Roflumilast clinical trials
Also written Daxas, Daliresp and ARQ-151.
How each study uses Roflumilast is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Breast cancer · Recruiting: 2 came in, 3 changed
What changed in your saved searches, Oct 31 – Nov 6:
A study of drug A after surgery for early breast cancer
Came in · now Recruiting
Drug B with hormone therapy in advanced breast cancer
Changed
· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
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Approvals
The first approval found in each region, with its record
- United States
- 28 Feb 2011 · DALIRESP · NDA 022522 (FDA, Drugs@FDA)
- European Union
- 5 Jul 2010 · Daxas · EMEA/H/C/001179 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
117 studies that test it; most in 2013 (13); 1 more planned to start later
| Year | Studies |
|---|---|
| 2003 | 6 |
| 2004 | 7 |
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 1 |
| 2008 | 2 |
| 2011 | 6 |
| 2012 | 6 |
| 2013 | 13 |
| 2014 | 5 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 5 |
| 2019 | 7 |
| 2020 | 5 |
| 2021 | 12 |
| 2022 | 5 |
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 6 |
| 2026 | 11 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 59 · Other 59
AstraZeneca (34) · Arcutis Biotherapeutics, Inc. (17) · Tanta University (7) · Johns Hopkins University (3) · Cairo University (3) · University of Calgary (2) · Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (2) · The University of Hong Kong (2)
Often tested with
Tested in the same studies.
Metformin (2) · Baclofen (1) · Memantine (1) · Azithromycin (1) · Theophylline (1) · Montelukast (1) · Donepezil (1) · Scopolamine (1)
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 7, 2 in phase 3
Studies that test Roflumilast, phase 3 first.
- Mar 2027Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder PatientsPhase 3 · Tanta University
- Aug 2027Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease PatientsPhase 2/3 · Tanta University
- Feb 2027Comparative Effectiveness of Roflumilast and Azithromycin in Reducing Exacerbations in Severe Chronic Obstructive Pulmonary Disease ( COPD ) Patients With Chronic Bronchitis PhenotypePhase 4 · Sidra Aziz
- Jun 2027Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid ArthritisPhase 2 · Horus University
- Jul 2027An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail PsoriasisPhase 4 · Modern Research Associates, PLLC
- Aug 2027Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.Phase 4 · Integrative Skin Science and Research
- Aug 2027An Open-label, Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Cutaneous Adverse Events Due to Checkpoint InhibitorsPhase 2 · Massachusetts General Hospital
Studies
Open first, then newest update. How each study uses Roflumilast is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 118
- Roflumilast Cream 0.3% for Moderate to Severe Atopic DermatitisRecruitingPhase 3Arcutis Biotherapeutics, Inc.NCT07916480Written as Roflumilast Cream 0.3%
- Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease PatientsNot yet recruitingPhase 2/3Tanta UniversityNCT07900087Written as Roflumilast
- Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis SuppurativaRecruitingPhase 2Harrison DermatologyNCT07689188Written as Roflumilast 0.3% topical foam
- An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail PsoriasisRecruitingPhase 4Modern Research Associates, PLLCNCT07725822Written as Roflumilast 0.3% topical cream
- An Open-label, Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Cutaneous Adverse Events Due to Checkpoint InhibitorsNot yet recruitingPhase 2Massachusetts General HospitalNCT07639840Written as Roflumilast 0.3% topical foam
- Comparative Effectiveness of Roflumilast and Azithromycin in Reducing Exacerbations in Severe Chronic Obstructive Pulmonary Disease ( COPD ) Patients With Chronic Bronchitis PhenotypeNot yet recruitingPhase 4Sidra AzizNCT07795086Written as Roflumilast Oral Tablet
- Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.RecruitingPhase 4Integrative Skin Science and ResearchNCT07560618Written as Roflumilast Cream 0.15%
- The Safety and Efficacy of Roflumilast Foam in HSRecruitingPhase 2Beth Israel Deaconess Medical CenterNCT07263230Written as Roflumilast 0.3% topical foam
- Effect of Roflumilast as Add-On Therapy in Rheumatoid ArthritisRecruitingPhase 2Horus UniversityNCT07632846Written as Roflumilast 500 Mcg Oral Tablet
- Utilization of a Microdevice for Psoriasis and Atopic DermatitisNot yet recruitingPhase 4University of California, San FranciscoNCT07352566Written as Roflumilast
- Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid ArthritisRecruitingPhase 2Horus UniversityNCT07566351Written as Roflumilast
- Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder PatientsRecruitingPhase 3Tanta UniversityNCT06860958Written as Roflumilast
- EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.Not yet recruitingPhase 2Eman Raafat SaidNCT07543640Written as Roflumilast 500 Mcg Oral Tablet
- Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot StudyRecruitingPhase 2Nora Mohamed AbdelrazikNCT07297602Written as Oral roflumilast
- A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in AdultsRecruitingPhase 2Ahmed IbrahimNCT07233291Written as Oral roflumilast
- Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy SkinRecruitingPhase 4Rao DermatologyNCT06440473Written as Roflumilast
- Efficacy of Roflumilast in Prevention of Peripheral NeuropathyNot yet recruitingPhase 1/2Mansoura UniversityNCT05884281Written as Roflumilast
- A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis SuppurativaCompletedPhase 2Tulane UniversityNCT07077902Written as Topical roflumilast 0.3% foam
- Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque PsoriasisCompletedPhase 3Arcutis Biotherapeutics, Inc.NCT04286607Written as Topical roflumilast
- Bioequivalence Study of Two Treatments for the Treatment of Plaque PsoriasisCompletedPhase 3Padagis LLCNCT05763082Written as roflumilast cream 0.3%
See all 118 studies that test Roflumilast →
Given beside what is tested · 1 — Roflumilast is usual care or a partner of the new treatment
As the comparator · 4 — what is tested is compared with Roflumilast
- A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPDNot yet recruitingPhase 2Ganzhou Hemay Pharmaceutical Co., LtdNCT07314242Written as Roflumilast Oral Tablet
- A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)TerminatedPhase 3Chiesi Farmaceutici S.p.A.NCT04636814Written as Roflumilast
- Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD PatientsCompletedPhase 2Chiesi Farmaceutici S.p.A.NCT01730404Written as Roflumilast
- Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once DailyCompletedPhase 4Fundación Pública Andaluza Progreso y SaludNCT01849341Written as Roflumilast 500 mcg per day
What changed recently
From the registry's own updates since Oct 15, 2026.
Started recruiting1
- Roflumilast Cream 0.3% for Moderate to Severe Atopic DermatitisNov 6, 2026NCT07916480
Newly registered2
- Roflumilast Cream 0.3% for Moderate to Severe Atopic DermatitisNov 4, 2026NCT07916480
- Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease PatientsOct 28, 2026NCT07900087
Codes
What other systems call Roflumilast · ClinicalTrials.gg INT004333
- MeSH (NLM) C424423RoflumilastConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) 0P6C6ZOP5UROFLUMILASTConfirmed FDA, NLM, Wikidata
- RxNorm 1091836Confirmed FDA, Wikidata
- Wikidata Q693482roflumilastConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C76890RoflumilastOne source FDA
- DrugBank DB01656One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C424423 | Roflumilast | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | 0P6C6ZOP5U | ROFLUMILAST | Confirmed FDA, NLM, Wikidata |
| RxNorm | 1091836 | — | Confirmed FDA, Wikidata |
| Wikidata | Q693482 | roflumilast | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C76890 | Roflumilast | One source FDA |
| DrugBank | DB01656 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.