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AMR Drug RepurposingSmart Screeningresearch prototype

Roflumilast

FDA-approved product (tablet, oral), marketed as Daliresp, Roflumilast, Zoryve.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

Chemical structure of Roflumilast
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Airway obstruction
  • Chronic bronchitis
  • Chronic obstructive pulmonary disease
  • Psoriasis

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Other antipsoriatics for topical use; Other systemic drugs for obstructive airway diseases
FDA pharmacologic class
Phosphodiesterase 4 Inhibitor FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis and MRSA. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA53.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli37.8% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae20.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis48.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Open Roflumilast in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-7.2 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.0 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-8.4 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.5 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Roflumilast with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Efficacy and Safety of Roflumilast Foam 0.3% in Trial Participants With Seborrheic Dermatitis

    NCT07683806 · start 2026-08-24

    Registered record
    Registry ID
    NCT07683806
    Conditions
    Seborrheic Dermatitis
    Interventions
    Roflumilast Foam 0.3%; Vehicle foam
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Not yet recruiting
    Start
    2026-08-24
    Completion
    2027-08-03
    Enrolment
    309

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSeborrheic Dermatitis
    InterventionRoflumilast Foam 0.3%; Vehicle foam
    PhasePhase 3
    Registry statusNot yet recruiting

  • Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

    NCT07352566 · start 2026-08-01

    Registered record
    Registry ID
    NCT07352566
    Conditions
    Psoriasis; Atopic Dermatitis
    Interventions
    In situ cutaneous microdevice; Triamcinolone; 5-Fluorouracil; Calcipotriene; Tapinarof; Crisaborole; Tacrolimus; Adalimumab; Etanercept; Certolizumab; Infliximab; Secukinumab; Ixekizumab; Apremilast; Risankizumab; Ustekinumab; Hydroxychloroquine; Methotrexate; Mycophenolate; Azathioprine; Chloroquine; Cyclosporine; Tofacitinib; Deucravacitinib; Dupilumab; Tralokinumab; Guselkumab; Tildrakizumab; Baractinib; Abrocitinib; Upadacitinib; Lebrikizumab; Nemolizumab; Ruxolitinib; Bimekizumab; Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Not yet recruiting
    Start
    2026-08-01
    Completion
    2030-06-01
    Enrolment
    10

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPsoriasis; Atopic Dermatitis
    InterventionIn situ cutaneous microdevice; Triamcinolone; 5-Fluorouracil; Calcipotriene +32 more
    PhasePhase 4
    Registry statusNot yet recruiting

  • Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD

    NCT07393685 · start 2026-08-01

    Registered record
    Registry ID
    NCT07393685
    Conditions
    Acute Exacerbation of Chronic Obstructive Pulmonary Disease; Influenza, Human; Virus Diseases
    Interventions
    Xuanfei Jiangzhuo Decoction; Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Not yet recruiting
    Start
    2026-08-01
    Completion
    2028-05-31
    Enrolment
    300

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Exacerbation of Chronic Obstructive Pulmonary Disease; Influenza, Human; Virus Diseases
    InterventionXuanfei Jiangzhuo Decoction; Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)
    PhaseNot recorded
    Registry statusNot yet recruiting

  • 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 Inhibitors

    NCT07639840 · start 2026-08-01

    Registered record
    Registry ID
    NCT07639840
    Conditions
    Immune-related Dermatitis
    Interventions
    Roflumilast 0.3% topical foam
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-08-01
    Completion
    2027-11-01
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionImmune-related Dermatitis
    InterventionRoflumilast 0.3% topical foam
    PhasePhase 2
    Registry statusNot yet recruiting

  • Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis

    NCT07566351 · start 2026-04-23

    Registered record
    Registry ID
    NCT07566351
    Conditions
    Rheumatoid Arthritis
    Interventions
    Roflumilast; Desloratadine; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-04-23
    Completion
    2027-07
    Enrolment
    90

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionRheumatoid Arthritis
    InterventionRoflumilast; Desloratadine; Placebo
    PhasePhase 2
    Registry statusRecruiting

  • EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.

    NCT07543640 · start 2026-04-01

    Registered record
    Registry ID
    NCT07543640
    Conditions
    Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis
    Interventions
    Methotrexate; Roflumilast 500 Mcg Oral Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-04-01
    Completion
    2026-08
    Enrolment
    56

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFlexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis
    InterventionMethotrexate; Roflumilast 500 Mcg Oral Tablet
    PhasePhase 2
    Registry statusNot yet recruiting

  • A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD

    NCT07314242 · start 2026-01-01

    Registered record
    Registry ID
    NCT07314242
    Conditions
    COPD (Chronic Obstructive Pulmonary Disease)
    Interventions
    Hemay005 tablets; Roflumilast Oral Tablet; Placebo tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-01-01
    Completion
    2027-12-31
    Enrolment
    120

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionCOPD (Chronic Obstructive Pulmonary Disease)
    InterventionHemay005 tablets; Roflumilast Oral Tablet; Placebo tablet
    PhasePhase 2
    Registry statusNot yet recruiting

  • 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 Study

    NCT07297602 · start 2025-11-20

    Registered record
    Registry ID
    NCT07297602
    Conditions
    Atopic Dermatitis
    Interventions
    Oral roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-11-20
    Completion
    2026-05-20
    Enrolment
    36

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAtopic Dermatitis
    InterventionOral roflumilast
    PhasePhase 2
    Registry statusRecruiting

  • Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

    NCT06860958 · start 2025-03-01

    Registered record
    Registry ID
    NCT06860958
    Conditions
    Depressive Disorder, Major
    Interventions
    Fluoxetine; Roflumilast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2025-03-01
    Completion
    2027-08-20
    Enrolment
    60

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionDepressive Disorder, Major
    InterventionFluoxetine; Roflumilast; Placebo
    PhasePhase 3
    Registry statusRecruiting

  • Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata

    NCT07174011 · start 2025-01-12

    Registered record
    Registry ID
    NCT07174011
    Conditions
    Alopecia; Alopecia Areata
    Interventions
    Roflumilast; intralesional steroid
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2025-01-12
    Completion
    2025-08-20
    Enrolment
    50

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAlopecia; Alopecia Areata
    InterventionRoflumilast; intralesional steroid
    PhasePhase 4
    Registry statusCompleted

  • Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis

    NCT06631170 · start 2024-11-21

    Registered record
    Registry ID
    NCT06631170
    Conditions
    Atopic Dermatitis (AD)
    Interventions
    Roflumilast Cream 0.15%; Vehicle cream
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2024-11-21
    Completion
    2025-07-13
    Enrolment
    354

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAtopic Dermatitis (AD)
    InterventionRoflumilast Cream 0.15%; Vehicle cream
    PhasePhase 3
    Registry statusCompleted

  • Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study

    NCT06648772 · start 2024-11-14

    Registered record
    Registry ID
    NCT06648772
    Conditions
    Plaque Psoriasis
    Interventions
    Roflumilast Cream 0.3%; Vehicle cream
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2024-11-14
    Completion
    2025-10-15
    Enrolment
    190

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPlaque Psoriasis
    InterventionRoflumilast Cream 0.3%; Vehicle cream
    PhasePhase 3
    Registry statusCompleted

  • Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin

    NCT06440473 · start 2024-05-28

    Registered record
    Registry ID
    NCT06440473
    Conditions
    Healthy Skin
    Interventions
    Roflumilast; Vehicle (Roflumilast 0.3% vehicle cream)
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2024-05-28
    Completion
    2024-07-28
    Enrolment
    3

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Skin
    InterventionRoflumilast; Vehicle (Roflumilast 0.3% vehicle cream)
    PhasePhase 4
    Registry statusUnknown

  • Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

    NCT05884281 · start 2023-07

    Registered record
    Registry ID
    NCT05884281
    Conditions
    Peripheral Neuropathy
    Interventions
    Roflumilast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Unknown
    Start
    2023-07
    Completion
    2023-12
    Enrolment
    60

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPeripheral Neuropathy
    InterventionRoflumilast; Placebo
    PhasePhase 1 / Phase 2
    Registry statusUnknown

  • Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

    NCT05763082 · start 2023-02-07

    Registered record
    Registry ID
    NCT05763082
    Conditions
    Plaque Psoriasis
    Interventions
    roflumilast cream 0.3%; Zoryve; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2023-02-07
    Completion
    2023-08-08
    Enrolment
    416

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPlaque Psoriasis
    Interventionroflumilast cream 0.3%; Zoryve; Placebo
    PhasePhase 3
    Registry statusCompleted