Drugs / Calcipotriol
Calcipotriol
also known as
Daivonex · Dovonex · CAL · calcipotriene · AKVANO · Dovonex (calcipotriol ointment, DIN 01976133 Leo Pharma),
Small molecule targets TSLP
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials · 1 met primary | ||||||
| Phase 0 | NCT05416320 | Aug → Nov 2023 | central centrifugal cicatricial alopecia | Wake Forest University Health Sciences | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT02019355 | Oct 2013 → Mar 2015 | actinic keratosis | Washington University School of Medicine | Completed | Met primary |
| Phase 115 trials · 1 missed | ||||||
| Phase 1 | NCT03898583 | Apr → Oct 2019 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT03476746 | Mar → Jul 2018 | — | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT03442244 | Jan → Feb 2018 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT03234673 | Aug 2017 → Aug 2018 | generalized vitiligo | Assiut University | Unknown | No outcome recorded |
| Phase 1 | NCT02973776 | Dec 2016 → Feb 2017 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02379793 | Mar → Apr 2015 | connective tissue disorder | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02193815 | Sep 2014 → Feb 2015 | psoriasis | Pfizer | Completed | Missed primary |
| Phase 1 | NCT02976727 | May 2014 → Aug 2015 | actinic keratosis | Dong-A University | Completed | No outcome recorded |
| Phase 1 | NCT01837576 | Apr → Jun 2013 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01646567 | Sep → Nov 2012 | psoriasis | TetraLogic Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01466478 | Nov → Dec 2011 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01297166 | Feb → Apr 2011 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01105234 | Apr → May 2010 | irritant dermatitis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01105286 | Apr → May 2010 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01043224 | Jan → Mar 2010 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03392311 | Jul → Oct 2019 | poisoning, psoriasis | Guangdong Provincial Hospital of Traditional Chinese Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT05488990 | Mar → Jun 2013 | psoriasis | Lipidor AB | Completed | No outcome recorded |
| Phase 1/2 | NCT01768013 | Jul → Oct 2012 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 215 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT04329221 | Jan 2026 → Jan 2029 | actinic keratosis, skin squamous cell carcinoma | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04642287 | Jan 2026 → Jan 2029 | actinic keratosis, disease related to solid organ transplantation, skin squamous cell carcinoma | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04580537 | Oct 2020 → Jun 2021 | psoriasis | Bispebjerg Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02038569 | Jan 2014 → Feb 2018 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01600222 | May 2012 → May 2013 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01229098 | Oct 2010 → Sep 2011 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01120223 | May 2010 → Aug 2012 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01083758 | Apr 2010 → Aug 2012 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00875277 | Apr → May 2009 | psoriasis | LEO Pharma | Completed | Met primary |
| Phase 2 | NCT00764751 | Sep → Dec 2008 | psoriasis | LEO Pharma | Completed | Missed primary |
| Phase 2 | NCT00704262 | May 2008 → Dec 2009 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00404196 | Oct 2006 → Mar 2007 | hand dermatosis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00392067 | Oct 2006 → Jun 2007 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00263718 | Dec 2005 → May 2006 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00445250 | — | radiodermatitis | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 311 trials · 2 met primary · 2 missed | ||||||
| Phase 3 | NCT05249972 | Jan → Aug 2022 | psoriasis | Lipidor AB | Unknown | No outcome recorded |
| Phase 3 | NCT05174598 | Oct 2018 → Nov 2019 | psoriasis | Cadila Pharnmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02668692 | Feb → Jun 2016 | psoriasis | LEO Pharma | Completed | Missed primary |
| Phase 3 | NCT01866163 | Jun → Oct 2013 | psoriasis | LEO Pharma | Completed | Met primary |
| Phase 3 | NCT01313221 | Apr 2011 → Dec 2012 | psoriasis | Amgen | Completed | Missed primary |
| Phase 3 | NCT01188928 | Sep 2010 → Mar 2011 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00691002 | May 2008 → Jan 2010 | psoriasis | LEO Pharma | Completed | Mixed |
| Phase 3 | NCT00640822 | Feb 2008 → Jun 2009 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00243464 | Sep 2005 → May 2006 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00216840 | Dec 2004 → Sep 2005 | psoriasis | LEO Pharma | Completed | Met primary |
| Phase 3 | NCT00216827 | Nov 2004 → Sep 2005 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07453238 | Oct 2026 → Mar 2027 expected | alopecia areata | Hayat Abad Medical Complex, Peshawar | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06499415 | Sep 2024 → Mar 2029 expected | actinic keratosis | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT00248456 | Oct 2005 → Feb 2006 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 4 | NCT00216892 | Apr → Dec 2005 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT06737406 | May 2025 → Jul 2026 overdue | common wart | Mazandaran University of Medical Sciences | Recruiting | No outcome recorded |
| — | NCT04440371 | Jun 2020 → Jul 2023 | generalized vitiligo | Jordan University of Science and Technology | Unknown | No outcome recorded |
| — | NCT02191007 | Nov 2013 → May 2014 | psoriasis | Xijing Hospital | Completed | No outcome recorded |
| — | NCT00871052 | Mar → May 2009 | polymorphic light eruption | Medical University of Graz | Completed | No outcome recorded |
| Comparator or background therapy40 trials | ||||||
| Phase 0 | NCT06880042 Comparator | May → Jun 2025 overdue | vitiligo | Dr ayesha wahid | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT04221906 Comparator | Jan → Mar 2020 | psoriasis | Boston Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02999776 Comparator | Nov 2016 → Dec 2017 | psoriasis | Pantec Biosolutions AG | Unknown | No outcome recorded |
| Phase 1 | NCT00358384 Comparator | Sep 2005 → Feb 2006 | psoriasis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT06333600 Comparator | May 2023 → Apr 2024 | androgenetic alopecia, skin disorder | Sohag University | Unknown | No outcome recorded |
| Phase 1/2 | NCT03069144 Comparator | Jan → Apr 2012 | psoriasis | Haus Bioceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT00987870 Comparator | Sep 2009 → Feb 2010 | arthritic joint disease, psoriasis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT00578370 Comparator | Nov 2007 → Apr 2008 | psoriasis | ISDIN | Completed | No outcome recorded |
| Phase 2 | NCT07410793 Comparator | Feb 2026 → Feb 2027 expected | psoriasis | Mae Fah Luang University | Recruiting | No outcome recorded |
| Phase 2 | NCT03848806 Comparator | Feb → Jul 2016 | psoriasis | Haus Bioceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02518048 Comparator | Aug 2015 → Jan 2016 | connective tissue disorder | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT02416258 Comparator | Apr → Jun 2015 | connective tissue disorder | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01368887 Comparator | Apr → Nov 2013 | psoriasis | DermiPsor, Ltd. | Suspended | No outcome recorded Stop: Business |
| Phase 2 | NCT01536938 Comparator | May → Sep 2012 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01536886 Comparator | May → Sep 2012 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00796211 Comparator | Nov → Dec 2008 | psoriasis | Zalicus | Completed | No outcome recorded |
| Phase 2/3 | NCT07658508 Comparator | Jul 2025 → Aug 2026 overdue | oral mucosa leukoplakia | Alexandria University | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT04071106 Comparator | Sep → Dec 2019 | psoriasis | Zagazig University | Unknown | No outcome recorded |
| Phase 2/3 | NCT01763424 Comparator | Jul 2011 → Dec 2012 | psoriasis | Isfahan University of Medical Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT01445886 Comparator | Jan 2011 → Jun 2012 | psoriasis | Yin-ku Lin | Completed | No outcome recorded |
| Phase 3 | NCT07453472 Comparator | Apr 2026 → Oct 2028 expected | oral mucosa leukoplakia | All India Institute of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02899962 Comparator | Feb 2017 → Jun 2019 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT02644954 Comparator | Jan → Jun 2016 | psoriasis | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 3 | NCT02310646 Comparator | Jan → Jul 2015 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT02132936 Comparator | Jun 2014 → Feb 2015 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01422434 Comparator | Jul 2011 → Apr 2012 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01195831 Comparator | Sep 2010 → Mar 2011 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00670241 Comparator | Apr 2008 → Feb 2009 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00216879 Background | Feb 2005 → Jul 2006 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 4 | NCT03866447 Comparator | Oct 2019 → Nov 2020 | acne | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT02533973 Comparator | Sep 2015 → Mar 2018 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 4 | NCT02733874 Comparator | Apr 2015 → Apr 2016 | psoriasis | First Hospital of China Medical University | Completed | No outcome recorded |
| — | NCT06685588 Comparator | Jan 2025 → Jan 2026 overdue | actinic keratosis | St Vincent's University Hospital, Ireland | Not yet recruiting | No outcome recorded |
| — | NCT07816575 Comparator | Mar 2024 → Jul 2025 | psoriasis | Al-Azhar University | Completed | No outcome recorded |
| — | NCT05954104 Comparator | Jul → Oct 2023 | alopecia areata | Egymedicalpedia | Completed | No outcome recorded |
| — | NCT06011083 Comparator | Aug 2022 → Feb 2023 | psoriasis | Assiut University | Completed | No outcome recorded |
| — | NCT04275024 Background | Apr → Jun 2020 | poisoning, psoriasis | Guangdong Provincial Hospital of Traditional Chinese Medicine | Completed | No outcome recorded |
| — | NCT03847441 Comparator | Oct 2017 → Dec 2018 | alopecia areata | Aswan University Hospital | Completed | No outcome recorded |
| — | NCT01413477 Comparator | Aug 2011 → Feb 2012 | allergic contact dermatitis | University of British Columbia | Unknown | No outcome recorded |
| — | NCT00705900 Comparator | Jan 2007 → Nov 2008 | psoriasis | NeoStrata Company, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2023-03-23 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064% glenmarkpharma.com ↗ |
| 2022-05-09 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064% glenmarkpharma.com ↗ |
| 2021-09-29 | MC2 Therapeutics | Results MC2 Therapeutics’ clinical research to be presented in four poster presentations at the European Academy of Dermatology and Venereology conference - EADV 2021 mc2therapeutics.com ↗
Calcipotriol and betamethasone dipropionate cream demonstrates rapid and clinically meaningful improvement of itch associated with plaque psoriasis |
| 2020-07-22 | MC2 Therapeutics | Regulatory MC2 Therapeutics Announces U.S. Food and Drug Administration Approval of Wynzora® Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for Adults with Plaque Psoriasis mc2therapeutics.com ↗
The FDA approval is based on the results of the US Phase 3 clinical trial 1 against active comparator Taclonex ® Topical Suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%). |
| 2020-07-16 | MC2 Therapeutics | Regulatory MC2 Therapeutics Announces Submission of Marketing Authorization Application in EU for Wynzora® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate) mc2therapeutics.com ↗
MC2 Therapeutics, a commercial stage pharmaceutical company focused on topical therapies for chronic inflammatory conditions, today announced the submission of its Marketing Authorization Application (MAA) in EU for Wynzora ® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate)) for the treatment of plaque psoriasis. |
| 2019-12-18 | MC2 Therapeutics | Results MC2 Therapeutics Announces Positive Top-line Results from EU Phase 3 Head-to-Head trial Comparing Wynzora™ Cream to Daivobet® Gel in Patients with Psoriasis mc2therapeutics.com ↗
Wynzora™ Cream demonstrates statistically significantly better treatment efficacy compared to Daivobet® Gel. |
| 2019-11-20 | MC2 Therapeutics | Regulatory MC2 Therapeutics Announces FDA Acceptance of its New Drug Application for Wynzora™ Cream for Treatment of Plaque Psoriasis mc2therapeutics.com ↗
MC2 Therapeutics, an emerging pharmaceutical company focused on novel PAD™ Technology-based topical therapies for chronic inflammatory conditions, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Wynzora™ Cream. |
| 2019-09-24 | MC2 Therapeutics | Regulatory MC2 Therapeutics Announces Submission of New Drug Application to US FDA for Wynzora™ Cream (Calcipotriene 0.005% and Betamethasone Dipropionate 0.064%) for Treatment of Plaque Psoriasis mc2therapeutics.com ↗
MC2 Therapeutics, a late clinical-stage pharmaceutical company focused on novel PAD™ Technology-based topical therapies for chronic inflammatory conditions, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for Wynzora™ Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for the treatment of plaque psoriasis. |
| 2017-12-28 | Lupin Limited | Regulatory Lupin receives FDA approval for generic Dovonex Scalp Solution lupin.com ↗
Mumbai: Pharma Major Lupin announced that it has received final approval for its Calcipotriene Topical Solution, 0.005% (Scalp Solution) from the United States Food and Drug Administration (FDA) to market a generic version of Dovonex Scalp Solution, 0.005% of Leo Pharmaceutical Products Ltd. |
All press releases naming this drug 10 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 96 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Calcipotriol | “A Phase 2 Maximal Use Systemic Exposure Study Evaluating the Safety and Efficacy of Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Gel Applied Once Daily...” NCT01229098 ↗93“A phase 2 trial evaluating the safety and efficacy of once daily use of LEO 80185 gel containing calcipotriol 50 mcg/g plus betamethasone 0.5mg/g (as dipropionate) in...” NCT02038569 ↗ “treatment with Xamiol® gel (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) once daily (as required) with Daivonex® scalp solution (calcipotriol 50 mcg/g)...” NCT02533973 ↗ “fixed-dose combination calcipotriol 50 μg/g + betamethasone dipropionate 0.5 mg/g (Cal/BD) cutaneous foam has been approved (Enstilar®, LEO Pharma) in the USA and EU for the...” PMID 32785881 ↗ Aug 2020 “A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g, is approved for the...” PMID 32965655 ↗ Sep 2020 “Daily self-administration of 1 to 5g Daivobet (Calcipotriol 50ug/g +Betamethasone, 0,5mg/g Gel) ointment, which is applied topically once per day for 8 weeks on one...” NCT02999776 ↗ “Effect of Calcipotriol Plus Betamethasone Dipropionate Topical Suspension on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to 17 Years) With Scalp Psoriasis” NCT01083758 ↗ “LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks” NCT02132936 ↗ “Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)” NCT04580537 ↗ “The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris.” NCT01768013 ↗ “LEO 90100 foam (containing calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g).” NCT03476746 ↗ |
| Known as | AKVANO | “Calcipotriol/AKVANO, 50 μg/g cutaneous solution” NCT05174598 ↗ |
| Known as | CAL | “Fixed combination calcipotriol as hydrate (Cal) 50 µg/g plus betamethasone as dipropionate (BD) 0.5 mg/g aerosol foam is an alcohol-free treatment for psoriasis.” PMID 27995521 ↗ Apr 20171“Calcipotriol (CAL) enhances thymic stromal lymphopoietin (TSLP), an epithelium-derived cytokine, which promotes antitumor immunity.” NCT06499415 ↗ |
| Known as | calcipotriene | “commercially available calcipotriene 0.005% cream (Dovonex)” PMID 20513160 ↗ 20101“Calcipotriol (Calcipotriene) is a form of vitamin D.” NCT04329221 ↗ |
| Known as | Daivonex | “Calcipotriol solution (Daivonex® scalp solution, calcipotriol 50 ug/ml) was purchased from LEO Pharmaceutical Products, Ltd. (Ballerupt, Denmark) and also distributed into 5-ml...” NCT01445886 ↗4“Calcipotriol ointment 50 mcg/g (Daivonex, Leo Pharma, Denmark) was applied twice for daily on treatment area for 15 consecutive days.” NCT02976727 ↗ “Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg” NCT02193815 ↗ “Daily application of Daivonex cream (calcipotriol 0.005%)” NCT04221906 ↗ “with Daivonex® scalp solution (calcipotriol 50 mcg/g)” NCT02533973 ↗ |
| Known as | Dovonex | “The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.” NCT03392311 ↗4“two different creams (5-fluorouracil, known as Efudix, and calcipotriol, known as Dovonex)” NCT06685588 ↗ “commercially available calcipotriene 0.005% cream (Dovonex)” PMID 20513160 ↗ 2010 “Dovonex® = calcipotriol” NCT01422434 ↗ “Dovonex” NCT04275024 ↗ |
| Known as | Dovonex (calcipotriol ointment, DIN 01976133 Leo Pharma), | “Dovonex (calcipotriol ointment, DIN 01976133 Leo Pharma),” NCT01413477 ↗ |
| Modality | Small molecule | “vitamin D analogues such as calcipotriol are used to treat psoriasis.” NCT01413477 ↗ |
| Route | Topical | “once daily topical treatment for up to 8 weeks” NCT00216840 ↗ |
| Target | TSLP | “synergistic impact of TSLP induction by calcipotriol in combination with the cytotoxic effects of 5-FU” NCT04642287 ↗ |