Drugs / betamethasone dipropionate
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betamethasone dipropionate

Small molecule

Developed for
psoriasis · chronic rhinosinusitis · osteoarthritis, knee · atopic eczema · chronic pain syndrome · connective tissue disorder · lichen planus, oral · shoulder impingement syndrome
+10 more · tinea infection · allergic contact dermatitis · aphthous stomatitis · carpal tunnel syndrome · central centrifugal cicatricial alopecia · epicondylitis · gout · lichen sclerosus et atrophicus · oral submucous fibrosis · rotator cuff syndrome
Investigated by
LEO Pharma · Beijing Tiantan Hospital · MC2 Therapeutics · Primus Pharmaceuticals · Prosoft Clinical · Psoriasis Treatment Center of Central New Jersey
+23 more · Derm Research, PLLC · Oticara Australia PTY LTD · Ache Laboratorios Farmaceuticos S.A. · Affiliated Hospital of Nantong University · Amgen · Assiut University · Beijing Children's Hospital · Bispebjerg Hospital · CMIC Co, Ltd. Japan · Centre Oscar Lambret · Eli Lilly and Company · First Affiliated Hospital of Fujian Medical University · Garlapati Komali · Glenmark Pharmaceuticals Ltd. India · Icahn School of Medicine at Mount Sinai · Incyte Corporation · Jacob Thyssen · Jooheung Lee · LEO Innovation Lab · Roche Pharma AG · Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · University of Alabama at Birmingham · University of Pittsburgh

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed psoriasis 2 milestones
Filed Japan (PMDA) Dovobet psoriasis 2017-06-22

“LEO Pharma K.K. has filed an application for the manufacturing and marketing approval of this product for psoriasis vulgaris in Japan.” kyowakirin.com ↗

Filed US (FDA) — psoriasis 2011-02-22

“today announced that it has filed an Abbreviated New Drug Application for calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment” perrigo.com ↗

Approved Indication not stated 3 milestones
Label expansions (2) US (FDA) DIPROLENE AF — 2001-10-03 – 2006-08-28 fda.gov ↗
Label expansion US (FDA) DIPROSONE — 1982-07-21 fda.gov ↗
Approved US (FDA) DIPROSONE — 1975-01-29 fda.gov ↗

Trials 60

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials
Phase 1 NCT03898583 Apr → Oct 2019 psoriasis LEO Pharma Completed No outcome recorded
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 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 NCT02355639 Jan → Apr 2015 connective tissue disorder LEO Pharma Completed No outcome recorded
Phase 1 NCT01946386 Sep → Oct 2013 psoriasis LEO Pharma Completed No outcome recorded
Phase 1 NCT01837576 Apr → Jun 2013 psoriasis LEO Pharma Completed No outcome recorded
Phase 1 NCT01466478 Nov → Dec 2011 psoriasis LEO Pharma Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05220293 Feb 2022 → Dec 2023 chronic rhinosinusitis Oticara Australia PTY LTD Terminated No outcome recorded
Phase 1/2 NCT01768013 Jul → Oct 2012 psoriasis LEO Pharma Completed No outcome recorded
Phase 214 trials · 1 met primary
Phase 2 NCT05882903 Aug 2023 → Jun 2025 overdue chronic rhinosinusitis Oticara Australia PTY LTD Recruiting No outcome recorded
Phase 2 NCT04580537 Oct 2020 → Jun 2021 psoriasis Bispebjerg Hospital Completed No outcome recorded
Phase 2 NCT03819218 Dec 2018 → Dec 2020 psoriasis MC2 Therapeutics Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03462927 Feb → Aug 2018 psoriasis MC2 Therapeutics Completed No outcome recorded
Phase 2 NCT03026478 May 2016 → Mar 2018 lichen planus, oral Garlapati Komali Unknown No outcome recorded
Phase 2 NCT02070965 Jan → Oct 2014 psoriasis Primus Pharmaceuticals 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 NCT00817219 Jul 2009 → Dec 2011 psoriasis LEO Pharma Completed No outcome recorded
Phase 314 trials · 4 met primary · 2 missed
Phase 3 NCT02582177 Jun 2019 → Jan 2020 tinea infection Ache Laboratorios Farmaceuticos S.A. Completed No outcome recorded
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 NCT02668692 Feb → Jun 2016 psoriasis LEO Pharma Completed Missed primary
Phase 3 NCT02527421 Aug 2015 → Mar 2019 psoriasis Primus Pharmaceuticals Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT02132936 Jun 2014 → Feb 2015 psoriasis LEO Pharma Completed No outcome recorded
Phase 3 NCT01947491 Nov 2013 → Jan 2015 psoriasis Primus Pharmaceuticals Completed Met 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 NCT00279162 Dec 2005 → Jul 2007 psoriasis LEO Pharma Completed No outcome recorded
Phase 414 trials
Phase 4 NCT04227288 Nov 2021 → Oct 2023 psoriasis University of Alabama at Birmingham Completed No outcome recorded
Phase 4 NCT05175001 May 2021 → Jun 2022 chronic pain syndrome Affiliated Hospital of Nantong University Unknown 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 NCT04073069 Sep 2019 → Aug 2020 — Beijing Tiantan Hospital Completed No outcome recorded
Phase 4 NCT04114097 Aug 2019 → Mar 2021 atopic eczema Jacob Thyssen Completed 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 not applicable7 trials
— NCT07626463 May 2026 → May 2027 expected acute cholecystitis Beijing Tiantan Hospital Recruiting No outcome recorded
— NCT07337772 Feb 2026 → Nov 2028 expected adrenal cortex disorder, osteoarthritis, knee First Affiliated Hospital of Fujian Medical University Recruiting No outcome recorded
— NCT06344403 Jun 2025 → Oct 2026 expected herpes zoster Beijing Tiantan Hospital Active not recruiting No outcome recorded
— NCT06785350 Jan → Sep 2025 overdue — Beijing Tiantan Hospital Recruiting No outcome recorded
— NCT06321354 Jul → Nov 2024 — Beijing Tiantan Hospital Completed No outcome recorded
— NCT05926895 Jun 2023 → Aug 2024 shoulder impingement syndrome Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey Completed No outcome recorded
— NCT05303766 Apr 2022 → Mar 2023 osteoarthritis, knee Assiut University Unknown No outcome recorded
Comparator or background therapy39 trials
Phase 1 NCT03758365 Comparator Nov 2018 vascular disorder MC2 Therapeutics Completed No outcome recorded
Phase 1 NCT03880357 Comparator Oct 2018 → Mar 2019 psoriasis Sun Pharmaceutical Industries, Inc. Completed No outcome recorded
Phase 1 NCT02376049 Comparator Feb → Jul 2015 atopic eczema LEO Pharma Completed No outcome recorded
Phase 1 NCT03399526 Comparator Feb → May 2013 psoriasis Bayer Completed No outcome recorded
Phase 1/2 NCT07256834 Comparator Nov → Dec 2025 overdue — Jinnah Postgraduate Medical Centre Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 15

DateIssuerRelease
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 ↗
Therefore, with this approval, Glenmark is eligible for 180-days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%.
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 ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%, the generic version of Enstilar® 1 Foam, 0.005%|0.064%, of Leo Pharma AS.
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
2021-01-13 Kyowa Kirin, Inc. Regulatory Approval of Dovobet® Foam for Psoriasis Vulgaris in Japan kyowakirin.com ↗
LEO Pharma K.K. (Head Office: Tokyo; Representative Director: Stefan Sakurai) has received an approval for manufacturing and marketing Dovobet® Foam for the treatment of psoriasis vulgaris
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 U.S. Food and Drug Administration (FDA) has approved Wynzora ® Cream (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 ↗
2020-02-14 Kyowa Kirin, Inc. Regulatory Sales Collaboration Agreement Reached for Dovobet® Foam Formulation for Psoriasis Vulgaris Treatment in Japan —Marketing Authorization Application Submitted— kyowakirin.com ↗
In addition, LEO Pharma K.K. announced that it applied for marketing authorization for the drug as an additional dosage form of Dovobet® on February 13, 2020.
2019-12-19 Lupin Limited Regulatory Lupin receives approval for Betamethasone Dipropionate Ointment USP (Augmented) lupin.com ↗
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 ↗
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 ↗
2019-04-04 Perrigo Company Regulatory Perrigo Announces Tentative FDA Approval For The Generic Version Of Sernivo® Spray, 0.05% perrigo.com ↗
today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Sernivo ® (betamethasone dipropionate) Spray 0.05%.

All press releases naming this drug 21 releases

DateIssuerRelease

Evidence & citations 22 cited values

Every value below carries the sentence it was read from. 102 sources stand behind the page.

FieldValueCited text
Known as Betamethasone dipropionate “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 ↗
80

“1ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml) steroid injection will be applied around the median nerve with a 22 G injector from...” NCT05475808 ↗

“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 spray formulation of betamethasone dipropionate 0.05% (BD spray 0.05%; Sernivo™ [betamethasone dipropionate] Spray 0.05%; Promius Pharma, LLC; Princeton, New Jersey, USA) has...” PMID 29657667 ↗ Apr 2018

“1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume with the cell suspension (which contains betamethasone dipropionate 5mg and betamethasone...” NCT03279796 ↗

“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

“Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical...” NCT01707043 ↗

“The two-compound topical suspension/gel containing calcipotriene plus betamethasone dipropionate is effective and safe in the treatment of psoriasis on the body and scalp...” PMID 23986161 ↗ Aug 2013

“Calcipotriene Plus Betamethasone Dipropionate Gel Compared to the Gel Vehicle in Scalp Psoriasis, in Patients Receiving Calcipotriene Plus Betamethasone Dipropionate Ointment...” NCT00279162 ↗

“All study patients will be randomized to receive one of four topical ointments (calcipotriol, betamethasone dipropionate, combination of both calcipotriol/betamethasone...” NCT01413477 ↗

“The local steroid injection ((1 ml Diprospan ®, Schering Plough containing 6.43 mg of betamethasone dipropionate and 2.63 mg of betamethasone sodium phosphate) will be...” NCT04000932 ↗

Show 70 more sources

Known as BD spray 0.05% “A spray formulation of betamethasone dipropionate 0.05% (BD spray 0.05%; Sernivo™ [betamethasone dipropionate] Spray 0.05%; Promius Pharma, LLC; Princeton, New Jersey, USA) has...” PMID 29657667 ↗ Apr 2018
Known as BDP “combination of calcipotriene (CAL) and betamethasone dipropionate (BDP)” PMID 37490268 ↗ Jul 2023
1

“calcipotriene \[CAL\]/betamethasone dipropionate \[BDP\] ointment” NCT03462927 ↗

Known as betamethasone “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 ↗
2

“LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)” NCT01866163 ↗

“Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)” NCT03462927 ↗

Known as Betamethasone diproprionate (0.5% ointment USP generic) “Betamethasone diproprionate (0.5% ointment USP generic)” NCT01413477 ↗
Known as Betamethasone-17,21-dipropionate ClinicalTrials.gov intervention name — accepted as the source's own label NCT01188928 ↗
Known as Betnovate “Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing corticosteroid ("Betnovate", betamethasone dipropionate ointment 0.1%) and placebo” NCT04114097 ↗
Known as BMDP CREAM “To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.” NCT05882903 ↗
Known as Calcipotriol/betamethasone dipropionate ClinicalTrials.gov intervention name — accepted as the source's own label NCT02004574 ↗
Known as Daivobet “Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the...” PMID 17135738 ↗ 2006
Known as DFD-01 “DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.” NCT02749799 ↗
2

“DFD-01 (betamethasone dipropionate) Spray, 0.05%” NCT02527421 ↗

“DFD-01 (Betamethasone Dipropionate) Spray 0.05%” NCT02070965 ↗

Known as diprolene “Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )” NCT04444726 ↗
Known as Diprolene AF “Diprolene® AF betamethasone dipropionate 0.05% cream.” NCT00820950 ↗
Known as Diprosone ClinicalTrials.gov intervention name — accepted as the source's own label NCT03525522 ↗
2

NCT00910676 ↗

NCT01466478 ↗

Known as diprospan “Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after...” NCT04073069 ↗
10

“Patients of IgG4-RD with mild symptoms are given one dose of diprospan and Iguratimod, 25mg, Bid.” NCT03368274 ↗

“Lidocaine mixed with diprospan injected into tender points.” NCT06344403 ↗

“Injection of steroids (diprospan) intra articularly” NCT02833545 ↗

NCT06785350 ↗

NCT07626489 ↗

NCT05983445 ↗

NCT07242846 ↗

NCT06321354 ↗

NCT07626463 ↗

NCT05175001 ↗

Known as Dovobet “Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the...” PMID 17135738 ↗ 2006
Known as Rinderon - DP “Rinderon® - DP = betamethasone dipropionate” NCT01422434 ↗
Known as Sernivo “A spray formulation of betamethasone dipropionate 0.05% (BD spray 0.05%; Sernivo™ [betamethasone dipropionate] Spray 0.05%; Promius Pharma, LLC; Princeton, New Jersey, USA) has...” PMID 29657667 ↗ Apr 2018
Known as Sernivo (betamethasone dipropionate, 0.05%) Spray “Sernivo (betamethasone dipropionate, 0.05%) Spray” NCT02749799 ↗
Known as Taclonex “Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the...” PMID 17135738 ↗ 2006
Modality Small molecule “Typically, topical steroids such as betamethasone dipropionate have been used for treating a number of inflammatory skin conditions, including eczema.” NCT01413477 ↗
Route Topical “once daily topical treatment for up to 8 weeks” NCT00216840 ↗