbieri, John S ; Barbieri, John S. ; Wafae, Bruna Galvao de Oliveira

Although many treatments are available for acne, these can be limited by lack of effectiveness, patient tolerance and adherence, and accessibility. This review provides a comprehensive summary of the latest developments in acne management, exploring a range of topical, systemic, and procedural treatments. The mechanisms of action, pivotal trial data, and potential role in clinical practice are reviewed for emerging therapies such as 1726 nm laser, sarecycline, clascoterone, trifarotene, minocycline foam, and fixed-dose combination topicals. The clinical pipeline is also summarized. In addition, opportunities to improve the patient experience with spironolactone and isotretinoin are discussed.

2025-01-01·Arquivos Brasileiros de Oftalmologia

Meibography health score: a simple grading system for isotretinoin-induced meibography alterations on patients with acne vulgaris

Article

作者: Wakamatsu, Tais Hitomi ; Medina, Rebecca Ignacio Subira ; Freitas, Denise de ; Hirai, Flavio ; Andrade, Fabio Mendonça Xavier

PURPOSETo develop a simple, subjective, and reliable grading scale for isotretinoin-induced meibography changes.METHODSAfter analyzing meibography images obtained from systemic isotretinoin users, a grading scale was proposed and named "meibography health score." The score ranged from 1 to 3, with decreasing gland reflectivity and identifiable margins. A total of 11 medical professionals were asked to grade 10 meibography images obtained from isotretinoin users using the proposed scale and were divided into three groups: (A) ophthalmologists with experience with meibography, (B) ophthalmologists with no experience with meibography, and (C) radiologists. The kappa statistic was determined to test interrater reliability.RESULTSThe overall kappa was approximately 0.64. The kappa scores for Groups A, B, and C were 0.78, 0.59, and 0.90, respectively. Grade 2 had the lowest kappa scores (0.62, 0.35, and 0.82 for A, B, and C, respectively) and grade 3 the highest (0.78, 0.90, and 1.0 for A, B and C, respectively). Furthermore, Group C had the highest kappa scores and Group B the lowest.CONCLUSIONThe meibography health score exhibited good interrater reliability, particularly in severe cases.

102

项与异维A酸相关的新闻（医药）

2024-11-12

·PRNewswire

Expert Study Reveals Groundbreaking Results in Mild to Severe Acne Treatment On Skin Types I to VI with Aerolase Neo Elite® Laser

TARRYTOWN, N.Y., Nov. 12, 2024 /PRNewswire/ -- A pivotal study led by renowned U.S. dermatologist Dr. Nazanin Saedi showcases the remarkable efficacy of the Aerolase Neo Elite® 650-microsecond 1064nm Nd:YAG laser in treating mild, moderate, and severe acne vulgaris. Now published as a peer-reviewed article in the Journal of Drugs in Dermatology, the study highlights the transformative results achieved with Neo Elite®, setting a new benchmark for acne treatment. Dr. Saedi, a board-certified dermatologist and Associate Clinical Professor at Thomas Jefferson University, explains, "This laser treatment offers faster and more effective results than traditional methods. Patients prize the immediate improvement and the pain-free experience, which translates to their fuller adherence to a treatment plan – even when teenage patients get distracted by their multiple life activities." Overcoming the Challenges of Acne—the World's Most Pervasive Skin Concern Traditional acne treatments often fall short of delivering effective, timely results. Retinoids like isotretinoin and antibiotics can lead to significant side effects, while medications and older device-based approaches tend to have slow onsets of action and extended treatment timelines. Legacy devices struggle with poor patient compliance because of tolerability issues —further exacerbating the challenges of managing acne. The Neo Elite® was specifically designed to address these issues with its innovative energy delivery system and unique pulse parameters, offering a more effective and patient-friendly solution. Key Clinical Findings: Significant Acne Reduction: Dr. Saedi's evaluation revealed an 84% reduction in acne lesions by the end of the 2-3-month treatment course, with sustained results rising to 87% reduction 90 days post-treatment. These mark the highest and fastest clearances in the clinical literature. High Patient Satisfaction: Neo Elite® has garnered a 90% satisfaction rate, highlighting its effectiveness and patient comfort. Broad Applicability and Safety: Clinically proven effective and safe for all ages and skin types, including darker and tanned skin, Neo Elite® is ideal for a diverse patient base. Eliminates patient risk of side effects from systemic acne medication Revolutionary Mechanism of Action Aerolase Neo Elite® employs a 650-microsecond pulse duration to deliver precise energy that targets acne through multiple, synergistic mechanisms: Sebum Production Reduction: Neo Elite® normalizes sebum levels, creating a less acne-prone environment. Inflammation Mitigation: Laser energy coagulates inflammatory processes, calming active acne and promoting healing. Bacterial Elimination: The heat from the laser effectively neutralizes C. acnes bacteria, a primary acne trigger. Resolution of Acne Aftermath: Clearance of physical sequelae of acne including post-inflammatory hyperpigmentation, erythema, and acne scarring. A Prime Healthcare Provider Growth Engine With approximately 50 million pediatric and adult Americans suffering from acne, Neo Elite® offers a powerful, patient-driven solution that empowers medical and aesthetic providers to exceed patient expectations, expand their client base, and boost practice revenue. About Aerolase Aerolase is pioneering the future of skin wellness with breakthrough laser technology designed for everyone, everywhere. By combining science-backed efficacy and precision with universal accessibility, Aerolase empowers healthcare providers to deliver safe, effective treatments for all skin types and concerns. With a commitment to inclusivity, innovation, and trust, Aerolase is setting new standards in skincare, delivering advanced, life-changing treatments for all. Contact: Gary Giblen at [email protected] SOURCE Aerolase WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果

2024-11-11

·CPHI制药在线

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2024-11-05

·Pharmaceutical Technology

FDA approves Journey Medical’s rosacea treatment Emrosi

Rosacea is thought to affect around 5% of the global population. Credit: Alona Siniehina / Shutterstock. The US’ Food and Drug Administration (FDA) has approved Journey Medical’s Emrosi, the brand name for its 40mg minocycline hydrochloride extended-release capsules, to be used in the treatment of dermatological condition rosacea. Developed in collaboration with Dr Reddy’s Laboratories, Emrosi – previously known as DFD-29 – is supported by positive data collected over two 16-week Phase III clinical trials. The results were shared in July 2023 and showed that DFD-29 successfully met all co-primary and secondary endpoints, establishing both safety and efficacy in comparison to placebo and current standard-of-care treatment Oracea, owned by Galderma Laboratories. Journey Medical now intends “to establish Emrosi as a new standard of care in the treatment of rosacea.” This is according to CEO Claude Maraoui, who believes the drug “has the potential to become the best-in-class oral medication to treat the condition”. Journey has reported that it is in the process of completing the manufacturing of Emrosi for the US market. It anticipates that the initial supply will be available to adult rosacea patients in the first half of 2025. The launch will mark a change in the treatment landscape. GlobalData’s 2022 ‘ Rosacea Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape ‘ report stated that Galderma was “the most prominent player in the rosacea space, offering a comprehensive portfolio of solutions”. However, it also warned that with “no presence in the late-stage pipeline and with its existing marketed products widely genericised, the company may lose its position in the rosacea market”. This balance is perhaps tipping, and Journey Medical – which GlobalData called a “less prominent player” in 2022 – is making a bid for the top spot in rosacea treatment. GlobalData is Pharmaceutical Technology’s parent company. Rosacea is a chronic inflammatory skin condition, which causes reddening of the skin, lesions and ‘spider veins’, usually around the nose and cheeks. Early symptoms may come and go, but the condition usually becomes more prominent over time. According to Yale Medicine, around 5% of the global population is affected , and untreated rosacea will progress over time, eventually leading to more severe symptoms such as facial swelling, thickened skin and eye inflammation. Rosacea treatment Emrosi will mark the latest offering in Journey Medical’s portfolio of dermatological treatments. Others include Accutane, Ximino and Amzeeq (all for varying severities of acne) and Zilxi, a topical rosacea treatment.

临床结果临床3期上市批准

100 项与异维A酸相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00348	异维A酸	D10BA01 D10AD04	DB00982

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
寻常痤疮	加拿大	Sun Pharmaceutical Industries Ltd.	2023-06-22
痤疮样疹	美国	Sun Pharmaceutical Industries, Inc.	2012-05-25
囊性痤疮	澳大利亚	Roche Products Pty Ltd.	1994-12-05

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
常染色体隐性鱼鳞病	临床3期	美国	-	2022-06-21
常染色体隐性鱼鳞病	临床3期	德国	-	2022-06-21
常染色体隐性鱼鳞病	临床3期	法国	-	2022-06-21
常染色体隐性鱼鳞病	临床3期	意大利	-	2022-06-21
常染色体隐性鱼鳞病	临床3期	加拿大	-	2022-06-21
X联锁鱼鳞病	临床3期	法国	-	2022-06-21
先天性鳞癣样红皮病	临床3期	-	Timber Pharmaceuticals LLC初创企业	-
寻常痤疮	临床前	加拿大	Cipher Pharmaceuticals, Inc.	2009-09-01
寻常痤疮	临床前	美国	Cipher Pharmaceuticals, Inc.	2009-09-01

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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


NCT05373901 (CTgov)	临床1期	高风险神经母细胞瘤	8	Dinutuximab Beta+13-cis-Retinoic Acid	繭襯窪鏇製顧膚範鑰鬱(獵衊範艱鏇構鑰餘觸簾) = 獵顧鏇蓋襯鹹齋膚繭夢醖製醖襯蓋齋鏇鑰築餘 (製網構壓簾鏇蓋夢憲鑰, 艱積壓餘糧獵窪廠鑰襯 ~ 築築廠窪糧膚範選餘顧) 更多	-	2024-10-04
NCT04385277 (ANBL19P1, CTgov)	临床2期	神经节成神经细胞瘤	41	FDG-Positron Emission Tomography+Dinutuximab+Temozolomide+Isotretinoin+Sargramostim+Irinotecan	繭餘簾醖簾窪顧獵積壓(獵獵壓衊襯鏇衊獵廠鏇) = 觸獵構鹽膚積簾醖積築餘鏇構壓鏇蓋夢鏇築簾 (齋願繭鏇夢鏇鏇簾憲範, 餘壓繭觸衊襯醖襯築蓋 ~ 衊願壓窪鬱艱糧淵蓋選) 更多	-	2024-08-14
EADV2023	N/A	肠易激综合征 \| 炎症性肠病	-	Isotretinoin	糧築艱製憲簾蓋鏇鑰糧(廠積鹽鑰選憲鑰廠鹽觸) = 艱壓淵蓋鹹壓衊構積餘窪壓築醖蓋鏇築憲齋淵 (膚鑰壓蓋壓艱廠壓製鏇, 2.5 ~ 7.7)	积极	2023-10-11
EADV2023	N/A	-	-	Isotretinoin	襯製範鑰鏇鬱糧顧窪鑰(艱蓋範壓網積範獵獵襯): HR = 0.82 (95% CI, 0.77 ~ 0.87), P-Value = <0.001 更多	积极	2023-10-11
EADV2023	N/A	-	-	Oral antibiotics		积极	2023-10-11
EADV2023	N/A	寻常痤疮	1,191	Surgical extraction + Isotretinoin	廠窪構廠餘憲網範膚製(蓋觸遞簾顧積選醖醖糧) = 鑰構醖蓋衊鹹鹹膚選構顧簾衊獵齋製糧壓遞衊 (窪夢積獵鑰鹹積繭鹹遞 ) 更多	积极	2023-10-11
WCD2023	N/A	寻常痤疮	30	Isotretinoin + SOD	顧網壓憲壓糧選遞壓齋(壓構遞襯鬱範鬱窪淵鏇) = 製壓願鑰獵鹹選夢選夢構壓蓋襯醖廠製鬱鬱鏇 (艱齋獵遞衊夢選網積願 )	积极	2023-07-03
WCD2023	N/A	脓疱型银屑病	-	Isotretinoin	(壓膚簾鏇餘糧膚廠選築) = 網齋糧積廠蓋製淵範範衊構構顧壓襯壓築蓋餘 (鬱範膚鏇範願壓鹽窪積 )	-	2023-07-03
EADV2023	N/A	寻常痤疮	-	Isotretinoin	淵壓淵壓齋鏇製願築鏇(壓網鑰願網鹽觸範鹽壓) = 艱窪築夢範糧網憲範觸糧鑰糧鑰鬱遞壓網壓繭 (鹽淵鹹鏇鏇齋淵製糧鬱 ) 更多	-	2023-05-18
NCT03786783 (ANBL17P1, CTgov)	临床2期	高风险神经母细胞瘤 \| 神经节成神经细胞瘤	42	External Beam Radiation Therapy+Etoposide+Carboplatin+Doxorubicin+Isotretinoin+Sargramostim+Topotecan+Dexrazoxane+Dinutuximab+Cyclophosphamide+Melphalan+Cisplatin+Vincristine+Thiotepa	鹽鏇壓餘選積鏇淵夢鏇(醖範餘膚獵餘遞壓憲壓) = 窪淵壓範觸夢淵廠鏇壓選膚構顧選簾衊構獵窪 (壓襯繭願夢艱淵蓋淵蓋, 壓範觸繭鏇網憲齋積範 ~ 憲鹽遞餘憲積構繭選膚) 更多	-	2023-03-14
NCT04154293 (CONTROL, EADV2022)	临床2期	X联锁鱼鳞病	-	TMB-001 0.05%	壓遞顧鏇顧鑰憲鹹蓋製(構窪鹽糧鹽膚襯夢鹹簾) = 顧觸壓窪蓋衊餘鑰獵齋積鹹選鏇願製簾餘顧選 (廠壓製窪網築鏇窪遞糧 ) 更多	-	2022-09-07
NCT04154293 (CONTROL, EADV2022)	临床2期	X联锁鱼鳞病	-	TMB-001 0.1%	壓遞顧鏇顧鑰憲鹹蓋製(構窪鹽糧鹽膚襯夢鹹簾) = 襯夢醖積衊簾襯糧蓋製積鹹選鏇願製簾餘顧選 (廠壓製窪網築鏇窪遞糧 ) 更多	-	2022-09-07