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

The University of Texas MD Anderson Cancer Center

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

NCT06685588

/ Not yet recruitingNot ApplicableIIT

Efficacy of Topical 5-FUvs Calcipotriol As PDT Pre-treatment for Field Actinic Keratoses

The purpose of this study is to compare two different creams (5-fluorouracil, known as Efudix, and calcipotriol, known as Dovonex) to see which one works better when used before Photodynamic Therapy (PDT) to treat sun-damaged skin on the scalp (called actinic keratoses).
PDT is often used on its own to treat these spots, but it doesn't always remove them completely. Using Efudix or Dovonex before PDT might improve the results, but we don't yet know which is better.
The main questions are -
1. Is efudix or dovonex better at treating actinic keratoses when used prior to PDT
2. Is efudix or dovonex more tolerable for patients?
Participants will be randomised to treat their scalp with efudix or dovonex for seven days prior to their first PDT treatment. They will be reviewed on day 7, prior to starting PDT, and again a week later when they present for their second PDT treatment.
During follow up, patients will be reviewed at 28 days, 3, 6, 9, and 12 months after treatment.
At each of these visits, the number of actinic keratoses will be counted, graded, mapped and photographed to allow assessment of improvement before and after treatment.

Start Date01 Jan 2025

Sponsor / Collaborator

St. Vincent's University Hospital

100 Clinical Results associated with Calcipotriene

100 Translational Medicine associated with Calcipotriene

100 Patents (Medical) associated with Calcipotriene

2,064

Literatures (Medical) associated with Calcipotriene

01 Apr 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Supramolecular cyclodextrin deep eutectic solvent-strengthened chitosan eutectogel as a novel percutaneous delivery system of resveratrol for anti-psoriasis

Article

Author: Xu, Yuehong ; Li, Bin ; Chen, Chen ; Li, Xiaojuan ; Li, Shuying ; Xiao, Ting

Psoriasis is a chronic and incurable inflammatory skin disease usually requiring long-term disease management. Natural phytochemical resveratrol (RES) has been known for high efficiency and low toxicity, exhibiting good anti-psoriasis potential. However, its biological activity is limited by poor solubility, chemical instability, and insufficient skin retention. Herein, we developed an adhesive eutectogel loaded with RES constructed through electrostatic and hydrogen bonding cross-linking between cyclodextrin-levulinic acid supramolecular deep eutectic solvent (DES) and chitosan (CS). A series of characterizations combined with molecular dynamics simulations demonstrated that such DES not only significantly increased the solubility and stability of RES, but also acted as the cross-linker and plasticizer in eutectogel preparation. When applied to the skin surface, the eutectogel formed a soft film in situ that established tight contact with the skin, thereby enhancing RES sustained penetration into the skin. In an imiquimod-induced psoriasis-like mice model, the eutectogel effectively alleviated psoriasis symptoms, inhibited the excessive proliferation of keratinocytes, and regulated the expression of IL-23/IL-17 axis-related factors, whose therapeutic effect was better than that of commercially available calcipotriol ointment. Overall, The DES-strengthened eutectogel offers a promising topical drug delivery platform for psoriasis treatment and expands the applications of green polysaccharide medical materials.

01 Mar 2025·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Combined topical 5-fluorouracil and calcipotriene effectively treats superficial keratinocyte carcinomas: A retrospective cohort study from 2 academic centers

Article

Author: Mirza, Fatima N. ; Ruiz, Emily ; Loranger, Nicole ; Lee, Truelian ; Karn, Emily ; Guggina, Lauren ; Libby, Tiffany ; Mirza, Fatima N ; Lowder, Ethan

01 Mar 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Design, synthesis, and anti-liver fibrosis activity of novel non-steroidal vitamin D receptor agonists based on open-ring steroid scaffold

Article

Author: Wang, Cong ; Shi, Bingyue ; Huang, Jiayi ; Li, Sitong ; Cheng, Nuo ; Gao, Fei ; Liu, Jiayi ; Zhang, Can ; Liu, Yichen ; Tong, Yu ; Guan, Chun ; Gao, Yi ; Wu, Yue

Vitamin D receptor (VDR) has emerged as a crucial target for the treatment of hepatic fibrosis, a condition characterized by excessive deposition of extracellular matrix (ECM) components leading to impaired liver function. Activation of VDR has been shown to inhibit the transformation of hepatic stellate cells (HSCs), which play a key role in the development of liver fibrosis, thus reducing ECM production. In this study, a series of 37 non-steroidal VDR agonists with novel scaffold were designed and synthesized utilizing the scaffold hopping strategy. Over one-third of these compounds demonstrated significant VDR affinity and agonistic activity. Among them, compound E15 exhibited the highest VDR agonistic activity, showing promising results in vitro by effectively inhibiting HSC activation. Further in vivo assessments of E15 in a carbon tetrachloride-induced murine model of liver fibrosis demonstrated significant anti-fibrotic activity. Histological analyses revealed a reduction in lesions, inflammatory cell infiltration, and collagen deposition. Concurrently, blood biochemical assays indicated decreased hepatic fibrosis markers and improved serum liver function indices. Notably, E15 achieved these therapeutic effects without inducing hypercalcemia, a common adverse effect associated with VDR agonists such as calcipotriol. These findings underscore the potential of E15 as a potent and safe therapeutic agent for the treatment of liver fibrosis.

News (Medical) associated with Calcipotriene

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

14 Nov 2024

·mc2therapeutics.com

MC2 Therapeutics Announces License and Commercialization Agreement for Wynzora® Cream in Canada

Copenhagen, November 14, 2024 – MC2 Therapeutics, a commercial stage biotech company focused on developing novel treatment paradigms within immunology and inflammation, announces today an agreement with Endo, Inc. (OTCQX: NDOI), through its subsidiary Paladin Pharma Inc., under which they have been granted exclusive rights to commercialize MC2’s Wynzora® Cream for the treatment of plaque psoriasis for adults in Canada. MC2 Therapeutics will receive upfront and milestone payments as well as royalties on the Canadian net sales of Wynzora® Cream. “Paladin is acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With its ambition and strategy to grow its dermatology franchise it is an excellent partner for MC2 to leverage Wynzora® in Canada” said Jesper J. Lange, Chief Executive Officer of MC2 Therapeutics. “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.” “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.” 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 an effective convenient-to-use aqueous formulation. Wynzora® Cream was approved in the US by the FDA on July 20th, 2020, and in the first country in Europe on July 9th, 2021. About MC2 Therapeutics A/S 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. Its pipeline includes two first-in-class drug candidates both in Phase 2 clinical development, with novel modes of action and potential in multiple indications (“I&I pipeline in a product”). For additional information on MC2 Therapeutics, please visit https://www.mc2therapeutics.com Contact: Lonni Goltermann, +45 2018 1111, investor@mc2therapeutics.com About Paladin Pharma Inc. 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 additional information, please visit https://www.paladin-pharma.com BACK

License out/inDrug ApprovalPhase 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 vulgaris	JP	Leo Pharma, Inc.	18 Jan 2000
Plaque psoriasis	US	LEO Pharma A/S	29 Dec 1993
Psoriasis	-	Leo Pharma, Inc.	01 Jan 1990

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Arthritis, Psoriatic	Phase 2	FR	Leo Pharma, Inc.	01 Apr 2015
Dermatitis, Atopic	Phase 2	CA	Leo Pharma, Inc.	01 Oct 2006
Dermatitis, Atopic	Phase 2	DK	Leo Pharma, Inc.	01 Oct 2006
Dermatitis, Atopic	Phase 2	FI	Leo Pharma, Inc.	01 Oct 2006
Dermatitis, Atopic	Phase 2	GB	Leo Pharma, Inc.	01 Oct 2006
Eczema	Phase 2	GB	Leo Pharma, Inc.	01 Oct 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EADV2022	Phase 3	Plaque psoriasis	-	Calcipotriene (CAL) and betamethasone dipropionate (BDP) cream	dsphpiophm(xjngcxismu) = oshpafeggk jgaijdsuwu (zwnmhergbw ) View more	-	07 Sep 2022
				Vehicle	dsphpiophm(xjngcxismu) = cwmjkdgpsr jgaijdsuwu (zwnmhergbw ) View more
EADV2022	Phase 3	Psoriasis of scalp	-	CAL/BDP cream	xwbmbedxbd(osreawobzo) = vrsdjapidm jeyvaovrgo (afbkmqhafw ) View more	-	07 Sep 2022
				Vehicle cream	xwbmbedxbd(osreawobzo) = lswtdgbhws jeyvaovrgo (afbkmqhafw ) View more
EADV2022	Phase 3	Plaque psoriasis	796	Calcipotriene and betamethasone dipropionate cream	omrvqsqhmi(cwjjkwsaay) = matjeohdxa qkgyykiwhy (nxhrdmtyjc ) View more	Positive	07 Sep 2022
				Calcipotriene and betamethasone dipropionate gel	omrvqsqhmi(cwjjkwsaay) = rxgndvrmju qkgyykiwhy (nxhrdmtyjc ) View more
Pubmed Manual	Not Applicable	Psoriasis vulgaris	166	Calcipotriene+LEO90100	bfttpeuyhm(rmojxmppjm) = lyzwfpeene pqtsehfcaq (iyhrvtnayp, 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	yypbzwpkak(ywfsrjheuz) = hrjhwujbtj uvkihxoexr (udekpggzwa )	-	12 May 2022
				Calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cream	yypbzwpkak(ywfsrjheuz) = fjtuxkoqiv uvkihxoexr (udekpggzwa )
NCT01694433 (CTgov)	Phase 2/3	Acne Vulgaris	66	Calcipotriene (Calcipotriene Cream)	yfxumjkbxu(lwoxjecabf) = vxfffrnoyt fogduhceep (idxeecxplc, sfbyrqayvg - sbaqmyqdqs) View more	-	07 May 2019
				Placebo (Placebo)	yfxumjkbxu(lwoxjecabf) = xnmibolqem fogduhceep (idxeecxplc, hmrtvfkile - ewufoarmkj) View more
NCT02411643 (CTgov)	Early Phase 1	Scleroderma, Localized	2	topical calcipotriene 0.005% ointment	ddclttztjl(ztbxmolcaz) = wgajzpeohu bjfvayrhaj (ddetmcydld, byrmpdypcw - pnhipjakfl) View more	-	13 Sep 2018
NCT02132936 (PSO-ABLE, Pubmed \| Am J Clin Dermatol)	Phase 3	Psoriasis	504	Cal/BD foam	vvubypkxkb(jepmnafknt) = jnjqviccos uvriowqzrx (uiupyuoxpv ) View more	-	01 Jun 2017
				Cal/BD gel	vvubypkxkb(jepmnafknt) = ajetzidqeq uvriowqzrx (uiupyuoxpv ) View more
NCT01745133 (CTgov)	Phase 4	Plaque psoriasis	63	Vehicle Foam	teehzittmr(thjzfskkfv) = hdwllxzmlq jfuaqbtdln (xocgzbssnp, wrzqqkqtjz - rrpzesnvwg) View more	-	17 Nov 2016
NCT01422434 (CTgov)	Phase 3	Psoriasis vulgaris	676	Dovonex® = calcipotriol (Dovonex® Ointment)	mssewqjafr(cbguyggvbb) = bsugyyymde esnicfathq (jlvrucwapk, rrcwtiupua - rzifykxsae) View more	-	11 Mar 2014
				LEO 90105 = calcipotriol + betamethasone dipropionate (LEO 90105 Ointment)	mssewqjafr(cbguyggvbb) = ueeobkmvyr esnicfathq (jlvrucwapk, vnnbztjyww - csznpazdmd) View more

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