曲法罗汀(Trifarotene) - 药物靶点：RARγ_在研适应症：寻常痤疮_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Trifarotene (USAN/INN)、CD-5789、Aklief

+ [1]

靶点

RARγ

作用方式

激动剂

作用机制

RARγ激动剂(维甲酸受体γ激动剂)

治疗领域

皮肤和肌肉骨骼疾病

在研适应症

寻常痤疮

非在研适应症

常染色体隐性鱼鳞病皮肤T细胞淋巴瘤板层状鳞癣

原研机构

Galderma Holding SA

在研机构

Galderma Holding SAGalderma Canada, Inc.Galderma Laboratories LP

+ [3]

非在研机构

Mayne Pharma International Pty Ltd.

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2019-10-04),

寻常痤疮

最高研发阶段(中国)临床3期

特殊审评孤儿药 (美国)、孤儿药 (欧盟)

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结构/序列

分子式C29H33NO4

InChIKeyMFBCDACCJCDGBA-UHFFFAOYSA-N

CAS号895542-09-3

关联

18

项与曲法罗汀相关的临床试验

CTRI/2024/08/072412

/ Not yet recruiting临床4期

A prospective, multi center, open label phase IV clinical study to evaluate the safety and efficacy of Trifarotene or Aklief 50 microgram per gram cream in subjects with acne vulgaris over 12 weeks. - NIL

开始日期2024-08-26

申办/合作机构

Galderma SA (Switzerland)

[+1]

NCT06733402

/ Completed临床1期

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and Each Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris.

To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.

开始日期2024-06-20

申办/合作机构

Taro Pharmaceuticals U.S.A., Inc.

NCT06063473

/ Completed临床1期

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) and to AKLIEF® Cream (Trifarotene 0.005%,Galderma) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris

开始日期2023-02-22

申办/合作机构

Taro Pharmaceuticals U.S.A., Inc.

100 项与曲法罗汀相关的临床结果

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100 项与曲法罗汀相关的转化医学

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100 项与曲法罗汀相关的专利（医药）

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66

项与曲法罗汀相关的文献（医药）

2025-04-01·INTERNATIONAL JOURNAL OF DERMATOLOGY

One Acne™: A holistic management approach to improve overall skin quality and treatment outcomes in acne with or without sensitive skin

Review

作者: Baldwin, Hilary ; Chavda, Rajeev ; Tan, Jerry ; Lain, Edward (Ted) ; Beleznay, Katie ; Brinkhuizen, Tjinta ; Layton, Alison M. ; Lachmann, Nadège ; Kircik, Leon

Abstract:

Acne and sensitive skin can take a profound toll on patients' well‐being, which can be exacerbated if the conditions are experienced together. This narrative review aims to identify appropriate treatments to facilitate a holistic management approach to acne (One Acne™), sensitive skin, and acne‐induced sequelae and describe the role of treatments in improving skin quality. Topical retinoids are considered the preferred first‐line option for acne treatment by dermatologists, either as monotherapy or in combination with other treatments, because of their ability to target various aspects of the disease. Tretinoin, trifarotene, adapalene, and tazarotene have all been assessed in clinical studies for managing acne‐associated scarring, with varying success, with the latter three reported to improve skin quality. Moreover, some corrective procedures, e.g., injectable non‐animal stabilized hyaluronic acid (NASHA) fillers, have proven effective for treating acne scarring. Both treatment types may complement each other to provide optimal treatment outcomes and patient satisfaction, as observed in several patients receiving concomitant treatment with NASHA fillers/topical trifarotene. Adjunctive use of cleansers, moisturizers, and photoprotection‐containing ingredients such as vitamin B3, glycerin, or pro‐vitamin B3 may also complement drug/corrective treatments to reduce skin irritation and risk of scarring, as well as improve skin hydration, tone, and overall appearance. This narrative review highlights that comprehensive skincare regimens should be used throughout acne patients' journeys to reduce treatment‐related irritation, improve treatment outcomes, adherence, and satisfaction, and enhance overall skin quality. Patients with sensitive skin should choose tailored skincare products to maintain skin barrier integrity and restore skin function.

2025-03-01·Dermatology and Therapy

Recommendations to Improve Outcomes in Acne and Acne Sequelae: A Focus on Trifarotene and Other Retinoids

Letter

作者: Noor, Omar ; Hamzavi, Iltefat ; Hebert, Adelaide ; Lain, Edward ; Kircik, Leon ; Moore, Angela ; Issa, Naiem ; Kwong, Pearl ; Woolery-Lloyd, Heather ; Schlesinger, Todd ; Weiss, Jonathan ; York, J P ; Alexis, Andrew ; Holcomb, Kate Zibilich ; Baldwin, Hilary ; Chavda, Rajeev

Acne vulgaris affects nearly 50 million people in the USA, ranking as the eighth most prevalent disease globally. This chronic inflammatory skin condition often results in sequelae, including atrophic acne scars, acne-induced macular erythema and acne-induced hyperpigmentation, impacting patients' quality of life. This commentary article reviews the use of topical retinoids, with a particular emphasis on trifarotene cream 0.005%, for managing both acne and acne sequelae. Topical retinoids are considered central to improving treatment outcomes because of their established efficacy, safety and tolerability. Adapalene, tretinoin and tazarotene have demonstrated efficacy in reducing acne and acne sequelae in several studies. Trifarotene has been extensively studied in Phase 3 trials, demonstrating notable success in treating mild-to-moderate acne. Recently, two large-scale, randomized, blinded, Phase 4 clinical trials investigated trifarotene cream 0.005% in patients with atrophic acne scarring and acne-induced hyperpigmentation across all Fitzpatrick phototypes. The START study found that there was a greater reduction in total atrophic acne scar count in the trifarotene group compared with the vehicle group at Week 24 (55.2% vs 29.9%) with statistical significance established as early as Week 2 (P = 0.001). Based on this evidence, we recommend that topical retinoids should be introduced as first-line therapy for the treatment of acne and acne sequelae. Retinoids should be implemented into a treatment routine as early as possible, especially for patients with darker Fitzpatrick phototypes or patients at risk of atrophic acne scarring. Furthermore, retinoids should be incorporated within a comprehensive skincare regimen that includes adequate photoprotection when treating patients with darker Fitzpatrick phototypes. Finally, management of acne and acne sequelae should include maintenance therapy with topical retinoids. This article supports the American Academy of Dermatology's call for acne sequelae treatment guidance and emphasizes the need for continued research to optimize patient care.

2025-02-01·Dermatology and Therapy

A Real-World Approach to Trifarotene Treatment in Patients with Acne and Acne Sequelae Based on the Experience of the Italian Acne Board

Letter

作者: Dall'Oglio, Federica ; Tretti Clementoni, Matteo ; Barbareschi, Mauro ; Annunziata, Maria Carmela ; Skroza, Nevena ; Monfrecola, Giuseppe ; Bettoli, Vincenzo ; Micali, Giuseppe ; Veraldi, Stefano

Acne and acne sequelae can have an important impact on patients' quality of life, affecting interpersonal relationships and social functioning. Acne-induced scars (AIS) and acne-induced macular hyperpigmentation (AIH), in particular, are a major concern for patients with acne, as their management is challenging and often unsatisfactory. Retinoids are considered the mainstay of acne treatment because of their action on multiple pathogenetic factors, and there is increasing evidence that they can also improve AIS and AIH. Trifarotene, a topical retinoid with selectivity for retinoic acid receptor (RAR)-γ, has undergone an extensive clinical development programme, demonstrating its efficacy in treating facial and truncal acne and improving acne sequelae. In this article, we review the main evidence supporting the use of trifarotene in patients with acne and acne sequelae and provide place-in-therapy suggestions based on the experience of the Italian Acne Board with this drug in real-life practice. Trifarotene can be used successfully, as monotherapy or in association with other treatments, in most clinical settings of acne, but it plays an essential role in patients with existing AIS and AIH, those with a clinical or personal history of scarring and those who are predisposed to AIH. Owing to its long-term efficacy and tolerability, trifarotene is also a good option as a maintenance treatment. As with other topical retinoids, patients undergoing trifarotene therapy should be given advice on how to minimise local irritation when starting treatment.

16

项与曲法罗汀相关的新闻（医药）

2025-09-03

·galderma.com

EADV 2025: scientific presentations supported by Galderma

Galderma will unveil updates from its dermatology portfolio at the 34th European Academy of Dermatology and Venereology (EADV) congress, taking place in Paris on September 17-20, 2025, including data on prurigo nodularis, atopic dermatitis, and sensitive skin. Galderma will also host a variety of events, including industry hubs on sensitive skin and acne, a symposium on itch, and several meet the expert sessions. Meet the expert session Exploring the treatment of acne sequelae with Aklief®: Insights from a phase 4 split-face study Meet the expert session Rethinking atopic dermatitis relief: Science-driven skincare solutions across the flare cycle Meet the expert session What would you do? A case-based discussion on atopic dermatitis (AD) treatment strategies Meet the expert session Unpacking sensitive skin syndrome: New insights into lifestyle and environmental impacts Industry hub A holistic approach to acne and acne sequelae: Combining retinoids, CTMP™ and cosmetic corrective procedures Meet the expert session Unpacking sensitive skin syndrome: New insights into lifestyle and environmental impacts Industry hub Sensitive skin syndrome: A rising phenomenon linked to modern lifestyles and environmental changes Meet the expert session Exploring the treatment of acne sequelae with Aklief®: Insights from a phase 4 split-face study Symposium Ditching the itch: Exploring the latest advances in atopic dermatitis and prurigo nodularis, targeting freedom from itch and long-term skin lesion control Meet the expert session Rethinking atopic dermatitis relief: Science-driven skincare solutions across the flare cycle

临床3期

2025-07-08

·蒲公英Ouryao

参比制剂（第93批）名单发布，多家国内原研入列

转自：国家药监局编辑：随风2025年07月08日，国家药监局发布了第93批次仿制药一致性评价参比制剂目录，共公布96个品规，京新药业的地达西尼胶囊、再鼎医药的甲苯磺酸奥马环素片、西安葛蓝新通制药的甲磺酸普雷福韦片等国内药企原研品种入列参比制剂名单；新增品种49个。经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第九十三批）。新增品种：地达西尼胶囊、硫酸拉罗替尼口服溶液、紫杉醇口服溶液、布地格福吸入气雾剂、甲苯磺酸他拉唑帕利胶囊、甲苯磺酸奥马环素片、甲磺酸普雷福韦片、硫酸吗啡注射液、克林霉素阿达帕林过氧苯甲酰外用凝胶、盐酸曲唑酮口服溶液、氯硝西泮口服滴剂、腹膜透析液（碳酸氢盐-G2.3%）、曲法罗汀乳膏等；仿制药参比制剂目录（第93批）

一致性评价

2025-06-05

·galderma.com

International Congress of Dermatology 2025: Galderma’s Scientific Presentations

Galderma will present data from across its Therapeutic Dermatology portfolio at the XIV International Congress of Dermatology (ICD), taking place in Rome, Italy, on June 18-21, 2025, including updates on its investigations in acne, non-melanoma skin cancer, and prurigo nodularis. First author Abstract title Presentation type S. Ständer Nemolizumab long-term efficacy and safety up to 100 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis Late-breaking abstract Presented Saturday, June 21, 2025, at 08:30 – 08:35 AM CET Orange room R. Szeimies Personalizing Actinic Keratosis Treatment for Immunocompromised Patients (IM-PAKT): Patient scenarios E-poster #1673 R. Szeimies Artificial daylight photodynamic therapy with methyl aminolevulinate (ArtLight): A real-world study E-poster #1675 A. Moore Quantifying pigmentation: A colorimetric analysis assessing the impact of trifarotene on acne-induced hyperpigmentation (AIH) E-poster #1680 M. Schaller Recommendations for long-term rosacea management from The Rosacea — Expert Advice on Combined and Holistic approaches (REACH) group’s Global Scientific Committee E-poster #1677 First author Abstract title Presentation type S. Ständer Nemolizumab long-term efficacy and safety up to 100 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis Late-breaking abstract Presented Saturday, June 21, 2025, at 08:30 – 08:35 AM CET Orange room R. Szeimies Personalizing Actinic Keratosis Treatment for Immunocompromised Patients (IM-PAKT): Patient scenarios E-poster #1673 R. Szeimies Artificial daylight photodynamic therapy with methyl aminolevulinate (ArtLight): A real-world study E-poster #1675 A. Moore Quantifying pigmentation: A colorimetric analysis assessing the impact of trifarotene on acne-induced hyperpigmentation (AIH) E-poster #1680 M. Schaller Recommendations for long-term rosacea management from The Rosacea — Expert Advice on Combined and Holistic approaches (REACH) group’s Global Scientific Committee E-poster #1677 Galderma will also host a symposium at ICD, exploring the latest advances in addressing itch and lesion control in both prurigo nodularis and atopic dermatitis. Further details can be found here and below. Speakers Symposium title Details Prof. Sarina Elmariah Dr. Brian Kim Prof. Martin Metz Dr. Andrew Pink Ditching the Itch: Latest Advances in Itch Relief and Long-Term Lesion Control for Atopic Dermatitis and Prurigo Nodularis Friday, June 20 12:30 – 1:30 PM CET Green Room Speakers Symposium title Details Prof. Sarina Elmariah Dr. Brian Kim Prof. Martin Metz Dr. Andrew Pink Ditching the Itch: Latest Advances in Itch Relief and Long-Term Lesion Control for Atopic Dermatitis and Prurigo Nodularis Friday, June 20 12:30 – 1:30 PM CET Green Room

100 项与曲法罗汀相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11225	曲法罗汀	D10AD06	DB12808

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	美国	Galderma Laboratories LP	2019-10-04

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2期	美国	Mayne Pharma International Pty Ltd.	2019-05-01
常染色体隐性鱼鳞病	临床2期	澳大利亚	Mayne Pharma International Pty Ltd.	2019-05-01
常染色体隐性鱼鳞病	临床2期	加拿大	Mayne Pharma International Pty Ltd.	2019-05-01
常染色体隐性鱼鳞病	临床2期	法国	Mayne Pharma International Pty Ltd.	2019-05-01
常染色体隐性鱼鳞病	临床2期	德国	Mayne Pharma International Pty Ltd.	2019-05-01
常染色体隐性鱼鳞病	临床2期	以色列	Mayne Pharma International Pty Ltd.	2019-05-01
常染色体隐性鱼鳞病	临床2期	西班牙	Mayne Pharma International Pty Ltd.	2019-05-01
常染色体隐性鱼鳞病	临床2期	乌克兰	Mayne Pharma International Pty Ltd.	2019-05-01
常染色体隐性鱼鳞病	临床2期	英国	Mayne Pharma International Pty Ltd.	2019-05-01
板层状鳞癣	临床2期	美国	Mayne Pharma International Pty Ltd.	2019-05-01

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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


NCT05550337 (CTgov)	临床3期	寻常痤疮	807	Trifarotene 0.005 % Topical Cream (Test: Trifarotene Cream, 0.005%)	遞艱壓遞鑰蓋築顧鹽鹹(遞鬱蓋淵夢窪齋遞獵醖) = 淵積壓壓窪築鑰觸艱遞網憲膚製蓋鑰艱鏇鏇糧 (艱餘衊膚廠獵鹽壓鹹餘, 33.364) 更多	-	2024-09-26
				AKLIEF® (AKLIEF®)	遞艱壓遞鑰蓋築顧鹽鹹(遞鬱蓋淵夢窪齋遞獵醖) = 鹽獵鬱壓簾鏇膚衊簾築網憲膚製蓋鑰艱鏇鏇糧 (艱餘衊膚廠獵鹽壓鹹餘, 23.547) 更多
NCT05089708 (LEAP, CTgov)	临床4期	色素沉着过多 \| 寻常痤疮	123	Trifarotene Vehicle Cream	網簾選壓艱鹹鹹鬱鬱鏇(廠壓築簾製餘醖網襯鏇) = 築製選願構夢壓餘遞壓願憲獵膚壓簾構夢膚糧 (餘醖鹹糧鬱壓鏇遞膚衊, 0.24) 更多	-	2023-12-20
NCT04856904 (Phase 4 Controlled Study, Pubmed \| Dermatol Ther (Heidelb))	临床4期	萎缩性痤疮瘢痕	121	Trifarotene 50 μg/g	鏇鹽淵選齋鹽夢夢壓壓(繭獵簾淵鏇願廠淵醖鬱) = The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity 範範觸憲鏇鹹顧窪願製 (鑰壓衊鬱鏇糧鬱築願鑰 )	积极	2023-12-01
				Vehicle
NCT05089708 (LEAP, EADV2023)	临床4期	色素沉着过多	-	Trifarotene 50µg/g cream	膚齋壓鬱繭鬱膚鹹構糧(繭鏇願淵糧積顧簾鑰壓) = 獵齋醖廠獵醖獵獵鏇艱構獵築齋壓鑰蓋遞憲製 (選糧鹹構製鏇衊鹹淵簾 ) 更多	积极	2023-10-11
				Vehicle cream	膚齋壓鬱繭鬱膚鹹構糧(繭鏇願淵糧積顧簾鑰壓) = 鹹遞膚壓夢簾願鑰積範構獵築齋壓鑰蓋遞憲製 (選糧鹹構製鏇衊鹹淵簾 ) 更多
WCD2023	临床3期	-	-	Trifarotene 0.005% cream	衊獵廠簾簾簾積鹹壓範(衊構鏇鹽膚衊鑰遞願鬱) = 範簾廠遞蓋網積鬱夢鏇膚鹹糧築衊繭簾鬱築憲 (憲膚醖淵夢襯壓製醖齋 )	积极	2023-07-03
				Vehicle	衊獵廠簾簾簾積鹹壓範(衊構鏇鹽膚衊鑰遞願鬱) = 選餘襯繭艱願淵醖齋蓋膚鹹糧築衊繭簾鬱築憲 (憲膚醖淵夢襯壓製醖齋 )
WCD2023	临床4期	严重痤疮	198	Combination therapy	構願選淵製遞獵艱鬱艱(鹹網選範範膚鑰夢築艱) = 夢鹽築廠艱壓鑰鑰顧壓鹽製鹹鏇醖憲網繭範廠 (衊鏇壓衊淵積願衊糧廠 ) 更多	-	2023-07-03
AAD2023	临床3期	-	-	Trifarotene 0.005% cream	網獵鬱壓繭憲顧膚構醖(鹽範築鬱齋糧繭鹽衊夢) = AEs occurred in 28.3% trifarotene group vs 23.5% vehicle-treated and rarely led to study discontinuation (1.9% trifarotene, 0.2% vehicle) 鑰選廠製構壓齋顧壓觸 (憲膚膚製醖遞鹹齋淵構 ) 更多	积极	2023-03-17
				Vehicle
EADV2022	临床3期	寻常痤疮	-	Trifarotene cream	衊顧構襯廠夢構壓繭蓋(構鹽網襯繭淵鏇鑰襯窪) = 遞鹹糧獵窪壓遞鹽膚鏇遞選膚鹹積鹹餘鹹齋範 (醖顧夢壓衊窪夢顧製窪 ) 更多	积极	2022-09-07
				Vehicle	衊顧構襯廠夢構壓繭蓋(構鹽網襯繭淵鏇鑰襯窪) = 衊餘餘夢壓願築積窪鹹遞選膚鹹積鹹餘鹹齋範 (醖顧夢壓衊窪夢顧製窪 ) 更多
NCT04451330 (DUAL, CTgov)	临床4期	寻常痤疮	202	Doxycycline Placebo+Trifarotene Vehicle	窪鹹積壓膚鹽窪壓鑰淵(壓糧夢窪觸築願構鹽廠) = 壓廠窪簾蓋構夢鏇醖願憲構淵糧鑰艱顧齋餘鹽 (構鬱構襯艱鹽艱壓鬱壓, 3.14) 更多	-	2022-05-10
NCT03915860 (CTgov)	临床3期	寻常痤疮	47	Trifarotene	壓繭窪鹹艱製積淵餘淵(積夢鏇鑰淵構廠廠觸鹹) = 顧積顧壓網襯糧願醖膚醖繭鑰窪齋醖製壓夢遞 (淵簾網願艱淵範積醖積, 2.97) 更多	-	2021-12-15