The goal of this clinical research study is to compare the effects of topical fluorouracil alone to topical fluorouracil plus topical calcipotriene in patients with multiple actinic keratoses. "Topical" means the medication is applied directly to the skin.

Start Date01 May 2025

Sponsor / Collaborator-

NCT06880042

/ Not yet recruitingEarly Phase 1IIT

COMPARISON of EFFICACY and SAFETY of NARROWBAND UVB with 0.1% TACROLIMUS VS NARROWBAND UVB with 0.005% CALCIPOTRIOL in TREATMENT of VITILIGO

Patient of stable and limited vitiligo less than 20% BSA will be recruited And evaluation of efficacy and safety of narrowband UVB with topical tacrolimus vs narrowband UVB and calcipotriol will be assessed

Start Date11 Mar 2025

Sponsor / Collaborator

Lahore General Hospital

NCT06737406

/ Not yet recruitingNot ApplicableIIT

Efficacy and Safety of 5-Fluorouracil (5FU) in Combination with Calcipotriol in Children (aged 4 to 18 Years) with Palmoplantar Wart: Double-blind, Placebo-controlled, Randomized Trial

Warts caused by the human papillomavirus (HPV) are one of the most common skin conditions among children. The prevalence of warts in school-aged children ranges from 10 to 20 percent. Warts are more common among immunocompromised patients [1, 2]. Some studies also show that the prevalence of viral warts in the pediatric population increases with age, peaking in adolescence. HPV is a DNA virus that replicates only in fully differentiated epithelial cells. More than 80 types of HPV have been identified. Types 27, 57, 2, and 1 are the most common types of HPV in skin warts in the general population. Warts usually affect patients of different age groups and various parts of the body, causing physical and psychological complications for patients (such as pain, discomfort, and embarrassment), which in turn lead to functional impairment. Warts often affect pressure points on the soles of the feet. Although most warts are asymptomatic, plantar warts are often associated with pain while walking, causing physical and psychological stress [3].
Various treatments such as keratolytic agents, cryotherapy, laser, antimitotic treatments, contact sensitizers, and intralesional injection of antigen have been used. There is no evidence that one treatment is superior to others, and in many cases, treatment of viral warts requires a combination of treatments. Treatment selection for patients should be based on variables such as wart size, number of lesions, anatomical location, patient preference, cost, convenience, side effects, and operator experience. It is important to emphasize that good communication between the patient, parents, and dermatologist is essential for successful treatment in children [2, 4].
Despite having various treatment approaches, treating plantar warts is challenging. No single treatment is effective in most patients, treatments are often painful, and they are associated with a high recurrence rate. Although nearly 75 percent of warts can resolve spontaneously within two years, patients often seek treatment for cosmetic reasons and pain. Many studies have examined the use of vitamin D compounds (calcipotriol) and 5-fluorouracil in wart patients separately or in combination with other drugs, but only one recent case report that tested the combination of these two showed very positive efficacy results [5, 6].
In 2009, Gladsjo et al. conducted a randomized clinical trial to evaluate the therapeutic effect of 5% fluorouracil cream in children (4 to 18 years old) with skin warts. In this study, 40 children with skin warts, each having at least two warts on their hands, were enrolled. Patients were randomly assigned to one of two groups: once-daily application of the cream or twice-daily application. Patients and their parents were instructed to gently file each wart with an emery board before applying a small amount of 5% 5-FU cream with a cotton-tipped applicator. The primary outcome of the study was the complete clearance of study warts. Clinical evaluations were performed at baseline and after 1 week, 3 weeks, and 6 weeks of treatment. 88 percent of treated warts cleared after 6 weeks of treatment, and 41 percent of individuals cleared at least one wart. There was no difference in treatment response between once-daily and twice-daily application. No significant blood levels of 5-fluorouracil were detected in any subject. At the 6-month follow-up, 87 percent of complete responders had no wart recurrence. They concluded that 5% fluorouracil cream is a safe, effective, and well-tolerated treatment for warts in children [1].
To date, no clinical trial has evaluated the combination of calcipotriol and 5-fluorouracil. Additionally, given that common current treatments such as cryotherapy are painful for children, achieving an effective, pain-free intervention is necessary. This study aims to evaluate the efficacy and side effects of the combination of 5-fluorouracil and calcipotriol in children (ages 4 to 18) with palmar and plantar warts in a randomized, double-blind, placebo-controlled clinical trial.

Start Date01 Feb 2025

Sponsor / Collaborator

Mazandaran University of Medical Sciences

100 Clinical Results associated with Calcipotriene

100 Translational Medicine associated with Calcipotriene

100 Patents (Medical) associated with Calcipotriene

2,082

Literatures (Medical) associated with Calcipotriene

01 Jul 2025·Biomaterials

An approach for psoriasis of microneedle patch simultaneously targeting multiple inflammatory cytokines and relapse related T cells

Article

Author: Zhang, Ying ; Chang, Jiao ; Li, Yan ; Luo, Yue ; Yin, Weimin ; Zhang, Xiaoyou ; Kuai, Le ; Xue, Tingting ; Li, Bin ; Luo, Ying ; Li, Yongyong ; Song, Jiankun ; Zhao, Yuge ; Huang, Li ; Sun, Jiuyuan ; Fei, Xiaoya ; Yang, Zichen

Psoriasis is a chronic inflammatory skin disorder affecting approximately 125 million people globally. Topical medications are a cornerstone of current treatment protocols; however, their efficacy in mitigating inflammation is constrained by their predominantly single-target mechanisms. A significant challenge is the lack of pharmaceuticals specifically targeting CD8⁺ tissue resident memory T (CD8⁺ TRM) cells, which are the targets in psoriasis relapse. Consequently, relapse rates can soar to 90% post-treatment discontinuation. In this study, we successfully screened a specific macrophage membrane capable of targeting multiple inflammatory factors at psoriatic sites. This membrane was coextruded with etomoxir, a compound that targets CD8⁺ TRM cells. To enhance drug retention and penetration, we employed a delivery strategy involving PDA and microneedles, resulting in the synthesis of PDA-Etomoxir-Macrophage membrane@microneedle (PEM@m). In vivo, PEM@m exhibited superior efficacy in alleviating psoriasis symptoms and preventing relapse compared to the clinical drug calcipotriol (Cal). Mechanistically, PEM@m broadly inhibits inflammatory signals, and its reduction of CD8⁺ TRM cells can be associated with decreased activity in the pentose phosphate pathway (PPP). Our study offers a novel and promising approach for the definitive treatment of psoriasis.

01 Jun 2025·Phytomedicine

A tri-compound formula comprising Ginsenoside Rg1, tetrandrine and icariin alleviates atopic dermatitis symptoms in a mouse model

Article

Author: Wu, Jia-Ying ; Yu, Zhi-Ling ; Wu, Ying ; Fan, Xiao-Yun ; Wong, Lut-Yi ; Wang, Xiao-Qi ; Chen, Ying-Jie ; Wang, Li ; Bai, Jing-Xuan ; Li, Amy Sze-Man ; Fu, Xiu-Qiong

BACKGROUNDAtopic dermatitis (AD) is characterized by both IgE- and non-IgE-mediated immune responses, as well as skin barrier dysfunction. Ginsenoside Rg1, tetrandrine, and icariin each exhibit distinct properties that may contribute to the management of AD. Ginsenoside Rg1 has demonstrated efficacy in mitigating IgE-mediated allergic rhinitis, while tetrandrine is known to suppress abnormal T-cell activation. Icariin has been shown to improve intestinal barrier function, which is crucial in conditions like AD. However, the potential effectiveness of the combined formula of these compounds, referred to as GTI, in treating AD remains unexplored.PURPOSEThis study aimed to investigate the anti-AD effects and mechanisms of GTI in a mouse model.METHODSA calcipotriol (MC903)-induced AD-like dermatitis mouse model was used to evaluate the anti-AD effects of GTI. Dermatitis scores and mouse ear thickness were recorded to assess disease severity. Ear tissues, ear-draining lymph nodes, spleens and sera were collected for use in the investigation of the effects and mechanisms of action of GTI.RESULTSTopical application of GTI significantly alleviated AD-like dermatitis in mice, as evidenced by decreased dermatitis scores, reduced ear thickening, and diminished epidermal and dermal thickness, along with lower levels of the inflammatory cytokines IL-1β and IL-4 in ear tissues. Unlike the positive dexamethasone, GTI had no significant toxicity in the model mice. Topical GTI lowered serum IgE levels and diminished the accumulation of eosinophils and mast cells in ear tissues of model mice, suggesting that GTI mitigates IgE-mediated allergic reactions. GTI significantly decreased the numbers of CD4⁺ T cells in ear tissues, ear-draining lymph nodes and the spleen, demonstrating its suppressive effect on hyperactive immune responses. The protein levels of ZO-1 and claudin-1, two tight junction proteins, were elevated in the ear tissues of mice treated with GTI, indicating a beneficial effect of this formula on skin barrier function. Additionally, GTI inhibited the activation of mitogen-activated protein kinases (MAPKs), as indicated by the downregulation of phospho-p38 (Thr180/182), phospho-ERK (Thr202/Tyr204), and phospho-JNK (Thr183/185) protein levels in mouse ear tissues.CONCLUSIONThis study, for the first time, demonstrated that the topical application of GTI alleviates symptoms of AD without overt toxicity in a calcipotriol-induced AD mouse model. The anti-AD effects of GTI are associated with the suppression of allergic reactions, reduction of hyperactive immune responses, improvement of skin barrier function, and inhibition of MAPK activation. These findings suggest that GTI has the potential to be developed into a safe and effective treatment for AD.

01 May 2025·Acta Pharmacologica Sinica

Gentiopicroside ameliorates psoriasis-like skin lesions in mice via regulating the Keap1-Nrf2 pathway and inhibiting keratinocyte activation

Article

Author: Zhang, Kai-Rong ; Feng, Chun-Lan ; Zhou, Rong ; Qi, Lu-Yao ; Zhou, Hu ; Wang, Hao-Yu ; Lei, Shu-Yue ; Ren, Jing ; Tang, Wei ; Yang, Tao ; Chen, Xin

Psoriasis is a chronic, systemic immune-mediated skin disease. Although many new strategies for psoriasis treatment have been developed, there is great need in clinic for treating psoriasis. Gentiopicroside (GPS), derived from Gentiana manshurica Kitagawa, has multiple pharmacological activities including anti-inflammatory, anti-oxidative and antiviral activities. In this study, we investigated the potential effects of GPS in imiquimod (IMQ)-induced psoriasis mouse model and the underlying mechanisms. The mice were sensitized on their shaved back with IMQ cream for 7 days with or without topical application of 1% or 2% GPS cream. We showed that the application of GPS cream significantly ameliorated psoriasis-like skin lesions; GPS effect was better than that of calcipotriol. GPS rectified the immune cells infiltration and keratinocytes activation in the skin lesions, and significantly inhibited TNF-α/IFN-γ stimulated human keratinocyte (HaCaT) activation in vitro. Proteomic analysis from keratinocytes with and without GPS treatment prompted that GPS regulated the Keap1-Nrf2 pathway, which was the most important pathway in regulating oxidative stress and inflammation. We demonstrated that GPS regulated the protein expression of p62 and Keap1, induced Nrf2 nuclear translocation followed by transcription of Nrf2 downstream antioxidant genes in HaCaT cells. Furthermore, the antioxidant effects of GPS were abolished in Nrf2^-/- keratinocytes. Simultaneously, Nrf2^-/- mice showed increased psoriasiform symptoms with a diminished protective effect in response to GPS treatment. Collectively, the study discloses that GPS inhibits keratinocyte activation and ameliorates psoriasis-like skin lesions in an Nrf2-dependent manner.

News (Medical) associated with Calcipotriene

28 Mar 2025

·pmlive.com

LEO and Reig Jofre partner to improve access to psoriasis therapy in Europe

L-R: Ignasi Biosca, CEO of Reig Jofre, and Juan Fran Cuello de Oro, general manager of LEO Pharma Iberia LEO Pharma and Reig Jofre have entered into a partnership aimed at improving access to LEO’s psoriasis treatment in Europe. The commercial agreement will focus on strengthening the promotion of Enstilar, an aerosol spray foam containing the vitamin D analogue calcipotriol and betamethasone dipropionate, for mild-to-moderate psoriasis within the scope of primary care across Spain. Approximately 125 million people worldwide are affected by some form of psoriasis, a chronic inflammatory condition that typically affects the skin, nails and joints. Up to 90% of patients have plaque psoriasis, characterised by distinct round or oval plaques typically covered by silvery-white scales. LEO’s fixed-dose combination therapy is designed to improve anti-psoriatic response in patients and has been recognised by Farmaindustria, the national association of the pharmaceutical industry in Spain, as an “incremental innovation” due to its advanced foam-based formulation. The collaboration between LEO and Reig Jofre will help extend the treatment’s reach, improve patient access and enhance support for healthcare professionals. “This agreement marks a significant milestone in positioning Reig Jofre and LEO Pharma as key players in medical dermatology in Spain,” Reig Jofre outlined in a statement, adding that the partnership “ensures that healthcare professionals receive the support, proximity and information needed to provide the best possible care to their patients”. LEO has already entered into a number of partnerships this year. Last month, it announced a collaboration with non-profit organisation DEBRA Research aimed at accelerating the development of treatments for epidermolysis bullosa, a group of rare and painful inherited skin disorders that cause the skin to become very fragile and tear or blister very easily. Though financial details of the alliance were not disclosed, the partners said they are hoping to “enhance scouting capabilities and provide additional capacity to accelerate the development of life-changing therapies for epidermolysis bullosa”. The company also partnered with Gilead Sciences in January to advance its small molecule oral STAT6 programme for inflammatory diseases. The deal, worth $1.7bn, gave Gilead global rights to develop, manufacture and commercialise the oral STAT6 programme. Meanwhile, LEO will hold exclusive global rights to STAT6 topical formulations in dermatology, and will have the option to co-commercialise oral programmes for dermatology indications outside the US.

License out/in

01 Mar 2025

·ir.jaspertherapeutics.com

Jasper Therapeutics Presents Clinical and Preclinical Briquilimab Data at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting

REDWOOD CITY, Calif., March 01, 2025 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, is presenting updated clinical data from the Phase 1b/2a BEACON study, as well as data from four preclinical studies evaluating briquilimab, at the AAAAI 2025 Annual Meeting, being held February 28 - March 3, 2025, in San Diego, CA. The BEACON update, based on a data-cut date of January 31, 2025, features approximately one month of additional dosing and follow-up from the 49 participants covered in Jasper’s preliminary data disclosure on January 8, 2025. Briquilimab continues to be well tolerated in the study and has continued to demonstrate a favorable safety profile, with no additional adverse events (AEs) potentially related to c-Kit blockade observed. The data collected in the study to-date support advancing briquilimab into a registrational program in CSU, beginning with a planned Phase 2b operationally adaptive study expected to commence in the second half of 2025. Final dose selection for the Phase 2b study will be further informed by additional clinical data from patients treated at doses of 180mg and higher, expected to be reported mid-year 2025. “I am pleased to present updated data from the BEACON study at AAAAI, which continue to demonstrate that treatment with briquilimab leads to rapid and deep clinical responses in omalizumab-experienced patients with moderate to severe CSU,” said Thomas B. Casale, M.D., Professor of Medicine and Pediatrics, University of South Florida Morsani College of Medicine. “The safety profile observed is also highly encouraging, with a low frequency of c-Kit related adverse events, which were transient, low-grade, and did not result in any dose delays or discontinuations. The favorable safety data reported in the study are supported by the predictable drug clearance observed, which may allow for restoration of signaling on c-Kit-expressing cells between doses. In addition, the early Tmax observed was consistent with rapid onset of clinical response. Taken together, I believe this data set underscores the potential of briquilimab to serve as a differentiated treatment option for patients with CSU.” “We remain very excited by the efficacy and safety data generated in the BEACON study,” said Ronald Martell, President and Chief Executive Officer of Jasper. “We believe that these data demonstrate the potential of briquilimab to differentiate from other therapies, approved and in-development, with regard to onset of action, depth of response, and safety/tolerability. With a substantial number of additional patients being enrolled in the BEACON and SPOTLIGHT studies, as well as patients rolling over from those studies to the Open-Label Extension study, we look forward to reporting data from approximately 70 additional patients treated with briquilimab doses of 180mg or higher around mid-year 2025. These data will inform final dose selection for our planned Phase 2b operationally adaptive study expected to commence later this year.” Details of the presentations are as follows: Abstract Title: Initial Results from BEACON, a Phase 1b/2a Dose Escalation Study of the anti-c-Kit Briquilimab Antibody in Adults with Chronic Spontaneous Urticaria (CSU)Publication Number: L24Session Title: Late Breaking Oral Abstract SessionSession Type: Oral Abstract SessionPresentation Date / Time: Saturday, March 1, 2025; 2:55 p.m. PST Abstract Title: Initial Results from BEACON, a Phase 1b/2a Dose Escalation Study of the anti-c-Kit Briquilimab Antibody in Adults with Chronic Spontaneous Urticaria (CSU)Poster Number: L24Session Title: Late Breaking Poster Session ISession Type: Poster SessionSession Date / Time: Saturday, March 1, 2025; 9:45 - 10:45 a.m. PST Abstract Title: Briquilimab, an Anti-c-Kit Antibody, Induces Durable Depletion of Mast Cells (MCs) Across Multiple Tissues in Mice Expressing Chimeric Human/Mouse CD117 (c-Kit)Poster Number: 540Session Title: Novel Mechanisms of Mast Cells, Basophils and IgESession Type: Poster SessionSession Date / Time: Saturday, March 1, 2025; 9:45 - 10:45 a.m. PST Abstract Title: Briquilimab Potently Inhibits Stem Cell Factor (SCF)/c-Kit Signaling and Induces Mast Cell ApoptosisPoster Number: 541Session Title: Novel Mechanisms of Mast Cells, Basophils and IgESession Type: Poster SessionSession Date / Time: Saturday, March 1, 2025; 9:45 - 10:45 a.m. PST Abstract Title: Briquilimab, an Anti-Human CD117 Antibody, Prevents Epicutaneous Oxazolone-Induced Features of Dermatitis in Mouse Model Expressing Chimeric Human/Mouse CD117Poster Number: 662Session Title: Atopic Dermatitis, Contact Dermatitis, Urticaria, AngioedemaSession Type: Poster SessionSession Date / Time: Sunday, March 2, 2025; 9:45 - 10:45 a.m. PST Abstract Title: Briquilimab, an Anti-Human CD117 Antibody, Treats Low-Calcemic Vitamin D3 Analog MC903-Induced Dermatitis in Mouse Model Expressing Chimeric Human/Mouse CD117Poster Number: 690Session Title: Atopic Dermatitis, Contact Dermatitis, Urticaria, AngioedemaSession Type: Poster SessionSession Date / Time: Sunday, March 2, 2025; 9:45 - 10:45 a.m. PST About Jasper Jasper is a clinical-stage biotechnology company focused on developing briquilimab as a therapeutic for chronic mast cell diseases. Briquilimab is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor c-Kit, thereby inhibiting signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via apoptosis which removes the underlying source of the inflammatory response in mast cell driven diseases such as chronic urticaria and asthma. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU, CIndU or asthma. Briquilimab has a demonstrated efficacy and safety profile in patients and healthy volunteers, with positive clinical outcomes in CSU and CIndU. For more information, please visit us at www.jaspertx.com. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, including with respect to its potential in mast cell driven diseases such as CSU, CIndU, and asthma, its potential to serve as a differentiated treatment option for patients with CSU, its potential to differentiate from other therapies, approved and in-development, with regard to onset of action, depth of response, and safety/tolerability and its potential allow for restoration of signaling on c-Kit-expressing cells between doses; Jasper’s expectations regarding advancing briquilimab into a registrational program in CSU, including the potential commencement of a Phase 2b operationally adaptive study and the expected timing for commencing such trial; the expected timing for reporting additional clinical data from the Phase 1b/2a BEACON study for patients treated at doses of 180mg and higher; and Jasper’s poster presentations and oral presentation of briquilimab data at the AAAAI 2025 Annual Meeting. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that prior test, study and trial results may not be replicated in continuing or future studies and trials; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Contacts: Alex Gray (investors)Jasper Therapeutics650-549-1454 agray@jaspertherapeutics.com Joyce Allaire (investors)LifeSci Advisors617-435-6602jallaire@lifesciadvisors.com Lauren Walker (media)Real Chemistry646-564-2156lbarbiero@realchemistry.com

Phase 2Clinical ResultAACRImmunotherapy

15 Nov 2024

·www.prnewswire.com

Endo Announces Agreement for Paladin Pharma to Commercialize Wynzora® Cream in Canada

MALVERN, Pa., Nov. 15, 2024 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today that it has entered into a definitive agreement with MC2 Therapeutics ("MC2") to commercialize Wynzora® Cream (calcipotriene and betamethasone dipropionate) in Canada through Endo's subsidiary Paladin Pharma Inc. "We look forward to working with MC2 to make Wynzora® Cream available to Canadians who suffer from plaque psoriasis," said Livio Di Francesco, Vice President and General Manager of Paladin. "If approved by Health Canada, Wynzora® Cream's unique formulation and clinical profile will offer patients a new treatment option designed for convenience of use in daily routines." "Paladin has an experienced and dedicated team, and we're pleased to work with them to introduce Wynzora® Cream in Canada," said Jesper J. Lange, Chief Executive Officer, MC2 Therapeutics. "The agreement aligns with our strategy to make Wynzora® Cream available to as many patients suffering from plaque psoriasis as possible globally." Wynzora® Cream was approved in the US by the FDA on July 20, 2020 and launched in Europe on February 18, 2022. About Wynzora® Cream Wynzora® Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis, including scalp psoriasis, in adults. Its dual mode of action is targeting the hallmark cytokines IL-23 and IL-17A/F immune axis and TNF-α expression in a single product. Wynzora® Cream is uniquely enabled by MC2's formulation and drug delivery system PAD Technology™, allowing a convenient-to-use aqueous formulation. About Endo and Paladin Pharma Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Paladin Pharma Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. Paladin has a focused marketing, medical and sales organization that has helped it evolve into one of Canada's leading specialty pharmaceutical companies. Paladin is an operating company of Endo, Inc. For more information, visit . 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. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Messrs. Di Francesco and Lange and any statements relating to product development and commercialization, treatment options and therapies, regulatory approval, efficacy and product availability. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, unfavorable or delayed regulatory review, uncertainties in and the timing for regulatory approval, changes in competitive, market or regulatory conditions, and consumer and physician acceptance of current and new products. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalLicense out/inPhase 2

100 Deals associated with Calcipotriene

External Link

KEGG	Wiki	ATC	Drug Bank
D01125	Calcipotriene	D05AX02	DB02300

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Psoriasis	China	LEO Pharmaceutical Products OOO	07 Aug 2001
Psoriasis vulgaris	Japan	Leo Pharma, Inc.	18 Jan 2000
Plaque psoriasis	United States	LEO Pharma A/S	29 Dec 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Psoriasis	Preclinical	India	Lipidor AB	03 Oct 2018
Plaque psoriasis	Preclinical	India	Cadila Pharmaceuticals Ltd.	20 Aug 2018
Psoriasis vulgaris	Preclinical	France	Leo Pharma, Inc.	01 Feb 2008
Psoriasis vulgaris	Preclinical	United Kingdom	Leo Pharma, Inc.	01 Feb 2008
Psoriasis vulgaris	Preclinical	Canada	Leo Pharma, Inc.	01 Feb 2008
Dermatitis, Atopic	Preclinical	Finland	Leo Pharma, Inc.	01 Oct 2006
Dermatitis, Atopic	Preclinical	Canada	Leo Pharma, Inc.	01 Oct 2006
Dermatitis, Atopic	Preclinical	United Kingdom	Leo Pharma, Inc.	01 Oct 2006
Dermatitis, Atopic	Preclinical	Denmark	Leo Pharma, Inc.	01 Oct 2006
Eczema	Preclinical	United Kingdom	Leo Pharma, Inc.	01 Oct 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCD2023	Not Applicable	Pityriasis Rubra Pilaris First line	-	Methotrexate	(zmvjqrwooh) = zatkfevmzr pggzjogqdz (qduqsfwmjl ) View more	-	03 Jul 2023
				Topical Calcipotriol	(zmvjqrwooh) = gindgevldl pggzjogqdz (qduqsfwmjl ) View more
EADV2022	Phase 3	Plaque psoriasis	796	Calcipotriene and betamethasone dipropionate cream	bupagvjlwm(dapwtcyoos) = tlkhltusig wbxksxfdlr (bornvkhitx ) View more	Positive	07 Sep 2022
				Calcipotriene and betamethasone dipropionate gel	bupagvjlwm(dapwtcyoos) = luzbtbdxyt wbxksxfdlr (bornvkhitx ) View more
Pubmed Manual	Not Applicable	Psoriasis vulgaris	166	Calcipotriene+LEO90100	(jgendfthgv) = mjpcyqhxyp pbzkhzuesn (vghxgjcpvx, 3.0) View more	Positive	18 Jul 2022
EADV2022	Not Applicable	Plaque psoriasis	-	Calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g aerosol foam	pzdbtnptrx(zvixeabruy) = rgtvgtwonu vdkszjycyv (ypkeoowxya )	-	12 May 2022
				Calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cream	pzdbtnptrx(zvixeabruy) = hbcogufcby vdkszjycyv (ypkeoowxya )
EADV2022	Not Applicable	Plaque psoriasis	-	Calcipotriol 0.005% plus betamethasone dipropionate 0.064% foam	xhrtaujwjw(zqwzmhgumx) = 0.8%/0.1% vs 7.4% tzpworlzqo (hhmghygoea ) View more	-	12 May 2022
				Halobetasol propionate 0.01% plus tazarotene 0.045% lotion
NCT01445886 (CTgov)	Phase 2/3	Psoriasis of nail	33	Calcipotriol Solution	zidgidnspm(liyaliczne) = tyzmlnitry xcukfngees (rweeghuolj, qkhbhmymbt - blqizvtddu) View more	-	28 Aug 2019
NCT01694433 (CTgov)	Phase 2/3	Acne Vulgaris	66	Calcipotriene (Calcipotriene Cream)	fgtltiofgt(onbahmdwqr) = jklvbqkssu oefgcjgzsy (bmkqrhgfyl, okugtdgodn - dlihqwgwol) View more	-	07 May 2019
				Placebo (Placebo)	fgtltiofgt(onbahmdwqr) = qqpzjlopwp oefgcjgzsy (bmkqrhgfyl, vuntjemgkp - vojdsswpes) View more
NCT00764751 (CTgov)	Phase 2	Psoriasis vulgaris	51	LEO 80122+calcipotriol+LEO 19123 (Group A: LEO 19123)	heweceqxom(dcimzhgnkk) = qwmuuqhgfe utviajbjhs (oqpusfmhls, bhhmeulyan - rfgihetmrr) View more	-	06 May 2019
				Dovonex (Group A: Dovonex®)	heweceqxom(dcimzhgnkk) = rvxwpvsvru utviajbjhs (oqpusfmhls, ijcnlnytss - lwpwchkpwb) View more
NCT01745133 (CTgov)	Phase 4	Plaque psoriasis	63	Vehicle Foam	xiijpbcrpe(jjtvuixich) = pnutzsltpd pwmnfvqzru (jdynexoxfi, yltxurywap - henttipgpd) View more	-	17 Nov 2016
NCT02193815 (CTgov)	Phase 1	Plaque psoriasis \| Psoriasis vulgaris	15	PF-06263276 (PF-06263276 4% Solution)	lqznnwxifi(qwlatogkby) = idiadywaiv rcfuthnbxq (utcrmyityp, yqtvmuyrfe - lavmlbmeky) View more	-	09 Jun 2016
				PF-06263276 (PF-06263276 Vehicle)	lqznnwxifi(qwlatogkby) = txecmhbkmi rcfuthnbxq (utcrmyityp, drkjkjbktf - hyitfxmlpe) View more

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