Drugs / Calcipotriene
Calcipotriene
also known as
Dovonex · CAL · calcipotriol hydrate · U0267 · Calcipotriene and betamethasone suspension · Calcipotriene Hydrate · calcipotriol · Daivonex · +1 more
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | SORILUX | — | 2012-09-27 – 2019-11-05 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | DOVONEX | — | 1996-08-15 – 1999-07-07 | fda.gov ↗ |
| Approved | US (FDA) | DOVONEX | — | 1993-12-29 | fda.gov ↗ |
Trials 40
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04839731 | Apr 2021 → Dec 2023 | skin squamous cell carcinoma | Carilion Clinic | Unknown | No outcome recorded |
| Phase 0 | NCT03996252 | Jul 2019 → Jan 2020 | actinic keratosis | Tulane University | Terminated | No outcome recorded |
| Phase 0 | NCT02411643 | Mar 2015 → Apr 2016 | localized scleroderma | Northwestern University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 19 trials · 1 missed | ||||||
| Phase 1 | NCT03892564 | Feb → Mar 2019 | phototoxic dermatitis | MC2 Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03899064 | Feb → Apr 2019 | photoallergic dermatitis | MC2 Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03596073 | Nov 2018 → Aug 2020 | breast cancer | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 1 | NCT03758365 | Nov 2018 | vascular disorder | MC2 Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03370406 | Aug 2018 → Sep 2027 expected | squamous cell carcinoma | Melissa Pugliano-Mauro | Recruiting | No outcome recorded |
| Phase 1 | NCT03469336 | Apr 2018 → Mar 2019 | psoriasis | Pfizer | Completed | Missed primary |
| Phase 1 | NCT03122353 | Apr → Nov 2017 | psoriasis | Tolmar Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01582932 | Apr 2013 → Aug 2018 | psoriasis | Mayne Pharma International Pty Ltd | Completed | No outcome recorded |
| Phase 1 | NCT01563068 | Apr 2012 → Aug 2015 | psoriasis | Mayne Pharma International Pty Ltd | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT05699603 | Jul 2024 → Feb 2027 expected | actinic keratosis | University of Arizona | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03819218 | Dec 2018 → Dec 2020 | psoriasis | MC2 Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03584360 | Sep 2018 | psoriasis | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 2 | NCT03462927 | Feb → Aug 2018 | psoriasis | MC2 Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01268527 | Mar → Dec 2010 | psoriasis | Eisai Inc. | Completed | Mixed |
| Phase 2 | NCT00817219 | Jul 2009 → Dec 2011 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00820950 | May 2007 → Jan 2009 | psoriasis | Incyte Corporation | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05381597 | Oct 2022 → Jun 2027 expected | skin squamous cell carcinoma in situ, superficial multifocal basal cell carcinoma | Boston University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT01694433 | Feb 2013 → Jan 2014 | acne | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 39 trials · 3 met primary · 2 missed | ||||||
| Phase 3 | NCT06851507 | Oct 2025 → Aug 2027 expected | actinic keratosis | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 3 | NCT03806790 | Jan → Jun 2019 | psoriasis | LEO Pharma | Completed | Missed primary |
| Phase 3 | NCT03802344 | Dec 2018 → Oct 2019 | psoriasis | MC2 Therapeutics | Completed | Met primary |
| Phase 3 | NCT03731091 | Oct 2018 → Mar 2020 | psoriasis | Glenmark Pharmaceuticals Ltd. India | Completed | No outcome recorded |
| Phase 3 | NCT01188928 | Sep 2010 → Mar 2011 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01139580 | May → Dec 2010 | psoriasis | Stiefel, a GSK Company | Completed | Met primary |
| Phase 3 | NCT00688519 | Mar → Dec 2008 | psoriasis | Stiefel, a GSK Company | Completed | Missed primary |
| Phase 3 | NCT00689481 | Mar → Oct 2008 | psoriasis | Stiefel, a GSK Company | Completed | Met primary |
| Phase 3 | NCT00279162 | Dec 2005 → Jul 2007 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04227288 | Nov 2021 → Oct 2023 | psoriasis | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT04555707 | Jun 2020 → Jun 2021 | psoriasis | Derm Research, PLLC | Unknown | No outcome recorded |
| Phase 4 | NCT04372277 | Apr 2020 → Mar 2021 overdue | psoriasis | Psoriasis Treatment Center of Central New Jersey | Recruiting | No outcome recorded |
| Phase 4 | NCT03827876 | Jan → Sep 2019 overdue | psoriasis | Psoriasis Treatment Center of Central New Jersey | Recruiting | No outcome recorded |
| Phase 4 | NCT03506477 | May 2018 → Sep 2019 | psoriasis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT03848871 | Dec 2017 → Nov 2018 | psoriasis | Derm Research, PLLC | Completed | No outcome recorded |
| Phase 4 | NCT03080545 | May → Oct 2017 | psoriasis | Psoriasis Treatment Center of Central New Jersey | Completed | No outcome recorded |
| Phase 4 | NCT01761019 | Jan 2013 → Sep 2014 | psoriasis | University of Pittsburgh | Completed | No outcome recorded |
| Phase 4 | NCT00437619 | Feb 2007 → Aug 2009 | psoriasis | Hoffmann-La Roche | Completed | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT03880357 Comparator | Oct 2018 → Mar 2019 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02940002 Comparator | Oct 2016 → Jan 2017 | psoriasis | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02680717 Comparator | Mar 2016 → May 2017 | scleroderma | Medical College of Wisconsin | Withdrawn | No outcome recorded |
| Phase 1 | NCT03399526 Comparator | Feb → May 2013 | psoriasis | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT03448081 Comparator | Feb → Nov 2018 | psoriasis | Sienna Biopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01301157 Comparator | Feb 2011 → Jan 2012 | psoriasis | Maruho Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00764751 Comparator | Sep → Dec 2008 | psoriasis | LEO Pharma | Completed | Missed primary |
| Phase 2 | NCT00625326 Comparator | Jan → Dec 2008 | psoriasis | Deltanoid Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03331523 Comparator | Oct 2017 → Oct 2018 | psoriasis | Glenmark Pharmaceuticals Ltd. India | Completed | No outcome recorded |
| Phase 4 | NCT04571151 Comparator | Jan → Nov 2021 | psoriasis | Skin Sciences, PLLC | Unknown | No outcome recorded |
| Phase 4 | NCT02858713 Background | Jan → Apr 2017 | — | Odense University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01745133 Comparator | Jan 2013 → May 2014 | psoriasis | Leon Kircik, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT01707043 Comparator | Oct 2012 → Sep 2013 | psoriasis | Wake Forest University | Completed | No outcome recorded |
| Phase 4 | NCT00437255 Comparator | Aug 2006 → Jun 2007 | psoriasis | Galderma R&D | Completed | No outcome recorded |
Press releases naming this drug 7 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Calcipotriene | “The combination topical suspension of calcipotriene 0.005% and betamethasone dipropionate 0.064% is a first-line treatment for moderate to severe psoriasis vulgaris and is FDA...” NCT01761019 ↗47“Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical...” NCT01707043 ↗ “This study will evaluate the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in...” NCT03506477 ↗ “Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients” NCT04372277 ↗ “Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Biologic Agents” NCT03080545 ↗ “Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation” NCT03899064 ↗ “MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation” NCT03892564 ↗ “Single application of MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream” NCT03758365 ↗ “Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064%” NCT03827876 ↗ “MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)” NCT03819218 ↗ “MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream” NCT03802344 ↗ |
| Known as | CAL | “combination of calcipotriene (CAL) and betamethasone dipropionate (BDP)” PMID 37490268 ↗ Jul 20231“calcipotriene \[CAL\]/betamethasone dipropionate \[BDP\] ointment” NCT03462927 ↗ |
| Known as | Calcipotriene and betamethasone suspension | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03122353 ↗ |
| Known as | Calcipotriene Hydrate | “Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA)” NCT03880357 ↗ |
| Known as | calcipotriol | “Participants received each of the following six treatments once daily for 18 days: three topical doses (2.3%, 0.8%, 0.23%) of PF-06763809, a vehicle and two active comparators...” PMID 32767679 ↗ Sep 2020 |
| Known as | calcipotriol hydrate | “calcipotriol hydrate 52.2 µg/g” NCT03806790 ↗ |
| Known as | Daivonex | “calcipotriol hydrate [Daivonex]” NCT00437619 ↗ |
| Known as | Dovonex | “Dovonex® calcipotriene 0.005%” NCT00820950 ↗ |
| Known as | Sorilux | “The study drugs that will be used in this study are Lexette® (0.05% Halobetasol propionate foam) and Sorilux® (calcipotriene foam).” NCT04571151 ↗ |
| Known as | U0267 | “U0267 is a vitamin D3 analog (calcipotriene) foam.” NCT00688519 ↗1“U0267 is a vitamin D3 analog (calcipotriene) foam.” NCT00689481 ↗ |
| Action | Inhibit | “It inhibits keratinocyte proliferation (cell growth)” NCT03370406 ↗ |
| Modality | Other / unclassified | “Calcipotriene is a vitamin D3 analog” NCT01563068 ↗ |
| Route | Topical | “Topical, once daily” NCT00437255 ↗ |