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    DRUG:

    roflumilast

    i
    Other names: APTA-2217, B9302-107, BY-217, BYK 20869, IN-ALR 01
    Company:
    Generic mfg.
    Drug class:
    PDE4 inhibitor
    Related drugs:
    14d
    Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (clinicaltrials.gov)
    P4, N=10, Not yet recruiting, University of California, San Francisco
    New P4 trial
    |
    5-fluorouracil • Jakafi (ruxolitinib) • hydroxychloroquine • cyclosporine • roflumilast • tofacitinib • Cosentyx (secukinumab) • Dupixent (dupilumab) • Ilumya (tildrakizumab-asmn) • chloroquine phosphate
    15d
    Ulcerative pyoderma gangrenosum in a 78-year-old woman treated with brodalumab: A case report. (PubMed, SAGE Open Med Case Rep)
    The patient was refractory to corticosteroids, dapsone, and roflumilast, and developed recurrent Gram-negative infections. Brodalumab may offer a safe and effective treatment option in refractory pyoderma gangrenosum, particularly in patients with contraindications to conventional therapies. This case supports further evaluation of IL-17 pathway inhibition in neutrophilic dermatoses.
    Journal
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    IL17A (Interleukin 17A) • IL17RA (Interleukin 17 Receptor A)
    |
    roflumilast
    21d
    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, Terminated, Chiesi Farmaceutici S.p.A. | Active, not recruiting --> Terminated; Strategic decision by Sponsor; not due to safety reasons
    Trial termination
    |
    roflumilast
    1m
    A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Ganzhou Hemay Pharmaceutical Co., Ltd
    New P2 trial
    |
    roflumilast
    1m
    Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Children's Hospital Medical Center, Cincinnati | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Mar 2026 | Trial primary completion date: Jun 2025 --> Oct 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    FMR1 (Fragile X Messenger Ribonucleoprotein 1)
    |
    roflumilast
    3ms
    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)
    |
    roflumilast
    3ms
    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
    |
    roflumilast
    4ms
    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
    |
    roflumilast
    5ms
    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
    |
    roflumilast
    6ms
    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 • roflumilast
    7ms
    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
    |
    roflumilast