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 · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 ↗ |
Trials 85 · started per year
today
EU approved 2010
US approved 2011
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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 | ||||||
| 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Phase 1 | NCT05796271 | Jan 2024 → Jan 2027 | lymphoma | The University of Texas Health Science Center at San Antonio | Withdrawn | No outcome recorded |
| Phase 1 | NCT04369547 | Jan 2022 → Sep 2023 | — | University of Calgary | Withdrawn | No outcome recorded |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 |
| 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 | No outcome recorded |
| Phase 1 | NCT01664624 | Jul → Nov 2012 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01354782 | May → Jun 2011 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| 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 | No outcome recorded |
| 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 | ||||||
| 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 | NCT07639840 | Aug 2026 → Aug 2027 expected | dermatitis | Massachusetts General Hospital | 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 expected | hidradenitis suppurativa | Tulane University | Recruiting | 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT01701934 | Feb 2013 → Oct 2014 | chronic obstructive pulmonary disease, metabolic syndrome X | Laval University | Terminated | No outcome recorded |
| Phase 2 | NCT01765192 | Feb → Oct 2013 | asthma | AstraZeneca | Completed | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT04845620 | Apr 2021 → Jun 2023 | atopic eczema | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT04773587 | Jan 2021 → Aug 2022 | atopic eczema | Arcutis Biotherapeutics, Inc. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01973998 | Nov 2013 → Nov 2017 | chronic obstructive pulmonary disease | Temple University | Completed | No outcome recorded |
| Phase 3 | NCT01313494 | Mar 2011 → May 2012 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 48 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 | 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 | No outcome recorded |
Also used as a comparator or background therapy in 43 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06643221 Comparator | Jan 2018 → May 2031 expected | leukemia, lymphoma | University of Arizona | Recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00940329 Comparator | Apr → Jul 2004 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| 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 |
| Phase 215 trials | ||||||
| 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 |
| Phase 2 | NCT00746382 Comparator | Nov 2008 → Jun 2009 | dermatitis | AstraZeneca | Withdrawn | No outcome recorded |
| 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 313 trials | ||||||
| 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 |
| 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 410 trials | ||||||
| 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 |
| Phase not applicable1 trial | ||||||
| — | NCT01572948 Comparator | Jun 2012 → Jun 2014 | chronic obstructive pulmonary disease | University of Alabama at Birmingham | Completed | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 134 sources stand behind the page.
| 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 2025122“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 ↗ |