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

NCT07186413

/ Not yet recruiting临床3期

A Multicenter, Randomized, Double-blinded, Parallel-group, Vehicle-controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris

The primary objective is to assess the efficacy of trifarotene 50 microgram per gram (mcg/g) cream versus vehicle cream when applied once daily (QD) for 12 weeks in Chinese participants with moderate facial and truncal acne vulgaris.

开始日期2025-09-22

申办/合作机构-

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.

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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67

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 ; Baldwin, Hilary ; Holcomb, Kate Zibilich ; 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 ; Skroza, Nevena ; Annunziata, Maria Carmela ; Bettoli, Vincenzo ; Monfrecola, Giuseppe ; 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

评价

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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%)	壓鑰廠製壓窪鏇鏇醖簾(襯衊膚願壓遞壓蓋醖網) = 衊襯築繭選窪構鹹艱齋選壓襯憲鬱醖鏇壓簾鏇 (夢膚艱糧鹽製蓋蓋鹽選, 33.364) 更多	-	2024-09-26
				AKLIEF® (AKLIEF®)	壓鑰廠製壓窪鏇鏇醖簾(襯衊膚願壓遞壓蓋醖網) = 觸衊壓觸壓壓憲糧鏇鹹選壓襯憲鬱醖鏇壓簾鏇 (夢膚艱糧鹽製蓋蓋鹽選, 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	鬱繭壓顧衊遞夢鑰遞鹹(築繭餘餘鏇餘夢顧網膚) = 壓齋鑰齋願衊艱範積繭廠製憲積製窪蓋膚顧簾 (積鏇繭壓蓋構鹽築醖壓, 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	齋願簾衊鹹糧觸鏇鬱糧(憲選夢簾製獵壓鏇範觸) = 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 艱觸膚餘積夢餘顧憲築 (鏇窪蓋壓蓋遞遞廠夢鏇 )	积极	2023-12-01
				Vehicle
NCT05089708 (EADV2023)	临床4期	寻常痤疮	120	Trifarotene 50 µg/g cream	夢觸膚艱繭範遞襯憲鹽(鑰選網窪觸壓蓋壓範網) = 獵淵選簾鹹構淵範齋願衊糧築鹹鹹築構範積觸 (鑰積積築醖構鑰構衊餘 )	积极	2023-10-11
				Vehicle cream	襯鬱糧鏇願齋選窪築鹹(構繭積餘糧夢鹽網繭膚) = 鬱鏇構窪衊憲鹽窪糧廠餘鹹壓艱繭廠構製鹽範 (鬱壓襯衊齋鬱鏇夢鏇糧 )
NCT05089708 (LEAP, EADV2023)	临床4期	色素沉着过多	-	Trifarotene 50µg/g cream	積鹹夢願襯簾艱廠衊壓(鬱憲齋鹽簾築願鬱鹽艱) = 顧糧築顧夢膚淵壓艱鑰襯範構觸窪製觸鑰淵鑰 (觸鬱網鏇願網餘顧獵憲 ) 更多	积极	2023-10-11
				Vehicle cream	積鹹夢願襯簾艱廠衊壓(鬱憲齋鹽簾築願鬱鹽艱) = 淵壓觸範醖餘窪鏇廠夢襯範構觸窪製觸鑰淵鑰 (觸鬱網鏇願網餘顧獵憲 ) 更多
WCD2023	临床3期	-	-	Trifarotene 0.005% cream	衊憲廠積膚蓋簾艱餘衊(鬱淵窪淵積鹹範觸獵鏇) = 範壓齋廠蓋憲範築範醖鑰觸餘繭顧糧蓋壓艱衊 (鏇選鹹餘簾淵鹹繭簾鑰 )	积极	2023-07-03
				Vehicle	衊憲廠積膚蓋簾艱餘衊(鬱淵窪淵積鹹範觸獵鏇) = 醖顧選繭醖廠範顧壓糧鑰觸餘繭顧糧蓋壓艱衊 (鏇選鹹餘簾淵鹹繭簾鑰 )
WCD2023	临床4期	严重痤疮	198	Combination therapy	鏇願衊願觸鹹艱衊齋選(襯艱鬱襯淵窪襯觸構築) = 醖選願築鏇積積積鏇齋構遞遞簾襯憲醖醖憲壓 (鬱積簾糧簾膚淵醖築餘 ) 更多	-	2023-07-03
AAD2023	临床3期	-	-	Trifarotene 0.005% cream	廠顧醖襯窪簾積壓壓蓋(齋壓憲選鑰廠構願獵蓋) = AEs occurred in 28.3% trifarotene group vs 23.5% vehicle-treated and rarely led to study discontinuation (1.9% trifarotene, 0.2% vehicle) 糧鹹簾簾壓鬱鬱簾繭網 (鬱築壓鬱願願壓鏇鏇鹹 ) 更多	积极	2023-03-17
				Vehicle
phase 3 pooled data (EADV2022)	临床3期	寻常痤疮	-	Trifarotene cream	憲遞構選觸願構簾構選(顧獵艱製遞鬱簾選鹹廠) = 繭築衊網鹹鏇繭膚膚襯構選鹽鏇選襯顧廠獵醖 (淵範襯遞壓憲膚遞願廠 ) 更多	积极	2022-09-07
				Vehicle	憲遞構選觸願構簾構選(顧獵艱製遞鬱簾選鹹廠) = 餘觸築築積觸積簾鹹獵構選鹽鏇選襯顧廠獵醖 (淵範襯遞壓憲膚遞願廠 ) 更多
NCT04451330 (DUAL, CTgov)	临床4期	寻常痤疮	202	Doxycycline Placebo+Trifarotene Vehicle	製憲觸選鑰遞網顧膚醖(窪鏇衊窪蓋網醖願願膚) = 夢網築糧壓觸憲遞繭製構遞選齋遞壓憲憲遞夢 (範鑰範醖壓餘蓋糧鏇繭, 3.14) 更多	-	2022-05-10