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2025-07-01

申办/合作机构

Centre Hospitalier Universitaire de Nice

NCT06942039

/ Not yet recruiting早期临床1期

A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age

Pilot study to determine feasibility of adding intrathecal chemotherapy and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age.

开始日期2025-06-01

申办/合作机构

C17 Council

CTRI/2025/04/085381

/ Not yet recruiting临床3期

comparative therapeutic efficacy of various doses of oral isotretinoin in verruca vulgaris - nil

开始日期2025-05-03

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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7,092

项与异维A酸相关的文献（医药）

2025-12-31·AUTOIMMUNITY

Deciphering distinct pathogenic mechanisms of ankylosing spondylitis and systemic sclerosis via shared biomarkers ZSWIM6 and CCL3L3: Insights from an integrative bioinformatics approach

Article

作者: Zhou, Chenxing ; Chen, Jiarui ; Zhan, Xinli ; Xue, Jiang ; Shi, Jianjun ; Zhou, Zhongxian ; Yang, Renbang ; Huang, Liangyu ; Huang, Chengqian ; Liu, Chong ; Chen, Tianyou ; Feng, Sitan ; Huang, Jieping ; Wu, Shaofeng ; Zhu, Jichong

Ankylosing Spondylitis (AS) and Systemic Sclerosis (SSc) are both autoimmune diseases, albeit with distinct anatomical targets. AS primarily affects the spine and sacroiliac joints, triggering inflammation and eventual fusion of the vertebrae. SSc predominantly impacts the skin and connective tissues, leading to skin fibrosis, thickening, and potential damage to vital organs such as the lungs, heart, and kidneys. Despite their differing anatomical manifestations, inflammation serves as a pivotal factor in both conditions. Exploring the causes of the different pathogenesis of inflammation in AS and SSc could provide new insights into their treatment. We selected RNA-seq profiles of peripheral blood mononuclear cells (PBMCs) from the GEO datasets GSE73754 and GSE19617. DEGs were identified using the Limma R package with an adjusted p-value cutoff of < 0.05. Gene Ontology pathway analysis, SVM recursive feature elimination, and Gene Set Enrichment Analysis (GSEA) were conducted to analyze the DEGs. CIBERSORT was applied to estimate immune cell composition and its correlation with hub genes. Single-cell RNA sequencing data from peripheral blood mononuclear cells in the GSE194315 dataset were included to support differential expression analysis and biomarker identification. Additionally, single-cell RNA sequencing data from bone marrow blood samples were utilized to further validate these findings, offering complementary insights into biomarker expression across distinct sample types. A total of 762 DEGs were identified between AS patients and controls, and 441 DEGs between SSc patients and controls. Both conditions showed enrichment in the Natural killer cell mediated cytotoxicity pathway. ZSWIM6 and CCL3L3 were identified as potential biomarkers in AS and SSc, with significant diagnostic capabilities demonstrated by ROC analysis. Correlation analysis revealed associations between these biomarkers and specific immune cell types. The study utilizing ZSWIM6 and CCL3L3 as potential biomarkers provides deep insights into the distinct molecular mechanisms of SSc and AS. These findings lay the foundation for future research on targeted therapies and enhance our understanding of immune cell interactions in these autoimmune diseases.

2025-12-01·TALANTA

Separation and photostability analysis of retinoic acid isomers and their derivatives based on ion mobility mass spectrometry and theoretical calculations

Article

作者: Wu, Fangling ; Zou, Ying ; Chi, Chaoxian ; Ding, Chuan-Fan

Retinoic acid (RA) regulates cell proliferation, differentiation, and apoptosis and exists in three primary isomers: all-trans-RA (ATRA), 9-cis-RA (9cRA), and 13-cis-RA (13cRA). RA derivatives, such as bexarotene (BT) and arotinoid acid (TTNPB), are used to treat cutaneous T-cell lymphoma and induce cellular pluripotency. Due to their distinct biological activities, accurate identification and analysis of these isomers are crucial. This study developed a rapid and efficient method for analyzing RA isomers and their derivatives using ion mobility mass spectrometry (IM-MS) and theoretical calculations. RA isomers and derivatives exhibit overlapping mobilities and cannot be separated by direct IM-MS. By forming ternary complexes with β-cyclodextrin (β-CD) and metal ions, baseline separation was achieved with a peak resolution (R_p-p) of up to 3.42. Tandem MS and theoretical calculations revealed distinct differences in interactions, spatial structures, and binding energies, enabling mobility-based separation. Photostability tests showed rapid photoisomerization of 13cRA into 9cRA and ATRA within seconds. Analysis of 13cRA soft capsules from four brands demonstrated good stability, with measured content aligning closely with labeled values. This method offers a new approach for accurate RA isomer analysis, with potential applications in pharmaceuticals and food industries.

2025-08-01·FOOD CHEMISTRY

Metabolomics unravels the formation pathway of advanced glycation end products in preserved egg yolk mediated by OH− during pickling

Article

作者: Xiang, Xiaole ; Dong, Shiqin ; Li, Shugang ; Huang, Yiqun ; Ye, Lin ; Yu, Zhuosi ; Chen, Le ; He, Yu

Metabolomics was first applied to explore the formation pathway and regulatory factors for advanced glycation end products (AGEs) in preserved egg yolk (PEY) during pickling. Most reactions that contributed to formation of AGEs, including oxidation and/or degradation of matrix/precursors and Maillard reaction, occurred primarily in PEY in early stage, and lipid oxidation occurred prior to protein oxidation. Additionally, the formation of N^ε-carboxymethyl-lysine (CML) in PEY was mainly attributed to glyoxal derived from D-glucuronic acid in early stage based on the correlation between metabolites and AGEs. Reactive oxygen radicals from oxidized lipids also promoted the enrichment of CML and N^ε-carboxymethyl-lysine (CEL). Moreover, during later stage, the accumulation of CEL was enhanced through methylglyoxal from Schiff bases, and acidic compounds could inhibit AGEs via hindering Maillard reaction. This manuscript pioneered the application of metabolomics to reveal the formation pathway of AGEs, and will provide new perspective on AGEs formation in foods.

131

项与异维A酸相关的新闻（医药）

5 小时之前

·ascletis.com

Ascletis Announces Phase III Trial of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne, Meets All Endpoints

- Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated statistically significant and clinically meaningful improvement compared to placebo in all primary, key secondary, and secondary endpoints - Denifanstat demonstrated a favorable safety and tolerability profile - Denifanstat was 98% and 178% more effective than U.S. Food and Drug Administration (FDA)-approved sarecycline and doxycycline with regard to placebo-adjusted percent treatment success, respectively, 18.6% for denifanstat versus 9.4% for sarecycline, 18.6% versus 6.7% for doxycycline - Denifanstat was 60% more effective than FDA-approved clascoterone cream with regard to placebo-adjusted percent treatment success, 18.6% for denifanstat versus 11.6% for clascoterone cream, respectively - The exceptional efficacy of denifanstat coupled with its favorable safety profile in the Phase III trial provides a potential major break-through for the treatment of acne Hong Kong, June 4, 2025-- Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today that denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, meets all primary, key secondary, and secondary endpoints in the Phase III clinical trial for the treatment of moderate to severe acne vulgaris (NCT06192264). The Phase III clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat once-daily oral tablet in 480 patients with moderate to severe acne vulgaris. Patients were enrolled and randomized into one active treatment arm and one placebo control arm at the ratio of 1:1 to receive 50 mg denifanstat oral tablet once daily or matching placebo for 12 weeks. Baseline characteristics were well balanced between denifanstat and placebo arms. Table 1 summarizes some of baseline characteristics. Primary, key secondary, and secondary endpoints can be found in Table 2. Primary endpoints included the percent treatment success (defined as an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12), the percent reduction from baseline in total lesion count, and the percent reduction from baseline in inflammatory lesion count. At week 12, percent treatment success was 33.2% compared to 14.6% for placebo, p<0.0001, percent reduction from baseline in total lesion count was 57.4% compared to 35.4% for placebo, p<0.0001, and percent reduction from baseline in inflammatory lesion count was 63.5% compared to 43.2% for placebo, p<0.0001. The key secondary endpoint, percent reduction from baseline in non-inflammatory lesion count at week 12, was 51.9% compared to 28.9% for placebo, p<0.0001. Denifanstat demonstrated a favorable safety and tolerability profile following 12 weeks of once-daily oral administration at 50 mg. The incidence rates of treatment-emergent adverse events (TEAEs) were comparable between denifanstat and placebo. No incidence rates of TEAEs related to study drug in any category exceeded 10%. Only two categories of TEAEs had an incidence rate of more than 5% (6.3% dry skin in denifanstat-treated patients versus 2.9% in the placebo group; 5.9% dry eye in denifanstat-treated patients versus 3.8% in the placebo group). All denifanstat-related adverse events (AEs) were mild or moderate. There were no denifanstat-related grade 3 or 4 AEs and no denifanstat-related serious AEs (SAEs). No deaths were reported. The mechanisms of action of denifanstat for the treatment of acne are (1) direct inhibition of facial sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes; and (2) inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation. Denifanstat’s unique mechanism of action directly reduces one of the main underlying causes of acne which is the overproduction of sebum. This makes denifanstat unique as most other acne treatments do not treat the underlying cause of the condition. “We are extremely pleased with the topline results of our Phase III trial. Denifanstat tablets demonstrated impressive efficacy beyond treatment success, showing significant reductions in total lesion count, inflammatory lesion count, and non-inflammatory lesion count. We are excited to be submitting this innovative treatment with the China National Medical Products Administration (NMPA) soon.” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. Table 3 highlights the excellent efficacy of denifanstat in a non-head to head comparison to other commonly used oral and topical acne treatments. Denifanstat demonstrated its exceptional efficacy across multiple key metrics compared to sarecycline, doxycycline and clascoterone cream. With regard to the placebo-adjusted percent treatment success and the placebo-adjusted percent reduction from baseline in inflammatory lesion count, denifanstat was 98% and 30% more effective than sarecycline, respectively, 178% and 178% more effective than doxycycline, respectively, and 60% and 59% more effective than clascoterone cream, respectively. With regard to the placebo-adjusted percent reduction from baseline in total lesion count, denifanstat was 189% and 85% more effective than doxycycline and clascoterone cream, respectively. With regard to the placebo-adjusted percent reduction from baseline in non-inflammatory lesion count, denifanstat was 411% and 102% more effective than sarecycline and clascoterone cream, respectively. Denifanstat has the potential to be a first-in-class, once-daily, oral acne therapeutic, potentially offering both exceptional efficacy and patient compliance with a favorable safety and tolerability profile. Compared to other oral acne treatments, denifanstat provides outstanding efficacy with excellent safety. There is no potential for antibiotic resistance or off target effects which can occur with tetracycline derivatives and no reported denifanstat-related severe AEs such as hepatotoxicity, hearing impairment and depression which are seen with isotretinoin. Denifanstat should also provide better adherence to treatment compared to topical therapies: an estimated 30% to 40% of patients do not adhere to their topical treatments[1]. Denifanstat is licensed from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China. “The Phase III clinical trial results for denifanstat are highly encouraging. The data demonstrate statistically significant improvements in treatment outcomes for moderate-to-severe acne patients, with percent treatment success of 33.2%, total lesion count reduction of 57.4% from baseline, inflammatory and non-inflammatory lesion counts decreasing by 63.5% and 51.9%, respectively, while maintaining a favorable safety and tolerability profile. Denifanstat’s first-in-class mechanism targeting FASN directly addresses a key cause for acne, establishing it as a groundbreaking therapeutic approach in acne treatment.” said Prof. Leihong Xiang, Chief Physician of Dermatological Department, Huashan Hospital, Fudan University, Executive Deputy Director of Institute of Dermatology, Fudan University, Deputy Director of Dermatology Division of Chinese Medical Doctor Association and principal investigator of denifanstat Phase III trial for moderate to severe acne. [1] Purvis CG, Balogh EA, Feldman SR. Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the Acne Treatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055. Table 1. Baseline characteristics of Phase III trial of denifanstat Baseline characteristics 50 mg denifanstat, oral, once daily (n=240) Placebo, oral, once daily (n=240) Total lesion count 102.2 102.1 Inflammatory lesion count 42.1 43.1 IGA=3 (moderate), % 85.8 85.8 IGA=4 (severe), % 14.2 14.2 Table 2. Efficacy endpoints of 50 mg denifanstat oral, once daily at week 12 versus placebo (intent-to-treat, ITT, analysis) Efficacy endpoints (1) 50 mg denifanstat, oral, once daily (n=240) Placebo, oral, once daily (n=240) Placebo adjusted p value Percent treatment success (2) (primary endpoint) 33.2 14.6 18.6 <0.0001 Percent reduction from baseline in total lesion count (primary endpoint) 57.4 35.4 22.0 <0.0001 Percent reduction from baseline in inflammatory lesion count (primary endpoint) 63.5 43.2 20.3 <0.0001 Percent reduction from baseline in non-inflammatory lesion count (key secondary endpoint) 51.9 28.9 23.0 <0.0001 Absolute reduction from baseline in total lesion count (secondary endpoint) 58.3 36.2 22.1 <0.0001 Absolute reduction from baseline in inflammatory lesion count (secondary endpoint) 26.6 18.4 8.2 <0.0001 Notes: (1) All efficacy endpoints are least square means. (2) Treatment success is defined as an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12. Table 3. Denifanstat compared to other commonly used acne treatments (not head-to-head comparison) Category Denifanstat (n=240) Sarecycline(1) (n=1002) Doxycycline(2) (n=216) Clascoterone cream(3) (n=722) Baseline characteristics Total lesion count 102.2 72.4 71.7 103.6 Inflammatory lesion count 42.1 30.0 33.6 42.7 IGA=3 (moderate), % 85.8 85.2 93.5 82.7 IGA=4 (severe), % 14.2 14.9 6.5 17.3 Efficacy endpoints at week 12 Placebo-adjusted percent treatment success 18.6 9.4 6.7 11.6 Placebo-adjusted percent reduction from baseline in total lesion count 22.0 NA 7.6 11.9 Placebo-adjusted percent reduction from baseline in inflammatory lesion count 20.3 15.6 7.3 12.8 Placebo-adjusted percent reduction from baseline in non-inflammatory lesion count 23.0 4.5 NA 11.4 Notes: (1) The sarecycline data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Moore, A., et al., J Drugs Dermatol 2018 Vol. 17 Issue 9 Pages 987-996. The non- inflammatory lesion count data are from FDA (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209521Orig1s000MultidisciplineR.pdf). (2) The doxycycline data at week 16 are from Moore, A., et al., J Drugs Dermatol 2015 Vol. 14 Issue 6 Pages 581-6. (3) The clascoterone cream (1%) data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Hebert. A, et al., JAMA Dermatology 2020 Vol. 156 Issue 6, DOI: 10.1001/jamadermatol.2020.0465. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline. For more information, please visit www.ascletis.com. Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) Peter.vozzo@icrhealthcare.com Ascletis Pharma Inc. PR and IR teams +86-181-0650-9129 (China) pr@ascletis.com ir@ascletis.com

临床结果ASCO会议临床2期临床3期

2025-05-09

·医药观澜

抗痤疮新药「阿达帕林过氧苯甲酰凝胶」在中国获批

▎药明康德内容团队报道今日（5月9日），中国国家药监局（NMPA）官网刚刚发布的批件信息显示，高德美（Galderma）公司的阿达帕林过氧苯甲酰凝胶上市申请已获得批准。公开资料显示，这是一款每日一次的处方药（英文商品名：Epiduo），已经获美国FDA批准用于治疗寻常性痤疮。截图来源：NMPA官网寻常性痤疮是一种慢性炎症性皮肤病，特征为开放性或闭合性粉刺及炎性病变（如丘疹、脓疱或结节）。寻常性痤疮往往会导致严重的身心疾病，如永久性疤痕、自我形象不佳、抑郁及焦虑，尤其是在青少年及年轻人中。寻常痤疮有多种病因，包括炎症及感染。毛囊及伴随的皮脂腺阻塞、痤疮角化杆菌的毛囊定植以及多种促炎细胞因子的产生，均可能导致非炎症性及炎症性病变的形成。本次在中国获批产品为阿达帕林过氧苯甲酰凝胶（0.3%/2.5%），它结合了两种有效的药物来治疗顽固的痤疮，并通过畅通毛孔和杀死细菌来防止痤疮的形成。其中，阿达帕林为第3代维A酸药物。维A酸类药物具有改善毛囊皮脂腺导管口角化、溶解微粉刺和粉刺、抗炎、预防和改善痤疮炎症后色素沉着和痤疮瘢痕等作用，它还能增加皮肤渗透性，在联合治疗中可以增加外用抗菌及抗炎药物的疗效。过氧苯甲酰是一种抗氧化剂，可缓慢释放新生态氧和苯甲酸，具有杀灭痤疮丙酸杆菌、抗炎及轻度溶解粉刺作用。过氧苯甲酰可单独使用，也可联合外用维A酸类药物或外用抗生素使用。2018年5月，高德美宣布了ALAMO 4期研究结果，该研究评估了阿达帕林和过氧化苯甲酰凝胶加口服多西环素200mg在12周治疗期间，对严重炎性痤疮（非结瘤性/非结块性）患者的疗效和安全性。该研究达到了“12周治疗期结束时炎性病变数量减少”的主要疗效终点。结果显示，在研究参与者中，与基线相比，阿达帕林和过氧化苯甲酰凝胶加多西环素的病变计数大幅减少，炎症病变减少66.2%，非炎症病变减少58.7%，第12周总病变减少62.6%。此外，37.1%的研究参与者通过研究者总体评估反应（IGA）评分为0（清除）或1（几乎清除）。在12周时，80.1%的研究参与者不再被认为是口服异维甲酸（一种治疗严重痤疮的药物）的候选人。希望这款阿达帕林过氧苯甲酰凝胶早日来到中国患者身边，为患者带来更多的治疗选择。参考资料：[1]2025年05月09日药品批准证明文件送达信息.From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250509152738101.html[2]Galderma Announces Results of ALAMO: A Real-World, Phase 4 Study Demonstrating Efficacy and Safety of Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% Plus Oral Doxycycline 200 mg in Treating Severe Inflammatory Acne. Retrieved Mar 7, 2018, from https://www.galderma.com/news/galderma-announces-results-alamo-real-world-phase-4-study-demonstrating-efficacy-and-safety免责声明：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。

临床2期临床3期

2025-03-26

·ir.journeymedicalcorp.com

Journey Medical Corporation Reports Full-Year 2024 Financial Results and Recent Corporate Highlights

FDA Approval of Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules) for Rosacea Emrosi Initial Distribution Ongoing; First Prescriptions Filled Total Revenues for the Full Year Ended December 31, 2024 were $56.1 million Met All Financial Guidance for 2024 Emrosi Phase 3 Clinical Trial Results Published in JAMA Dermatology Company to Hold Conference Call Today at 4:30 p.m. ET SCOTTSDALE, Ariz., March 26, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”) approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced financial results and recent corporate highlights for the full year ended December 31, 2024. Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer, said, “We delivered a solid performance in 2024, meeting all of our financial guidance ranges and received first cycle FDA approval for Emrosi™ in November, ahead of the scheduled PDUFA date. Emrosi’s superb Phase 3 clinical results demonstrated its best-in-class profile, and we expect it will become the standard of care and transform our business. Our cash position remains strong ahead of Emrosi’s launch and our objective is to deliver enhanced revenue growth and become sustainably EBITDA positive. I am pleased to report that we have begun distribution of Emrosi, that first prescriptions have been dispensed and that we continue to execute ahead of schedule, with full promotion expected in April 2025.” 2024 Financial Guidance: 2024 Financial Results: Total revenues were $56.1 million for the full year 2024 compared to $79.2 million for the full year of 2023. Product revenue, net decreased $4.5 million, or 8%, to $55.1 million for 2024, from $59.7 million for 2023, due to overall higher rebates costs across the Company’s product portfolio and lower unit sales volumes, mainly from our legacy products. Increases in unit sales volumes for Qbrexza® and Accutane® were offset by higher rebate costs. Other revenue for 2023 reflects a one-time upfront license payment of $19.0 million and $0.5 million in product related royalties for Qbrexza from Maruho Ltd., our exclusive licensing partner in Japan. 2024 reflects a $1.0 million milestone payment pursuant to Journey’s license agreement with Cutia Therapeutics (HK) Limited (“Cutia”) that became payable to us upon Cutia receiving marketing approval for Amzeeq® in the People’s Republic of China. Cost of goods sold (“COGS”) decreased by $2.0 million, or 9%, to $20.9 million for 2024, from $22.9 million for 2023 due to a decrease in product royalties, stemming from the contractual royalty decreases in 2023 and the discontinuation of Ximino. The Company’s gross margin percentage slightly improved from period-to-period, as the cost savings noted above were partially offset by higher product COGS. SG&A expenses decreased by $3.7 million, or 8%, to $40.2 million for 2024, from $43.9 million for 2023. The decrease is mainly due to expense reduction efforts primarily in sales and marketing, partially offset by increases in non-cash share-based compensation expense, Emrosi launch expenses, and increased SG&A related to the expansion of our market access and coverage platforms. R&D expenses were $9.9 million for 2024, compared to $7.5 million for 2023. R&D expenses for 2024 include a $4.1 million application filing fee payment to the FDA for Emrosi, and a $3.0 million milestone payment triggered by the FDA’s acceptance of the Company’s NDA application for Emrosi. Clinical trial expenses were significantly lower than 2023, as clinical development for Emrosi concluded in 2024. The Company’s net loss was $(14.7) million, or $(0.72) per share basic and diluted for the full year 2024, compared to the net loss of $(3.9) million or $(0.21) per share basic and diluted for the full year 2023. Net loss for 2023 includes revenue from the Maruho upfront fee license payment of $19.0 million and $0.5 million in product related royalties. The Company’s non-GAAP results in the table below reflect Adjusted EBITDA of $0.8 million, or $0.04 per share basic and $0.03 per share diluted for the full year 2024. This compares to Adjusted EBITDA of $15.6 million, or $0.85 per share basic and $0.75 per share diluted for the full year 2023. Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are non-GAAP financial measures, each of which are reconciled to the most directly comparable financial measures calculated in accordance with GAAP below. At December 31, 2024, Journey Medical’s cash and cash equivalents totaled $20.3 million, compared to $22.5 million on September 30, 2024, and $27.4 million on December 31, 2023, a decrease of $2.2 million for the quarter and a decrease of $7.1 million from the prior-year period. Recent Corporate Highlights: In March 2025, Journey Medical announced publication in the Journal of the American Medical Association - Dermatology of the Phase 3 clinical trial results of Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) to treat rosacea. Emrosi achieved the co-primary and all secondary endpoints with no significant safety issues when administered once daily for 16 weeks. In February 2025, Journey Medical hosted a conference call and webcast to discuss its U.S. commercial launch plan for Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules) for the treatment of rosacea. A replay of the webcast is available on the IR calendar page of the Journey Medical website, here. In November 2024, the U.S. FDA approved Emrosi for the treatment of inflammatory lesions of rosacea in adults. In October 2024, clinical data were presented at the 44th Fall Clinical Dermatology Conference assessing the dermal and systemic pharmacokinetics of Emrosi versus oral Doxycycline 40 mg capsules (Oracea®)1 in healthy subjects. In July 2024, Journey Medical appointed Michael C. Pearce to its Board of Directors. Mr. Pearce is an accomplished executive, with substantial strategic, business and financial expertise across many industries, including healthcare. In April 2024, Journey Medical appointed Joseph M. Benesch as its permanent Chief Financial Officer. Mr. Benesch served as Journey Medical’s Interim Chief Financial Officer since January 2023 and previously, he was Corporate Controller at the Company since November 2021. Conference Call and Webcast InformationJourney Medical management will conduct a conference call and audio webcast on March 26, 2025, at 4:30 p.m. ET. To listen to the conference call, interested parties within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Journey Medical conference call. Participants can register for the conference here: https://dpregister.com/sreg/10197674/feaf5b7354. Please note that registered participants will receive their dial-in number upon registration. A live audio webcast can be accessed on the News and Events page of the Investors section of Journey Medical’s website, www.journeymedicalcorp.com, and will remain available for replay for approximately 30 days after the meeting. (1) Oracea® is a registered trademark of Galderma Holdings, S.A. Société Anonyme. About Journey Medical CorporationJourney Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets eight FDA approved prescription drugs that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com. Forward-Looking StatementsThis press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization of our recently approved product, Emrosi™, and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact:Jaclyn Jaffe (781) 652-4500ir@jmcderm.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com Use of Non-GAAP Measures: In addition to the GAAP financial measures as presented in our Form 10-K that will be filed with the Securities and Exchange Commission (“SEC”), the Company has, in this press release, included certain non-GAAP measurements, including Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted. We define Adjusted EBITDA as net income (loss) excluding interest, taxes and depreciation and amortization, less certain other non-cash and infrequent items not considered to be normal, recurring operating expenses, including, share-based compensation expense, amortization and impairments of acquired intangible assets, severance, short-term research and development expense and foreign exchange transaction losses. In particular, we exclude the following matters for the reasons more fully described below: Share-Based Compensation Expense: We exclude share-based compensation from our adjusted financial results because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Gain on Extinguishment of Debt: We exclude the gain on extinguishment of debt to settle amounts owed as part of license installment payments, because we consider this to be a non-cash, non-recurring item. Short-Term Research and Development Expense: We exclude research and development costs incurred in connection with Emrosi, formerly referred to as DFD-29, including the filing fee payment made to the FDA and contractual milestone payments, which was the only product in our portfolio not approved for marketing and sale during the reporting period, because we do not consider such costs to be normal, recurring operating expenses that are core to our long-term strategy. Instead, our long-term strategy is focused on the marketing and sale of our core FDA-approved dermatological products and out licensing our intellectual property and related technologies. Amortization and Impairments of Acquired Intangible Assets: We exclude the impact of certain amounts recorded in connection with the acquisitions of intangible assets that are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. These amounts may include non-cash items such as the amortization impairments of acquired intangible assets. Loss Recovery: We exclude the loss recovery payment because we consider this to be a one-time, non-recurring source of income. Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are determined by dividing the resulting Adjusted EBITDA by the number of shares outstanding on an actual and fully diluted basis. Management believes the use of these non-GAAP measures provide meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making, (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance and (iii) it is used by institutional investors and the analyst community to help analyze the Company's results. However, Adjusted EBITDA, Adjusted EBITDA per share basic, Adjusted EBITDA per share diluted and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors. The table below provides a reconciliation from GAAP to non-GAAP measures: Released March 26, 2025

临床3期高管变更财报临床结果上市批准

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
囊性痤疮	澳大利亚	Roche Products Pty Ltd.	1994-12-05
痤疮样疹	美国	Hoffmann-La Roche, Inc.	1982-05-07

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	加拿大	-	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	德国	-	2022-06-21
常染色体隐性鱼鳞病	临床3期	意大利	-	2022-06-21
X联锁鱼鳞病	临床3期	美国	-	2022-06-21
X联锁鱼鳞病	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
X联锁鱼鳞病	临床3期	德国	-	2022-06-21
X联锁鱼鳞病	临床3期	意大利	-	2022-06-21

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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


NCT03076021 (CTgov)	临床4期	-	33	isotretinoin (Pre-isotretinoin)	糧廠網艱淵餘顧窪範觸(餘廠餘網鹹襯鏇積獵壓) = 選齋鹹簾餘艱構構鏇壓鑰醖餘遞醖鏇憲選齋齋 (構夢餘餘簾願鹽糧觸艱, 簾選餘艱憲壓網艱糧壓 ~ 衊蓋選壓鏇淵齋襯觸遞) 更多	-	2025-01-28
				Isotretinoin (With Isotretinoin)	糧廠網艱淵餘顧窪範觸(餘廠餘網鹹襯鏇積獵壓) = 繭範鹹蓋遞顧鏇艱淵膚鑰醖餘遞醖鏇憲選齋齋 (構夢餘餘簾願鹽糧觸艱, 築醖選鹹齋膚選鹹網簾 ~ 繭餘糧顧齋窪範鹹餘廠) 更多
NCT05295732 (ASCEND, NEWS) 人工标引	临床3期	鱼鳞病	-	-	構衊築遞積糧壓齋願遞(簾壓襯淵顧鑰構窪鑰範) = not met 餘襯鏇廠廠衊範簾鏇糧 (鑰選鬱齋淵積範選淵獵 ) 未达到更多	不佳	2024-08-22
				-
EULAR2024	N/A	腰痛	-	Isotretinoin use for acne vulgaris	糧壓齋艱壓憲醖廠鹽艱(憲糧廠繭範蓋鬱糧顧蓋) = 59 patients who developed inflammatory low back pain after isotretinoin use were included 糧餘衊齋製鬱壓製鬱膚 (壓鏇醖壓積選鹽鹹築廠 ) 更多	-	2024-06-05
EADV2023	N/A	-	-	Isotretinoin	鑰襯衊鏇簾範顧積窪選(選選製觸網築鬱繭醖壓): HR = 0.82 (95% CI, 0.77 ~ 0.87), P-Value = <0.001 更多	积极	2023-10-11
				Oral antibiotics
EADV2023	N/A	肠易激综合征 \| 炎症性肠病	-	Isotretinoin	鹹淵淵範廠糧觸網繭艱(蓋廠膚壓壓願遞餘襯艱) = 糧築網積糧壓簾齋製壓選窪範餘繭積積網鹹窪 (顧蓋糧衊顧糧蓋夢壓積, 2.5 ~ 7.7)	积极	2023-10-11
EADV2023	N/A	寻常痤疮	1,191	Surgical extraction + Isotretinoin	獵窪壓廠糧衊襯窪製蓋(構構艱膚鹹獵夢鏇鬱齋) = 築繭鹽窪繭構獵鹽製齋構鑰觸鬱醖簾廠繭觸積 (壓範獵網網蓋簾顧繭網 ) 更多	积极	2023-10-11
THU376 (ENDO2023)	N/A	2型糖尿病	-	Isotretinoin	簾廠鏇觸網願鑰艱艱糧(夢衊膚壓襯糧鏇憲簾齋) = presented with hyperglycemia, acidosis, hypertriglyceridemia, elevated anion gap, low bicarbonate, and elevated ketones 鬱網憲構憲襯鹽選憲積 (餘餘願顧構窪蓋製齋廠 ) 更多	积极	2023-10-05
				Basal-bolus insulin
WCD2023	N/A	寻常痤疮	30	Isotretinoin + SOD	膚簾襯廠憲構糧窪蓋鏇(獵鬱齋壓簾構鏇壓鬱觸) = 積顧鹹鏇繭積膚顧製餘獵糧齋襯醖製鏇淵鬱鑰 (積遞積鏇膚襯範窪範獵 )	积极	2023-07-03
WCD2023	N/A	脓疱型银屑病	-	Isotretinoin	構淵顧獵鏇觸廠簾鑰積(製淵繭顧觸衊築艱糧鏇) = 鏇築繭網窪觸窪蓋餘襯簾餘廠蓋製選願構觸廠 (鹹鏇鬱願衊簾餘鏇簾淵 )	-	2023-07-03
COG ALTE15N2—LEAHRN (ASCO2023) 人工标引	N/A	高风险神经母细胞瘤	375	chemotherapy + radiation + isotretinoin + anti-GD2 antibody therapy + MIBG + single or tandem ASCT(Busulfan/Melphalan (BuMel), Carboplatin/Etoposide/Melphalan (CEM), Thiotepa/Cytoxan,Busulfan/Melphalan (BuMel), Carboplatin/Etoposide/Melphalan (CEM), Thiotepa/Cytoxan, and total body irradiation	觸壓廠獵鹹繭壓繭獵製(淵遞鏇獵製夢網繭醖艱) = 鹽蓋窪製網鹹淵蓋蓋蓋積鑰鏇繭鹹築觸膚繭鹹 (鑰齋遞鏇積蓋遞構鑰廠 ) 更多	不佳	2023-05-31
				single Carboplatin/Etoposide/Melphalan (CEM)Carboplatin/Etoposide/Melphalan (CEM)	-