Drugs / Roflumilast
Roflumilast
also known as
ARQ-151 · APTA-2217 · Daliresp · ZORYVE · Roflumilast (generic name) · ARQ-154 · ARQ-154 (ROFLUMILAST FOAM) · B-9302-107 · +5 more
Regulatory milestones approvals, filings & regulatory actions · 21 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed atopic eczema 3 milestones | |||||
| Filed | US (FDA) | ZORYVE | atopic eczema | 2026-07-08 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.05%” arcutis.com ↗ “The FDA accepted an sNDA for ZORYVE cream 0.05% to expand the indication for the treatment of mild to moderate atopic dermatitis” arcutis.com ↗ |
| Filed | US (FDA) | ZORYVE | atopic eczema | 2024-12-16 | “today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ZORYVE (roflumilast) cream 0.05%” arcutis.com ↗ “The Company submitted an sNDA for ZORYVE cream 0.05% to the FDA for the treatment of atopic dermatitis in children ages 2 to 5” arcutis.com ↗ “Supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% submitted to the U.S. Food and Drug Administration (FDA).” arcutis.com ↗ |
| Filed | US (FDA) | — | atopic eczema | 2023-09-12 | “submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic...” arcutis.com ↗ “FDA has accepted its supplemental new drug application (sNDA) for roflumilast cream 0.15% for the treatment of atopic dermatitis (AD)” arcutis.com ↗ “In September 2023, Arcutis submitted an sNDA to the FDA for roflumilast cream 0.15% for the treatment of atopic dermatitis” arcutis.com ↗ |
| Filed psoriasis 7 milestones | |||||
| Filed | US (FDA) | ZORYVE | psoriasis | 2025-11-17 | “today announced the FDA acceptance of a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3%” arcutis.com ↗ “sNDA accepted for ZORYVE cream 0.3% for the treatment of plaque psoriasis down to 2 years of age” arcutis.com ↗ |
| Filed | US (FDA) | ZORYVE | psoriasis | 2025-09-03 | “today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication of ZORYVE” arcutis.com ↗ |
| Filed | US (FDA) | ZORYVE | psoriasis | 2024-07-23 | “This important milestone represents our fifth topical roflumilast regulatory submission in the United States in less than three years” arcutis.com ↗ “today announced the submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%” arcutis.com ↗ “The Company submitted an sNDA for ZORYVE foam for scalp and body psoriasis to the FDA in July 2024” arcutis.com ↗ |
| Filed | Other | — | psoriasis | 2022-07-11 | “Health Canada has accepted for review the New Drug Submission (NDS) for roflumilast cream 0.3% for the treatment of plaque psoriasis” arcutis.com ↗ |
| Filed | US (FDA) | — | psoriasis | 2022-06-06 | “Arcutis has also submitted an NDA for a closely related cream formulation of topical roflumilast for the treatment of plaque psoriasis” arcutis.com ↗ |
| Filed | US (FDA) | — | psoriasis | 2021-12-22 | “Arcutis has also submitted a New Drug Application (NDA) for a closely related cream formulation of topical roflumilast for the treatment of plaque psoriasis” arcutis.com ↗ “Arcutis has also filed a New Drug Application for a closely related cream formulation of topical roflumilast for the treatment of plaque psoriasis” arcutis.com ↗ “FDA accepted for filing the company’s New Drug Application (NDA) for roflumilast cream for the treatment of plaque psoriasis” arcutis.com ↗ “acceptance for review of the company’s new drug application (NDA) for roflumilast cream for the treatment of psoriasis” arcutis.com ↗ |
| Filed | US (FDA) | — | psoriasis | 2021-10-04 | “today announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream for the treatment of mild-to-severe plaque psoriasis” arcutis.com ↗ |
| Filed seborrheic dermatitis 2 milestones | |||||
| Filed | US (FDA) | — | seborrheic dermatitis | 2023-02-21 | “submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast foam 0.3% for the treatment of moderate to severe seborrheic dermatitis” arcutis.com ↗ “In April 2023, the FDA accepted Arcutis’ NDA submission for the treatment of moderate-to-severe seborrheic dermatitis” arcutis.com ↗ |
| Filed | Other | — | seborrheic dermatitis | — | “acceptance of a new drug submission for roflumilast foam 0.3% for the treatment of adults and children down to age 9 by Health Canada.” arcutis.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (5) | US (FDA) | ZORYVE | — | 2023-10-05 – 2026-06-29 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | DALIRESP | — | 2017-08-31 – 2018-01-23 | fda.gov ↗ |
| Approved | US (FDA) | DALIRESP | — | 2011-02-28 | fda.gov ↗ |
| Approved | EU (EMA) | Daxas | — | 2010-07-05 | europa.eu ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04090294 | Oct 2019 → Sep 2020 | bronchiectasis | Assiut University | Unknown | No outcome recorded |
| Phase 0 | NCT01888952 | Jul 2013 → Jan 2015 | neoplasm of mature B-cells | Anand B. Karnad | Completed | No outcome recorded |
| Phase 112 trials · 1 missed | ||||||
| Phase 1 | NCT06977711 | Jun 2025 → Oct 2026 expected | diffuse large B-cell lymphoma | The University of Texas Health Science Center at San Antonio | Recruiting | No outcome recorded |
| Phase 1 | NCT06457191 | Nov 2024 → Aug 2025 overdue | brain disorder | University of Calgary | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05796271 | Jan 2024 → Jan 2027 | lymphoma | The University of Texas Health Science Center at San Antonio | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04369547 | Jan 2022 → Sep 2023 | — | University of Calgary | Withdrawn | No outcome recorded |
| Phase 1 | NCT04279119 | Mar 2020 → Mar 2021 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04156191 | Dec 2019 → May 2023 | atopic eczema | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04108377 | Jan 2019 → Dec 2022 | asthma | University of California, Davis | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03458546 | May 2018 → Dec 2021 | B-cell non-Hodgkin lymphoma | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 1 | NCT02079844 | Mar 2014 → Jun 2015 | schizophrenia | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02051335 | Jan → May 2014 | Alzheimer disease | AstraZeneca | Completed | Mixed |
| Phase 1 | NCT01664624 | Jul → Nov 2012 | type 2 diabetes mellitus | AstraZeneca | Completed | Missed primary |
| Phase 1 | NCT01354782 | May → Jun 2011 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1/24 trials · 1 met primary | ||||||
| Phase 1/2 | NCT02743377 | Apr 2018 → Oct 2019 | nervous system disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 1/2 | NCT03392168 | Dec 2017 → May 2018 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | Met primary |
| Phase 1/2 | NCT01862029 | May 2013 → Jul 2017 | obesity disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 1/2 | NCT02097992 | Feb 2013 → Jul 2015 | chronic obstructive pulmonary disease | University of Miami | Completed | No outcome recorded |
| Phase 230 trials · 3 met primary · 1 missed | ||||||
| Phase 2 | NCT07639840 | Nov 2026 → Aug 2027 expected | dermatitis | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07263230 | Sep 2026 → Aug 2028 expected | hidradenitis suppurativa | Beth Israel Deaconess Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07689188 | Aug 2026 → Mar 2028 expected | hidradenitis suppurativa | Harrison Dermatology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07632846 | May → Oct 2026 expected | rheumatoid arthritis | Horus University | Recruiting | No outcome recorded |
| Phase 2 | NCT07566351 | Apr 2026 → Jun 2027 expected | rheumatoid arthritis | Horus University | Recruiting | No outcome recorded |
| Phase 2 | NCT07543640 | Apr → Aug 2026 overdue | psoriasis | Eman Raafat Said | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07297602 | Nov 2025 → May 2026 overdue | atopic eczema | Nora Mohamed Abdelrazik | Recruiting | No outcome recorded |
| Phase 2 | NCT07077902 | Sep 2025 → Sep 2026 | hidradenitis suppurativa | Tulane University | Completed | No outcome recorded |
| Phase 2 | NCT07233291 | Aug 2025 → Feb 2026 overdue | psoriasis | Ahmed Ibrahim | Recruiting | No outcome recorded |
| Phase 2 | NCT07105254 | Aug 2025 → May 2026 overdue | vitiligo | Derm Texas, PLLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06998056 | Jun → Dec 2025 | atopic eczema | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05418049 | Sep 2022 → Oct 2025 overdue | fragile X syndrome | Children's Hospital Medical Center, Cincinnati | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04658654 | Nov 2021 → Oct 2023 | amnestic disorder, cognitive impairment with or without cerebellar ataxia, dementia | Maastricht University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT04854811 | Jul 2021 → Dec 2023 | cerebrovascular disorder | Maastricht University | Completed | No outcome recorded |
| Phase 2 | NCT04744090 | Mar → Dec 2021 | adult acute respiratory distress syndrome | Cairo University | Completed | No outcome recorded |
| Phase 2 | NCT04746911 | Mar 2021 → May 2022 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04655313 | Nov 2020 → Jan 2022 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04322929 | Nov 2020 → Jun 2024 | bronchiectasis | The University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT04445987 | Jun 2020 → Nov 2022 | seborrheic dermatitis | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04128007 | Jan → Sep 2020 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT03988816 | Dec 2019 → Dec 2020 | bronchiectasis | University of Sao Paulo General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03764475 | Dec 2018 → Oct 2020 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03638258 | Sep 2018 → May 2019 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT03428334 | May 2018 → Aug 2019 | bronchiectasis | The University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT01703260 | Jun 2013 → Sep 2014 | metabolic dysfunction-associated steatohepatitis | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT01856764 | Jun 2013 → Mar 2014 | atopic eczema | AstraZeneca | Completed | Missed primary |
| Phase 2 | NCT01765192 | Feb → Oct 2013 | asthma | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT01701934 | Feb 2013 → Oct 2014 | chronic obstructive pulmonary disease, metabolic syndrome X | Laval University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01580748 | May → Dec 2012 | bronchiectasis | Seoul National University Bundang Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01433666 | Sep 2011 → Jul 2012 | dementia | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05684744 | Jan → May 2023 | psoriasis | Cairo University | Completed | No outcome recorded |
| Phase 2/3 | NCT00242294 | Nov 2004 → Sep 2006 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2/3 | NCT00242307 | May 2004 → Sep 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 326 trials · 7 met primary · 3 missed | ||||||
| Phase 3 | NCT07683806 | Aug 2026 → Jun 2027 expected | seborrheic dermatitis | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06631170 | Nov 2024 → May 2025 | atopic eczema | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06648772 | Nov 2024 → Oct 2025 | psoriasis | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05369793 | Aug 2022 → Oct 2023 | diabetic neuropathy, type 2 diabetes mellitus | Tanta University | Completed | No outcome recorded |
| Phase 3 | NCT04973228 | Jul 2021 → Apr 2022 | seborrheic dermatitis | Arcutis Biotherapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT04845620 | Apr 2021 → Jun 2023 | atopic eczema | Arcutis Biotherapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT04755946 | Mar → Jun 2021 | diabetic kidney disease | Tanta University | Unknown | No outcome recorded |
| Phase 3 | NCT04804605 | Feb 2021 → May 2024 | atopic eczema | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04773600 | Feb 2021 → Sep 2022 | atopic eczema | Arcutis Biotherapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT04773587 | Jan 2021 → Aug 2022 | atopic eczema | Arcutis Biotherapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT04286607 | Feb 2020 → Jan 2024 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04211363 | Dec 2019 → Nov 2020 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT02340520 | Dec 2014 → Aug 2016 | chronic obstructive pulmonary disease | UConn Health | Completed | No outcome recorded |
| Phase 3 | NCT02165826 | May 2014 → Sep 2015 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT01973998 | Nov 2013 → Nov 2017 | chronic obstructive pulmonary disease | Temple University | Completed | Missed primary |
| Phase 3 | NCT01313494 | Mar 2011 → May 2012 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00246935 | May 2005 → Jan 2007 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00246922 | Dec 2004 → Jan 2007 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00108823 | Oct 2004 → ? | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00163475 | May 2004 → Aug 2005 | asthma | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00076076 | Dec 2003 → Jun 2005 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00076089 | Dec 2003 → Dec 2005 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT00073177 | Nov 2003 → ? | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00062582 | Jun 2003 → ? | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00163527 | Apr 2003 → Nov 2005 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00430729 | Jan 2003 → ? | chronic obstructive pulmonary disease | AstraZeneca | Completed | Missed primary |
| Phase 410 trials · 1 missed | ||||||
| Phase 4 | NCT07795086 | Feb 2027 expected | chronic obstructive pulmonary disease | Sidra Aziz | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07725822 | Sep 2026 → Jul 2027 expected | psoriasis | Modern Research Associates, PLLC | Recruiting | No outcome recorded |
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07560618 | Apr 2026 → Aug 2027 expected | atopic eczema | Integrative Skin Science and Research | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05684484 | Feb 2023 → Apr 2024 | ulcerative colitis | Tanta University | Completed | No outcome recorded |
| Phase 4 | NCT02018432 | Dec 2013 → Dec 2015 | chronic obstructive pulmonary disease | Asan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01830959 | Apr 2013 → May 2016 | sarcoidosis | University of Cincinnati | Unknown | No outcome recorded |
| Phase 4 | NCT01745848 | Feb 2013 → Jun 2016 | chronic obstructive pulmonary disease | University of Pittsburgh | Completed | No outcome recorded |
| Phase 4 | NCT01849341 | Jul 2012 → Dec 2013 | chronic obstructive pulmonary disease | Fundación Pública Andaluza Progreso y Salud | Completed | No outcome recorded |
| Phase 4 | NCT01443845 | Sep 2011 → Nov 2015 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Missed primary |
| Comparator or background therapy43 trials | ||||||
| Phase 0 | NCT06643221 Comparator | Jan 2018 → May 2031 expected | leukemia, lymphoma | University of Arizona | Recruiting | No outcome recorded |
| Phase 1 | NCT00940329 Comparator | Apr → Jul 2004 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1/2 | NCT05884281 Comparator | Jul → Dec 2023 | peripheral neuropathy | Mansoura University | Unknown | No outcome recorded |
| Phase 1/2 | NCT04751071 Comparator | Feb 2021 → Oct 2024 | major depressive disorder | Sadat City University | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT07314242 Comparator | Jan 2026 → Dec 2027 expected | chronic obstructive pulmonary disease | Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05278624 Comparator | Apr 2022 → Feb 2023 | rosacea | Dermatology Consulting Services, PLLC | Completed | No outcome recorded |
| Phase 2 | NCT06677788 Comparator | Apr 2022 → Sep 2024 | metabolic dysfunction-associated steatohepatitis | Tanta University | Completed | No outcome recorded |
| Phase 2 | NCT04549870 Comparator | Jan 2021 → Dec 2022 | psoriasis | Bispebjerg Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04091646 Comparator | Dec 2019 → Aug 2020 | seborrheic dermatitis | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03916081 Comparator | May → Nov 2019 | atopic eczema | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03532490 Comparator | Aug 2018 → Jul 2021 | asthma, obesity disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT02671942 Comparator | Mar 2016 → Jun 2018 | chronic obstructive pulmonary disease | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Terminated | No outcome recorded |
| Phase 2 | NCT02451540 Comparator | Sep 2015 → Aug 2017 | chronic obstructive pulmonary disease | FLUIDDA nv | Terminated | No outcome recorded |
| Phase 2 | NCT01730404 Comparator | Oct 2012 → Oct 2013 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01473758 Comparator | Feb 2012 → Mar 2014 | chronic obstructive pulmonary disease | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT00746434 Comparator | Nov 2008 → Jun 2009 | psoriasis | AstraZeneca | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT00746382 Comparator | Nov 2008 → Jun 2009 | dermatitis | AstraZeneca | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT01140542 Comparator | Aug 2006 → Nov 2007 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01365533 Comparator | Dec 2004 → Jul 2005 | allergic asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT06860958 Comparator | Mar 2025 → Mar 2027 expected | major depressive disorder | Tanta University | Recruiting | No outcome recorded |
| Phase 3 | NCT05028582 Comparator | Aug 2021 → Jun 2022 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04636814 Comparator | Jul 2021 → Dec 2025 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04800172 Comparator | May 2021 → Mar 2022 | obesity disorder, prediabetes syndrome | Tanta University | Completed | No outcome recorded |
| Phase 3 | NCT04069312 Comparator | Feb 2020 → Mar 2026 | chronic bronchitis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 3 | NCT04211389 Comparator | Dec 2019 → Nov 2020 | psoriasis | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04122547 Comparator | Jan → Dec 2015 | bronchiectasis | Prince of Songkla University | Completed | No outcome recorded |
| Phase 3 | NCT01509677 Comparator | Feb 2012 → Feb 2016 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00424268 Comparator | Jan 2007 → Jan 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00313209 Comparator | Apr 2006 → Jul 2007 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00297115 Comparator | Mar 2006 → Apr 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00297102 Comparator | Feb 2006 → Jul 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00242320 Comparator | Aug 2005 → May 2007 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT07174011 Comparator | Jan → May 2025 | alopecia areata | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT06440473 Comparator | May → Jun 2024 | — | Rao Dermatology | Unknown | No outcome recorded |
| Phase 4 | NCT05682859 Comparator | Sep 2023 → Apr 2025 | — | Jacob Pontoppidan Thyssen | Unknown | No outcome recorded |
| Phase 4 | NCT02187250 Comparator | Mar → Jun 2014 | obesity disorder, polycystic ovary syndrome | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 4 | NCT02037672 Comparator | Sep → Dec 2013 | obesity disorder, polycystic ovary syndrome | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 4 | NCT03073798 Comparator | Mar 2013 → May 2015 | chronic bronchitis, pulmonary emphysema | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT01630200 Comparator | May 2012 → Jan 2016 | chronic obstructive pulmonary disease | Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology | Completed | No outcome recorded |
| Phase 4 | NCT01595750 Comparator | May → Jul 2012 | chronic obstructive pulmonary disease | Spanish Research Center for Respiratory Diseases | Unknown | No outcome recorded |
| Phase 4 | NCT01480661 Comparator | Dec 2011 → Apr 2013 | chronic obstructive pulmonary disease | FLUIDDA nv | Completed | No outcome recorded |
| Phase 4 | NCT01329029 Comparator | May 2011 → Mar 2014 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| — | NCT01572948 Comparator | Jun 2012 → Jun 2014 | chronic obstructive pulmonary disease | University of Alabama at Birmingham | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 81
| Date | Issuer | Release |
|---|---|---|
| 2026-10-09 | Arcutis Biotherapeutics, Inc. | Results Arcutis Presents ZORYVE® (roflumilast) Data and Real-World Topical Corticosteroid Research at EADV and Fall Clinical arcutis.com ↗
New analyses from the ARRECTOR and DERMIS-1/2 trials further demonstrate ZORYVE’s efficacy and symptom improvements across the body in individuals with psoriasis |
| 2026-07-08 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months arcutis.com ↗
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months. |
| 2026-06-29 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2 arcutis.com ↗ |
| 2026-04-27 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months arcutis.com ↗
today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) |
| 2026-03-28 | Arcutis Biotherapeutics, Inc. | Results Arcutis Presents New Phase 2 Results in Infants with Atopic Dermatitis in Late-Breaking Session Today at the 2026 American Academy of Dermatology Annual Meeting arcutis.com ↗
ZORYVE cream improved signs and symptoms of mild to moderate atopic dermatitis in infants aged 3 months to less than 24 months over four weeks |
| 2026-03-10 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data with ZORYVE® (roflumilast) Cream 0.05% for Treatment of Mild-to-Moderate Atopic Dermatitis in Children Ages 2–5 in Pediatric Dermatology arcutis.com ↗
ZORYVE cream 0.05% was safe and well-tolerated, with efficacy that was maintained and improved over time up to 56 weeks of treatment |
| 2026-02-02 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Positive Topline Results for INTEGUMENT-INFANT Phase 2 Trial of ZORYVE® (roflumilast) Cream 0.05% in Infants with Mild to Moderate Atopic Dermatitis arcutis.com ↗
ZORYVE cream improved the severity of disease and reduced the area of skin affected by atopic dermatitis, with 58% of participants achieving EASI-75 at Week 4. |
| 2025-11-17 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5 arcutis.com ↗
The FDA has set a PDUFA target action date of June 29, 2026, for this application. |
| 2025-11-04 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data of ZORYVE® (roflumilast) Foam 0.3% in Individuals with Seborrheic Dermatitis in American Journal of Clinical Dermatology arcutis.com ↗
ZORYVE foam 0.3% was safe, well-tolerated, and demonstrated durable and continuously improving efficacy in the treatment of seborrheic dermatitis up to 52 weeks |
| 2025-10-24 | Arcutis Biotherapeutics, Inc. | Results Arcutis to Present New Quality of Life and Long-Term Data with ZORYVE® (roflumilast) Cream 0.15% and 0.05% for the Treatment of Atopic Dermatitis at the Fall Clinical Dermatology Conference arcutis.com ↗
New data from Phase 3 studies show once-daily ZORYVE cream helped reduce sleep disruptions in individuals with atopic dermatitis aged ≥2 years |
| 2025-10-06 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5 arcutis.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE ® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age. |
| 2025-09-17 | Arcutis Biotherapeutics, Inc. | Results Arcutis To Present Multiple New ZORYVE® (roflumilast) Data Analyses at European Academy of Dermatology and Venereology Congress arcutis.com ↗
New analysis of ZORYVE foam 0.3% demonstrates reduction in signs and symptoms of seborrheic dermatitis in individuals with diverse skin types |
| 2025-09-03 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5 arcutis.com ↗
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication of ZORYVE ® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children down to the age of 2. |
| 2025-06-06 | Arcutis Biotherapeutics, Inc. | Results Arcutis to Present New Long-Term Results of ZORYVE® (roflumilast) Cream at the 2025 Revolutionizing Atopic Dermatitis Conference arcutis.com ↗
New data demonstrate that for children ages 2 to 5 who achieved disease clearance and switched to proactive twice-weekly application of investigational ZORYVE cream 0.05%, the median duration of disease control was 238 days |
| 2025-05-22 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis’ ZORYVE® (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older arcutis.com ↗ |
| 2025-05-07 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Publication of Positive Data from ARRECTOR Trial Evaluating ZORYVE® (roflumilast) Foam 0.3% in Individuals with Psoriasis in Journal of American Medical Association Dermatology arcutis.com ↗ |
| 2025-03-07 | Arcutis Biotherapeutics, Inc. | Results Arcutis to Highlight Data from Phase 3 Trials for Scalp and Body Psoriasis and Atopic Dermatitis at the 83rd American Academy of Dermatology Meeting arcutis.com ↗
At all timepoints assessed during the four-week trial, more than 91% of participants reported no or mild sensation at the application site and investigators reported no irritation or minimal erythema (redness) in ≥ 97% of participants in these subgroups. |
| 2025-02-28 | Arcutis Biotherapeutics, Inc. | Results Arcutis to Present Two Posters at the 83rd American Academy of Dermatology Annual Meeting arcutis.com ↗
A second presentation will spotlight data from its Phase 3 ARRECTOR trial demonstrating significant improvements in patient-related outcomes with roflumilast foam 0.3% in individuals older than 12 years with psoriasis of the scalp and body. |
| 2025-02-26 | Arcutis Biotherapeutics, Inc. | Regulatory U.S. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis arcutis.com ↗ |
| 2025-02-25 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update arcutis.com ↗
Supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream, 0.05%, submitted to the Food and Drug Administration (FDA) for the treatment of atopic dermatitis in children ages 2 to 5 |
| 2025-02-24 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Publication of Positive Data from INTEGUMENT-PED Trial Evaluating ZORYVE® (roflumilast) Cream 0.05% in Children 2 to 5 Years Old with Mild to Moderate Atopic Dermatitis in Pediatric Dermatology arcutis.com ↗
ZORYVE® (roflumilast) cream 0.05% improved atopic dermatitis (AD) across all primary and secondary efficacy endpoints, with significant improvement as early as Week 1 on multiple efficacy endpoints. |
| 2024-12-16 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Submits ZORYVE® (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis arcutis.com ↗ |
| 2024-10-24 | Arcutis Biotherapeutics, Inc. | Results Arcutis Presents Positive Patient-Reported Outcome Data for ZORYVE® (Roflumilast) Cream 0.15% in Atopic Dermatitis at American College of Allergy, Asthma and Immunology 2024 Annual Scientific Meeting arcutis.com ↗
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new patient-reported outcome data demonstrating that ZORYVE cream 0.15% improved the impact of AD on patients, families, and caregivers. |
| 2024-10-18 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Announces Health Canada Approval of ZORYVE® (Roflumilast) Foam 0.3% to Treat Seborrheic Dermatitis in Individuals 9 Years of Age and Older arcutis.com ↗
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that its wholly-owned subsidiary Arcutis Canada, Inc. has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients 9 years of age and older. |
| 2024-09-24 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Accepts Arcutis’ Supplemental New Drug Application for ZORYVE® (roflumilast) Foam for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over arcutis.com ↗
The FDA assigned the application a PDUFA target action date of May 22, 2025. |
| 2024-09-24 | Arcutis Biotherapeutics, Inc. | Results New Data Shows ZORYVE® (Roflumilast) Cream 0.15% Provided Consistent Improvement of Atopic Dermatitis in Individuals With Diverse Skin Types arcutis.com ↗
ZORYVE demonstrated consistent efficacy in disease clearance and reduction in itch for individuals with atopic dermatitis (AD) regardless of race, ethnicity, and Fitzpatrick skin type |
| 2024-09-19 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Publication of ZORYVE® (roflumilast) Cream 0.15% Pivotal Results from Phase 3 INTEGUMENT-1 and -2 Trials in Mild to Moderate Atopic Dermatitis in Journal of American Medical Association Dermatology arcutis.com ↗
ZORYVE ® (roflumilast) cream 0.15% improved atopic dermatitis (AD) across multiple efficacy endpoints while demonstrating favorable safety and tolerability |
| 2024-08-28 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Positive Long-Term Results of Roflumilast Cream 0.05% Show Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis arcutis.com ↗
In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment of up to 56 weeks in duration. |
| 2024-08-14 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Announces Second Quarter 2024 Financial Results and Provides Business Update arcutis.com ↗
Submitted Supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam to the Food & Drug Administration (FDA) for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over |
| 2024-07-23 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over arcutis.com ↗
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis. |
| 2024-07-09 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age arcutis.com ↗ |
| 2024-06-10 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces New Long-Term Data of Roflumilast Cream 0.15% for the Treatment of Mild to Moderate Atopic Dermatitis (AD) in Adults and Children Down to Age Six Presented at Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference arcutis.com ↗
In the study, roflumilast cream was well-tolerated, with no new safety signals observed over 56 weeks of treatment. |
| 2024-05-13 | Arcutis Biotherapeutics, Inc. | Results Expert Panel Review Further Validates Use of ZORYVE® (roflumilast) Topical Foam, 0.3% for Treatment of Seborrheic Dermatitis Across Diverse Hair Types Published in Journal of Clinical and Aesthetic Dermatology arcutis.com ↗
Eight of nine experts expressed feeling “extremely confident” about prescribing ZORYVE foam to patients of diverse skin and hair types, including individuals with previous hair treatments, based on review of formulation data |
| 2024-03-10 | Arcutis Biotherapeutics, Inc. | Results Arcutis Presents Late-Breaking Data From INTEGUMENT-PED Phase 3 Trial of Roflumilast Cream 0.05% in Atopic Dermatitis in Children Ages 2 to 5 at the American Academy of Dermatology Annual Meeting arcutis.com ↗
Investigational roflumilast cream 0.05% met the primary endpoint and all secondary endpoints, showing significant improvement across multiple efficacy endpoints as early as Week 1 |
| 2024-01-29 | Arcutis Biotherapeutics, Inc. | Results Journal of the American Academy of Dermatology Publishes ZORYVE (roflumilast) Foam, 0.3% Results for Seborrheic Dermatitis from Pivotal Phase 3 Trial arcutis.com ↗
today announced that the Journal of American Academy of Dermatology (JAAD) published positive results from the pivotal Phase 3 STRATUM trial evaluating ZORYVE (roflumilast) foam, 0.3% as a once-daily steroid-free treatment for seborrheic dermatitis. |
| 2024-01-14 | Arcutis Biotherapeutics, Inc. | Results ZORYVE® (Roflumilast) Topical Foam, 0.3% Clears Seborrheic Dermatitis in Individuals Who Previously Reported an Inadequate Response to Topical Steroids arcutis.com ↗ |
| 2024-01-14 | Arcutis Biotherapeutics, Inc. | Results Majority of Individuals with Atopic Dermatitis Improved with Arcutis’ Roflumilast Cream 0.15% According to New Data from Phase 3 Program arcutis.com ↗
today announced new individual patient response data showing the vast majority of individuals (91.5%) treated with investigational roflumilast cream 0.15% had a measurable improvement in Eczema Area and Severity Index (EASI) in 4 weeks. |
| 2023-12-15 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older arcutis.com ↗
ZORYVE is a once-daily steroid-free foam and the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades. |
| 2023-11-29 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Accepts Arcutis’ Supplemental New Drug Application for Roflumilast Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to Age 6 arcutis.com ↗
today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for roflumilast cream 0.15% for the treatment of atopic dermatitis (AD) in adults and children down to age 6. |
| 2023-10-20 | Arcutis Biotherapeutics, Inc. | Results New Data Shows ZORYVE® (Roflumilast) Cream 0.3% Provided Measurable Improvement of Plaque Psoriasis in Nearly All Individuals in DERMIS Trials arcutis.com ↗
At Week 8, a statistically significant greater percentage of patients achieved a 50% reduction in PASI scores (PASI-50), with 72.1% of patients treated with ZORYVE compared to 25.5% of those treated with vehicle (P<0.0001). |
| 2023-10-13 | Arcutis Biotherapeutics, Inc. | Results Arcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress arcutis.com ↗
Two thirds (65.3%) of roflumilast-treated patients achieved a clinically significant reduction in itch compared to 30.3% of vehicle-treated patients at Week 8 (P<0.0001) as measured by a four-point (4-pt) change from baseline in SI-NRS. |
| 2023-10-06 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11 arcutis.com ↗ |
| 2023-09-19 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Positive Results from INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5 arcutis.com ↗
today announced that the INTEGUMENT-PED pivotal Phase 3 trial of roflumilast cream 0.05%, in children ages 2 to 5 years with mild to moderate atopic dermatitis (AD) met its primary endpoint and all secondary endpoints. |
| 2023-09-12 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Submits Roflumilast Cream 0.15% Supplemental New Drug Application to the FDA for the Treatment of Atopic Dermatitis in Adults and Children Ages 6 Years and Older arcutis.com ↗ |
| 2023-09-07 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Positive Long-Term Results of Roflumilast Cream 0.15% Showing Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Mild to Moderate Atopic Dermatitis (AD) arcutis.com ↗
In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment up to 56 weeks in duration. |
| 2023-04-28 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Announces Canadian Approval of ZORYVE™ (roflumilast) Cream 0.3% for Treatment of Plaque Psoriasis in Individuals 12 Years and Older arcutis.com ↗
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced today that its next-generation topical PDE4 inhibitor therapy for plaque psoriasis, ZORYVE™ (roflumilast) cream 0.3%, has received regulatory approval from Health Canada. |
| 2023-04-19 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Roflumilast Tablets, 250 mcg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Roflumilast Tablets, 250 mcg (USRLD: Daliresp Tablets, 250 mcg). |
| 2023-04-18 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Announces FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older arcutis.com ↗ |
| 2023-03-18 | Arcutis Biotherapeutics, Inc. | Results Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting arcutis.com ↗
New INTEGUMENT-1 and INTEGUMENT-2 data show a rapid and significant reduction in itch as early as 24 hours after the first application of roflumilast cream 0.15% |
| 2023-02-21 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Submits Topical Roflumilast Foam 0.3% New Drug Application to the FDA for the Treatment of Seborrheic Dermatitis in Adults and Adolescents arcutis.com ↗
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast foam 0.3% for the treatment of moderate to severe seborrheic dermatitis in adults and adolescents. |
| 2023-01-14 | Arcutis Biotherapeutics, Inc. | Results Arcutis Presents New Phase 2 Long-Term Data Showing Sustained Efficacy and Clearance for a Median of 10 Months with Roflumilast Cream in Adults with Chronic Plaque Psoriasis arcutis.com ↗
Efficacy was consistent over time across all endpoints, and no lessening of response (no tachyphylaxis) from roflumilast cream was observed |
| 2022-12-19 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% for Expanded Indication for the Treatment of Plaque Psoriasis in Children Down to 2 Years of Age arcutis.com ↗ |
| 2022-12-12 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Positive Topline Results from Second Atopic Dermatitis Pivotal Phase 3 Trial of Roflumilast Cream in Adults and Children Aged 6 and Older arcutis.com ↗
The study met its primary endpoint, with 28.9% of individuals treated with roflumilast cream 0.15% achieving IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4, compared to 12.0% of individuals treated with vehicle (P<0.0001). |
| 2022-11-28 | Arcutis Biotherapeutics, Inc. | Results Study Showing Significant Improvements in Itch and Itch-Related Sleep Loss with Roflumilast Cream in Adults with Plaque Psoriasis Published in American Journal of Clinical Dermatology arcutis.com ↗
Newly published phase 2b trial data show those treated with roflumilast cream had significantly greater improvements in itch compared to those treated with vehicle by Week 2 as assessed by the Worst Itch Numeric Rating Scale (WI-NRS) and Psoriasis Symptom Diary (PSD) |
| 2022-11-15 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Positive Topline Results from INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis in Adults and Children Aged Six Years and Older arcutis.com ↗
Study met the primary endpoint and all secondary endpoints |
| 2022-09-26 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Positive Topline Results from ARRECTOR Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Scalp and Body Psoriasis arcutis.com ↗
The study met its co-primary endpoints of S-IGA Success and B-IGA Success, and all secondary endpoints. |
| 2022-09-20 | Arcutis Biotherapeutics, Inc. | Results Journal of the American Medical Association Publishes Roflumilast Cream 0.3% Results from Pivotal DERMIS-1 and -2 Phase 3 Trials in Plaque Psoriasis arcutis.com ↗
Roflumilast cream showed higher efficacy compared to vehicle in both Phase 3 studies on the primary efficacy endpoint of Investigator Global Assessment (IGA) success, with 40% of roflumilast cream treated patients achieving IGA success at eight weeks |
| 2022-09-09 | Arcutis Biotherapeutics, Inc. | Results New Data from Arcutis’ STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis Presented at European Academy of Dermatology and Venereology (EADV) Congress arcutis.com ↗
The study met the primary endpoint with 80.1% of individuals treated with roflumilast foam achieving ‘IGA Success’ compared to 59.2% of patients treated with vehicle (P<0.0001) at week eight. |
| 2022-07-29 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Approves Arcutis’ ZORYVE™ (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older arcutis.com ↗ |
| 2022-07-11 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Biotherapeutics Announces Health Canada Accepts for Review the New Drug Submission for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis arcutis.com ↗
Health Canada has accepted for review the New Drug Submission (NDS) for roflumilast cream 0.3% for the treatment of plaque psoriasis in adults and adolescents. |
| 2022-06-06 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Positive Topline Results from STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis arcutis.com ↗
The study met the primary endpoint with 80.1% of individuals treated with roflumilast foam achieving ‘IGA Success’ compared to 59.2% of patients treated with vehicle (P<0.0001) at week eight. |
| 2022-03-28 | Arcutis Biotherapeutics, Inc. | Results Arcutis Highlights Growth Opportunities at Investor Day in Advance of 2022 Catalysts arcutis.com ↗
Clinical program for topical roflumilast continues to advance with announcement of new long-term Phase 2 data in seborrheic dermatitis and three Phase 3 data readouts expected in 2022 |
| 2022-03-25 | Arcutis Biotherapeutics, Inc. | Results Arcutis’ Roflumilast Foam Demonstrates Clinically Meaningful Results and Patient Quality of Life Improvements in Phase 2 Seborrheic Dermatitis Study arcutis.com ↗
Previously reported safety and efficacy data was recapitulated along with new patient quality of life data that showed significant improvement in all emotional, symptom, and function measures. |
| 2022-03-25 | Arcutis Biotherapeutics, Inc. | Results Arcutis Presents New Data on Once-Daily Roflumilast Cream for Plaque Psoriasis from DERMIS Phase 3 Trials at American Academy of Dermatology Annual Meeting arcutis.com ↗
Pooled analysis of DERMIS-1 and DERMIS-2 demonstrated significantly more roflumilast-treated patients achieved Investigator Global Assessment (IGA) success (40%) at week 8 compared to vehicle (7%), consistent with results from the individual studies |
| 2022-02-15 | Zydus Lifesciences Limited | Regulatory Zydus gets 180 days shared exclusivity for Roflumilast Tablets zyduslife.com ↗
Zydus’ U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the USFDA to market Roflumilast Tablets in the strength of 500 mcg and a tentative approval for Roflumilast Tablets, 250 mcg (US RLD - DALIRESP®). |
| 2021-12-22 | Arcutis Biotherapeutics, Inc. | Regulatory FDA Accepts Arcutis Biotherapeutics’ New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis arcutis.com ↗
today announced the U.S. Food and Drug Administration’s (FDA) acceptance for review of the company’s new drug application (NDA) for roflumilast cream for the treatment of psoriasis in adults and adolescents. |
| 2021-12-13 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Data Comparing the Vehicle in Investigational Roflumilast Cream Against a Commercial Ceramide-Containing Moisturizing Cream arcutis.com ↗
today announced data suggesting that Arcutis’ proprietary cream vehicle had similar moisturizing properties as a commercially marketed, dermatologist-recommended, ceramide-containing moisturizer in adults with mild eczema. |
| 2021-10-04 | Arcutis Biotherapeutics, Inc. | Regulatory Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis arcutis.com ↗ |
| 2021-09-30 | Arcutis Biotherapeutics, Inc. | Results New Data Highlighting Itch Reduction with Topical Roflumilast in Multiple Dermatologic Conditions Presented at European Academy of Dermatology and Venereology Congress arcutis.com ↗
Once-daily roflumilast cream reduced both the severity and burden of itch, and improved quality of life, in the DERMIS-1 and DERMIS-2 Phase 3 pivotal studies in chronic plaque psoriasis. |
| 2021-05-06 | Arcutis Biotherapeutics, Inc. | Results Arcutis Biotherapeutics Showcases Pivotal DERMIS-1 and -2 Phase 3 Trial Data for Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis at EADV Spring Symposium 2021 arcutis.com ↗
Data show roflumilast produced robust efficacy compared to vehicle in both Phase 3 studies on the primary efficacy endpoint of IGA success at eight weeks |
| 2021-04-23 | Arcutis Biotherapeutics, Inc. | Results Arcutis Biotherapeutics Showcases New Roflumilast Data in Psoriasis and Seborrheic Dermatitis at American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) 2021 arcutis.com ↗
Data demonstrate roflumilast foam was well-tolerated and improved scalp and body psoriasis as early as two weeks after treatment initiation |
| 2021-04-19 | Arcutis Biotherapeutics, Inc. | Results Arcutis Biotherapeutics to Present New Roflumilast Data at The American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) arcutis.com ↗
The data include positive results from a Phase 2b study of roflumilast foam for the treatment of scalp and body psoriasis, as well as a Phase 2 study of roflumilast foam in patients with seborrheic dermatitis. |
| 2021-02-01 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Positive Topline Results from Pivotal DERMIS-1 and -2 Phase 3 Trials of Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis arcutis.com ↗ |
| 2020-12-01 | Arcutis Biotherapeutics, Inc. | Results Data from Long-Term Safety Study Support Chronic Use of ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Plaque Psoriasis arcutis.com ↗
At 52 to 64 weeks of treatment, over one-third of subjects demonstrated IGA Success and 45% of subjects had attained an IGA of clear or almost clear |
| 2020-11-23 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Positive Topline Data from Phase 2b Study of ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Scalp and Body Psoriasis arcutis.com ↗
Roflumilast foam 0.3% administered once daily for 8 weeks demonstrated statistically significant improvements compared to a matching vehicle foam on key efficacy endpoints in 304 adult and adolescent patients with plaque psoriasis that included plaques on the scalp. |
| 2020-11-02 | Arcutis Biotherapeutics, Inc. | Results Arcutis Biotherapeutics Presents New Positive Data from Phase 2 Studies of ARQ-151 (Topical Roflumilast Cream) in Chronic Plaque Psoriasis and Atopic Dermatitis arcutis.com ↗ |
| 2020-08-03 | Arcutis Biotherapeutics, Inc. | Results The Journal of Drugs in Dermatology Publishes Results from Positive Phase 1/2a Trial of Arcutis’ ARQ-151 (Topical Roflumilast Cream) for the Treatment of Chronic Plaque Psoriasis arcutis.com ↗
Arcutis Biotherapeutics, Inc . (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, announced today that The Journal of Drugs in Dermatology has published positive results from a Phase 1/2a trial of its investigational drug topical roflumilast cream for the treatment of chronic plaque psoriasis. |
| 2020-07-31 | Arcutis Biotherapeutics, Inc. | Results Preliminary Data from Long-Term Safety Study Support Chronic Use of ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Plaque Psoriasis arcutis.com ↗
Once-daily roflumilast demonstrated favorable safety and tolerability over 52 to 64 weeks of treatment |
| 2020-07-15 | Arcutis Biotherapeutics, Inc. | Results The New England Journal of Medicine Publishes Results from Positive Phase 2b Trial of Arcutis’ ARQ-151 (Topical Roflumilast Cream) for the Treatment of Chronic Plaque Psoriasis arcutis.com ↗
These results demonstrate that ARQ-151 (roflumilast cream) administered once daily was superior to a matching vehicle in treating psoriasis, as measured by a rating of clear or almost clear at week six on the Investigator Global Assessment (IGA) scale. |
| 2019-12-16 | Arcutis Biotherapeutics, Inc. | Results Arcutis Announces Top Line Results for Phase 2 Proof-of-Concept Clinical Trial Evaluating ARQ-151 as a Potential Topical Treatment for Atopic Dermatitis arcutis.com ↗ |
| 2019-07-22 | Arcutis Biotherapeutics, Inc. | Results Arcutis, Inc. Announces Positive Top Line Results for Phase 2b Clinical Trial Evaluating ARQ-151 as a Potential Topical Treatment for Plaque Psoriasis arcutis.com ↗ |
All press releases naming this drug 145 releases
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Evidence & citations 17 cited values
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| Field | Value | Cited text |
|---|---|---|
| Known as | Roflumilast | “Two 4-week, phase 2, open-label, maximal usage pharmacokinetic (PK) and safety studies of once-daily roflumilast cream 0.3% (a potent phosphodiesterase 4 inhibitor) were...” PMID 40862624 ↗ Aug 2025124“The efficacy and safety of once-daily roflumilast foam 0.3%, a potent phosphodiesterase 4 inhibitor, has been demonstrated in patients with seborrheic dermatitis (SD).” PMID 41175336 ↗ Nov 2025 “Roflumilast cream (ARQ-151) is a highly potent, selective phosphodiesterase-4 inhibitor in development for once-daily topical treatment of chronic plaque psoriasis.” PMID 32845114 ↗ Aug 2020 “ARQ-151 roflumilast cream 0.05% (open label)” NCT06998056 ↗ |
| Known as | APTA-2217 | “The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with asthma, who completed the 24-week evaluation of...” NCT00246922 ↗3“The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with chronic obstructive pulmonary disease (COPD)” NCT00246935 ↗ “The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with chronic obstructive pulmonary disease (COPD).” NCT00242294 ↗ “The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma.” NCT00242307 ↗ |
| Known as | ARQ-151 | “This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment...” NCT04211363 ↗8“Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial.” PMID 36370336 ↗ Nov 2022 “Roflumilast cream (ARQ-151) is a highly potent, selective phosphodiesterase-4 inhibitor in development for once-daily topical treatment of chronic plaque psoriasis.” PMID 32845114 ↗ Aug 2020 “ARQ-151 roflumilast cream 0.05% (open label)” NCT06998056 ↗ |
| Known as | ARQ-154 | “This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA).” NCT04445987 ↗ |
| Known as | ARQ-154 (ROFLUMILAST FOAM) | ChEMBL registry synonym — accepted as the source's own label CHEMBL193240 ↗ |
| Known as | B-9302-107 | ChEMBL registry synonym — accepted as the source's own label CHEMBL193240 ↗ |
| Known as | BY-217 | ChEMBL registry synonym — accepted as the source's own label CHEMBL193240 ↗ |
| Known as | BYK-20869 | ChEMBL registry synonym — accepted as the source's own label CHEMBL193240 ↗ |
| Known as | Daliresp | “1 tablet of Roflumilast (Daliresp®), 250µg, once daily during the first 4 weeks of treatment then 1 tablet of Roflumilast (Daliresp®), 500µg, once daily for the remaining...” NCT04636814 ↗2“Roflumilast (Daliresp, Daxas) is a FDA-approved phosphodiesterase 4 (PDE4) inhibitor for the treatment of moderate-to-severe chronic obstructive pulmonary disease.” PMID 31213865 ↗ May 2019 “Roflumilast 500 MCG Oral Tablet [DALIRESP]” NCT05684484 ↗ |
| Known as | Daxas | “Roflumilast (Daliresp, Daxas) is a FDA-approved phosphodiesterase 4 (PDE4) inhibitor for the treatment of moderate-to-severe chronic obstructive pulmonary disease.” PMID 31213865 ↗ May 2019 |
| Known as | Libertek | ChEMBL registry synonym — accepted as the source's own label CHEMBL193240 ↗ |
| Known as | ROF | “Sarcoidosis patients with pulmonary fibrosis and at least two acute episodes in the previous year were randomized to receive either roflumilast (ROF) or placebo (PLA) in a...” PMID 34744427 ↗ Sep 2021 |
| Known as | Roflumilast (generic name) | “Roflumilast (generic name)” NCT07297602 ↗1“Roflumilast (generic name)” NCT07233291 ↗ |
| Known as | ZORYVE | “A Phase 3 Multicenter, Double-blind, Vehicle-controlled Brigding Study to Evaluate the Efficacy and Safety of Roflumilast Cream 0.15% (ZORYVE®) in the Treatment of Patients...” NCT06631170 ↗2“This study will assess the safety and efficacy of Roflumilast foam 0.3% (ZORYVE®) versus vehicle applied once a day for 8 weeks by trial participants with seborrheic dermatitis.” NCT07683806 ↗ “topical 0.3% roflumilast (Zoryve)” NCT06440473 ↗ |
| Action | Inhibit | “The safety profile of roflumilast, a phosphodiesterase 4 inhibitor,” PMID 26612545 ↗ Nov 2015 |
| Modality | Small molecule | “Roflumilast is a novel, orally active, selective enzyme inhibitor” NCT00163475 ↗ |
| Route | Oral | “Oral Roflumilast (250 mcg or 500 mcg) Daily” NCT00073177 ↗ |