A Phase I Randomized, Double-Blind, Placebo-Controlled, Multiple Oral Dose Trial to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IBI353 (Orismilast) in Healthy Subjects

This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD of multiple dose of modified-release IBI353 administered orally in healthy subjects. The study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment period and 1 week of safety follow up after completion of last dose.

开始日期2022-11-30

申办/合作机构

信达生物制药（苏州）有限公司

CTR20222393 / Completed临床1期

评估IBI353在中国健康受试者中多次口服给药的药代动力学、安全性和耐受性的随机、双盲、安慰剂对照、I期临床研究

主要目的：评估IBI353在中国健康受试者中多次口服给药后的药代动力学特征。次要目的：评估IBI353在中国健康受试者中多次口服给药后的安全性和耐受性。

开始日期2022-11-24

申办/合作机构

信达生物制药（苏州）有限公司

[+2]

NCT05469464 / Active, not recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate to Severe Atopic Dermatitis

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

开始日期2022-07-11

申办/合作机构

UNION Therapeutics A/S

100 项与 Orismilast 相关的临床结果

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100 项与 Orismilast 相关的转化医学

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100 项与 Orismilast 相关的专利（医药）

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项与 Orismilast 相关的文献（医药）

2024-05-01·Journal of the European Academy of Dermatology and Venereology : JEADV

Orismilast for the treatment of mild to severe hidradenitis suppurativa: Week 16 data from OSIRIS, a Phase 2a, open‐label, single‐centre, single‐arm, dose‐finding clinical trial

Article

作者: Jemec, G B E ; Saunte, D M ; Sedeh, F B ; Taudorf, E H ; Frederiksen, C G

Abstract:

Background:

Hidradenitis suppurativa (HS) is a disease with an unmet need for treatment.

Objective:

To examine tolerability, safety and efficacy of oral phosphodiesterase‐4 (PDE4) inhibitior orismilast 10–40 mg twice daily (BID) in HS.

Methods:

A Phase 2a, single‐arm, single‐centre, open‐label, 16‐week trial in HS patients. Adjustments in maximal dose and titration were allowed, to improve tolerability, dividing the study population in two groups who completed and discontinued 16 weeks of treatment.Descriptive statistics were applied to efficacy data from patients who completed treatment and patients who discontinued treatment prematurely. A last‐observation‐carried‐forward (LOCF) approach was used for patients who discontinued treatment.The primary endpoint was percent change in the total number of abscesses and nodules (AN‐count) at Week 16, with the HS Clinical Response with a 50% reduction in the AN‐count (HiSCR50) as key secondary endpoint.

Results:

Of the 20 patients included, 9 completed 16 weeks of treatment and 11 discontinued treatment prematurely. The mean AN‐count was reduced with 33.1% in patients who completed treatment and with 12.0% in patients who discontinued. HiSCR50 was achieved by 67.0% and 27.0% of patients who completed and discontinued treatment, respectively. Most adverse events were mild to moderate.

Conclusions:

Oral orismilast demonstrated a dose‐dependent tolerability, with mild to moderate adverse effects. Further, the results of this exploratory trial indicate that orismilast may lead to clinical improvements in HS. However, larger trials with tolerable dose ranges are warranted.The Trial is registered at Clinicaltrials.gov (UNI50007201) and EudraCT.ema.europa.eu (2021‐000049‐42).

2024-03-01·Journal of the American Academy of Dermatology

Orismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS)

Article

作者: Blauvelt, Andrew ; Hunter, Hamish J A ; Gooderham, Melinda ; Carlsson, Anna ; Andres, Philippe ; Warren, Richard B ; Langley, Richard G ; Kjøller, Kim D ; Strober, Bruce E ; Egeberg, Alexander ; Mrowietz, Ulrich ; Sommer, Morten O A ; French, Lars E ; Soerensen, Per

BACKGROUND:

Orismilast is a novel oral phosphodiesterase-4 (PDE4) B/D inhibitor being investigated as a potential treatment for moderate-to-severe psoriasis.

OBJECTIVE:

To evaluate efficacy and safety of orismilast modified-release formulation in moderate-to-severe psoriasis.

METHODS:

This multicenter, randomized (1:1:1:1 to 20, 30, 40 mg orismilast or placebo, twice daily), double-blinded, placebo-controlled, parallel-group, phase 2b, 16-week, dose-ranging study evaluated orismilast in adults with moderate-to-severe plaque psoriasis (NCT05190419). Efficacy end points were analyzed using multiple imputation.

RESULTS:

Of 202 randomized patients, baseline characteristics were balanced across arms, except greater severe disease proportions for orismilast vs placebo. Orismilast showed significant improvements in the primary end point, percentage change in Psoriasis Area and Severity Index (PASI), from baseline to week 16 (orismilast -52.6% to -63.7% and placebo, -17.3%; all P <.001). Greater proportions receiving orismilast achieved PASI75 (39.5%-49.0%; P <.05) and PASI90 (22.0%-28.3%; P <.05 for 20 and 40 mg) vs placebo (PASI75, 16.5% and PASI90, 8.3%) at week 16. Safety findings were as expected with PDE4 inhibition; dose-dependent tolerability effects observed.

LIMITATIONS:

Small sample size, disease severity imbalance between groups, limited duration and diversity in study population.

CONCLUSION:

Orismilast demonstrated greater efficacy vs placebo and a safety profile in line with PDE4 inhibition.

2023-04-01·Journal of the European Academy of Dermatology and Venereology : JEADV

Pharmacology of orismilast, a potent and selective PDE4 inhibitor

Article

作者: Guttman, Emma ; Warren, Richard B. ; Kjøller, Kim ; Skak‐Nielsen, Tine ; Weiss, Anne ; Silverberg, Jonathan I. ; Andres, Philippe ; Strober, Bruce ; Felding, Jakob ; Sommer, Morten O. A. ; French, Lars E. ; Tutkunkardas, Deniz

Abstract:

Background:

There remains an unmet need for oral medications that are safe and efficacious for long‐term management of chronic inflammatory skin diseases (CISD). Inhibition of phosphodiesterase 4 (PDE4) can modulate a broad range of pro‐inflammatory cytokines that play a major role in CISD pathogenesis. Orismilast is a second generation PDE4 inhibitor in clinical development for CISD treatment.

Objectives:

The objective of this study was to examine the PDE4 enzymatic activity and anti‐inflammatory effects of orismilast in vitro, ex vivo, and in vivo.

Methods:

The PDE1‐11 enzymatic activity of orismilast was tested in vitro using a single concentration of 308 nM orismilast. The PDE4 selectivity and inhibitory potency was further examined in a radiometric assay. Orismilast was tested on human whole blood and human peripheral blood mononuclear cells (PBMC) to determine effects on its cytokine secretion and inhibition profile ex vivo. Orismilast was orally administered in a murine model of chronic oxazolone‐induced ear skin inflammation. Ear thickness, a marker of inflammation, and inflammatory cytokines were analysed.

Results:

Orismilast selectively inhibited PDE4 and demonstrated potent inhibition of PDE4B and PDE4D subtype splice variants in vitro. Orismilast inhibited whole blood and PBMC production of tumour necrosis factor α (TNFα), and the secretion of T‐helper (Th)1 (TNFα and IFNγ), Th17 (IL‐22 and IL‐23), and Th2 (IL‐4, IL‐5, and IL‐13) related cytokines in PBMC. In vivo, 10 and 30 mg/kg doses of orismilast significantly reduced ear thickness and inflammation markers (p < 0.0001, respectively).

Conclusion:

Orismilast displayed selective and potent PDE4 inhibition and broad‐spectrum anti‐inflammatory activity in several pre‐clinical models. The results of the study support clinical development of oral orismilast as a novel treatment option for CISD including psoriasis, atopic dermatitis, and hidradenitis suppurativa.

项与 Orismilast 相关的新闻（医药）

2024-06-13

·Pharmaceutical Technology

Leo’s single-dose autoinjector secures FDA approval for atopic dermatitis

Adbry targets the cytokine IL-13, which drives inflammatory processes of symptoms commonly seen in atopic dermatitis. Credit: Pormezz / Shutterstock. Leo Pharma has announced that its injection treatment for atopic dermatitis, Adbry (tralokinumab-ldrm), will gain an alternative mode of administration following a US Food and Drug Administration (FDA) approval for its single-dose autoinjector. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems Adbry targets interleukin-13 (IL-13), a cytokine that drives inflammatory processes associated with the symptoms of atopic dermatitis. Adbry is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies, following a December 2021 approval. According to GlobalData’s consensus forecasts, Adbry is expected to generate global sales of $1.3bn in 2030. The treatment produced net global sales of $106m in 2023. GlobalData is the parent company of Pharmaceutical Technology . As per the 13 June press announcement, the treatment will now be available for adult patients as a 300 mg/2 mL single dose autoinjector treatment as another option to the existing 150 mg/1 mL pre-filled injectable, which will continue to be available in the US. Leo Pharma is taking steps to make the newly approved device available to US patients in the coming months, EVP and President, Region North America at Leo Pharma, Brian Hilberdink said in the press release. “We understand that no patient is the same, and through this extended approval we have taken a positive step forward to equip those living with atopic dermatitis with more choices,” said Shannon Schneider, Senior Medical Affairs Director at LEO Pharma. See Also: NPX-267 by NextPoint Therapeutics for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval PF-07960613 by Pfizer for Respiratory Syncytial Virus (RSV) Infections: Likelihood of Approval Ballerup, Denmark-based LEO is not the only pharma making strides in the atopic dermatitis space. As per a GlobalData report , the atopic dermatitis market is predicted to be worth $24.4bn across the 61 geographical markets in 2030, with 71.8% of that coming from the seven major markets of US, France, Germany, Italy, Spain, UK, and Japan.” Earlier in the week, Denmark-based Union Therapeutics shared positive data from its Phase IIb ADESOS study (NCT05469464) which evaluated orismilast as an oral treatment for moderate- to-severe atopic dermatitis. Union is looking to initiate a Phase III programme and has reached out to the FDA with initial plans. Also in the picture is Dermavant’s nonsteroidal topical nonsteroidal, VTAMA (tapinarof), which received FDA acceptance for its supplemental New Drug Application (sNDA). According to GlobalData’s analysts, atopic dermatitis presents a mine of opportunities , particularly for drugs that target AhR due to the low rate of adverse effects seen in previous clinical trials.

临床结果上市批准临床2期临床3期

2024-06-04

·PRNewswire

UNION therapeutics announces successful completion of the ADESOS Phase 2b study and presentation of data at the RAVE Conference 2024

ADESOS Phase 2b study evaluating orismilast as an oral treatment in 233 patients with moderate-to-severe atopic dermatitis (AD) has successfully completed Results from the ADESOS study have been selected for an oral presentation at the late breaking research sessions at the RAVE Conference 2024 Orismilast is a next generation, high potency PDE4 B/D selective inhibitor with reported positive results from a Phase 2b study in psoriasis and Phase 2 study in hidradenitis suppurativa (HS); orismilast is currently being evaluated in an ongoing IIT study in ulcerative colitis (UC) UNION is progressing orismilast to Phase 3 development in AD HELLERUP, Denmark, June 4, 2024 /PRNewswire/ -- UNION therapeutics A/S (UNION), a privately held, clinical stage, pharmaceutical development company focused on immunology, today announces successful completion of the ADESOS Phase 2b, randomized, dose-finding study evaluating orismilast as an oral treatment in 233 patients with moderate-to-severe AD. Topline results from the ADESOS study have been selected for an oral presentation by the Signatory Investigator, Professor Jonathan Silverberg, MD, PhD, MPH at the late breaking research sessions at Revolutionizing Alopecia Areata, Vitiligo, and Eczema (RAVE) Conference on June 8-10, 2024, in Chicago, United States. It will be the first presentation of data from the ADESOS study. Presentation details Presentation: Efficacy and safety of orismilast, a potent PDE4B/D inhibitor, in adults with moderate-to-severe atopic dermatitis: a Phase 2b randomized, double-blind, placebo-controlled clinical trial (ADESOS) Presenter: Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences and Signatory Investigator for ADESOS Date and time: Monday June 10, 2024, at 1:30 PM - 4:40 PM CDT. Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences and Signatory Investigator for ADESOS study, said: "AD is one of the most common chronic inflammatory skin diseases worldwide. Innovation in recent years has brought good injectable treatments to patients, but a significant unmet medical need for a safe and effective oral treatment still exists. Orismilast offers the potential for a safe oral treatment with early itch reduction and holds a significant promise as a novel treatment option in AD." Kim Kjøller, Co-Chief Executive Officer of UNION therapeutics, adds: "The results from the ADESOS study with orismilast in atopic dermatitis (AD) follows positive read outs in psoriasis and hidradenitis suppurativa (HS) confirming the potential of orismilast as a safe oral treatment across immunology. We are pleased that the Phase 2b results from the ADESOS study have been selected for an oral presentation at the RAVE Conference in Chicago and look forward to the results being shared and discussed with the leading experts in the field." Orismilast is developed as a next-generation, high potency PDE4B/D selective inhibitor targeting first-in-class positions in AD and hidradenitis suppurativa (HS), and best in class in psoriasis. The efficacy and safety profile of orismilast have been evaluated in the previously reported IASOS Phase 2b study in psoriasis and OSIRIS Phase 2 study in HS. Data of these studies has been presented at leading scientific conferences and data is published in peer-reviewed journals, including the Journal of American Academy of Dermatology (JAAD) and the Journal of European Academy of Dermatology and Venerology (JEADV). UNION has scheduled an End of Phase 2 meeting with the FDA to discuss advancing the orismilast development program into Phase 3 studies in AD. About the ADESOS Phase 2b study The Phase 2b study was a randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy and safety of orismilast in patients with moderate to severe AD. The study included 233 patients who were randomized to three active doses (20mg, 30mg, and 40 mg) of orismilast or placebo administered twice daily. The study was conducted in centers in Europe and in the US. About orismilast Orismilast is a next generation, high potency PDE4 inhibitor targeting the PDE4B/D subtypes linked to inflammation, demonstrating potent inhibition of Th1, Th2 and Th17 pathways. It acts early in the inflammation cascade, inducing a broad range of anti-inflammatory effects across multiple cytokines involved in many dermatological and immunological diseases.1) UNION is developing orismilast as an oral treatment, based on the well-known safety profile of the PDE4 class, across immunology, initially targeting best-in-class or first-in-class positions in atopic dermatitis (AD), hidradenitis suppurativa (HS), psoriasis and ulcerative colitis (UC). The FDA has cleared UNION's Investigational New Drug (IND) application for orismilast and granted Fast Track designation for orismilast for the treatment of moderate to severe AD as well as for the treatment of moderate to severe HS. About atopic dermatitis AD is a chronic inflammatory skin disease affecting 2.1-4.9 % of the adult population worldwide and is the most common skin disease among children.2) There were approximately 20 million diagnosed moderate-to-severe adult patients with AD in 2023 in the Seven Major Markets (United States, France, Germany, Italy, Spain, UK, and Japan).3) Disease symptoms are characterized by recurrent eczematous skin lesions and intense itch. AD has a substantial psychosocial impact on patients and relatives.4) During disease flares, approximately 80% of patients may experience disturbed sleep, which may also disrupt the sleep of family members.5) The disease also appears to impact the mood and patients have an increased risk of anxiety and depression.6) Sources 1) Blauvelt A et al., Dermatology and Therapy 2023: Next Generation PDE4 Inhibitors that Selectively Target PDE4B/D Subtypes: A Narrative Review - PubMed (nih.gov) & Silverberg J.I. et al., JEADV 2022: & Warren R.B. et al., JEADV 2022: 2) Barbarot S et al,. Allergy 2018: 3) EvaluatePharma 2023 4) Laughter MR et al., British Journal of Dermatology 2021: 5) Eichenfield LF et al., Journal of the American Academy of Dermatology 2014: 6) Drucker AM et al., The Journal of Investigative Dermatology 2017: Contacts Morten Boesen, Chief Financial Officer, UNION therapeutics A/S +45 2381 5487 [email protected] Sarah Toft-Jørgensen, Director of Communications and IR, UNION therapeutics A/S +45 5385 3044 [email protected] About UNION therapeutics UNION therapeutics is a privately held, clinical stage, pharmaceutical development company focused on immunology. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and seasoned pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at This information was brought to you by Cision

临床2期快速通道临床结果临床3期

2024-04-09

·CPHI制药在线

从赛默制药克立硼罗抢首仿，看国内PDE-4抑制剂研发布局

关注并星标CPHI制药在线日前，国家药监局官网显示，浙江赛默制药以仿制4类提交的克立硼罗软膏上市申请获得CDE承办受理。目前，国内只有原研药企辉瑞的克立硼罗软膏获批上市，还未有企业获批生产克立硼罗软膏仿制药。克立硼罗首仿之争克立硼罗是一种新型小分子、非激素、非甾体类抗炎的磷酸二酯酶4（PDE-4）抑制剂，由Anacor公司原研。2016年，辉瑞斥资52亿美元收购Anacor，获得克立硼罗等。2016年，克立硼罗获FDA批准上市（商品名：Eucrisa），用于治疗2岁及以上轻至中度特应性皮炎（AD）患者。在国内，克立硼罗软膏于2019年被纳入《第二批临床急需境外新药》名单。2020年7月，克立硼罗获NMPA批准上市，适应症为治疗2岁及以上患者的轻中度AD，成为中国首个获批的非激素性PDE-4抑制剂。2023年8月，克立硼罗软膏获批新适应症，将适用年龄范围从2岁以上拓展至3个月以上。除了辉瑞的克立硼罗软膏获批外，国内暂无其他企业获批上市。不过克立硼罗的核心化合物专利将于2026年到期，目前国内已有多家药企提交了克立硼罗软膏仿制药上市申请，包括南京万融健诚医药、齐鲁制药、杭州领业医药、浙江高跖医药、江西科睿药业、江苏万高药业。未来谁将斩获首仿，尚不可知。 PDE-4抑制剂国内研发布局由于AD治疗潜在市场需求巨大，这一"钱景"催生了国内PDE-4抑制剂的研发热潮。该抑制剂通过抑制机体细胞内环磷酸腺苷（cAMP）降解，升高细胞内的cAMP以调控促炎细胞因子水平从而抑制炎症反应，对于包括AD、银屑病等免疫和炎症领域相关疾病的治疗具有显著的临床意义和价值。目前，国内上市的PDE-4抑制剂只有两款，分别是辉瑞的克立硼罗以及安进的阿普米司特（2021年获NMPA批准治疗中重度斑块状银屑病）。国内进入临床阶段的在研PDE-4抑制剂约有十余种。 2021年6月，优锐医药和Verona Pharma达成协议，优锐医药将获得Verona Pharma在研的一款吸入式PDE3/4双抑制剂新药Ensifentrine（RPL554）的独家权利。 Ensifentrine双重抑制机理使其能够凭借单一化合物即可兼具支气管扩张与抗炎活性。Ensifentrine还能激活囊性纤维化跨膜转导调节子（CFTR），有利于降低粘液粘度和改善粘膜纤毛清除，赋予了其在囊性纤维化、哮喘和其他呼吸系统疾病中的应用潜力。在一项III期研究中，结果表明，Ensifentrine组在第12周的平均FEV1曲线下面积（肺功能检测指标）较基线的变化为94mL（P<0.0001），表示研究达到主要终点。 2021年9月，信达生物与UNION therapeutics共同宣布，双方就UNION用于治疗炎症性皮肤病的主要候选药物orismilast--一款处于临床II期的PDE-4抑制剂，达成协议，信达生物将获得orismilast在中国研究、开发和商业化的独家权益。UNION将收到2000万美元的首付款，并有权获得累计不超过2.47亿美元的里程碑付款等。在针对特应性皮炎的IIa期临床研究中，orismilast表现出潜在的BIC潜质，显示出更好的抗炎作用，以及通过创新的缓释方式获得更好的耐受性，有望解决炎症性皮肤病患者群体的未满足需求。 2022年11月，济川药业与恒翼生物共同宣布，二者约定在中国内地对恒翼生物拥有的一种PDE-4抑制剂以及组合产品等约定的适应症进行合作。根据协议，济川药业支付的首付款将不超过1.8亿人民币，开发里程碑付款将不超过1212.5万美元等。 2023年10月，丽珠医药与苏州兰晟医药共同宣布，双方就兰晟医药开发的LS21031签署了一项在大中华区的专利及技术转让协议。LS21031是兰晟医药研发的一款创新高选择性PDE-4变构调节剂，于2023年3月在中国获批临床，适应症为抑郁症。根据协议，丽珠医药将获得相关技术，兰晟医药则获得1500万元首付款，后续还可获得最高不超过7000万元的开发里程碑金和8000万元的销售里程金。 PDE-4抑制剂，作为新一代治疗炎症性疾病的药物，在临床上取得了亮眼的成绩。无论是国内还是国外，这一领域的研究与投资热潮仍在持续。另外随着一些药品专利到期，仿制药市场的竞争也日趋激烈。未来，迎接PDE-4赛道的将是一场腥风血雨。主要参考资料： 1、 https://www.prnasia.com/story/321878-1.shtml. 2、Luelmo J, Gratacós J, Martínez-Losa M M, et al. A report of 4 years of experience of a multidisciplinary unit of psoriasis and psoriatic arthritis[J]. Reumatología Clínica (English Edition), 2014, 10(3): 141-146. 3、Torre Alonso JC, et al. Expert recommendations for the use of apremilast in psoriatic arthritis. Reumatol Clin (Engl Ed). 2022 May 7:S2173-5743(22)00092-2.【智药研习社近期课程预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

并购专利到期上市批准临床3期

100 项与 Orismilast 相关的药物交易

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研发状态

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
自身免疫性疾病	临床2期	中国	信达生物制药（苏州）有限公司	2022-01-30
自身免疫性疾病	临床2期	丹麦	UNION Therapeutics A/S	2022-01-30
化脓性汗腺炎	临床2期	-	UNION Therapeutics A/S	2021-10-01
特应性皮炎	临床2期	丹麦	UNION Therapeutics A/S	2020-07-11
寻常性银屑病	临床2期	德国	Leo Pharma, Inc.	2016-09-01
斑块状银屑病	临床2期	德国	LEO Pharma A/S	2016-06-05
溃疡性结肠炎	临床2期	-	UNION Therapeutics A/S	-
银屑病	临床2期	-	UNION Therapeutics A/S	-

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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


NCT05190419 (IASOS, CTgov)	临床2期	斑块状银屑病	202	Placebo (Placebo Tablets BID)	襯鬱齋廠夢鬱鑰簾簾襯(觸鑰鹽鑰獵範築齋願鏇) = 製夢糧積築壓繭膚餘夢鏇願鏇糧夢醖廠淵艱壓 (餘鏇蓋構衊糧窪襯鹽網, 繭廠鹹鬱遞積遞願願顧 ~ 餘網廠鹽選鹹鬱襯製網) 更多	-	2024-04-16
				Orismilast modified release tablets (Orismilast Modified Release Tablets 20 mg BID)	襯鬱齋廠夢鬱鑰簾簾襯(觸鑰鹽鑰獵範築齋願鏇) = 觸鑰齋選繭鹹鏇鏇積鬱鏇願鏇糧夢醖廠淵艱壓 (餘鏇蓋構衊糧窪襯鹽網, 積壓獵製鬱淵夢鹽壓糧 ~ 齋糧廠築膚鹽憲構構糧) 更多
EADV2023	临床2期	化脓性汗腺炎	20	Orismilast 10 mg	遞醖糧壓築膚製衊憲築(糧齋夢鏇醖製鬱夢選鬱) = 遞淵網鬱鹹夢鑰觸鹹膚鏇鏇鏇願觸壓顧衊憲齋 (襯衊簾製積齋築選顧鹽 ) 更多	-	2023-10-11
				Orismilast 40 mg BID	遞醖糧壓築膚製衊憲築(糧齋夢鏇醖製鬱夢選鬱) = 遞積艱鹽鬱淵廠繭範糧鏇鏇鏇願觸壓顧衊憲齋 (襯衊簾製積齋築選顧鹽 ) 更多
NCT05190419 (IASOS, EADV2023)	临床2期	银屑病	202	Orismilast 20 mg	夢糧鏇築獵獵選製網齋(鏇簾夢築觸鹽鏇鹹鬱鏇) = 醖鏇遞構淵醖鬱鹹獵夢積餘選膚壓鏇獵憲構糧 (鑰衊淵製夢顧鏇顧築襯 ) 更多	积极	2023-10-11
				Orismilast 30 mg	夢糧鏇築獵獵選製網齋(鏇簾夢築觸鹽鏇鹹鬱鏇) = 膚築範醖繭窪鹽顧餘獵積餘選膚壓鏇獵憲構糧 (鑰衊淵製夢顧鏇顧築襯 ) 更多
EADV 12022 \| EADV 22022	临床2期	银屑病	36	Orismilast IR	糧願網鏇壓襯繭糧夢壓(糧鏇鹽鏇鹽構獵糧壓築) = The high GI AE (88.9%) and discontinuation rates in the phase 2a trial led to the development of an MR tablet to improve the GI tolerability by changing the release profile of orismilast. In the phase 1 trial, part 1 showed that orismilast MR achieved comparable PK, including t max , to orismilast IR, despite a slower dissolution rate. No nausea was observed in the MR arm and the rate of GI AEs was lower in the MR arm vs the IR arm (16.7% vs 33.3%, respectively). 襯簾糧膚鹹選築築鑰鏇 (夢衊鏇顧鏇淵膚壓廠糧 )	-	2022-09-07
				Placebo