[Translation] A Phase III, randomized, investigator-blinded, active-controlled, parallel-group, multicenter trial comparing the efficacy and safety of LEO 90100 and Depo-Perot® Ointment for 4 weeks in Chinese adult subjects with stable plaque psoriasis

主要目的：评价LEO 90100与得肤宝®软膏相比对稳定性斑块状银屑病严重程度和范围的有效性。次要目的：评价LEO 90100与得肤宝®软膏相比治疗稳定性斑块状银屑病的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of LEO 90100 compared with Defubain® Ointment on the severity and extent of stable plaque psoriasis. Secondary objective: To evaluate the safety of LEO 90100 compared with Defubain® Ointment in the treatment of stable plaque psoriasis.

Start Date21 Jun 2023

Sponsor / Collaborator

LEO Laboratories Ltd.

[+2]

NCT05919082 / CompletedPhase 3

A Phase 3, Randomised, Investigator-blind, Active-controlled, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of 4-weeks Treatment With LEO 90100 and Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis

This study is conducted to assess the efficacy and safety of LEO 90100 when used on the body for the treatment of stable plaque psoriasis in native adult Chinese subjects, compared to Daivobet® ointment.

Start Date21 Jun 2023

Sponsor / Collaborator

Leo Pharma, Inc.

NCT05811234 / Active, not recruitingNot Applicable

An International, Prospective, Observational Cohort Study to Assess Patient Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults (PRO-SCALP)

The main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of Calcipotriene/Betamethasone Dipropionate (CAL/BDP) PAD cream in a real-world setting.

Start Date13 Jun 2023

Sponsor / Collaborator

Almirall SA

100 Clinical Results associated with Betamethasone Dipropionate/Calcipotriene

100 Translational Medicine associated with Betamethasone Dipropionate/Calcipotriene

100 Patents (Medical) associated with Betamethasone Dipropionate/Calcipotriene

Literatures (Medical) associated with Betamethasone Dipropionate/Calcipotriene

31 Dec 2023·The Journal of dermatological treatment

Potential biomarkers for psoriasis topical treatment by in-depth serum proteomics

Article

Author: Yu, Xiaobo ; Deng, Hao ; Zhang, Xiaomei ; Yu, Jingjie ; Lu, Chuanjian ; Yao, Danni ; Cui, Jingwen ; Deng, Jingwen ; Ye, Shuyan ; Yan, Yuhong ; Han, Ling

BACKGROUND:

Psoriasis is a chronic skin disease, and topical sequential therapy with a combination of calcipotriol and calcipotriol betamethasone is currently approved topical treatment. However, the exact mechanism by which this treatment regimen relieves psoriasis is unknown.

METHOD:

We assembled a cohort of 65 psoriasis patients and divided post-treatment cohort into responder group and non-responder group according to the Psoriasis Area Severity Index (PASI) score after 12-week treatment. We measured the expression levels of proteins in collected 130 serum samples using our in-depth proteomics platform with a data-independent acquisition mass spectrometer and antibody microarray. We performed bioinformatics analyses of the biologic processes and signaling pathways that were changed in the responder group and constructed a proteomics landscape of psoriasis pathogenesis response to treatment. We then validated the biomarkers of disease severity in an independent cohort of 88 samples using an enzyme-linked immunosorbent assay.

RESULTS:

We first identified 174 differentially expressed proteins (DEPs) for comparative analysis of proteins between responders and non-responders at baseline (p < 0.05). Then pathway analysis showed that the responders focused more on signaling molecules and interaction, complement and coagulation cascades, whereas the non-responders more on signal transduction and IL-17 signaling pathways. We further identified four candidate biomarkers (COLEC11, C1QA, BNC2, ITIH4) response to treatment. We also found 125 DEPs (p < 0.05) after treatment compared with before treatment in responder group. Pathway analysis showed an enrichment in pathways related to complement and coagulation cascades, phagosome, ECM-receptor interaction, cholesterol metabolism, vitamin digestion and absorption. CD14 was validated as potential biomarkers for the disease severity of psoriasis and treatment targets.

CONCLUSION:

In this work, we analyzed the response to topical sequential therapy and finally identified four biomarkers. Additionally, we found that topical sequential therapy may alleviate psoriasis by regulating lipid metabolism and modulating the immune response by affecting the complement activation process.

01 Nov 2023·European review for medical and pharmacological sciences

The role of the foam formulation in improving psoriasis treatment acceptability: a real-life experience and a literature review.

Review

Author: Papa, S ; Gasparini, S ; Martella, A ; Giovene, G L

BACKGROUND:

Topical therapies represent the first-line treatment for mild-to-moderate psoriasis. Among various topical options, the fixed-dose combination of calcipotriene (Cal) and betamethasone dipropionate (BD) foam (Enstilar®, LEO Pharma, Ballerup, Denmark) showed superior efficacy to Cal and BD monotherapy and ointment and gel formulations. In addition, the Cal/BD foam is the only topical treatment allowed for either reactive treatment of relapse or twice-weekly maintenance use. Since treatment acceptability is crucial to optimize adherence, this paper presents a case series from a multicenter experience using the Cal/BD foam, to further characterize the use of this therapeutic approach. In addition, a narrative review of studies evaluating the acceptability of the Cal/BD foam, even compared with other formulations, is provided.

CASE SERIES:

The case series involved adult patients with mild-to-moderate psoriasis treated with the Cal/BD foam from October 2021 to June 2022. A clinical and dermoscopic evaluation of plaques was provided for all patients. Data from the clinical practice report complete clinical resolution of plaques in most patients after 4 weeks of active treatment with the Cal/BD foam, and the dermoscopic clearance after a maximum of 8 weeks. Full adherence to treatment was also reported. Literature evidence suggests that the Cal/BD foam is easy to apply and presents high cosmetic acceptance, rapid onset of action, high efficacy, optimal safety, and a high patient preference. The high satisfaction obtained with Cal/BD foam suggests that this formulation is better accepted than others.

CONCLUSIONS:

The Cal/BD foam represents a valuable approach for managing mild-to-moderate psoriasis, both in short and long-term treatment.

01 Apr 2023·Journal of cosmetic dermatology

Comparative evaluation of the efficacy of topical tacrolimus 0.03% and topical calcipotriol 0.005% mixed with betamethasone dipropionate versus topical clobetasol 0.05% in treatment of alopecia areata: A clinical and trichoscopic study

Article

Author: Radwan, Mona ; Nassar, Amany ; Albalat, Waleed ; Elradi, Mona

Abstract:

Background:

Alopecia areata (AA) is a common non‐scarring hair loss disorder that affects children and adults with a great psychological burden because of its recurrent and sometimes treatment‐refractory nature.

Objective:

To compare the efficacy of topical calcineurin inhibitor, topical potent steroid combined with vitamin D analogue versus topical superpotent steroid in treatment of localized AA.

Patients and Methods:

Sixty subjects with chronic (>1 year) localized (SALT score < 25%) AA, confirmed clinically and dermoscopically, were randomized into three groups. Group I used topical 0.03% tacrolimus (Tarolimus®), group II used topical potent steroid combined with vitamin D analogue (Daivobet®). and group III used topical superpotent steroid (Dermovate®). All patients continued a daily therapy for three successive months and were followed up for three other months. Assessment was done using PULL test, SALT score, and dermoscopic comparison before and after therapy.

Results:

Group II showed comparable statistical results to group III with lower values in a non‐statistically significant way. Group I achieved the least improvement among all groups.

Conclusion:

Combined vitamin D analogues with potent steroid appears to be a more convenient treatment for localized AA than superpotent steroids because of less side effects and comparable efficacy. Tacrolimus needs further research or formula customization to be used as a topical therapy for AA.

News (Medical) associated with Betamethasone Dipropionate/Calcipotriene

26 Aug 2024

·www.businesswire.com

LEO Pharma Delivers 11% Revenue Growth (CER) in H1 and Upgrades Financial Outlook for the Year

BALLERUP, Denmark--( BUSINESS WIRE )-- NOT FOR UK USE – NOT INTENDED FOR UK MEDIA During the first six months of 2024, LEO Pharma continued to execute on its strategy with the dermatology portfolio as the primary growth driver. With revenue growth of 11% in constant exchange rates (CER) and EBITDA margin of 9% in the first half of the year, LEO Pharma remains on course to deliver solid financial performance for the full year and the financial outlook has been updated accordingly. “ We are very pleased with the consistent, solid sales increase in H1 2024, reflecting that 100 million people are now benefiting from our innovative treatments across the globe, especially within dermatology where revenue grew by 13% (CER). The continued improvement in our earnings is the result of our strategy, commercial success, and decisive actions on cost structure. We continue to make progress on our strategic aspirations. Our focus for the rest of 2024 will be on paving the way for the potential launch of delgocitinib in Europe, progressing and expanding our pipeline, and remaining firm in our strategic execution,” says CEO Christophe Bourdon. H1 2024 financial highlights Revenue grew 11% (CER) to DKK 6,375 million (H1 2023: DKK 5,797 million). Reported growth was 10%. Dermatology revenue grew 13% (CER) to DKK 5,101 million (H1 2023: DKK 4,576 million), driven by strong growth of Adtralza®/Adbry® for atopic dermatitis (AD) and solid growth in the core dermatology portfolio. Adbry®/Adtralza® revenue increased by 84% (CER) driven by continued uptake across markets, especially in North America. Core dermatology portfolio delivered growth of 5% (CER) across markets. Growth was largely driven by Enstilar® and Protopic®. Growth across all regions: North America up 43%, Europe up 7%, Rest of the World up 6% (CER). North America continues to be the key growth driver with revenue of DKK 1,022 million. Thrombosis revenue increased by 8% (CER) driven by sales across European markets and positively impacted by certain extraordinary items during H1 2024, with underlying growth being 4%. Adjusted EBITDA was DKK 599 million (H1 2023: DKK 488 million) corresponding to a EBITDA margin of 9%, benefiting from revenue growth and operational efficiencies. EBIT was negative DKK 235 million, which represents an improvement of DKK 99 million compared to H1 2023. Free cash flow for H1 2024 was a net outflow of DKK 779 million, improved compared to H1 2023 (H1 2023: DKK (2,035) million). Progress on strategic priorities With a solid track record of delivering on the financial turnaround and consistent double-digit revenue growth, LEO Pharma remains fully committed to transforming the company into a global leader in medical dermatology. An established commercial platform with a diversified product portfolio, along with strong launch capabilities, is in place ahead of the planned launch of delgocitinib in Germany in Q4. Positive Committee for Medicinal Products for Human Use (CHMP) opinion recommending European approval of delgocitinib for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. Publication of results from pivotal DELTA 1 and DELTA 2 trials with delgocitinib in The Lancet, one of the most influential peer-reviewed medical periodicals in the world. The DELTA 1 and DELTA 2 trials investigated the safety and efficacy of investigational delgocitinib cream in adult patients with moderate to severe CHE. U.S. business strengthened with the FDA approval of Adbry® 300 mg single-dose autoinjector for adult patients. Successful Enstilar® phase 3 trial results in China confirms LEO Pharma’s commitment to expanding its presence in China. Phase 3 trial of TMB-001 in congenital ichthyosis did not show a statistically significant difference between active treatment and vehicle. 2024 financial outlook With our consistent increase in sales performance in H1 2024, LEO Pharma is revising its full-year revenue growth outlook upwards compared to what was shared on 3rd May 2024. Full-year revenue growth is now projected to be 9-11% in CER (before: 5-8%). The upwards revision is driven by stronger financial performance in the U.S. in addition to delayed impact from price reforms and generic competition in selected geographies. As a result of the solid first half year results, LEO Pharma is also revising its outlook upwards for adjusted EBITDA margin from a positive mid-single digit margin to a positive margin range of 6-8%. We continue to expect significant improvements in EBIT and net result relative to 2023, although still expecting to deliver both negative EBIT and net result for full year 2024. Potential changes in key assumptions for market growth and unexpected health care and pricing reforms are key risk factors, among others, which could change the outlook for the year. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is a limited liability company and is headquartered in Denmark with a global team of approx. 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion. Forward-looking statements This announcement contains forward-looking statements, including forecasts of future revenue and operating profit, as well as expected business-related events. Such statements are subject to risks and uncertainties, as various factors, some of which are beyond LEO Pharma’s control, may cause actual results and performance to differ materially from the forecasts made in this announcement.

Drug ApprovalPhase 3Financial StatementClinical Result

14 Mar 2024

·www.prnewswire.com

Psoriasis in America - Insights into Psoriasis Patient Demographics, Quality of Life, Information-seeking Behaviors, HCP Engagement and Treatment Experiences

DUBLIN, March 14, 2024 /PRNewswire/ -- The "Psoriasis in America 2023: Understanding the Psoriasis Patient Experience" report has been added to ResearchAndMarkets.com's offering. Approximately 7.5 million people in the United States have psoriasis. This Psoriasis in America report provides a comprehensive look at life for those living with psoriasis. Using detailed quantitative data, it gives a full picture of the psoriasis patient experience - from symptoms to treatment to HCP relationships to quality of life - so you can make informed, strategic decisions, identify opportunities, and understand potential challenges. The report offers an in-depth look at the psoriasis patient experience. This large-scale, patient-reported data leverages vital quantitative insights essential to understanding key touchpoints in the psoriasis patient journey, including condition management, HCP engagement, quality of life, treatment experience and satisfaction, and much more. This report lifts the curtain on life with psoriasis, giving stakeholders an actionable look at the behaviors, attitudes, perceptions, needs, and experiences of people living with the condition. Data can be used to inform strategic decisions, including product communications, competitive assessments, concept development, landscape analyses, patient journey overlays, and forecasting inputs. This report also addresses important questions that stakeholders may not even know to ask while offering valuable insights into must-have patient-reported data points not available anywhere else. Add-on custom data analysis opportunities are also available for an additional cost - please see the report following purchase for more information. The analyst reaches millions of people through its portfolio of 45+ condition-specific online health communities - including PlaquePsoriasis.com - to provide information, connection, and support to patients and caregivers in the U.S. This report includes a deep-dive into: Psoriasis patient demographics Age, gender, ethnicity, marital status, children, employment status, income, location, insurance, and other health conditions Impact of psoriasis on quality of life Severity, impact on quality of life, symptoms experienced, and what patients wish others better understood Information-seeking behaviors Information sources used, plus topics of interest HCP engagement Primary HCP seen for condition, satisfaction with HCP, and discussion about brands aware of/not used Psoriasis treatment awareness and experiences Aided awareness of specific treatments, treatment experience, satisfaction with current treatments, perceived control with current treatment plan, and interest/participation in clinical trials Key questions answered in this report: To what extent do people say psoriasis impacts their overall quality of life? What's the average number of flares in the past year? What do patients wish others understood about psoriasis? What percentage of patients see a specialist for psoriasis treatment? What treatments have the highest aided brand awareness among patients? What percentage of patients use a biologic? How many patients feel their psoriasis is well-controlled on their current treatment plan? What percentage of patients are likely to switch or add new treatments in the next six months? What medications have patients discussed with their HCP? What are the top online resources people with psoriasis use to find information? What kinds of content and information do patients search for? What percentage of patients search for information on treatment options? Methodology Psoriasis in America consists of: A 20-minute online quantitative survey, covering demographics, comorbidities, quality of life/impact, HCP interactions, as well as treatment awareness, experiences, and discussions Qualitative patient insights from open-ended responses Additional details: Fielded: January 16, 2023 to April 14, 2023 Convenience sample of 490 respondents diagnosed with psoriasis Respondents are age 18+, living in the U.S., and are recruited from proprietary online health communities and recruiting partners Key Topics Covered: Respondent Demographics Research Highlights Condition Status and Quality of Life Severity and Exacerbations Symptoms Experienced Impact on Quality of Life Qualitative Patient Insights Information-Seeking Behaviors Resources Used to Manage Health Types of Content/Information Sought Treatment Awareness and Experiences Primary HCP Seen for Psoriasis Care Aided Brand Awareness of Treatments Treatment Usage Condition Control on Current Treatment and Clinical Trial Interest Treatment Discussions with HCP Appendix with All Data Charts and Distributions Brands and treatments mentioned in this report include: Topical corticosteroid (such as hydrocortisone) BRYHALIT (halobetasol propionate) lotion DesOwen (desonide) SERNIVOT (betamethasone dipropionate) SORILUXT Foam (calcipotriene) TACLONEX (calcipotriene and betamethasone) TAZORAC (tazarotene) VECTICAL (calcitriol) VTAMA (tapinarof) ZITHRANOLT-RR (anthralin) ZORYVET (roflumilast) Acitretin (SORIATANE) ARAVA (leflunomide) Azathioprine (such as IMURAN, AZASAN) Cyclosporine (such as Sandimmune, NEORAL, RESTASIS) Methotrexate (eg, Rheumatrex), also sometimes given as an injection OTEZLA (apremilast) PLAQUENIL (hydroxychloroquine) RINVOQ (upadacitinib) SOTYKTUT (deucravacitinib) Sulfasalazine (Azulfidine) XELJANZ/XELJANZ XR (tofacitinib citrate) AMJEVITAT (adalimumab-atto) Hide until launched in US AVSOLA (infliximab-axxq) CIMZIA (certolizumab) COSENTYX (secukinumab) CYLTEZO (adalimumab-adbm) Hide until launched in US ENBREL (etanercept) ERELZIT (etanercept-szzs) Hide until launched in US HULIO (adalimumab-fkjp) Hide until launched in US HUMIRA (adalimumab) HYRIMOZ (adalimumab-adaz) Hide until launched in US ILUMYAT (tildrakizumab-asmn) INFLECTRA (infliximab-dyyb) IXIFIT (infliximab-qbtx) Hide until launched in US ORENCIA (abatacept) REMICADE (infliximab) RENFLEXIST (infliximab-abda) SIMPONI (golimumab) SIMPONI ARIA (golimumab for infusion) SILIQT (brodalumab) SKYRIZI (risankizumab-rzaa) STELARA (ustekinumab) TALTZ (ixekizumab) TREMFYA (guselkumab) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

12 Mar 2024

·www.prnewswire.com

Hyphens Pharma licenses Wynzora® Cream for ASEAN countries from MC2 Therapeutics

Wynzora® Cream is approved and marketed in Italy, Germany, Spain, the United Kingdom, and the United States. SINGAPORE, March 12, 2024 /PRNewswire/ -- Hyphens Pharma International Limited (" Hyphens Pharma", or the " Company", and together with its subsidiaries, the " Group"), Singapore's leading specialty pharmaceutical and consumer healthcare group, is pleased to announce that its subsidiary, Hyphens Pharma Pte. Ltd., has entered into an exclusive license, supply and commercialisation agreement (the " Agreement") with MC2 Therapeutics (" MC2") for the exclusive rights to register and commercialise Wynzora® Cream and all future product extensions and/or improvements for the topical treatment of plaque psoriasis in the 10 ASEAN countries. Wynzora® Cream (), is a leading topical treatment for plaque psoriasis, including scalp psoriasis in adults. Psoriasis sufferers endure a significant psychological burden due to the visible nature of the skin lesions, its comorbidity, and its chronicity[1]. Wynzora® Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate that has demonstrated high efficacy with quick improvement within 1 week in clinical studies[2]. Its dual mode of action targets the hallmark cytokines IL-23 and IL-17A/F immune axis and TNF-α expression in a single product. It is uniquely enabled by MC2's formulation and drug delivery system PAD Technology™, allowing for an effectful convenient-to-use aqueous formulation. Wynzora® Cream has been approved and marketed in key markets including Italy, Germany, Spain, the United Kingdom, and the United States. "Hyphens Pharma is a leading specialty pharma company focused on the commercialisation of innovative pharmaceutical products in the ASEAN region. It has a clear ambition and strategy to grow its dermatology franchise and is an excellent partner for MC2 to leverage Wynzora® in the region, a large and growing market with over 600 million people," said Mr Jesper J. Lange, Chief Executive Officer of MC2, "This deal substantiates our strategy to make Wynzora® available to as many patients suffering from plaque psoriasis as possible globally, as we continue to develop and expand our pipeline of innovative first-in-class drug candidates within immunology and inflammation", added Mr Lange. Mr Lim See Wah ( 林世华 ) , Chairman and CEO of Hyphens Pharma remarked: "MC2's commitment to develop novel treatment paradigms for skin diseases is synergistic with Hyphens' presence and ambition to be a regional leader in ASEAN. Wynzora® is a proven effective treatment for plaque psoriasis in the United States and Europe. Leveraging our strong regulatory and commercial capabilities, we will work closely with MC2 to accelerate the launch of Wynzora® in the ASEAN region, which will benefit Asian patients suffering from psoriasis." Pursuant to the Agreement, the Group will pay MC2 a total of EUR 2.5 million, which includes an upfront payment and fees upon reaching certain regulatory milestones. In addition, MC2 will be entitled to receive fees for sales milestones and double-digit royalties on net sales. The Agreement will not have a material effect on the net tangible assets or earnings per share of the Group for the financial year ending 31 December 2024. About Hyphens Pharma International Limited () Hyphens Pharma International Limited and its subsidiaries (the "Group") is Singapore's leading specialty pharmaceutical and consumer healthcare group, leveraging on its diverse footprint in ASEAN countries. The Group has a direct presence in Singapore, Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering 14 other markets – Bangladesh, Brunei, Cambodia, Hong Kong S.A.R., Macau S.A.R., Myanmar, South Korea, Sri Lanka and Gulf Cooperation Council countries, including Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates. Singapore is the Group's regional headquarters, where its strategic planning, finance, regulatory affairs, research and development, legal, business development and logistics operations are based. The Group's core business comprises the following segments: Specialty Pharma Principals, Proprietary Brands, and Medical Hypermart & Digital. Besides marketing and selling a range of specialty pharmaceutical products in selected ASEAN countries through exclusive distributorship or licensing and supply agreements with brand principals mainly from Europe and the United States, the Group also develops, markets and sells its own proprietary range of dermatological products and health supplement products. In addition, the Group operates a medical hypermart for healthcare professionals, healthcare institutions and retail pharmacies, to supply pharmaceutical products and medical supplies and an online pharmacy for doctors to prescribe and have medications delivered to their patients' homes. About MC2 Therapeutics () MC2 Therapeutics is a commercial stage biotech company focused on developing novel treatment paradigms within immunology and inflammation. Its pioneering approach in immunology is anchored in a deep understanding of skin biology, clinical expertise and cross-silo thinking. Besides Wynzora® Cream, MC2 has a pipeline that includes two first-in-class drug candidates, both in Phase 2 clinical development. This media release has been reviewed by the Company's sponsor, SAC Capital Private Limited (the "Sponsor"). It has not been examined or approved by the Singapore Exchange Securities Trading Limited (the "SGX-ST") and the SGX-ST assumes no responsibility for the contents of this media release, including the correctness of any of the statements or opinions made or reports contained in this media release. CONTACT: Issued on behalf of Hyphens Pharma International Limited, For media enquires contact: Mr Derek Chng / Mr Gerald Woon, Email / DID / Mobile: [email protected]/ (65) 6704 9285 / (65) 9638 8635, [email protected] / (65) 6704 9268 / (65) 9694 8364; The contact person for the Sponsor is Ms Lee Khai Yinn (Tel: (65) 6232 3210) at 1 Robinson Road, #21-00 AIA Tower, Singapore 048542. SOURCE Hyphens Pharma International Limited

License out/inPhase 2Drug Approval

100 Deals associated with Betamethasone Dipropionate/Calcipotriene

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	D05AX52	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Scalp Psoriasis	GB	Almirall SA	29 Jul 2021
Psoriasis	CH	LEO Pharma A/S	04 Sep 2008
Plaque psoriasis	US	LEO Pharma A/S	09 May 2008
Psoriasis vulgaris	US	LEO Pharma A/S	09 Jan 2006

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Scalp Dermatoses	Phase 3	CN	Leo Pharma, Inc.	01 Sep 2010
Arthritis, Psoriatic	Phase 2	FR	Leo Pharma, Inc.	01 Jan 2009
Allergic skin reaction	Phase 1	US	MC2 Therapeutics Ltd.	13 Feb 2019
Skin and Connective Tissue Diseases	Phase 1	JP	Leo Pharma, Inc.	01 Mar 2015
Dermatitis, Phototoxic	Phase 1	JP	Leo Pharma, Inc.	01 Dec 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05919082 (NEWS) Manual	Phase 3	Plaque psoriasis	604	LEO 90100	wcjmufkmjg(oarxhmgcfr) = Enstilar®在主要终点上相较于得肤宝®（卡泊三醇倍他米松软膏）表现出优效性 mvjregceht (zuhqlqoxmq ) Met View more	Positive	08 May 2024
				得肤宝
NCT03308799 (Biospace) Manual	Phase 3	Skin Pigmentation	-	Calcipotriene+Betamethasone Dipropionate/Calcipotriene (Patients with skin of color (Fitzpatrick IV-VI))	ssrkfwqlrc(gaeqsqkkyr) = ewsphtvqmp xuojnamizs (hvhdvznmxy ) View more	Positive	15 Sep 2022
Pubmed Manual	Not Applicable	Psoriasis vulgaris	166	Calcipotriene+LEO90100	fgzfdwomre(wohydzmbhm) = arngvbmwka brnlhovozl (vdctlsvloz, 3.0) View more	Positive	18 Jul 2022
NCT02668692 (CTgov)	Phase 3	Psoriasis vulgaris	213	LEO 80185 gel	gnfrcbuagi(skklvggzfl) = jrkktkejru wmpxnvjmza (sstxqltbey, vupcjpvcqa - pafbcyjjre) View more	-	27 Jul 2021
NCT02899962 (PSO-LONG trial, Pubmed \| J Am Acad Dermatol) Manual	Phase 3	Plaque psoriasis	545	Cal/BD foam	lrdgcofjhe(lbyjssiwys) = hppcmfpnyw eilkpzjrqf (bdlblxifdg ) View more	Superior	01 May 2021
				vehicle foam	lrdgcofjhe(lbyjssiwys) = tvpwbwtopz eilkpzjrqf (bdlblxifdg ) View more
NCT03819218 (CTgov)	Phase 2	Psoriasis vulgaris	7	MC2-01 cream	vgtjbqwmkq(uofwcnedmn) = zzssctrwhc zjdbdgbedt (wiqbjljqdd, qgyvqqpdke - tunycydwqi) View more	-	21 Feb 2021
NCT03506477 (CTgov)	Phase 4	Plaque psoriasis	25	Enstilar® foam (Enstilar® Foam)	zhtkvaxcec(jmkptwwnen) = ydxtbirqtc xginarzydi (kdpaecdygn, mosgxtpcqf - zsievxvven) View more	-	20 Jan 2021
				Vehicle Foam (Vehicle Foam)	zhtkvaxcec(jmkptwwnen) = badfmccegf xginarzydi (kdpaecdygn, jviljslmda - outxpkdwnb) View more
NCT03806790 (CTgov)	Phase 3	Psoriasis vulgaris	182	LEO 90100 foam (LEO 90100 Foam)	kvjwisqxqj(kwiahapdhq) = pjpgcalikg yirwvxdpqt (nqyqdxykcx, klxcuthqnu - awhdtrtlbc) View more	-	16 Dec 2020
				Dovobet® ointment (Dovobet® Ointment)	kvjwisqxqj(kwiahapdhq) = hbinufclag yirwvxdpqt (nqyqdxykcx, rpmqfkecnl - oeqybgcbkb) View more
NCT03802344 (CTgov)	Phase 3	Psoriasis vulgaris	498	MC2-01 cream (MC2-01 Cream)	lrcrpfobfc(bqctaucvbx) = qupwlrzlof tfgjmhmxft (vymoptkoif, iusshatjtm - txusjrvkey) View more	-	27 Nov 2020
				Cal/BDP combination (Cal/BDP Combination)	lrcrpfobfc(bqctaucvbx) = ttisbmleit tfgjmhmxft (vymoptkoif, vzhookftng - isjxbgheyk) View more
NCT02387853 (Pubmed \| J Eur Acad Dermatol Venereol) Manual	Phase 2	Plaque psoriasis	106	Cal/BD foam	fvmdculxqm(uzeehplwph) = bxagsymivq owtohdozjl (nyfcyvmtsj ) View more	Positive	01 Sep 2020

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis