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    DRUG:

    Daliresp (roflumilast)

    i
    Other names: APTA-2217, B9302-107, BY-217, BYK 20869, IN-ALR 01
    Company:
    AbbVie, AstraZeneca, Takeda
    Drug class:
    PDE4 inhibitor
    Related drugs:
    16d
    Efficacy and Safety of Roflumilast versus Alpha-Lipoic Acid in Type 2 Diabetes with Neuropathy: A Comparative Clinical Study. (PubMed, Diabetes Metab Syndr Obes)
    Roflumilast may offer superior glycemic and oxidative stress control benefits, though neuropathy symptoms control was comparable to ALA. (NCT05369793).
    Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    |
    Daliresp (roflumilast)
    1m
    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) (clinicaltrials.gov)
    P3, N=3973, Active, not recruiting, Chiesi Farmaceutici S.p.A. | Recruiting --> Active, not recruiting | Trial completion date: Apr 2027 --> Dec 2025 | Trial primary completion date: Apr 2027 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Daliresp (roflumilast)
    2ms
    Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE) (clinicaltrials.gov)
    P4, N=1032, Active, not recruiting, Johns Hopkins University | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Daliresp (roflumilast)
    3ms
    AA: Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata (clinicaltrials.gov)
    P4, N=50, Completed, Cairo University
    New P4 trial
    |
    Daliresp (roflumilast)
    4ms
    Inhibition of phosphodiesterase 4 and 7 regulates breast cancer cell proliferation. (PubMed, Biochim Biophys Acta Gen Subj)
    The selective PDE4 inhibitor roflumilast demonstrated potential as a therapeutic agent when combined with specific breast cancer treatments, offering a novel approach in breast cancer therapy.
    Journal
    |
    CASP3 (Caspase 3) • ANXA5 (Annexin A5)
    |
    paclitaxel • tamoxifen • doxorubicin hydrochloride • Daliresp (roflumilast)
    5ms
    The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Sadat City University | N=80 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Daliresp (roflumilast)
    5ms
    A New Adjuvant Treatment for Glioblastoma Using Aprepitant, Vortioxetine, Roflumilast and Olanzapine: The AVRO Regimen. (PubMed, Int J Mol Sci)
    One of these 24 drugs is olanzapine, added to AVRO. Given the short median survival of GB as of mid-2025, the clinician and researcher community will benefit from wider awareness of the anti-GB effects of these four nononcology drugs.
    Review • Journal
    |
    B3GAT1 (Beta-1,3-Glucuronyltransferase 1)
    |
    Daliresp (roflumilast) • olanzapine
    5ms
    Roflumilast and TMS Motor Plasticity (clinicaltrials.gov)
    P1, N=20, Active, not recruiting, University of Calgary | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Daliresp (roflumilast)
    6ms
    Roflumilast reduces the number of lung adenocarcinomas, inflammation, and emphysema in a smoking-induced mouse model. (PubMed, BMC Pulm Med)
    This study highlights the potential use of roflumilast as a chemopreventive agent for patients with chronic obstructive pulmonary disease who are at risk of lung cancer and underscores its relevance for future clinical application and research on phosphodiesterase-4 inhibitors.
    Preclinical • Journal
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL1B (Interleukin 1, beta)
    |
    Daliresp (roflumilast)
    7ms
    Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL) (clinicaltrials.gov)
    P1, N=10, Recruiting, The University of Texas Health Science Center at San Antonio
    New P1 trial
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Zynlonta (loncastuximab tesirine-lpyl) • Daliresp (roflumilast)
    9ms
    Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients (clinicaltrials.gov)
    P3, N=60, Recruiting, Tanta University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Daliresp (roflumilast) • fluoxetine
    9ms
    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) (clinicaltrials.gov)
    P3, N=3980, Recruiting, Chiesi Farmaceutici S.p.A. | Trial completion date: Sep 2027 --> Apr 2027 | Trial primary completion date: Sep 2027 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    Daliresp (roflumilast)