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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 MRSA and M. tuberculosis. 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.

  • Role of Roflumilast in Ulcerative Colitis

    NCT05684484 · start 2023-02-01

    Registered record
    Registry ID
    NCT05684484
    Conditions
    Ulcerative Colitis
    Interventions
    Roflumilast 500 MCG Oral Tablet [DALIRESP]; amino salicylic acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2023-02-01
    Completion
    2024-09-15
    Enrolment
    52

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

    ConditionUlcerative Colitis
    InterventionRoflumilast 500 MCG Oral Tablet [DALIRESP]; amino salicylic acid
    PhasePhase 4
    Registry statusCompleted

  • Roflumilast Versus Methotrexate in Psoriasis

    NCT05684744 · start 2023-01-09

    Registered record
    Registry ID
    NCT05684744
    Conditions
    Psoriasis
    Interventions
    Roflumilast; Methotrexate
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2023-01-09
    Completion
    2023-05-14
    Enrolment
    30

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

    ConditionPsoriasis
    InterventionRoflumilast; Methotrexate
    PhasePhase 2 / Phase 3
    Registry statusCompleted

  • Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy

    NCT05369793 · start 2022-08-01

    Registered record
    Registry ID
    NCT05369793
    Conditions
    Type 2 Diabetes (Adult Onset); Diabetic Neuropathies
    Interventions
    Alpha lipoic acid; Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2022-08-01
    Completion
    2023-10-10
    Enrolment
    60

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

    ConditionType 2 Diabetes (Adult Onset); Diabetic Neuropathies
    InterventionAlpha lipoic acid; Roflumilast
    PhasePhase 3
    Registry statusCompleted

  • Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea

    NCT05278624 · start 2022-04-15

    Registered record
    Registry ID
    NCT05278624
    Conditions
    Rosacea
    Interventions
    Roflumilast Cream
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2022-04-15
    Completion
    2023-02-17
    Enrolment
    40

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

    ConditionRosacea
    InterventionRoflumilast Cream
    PhasePhase 2
    Registry statusCompleted

  • Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH

    NCT06677788 · start 2022-04-01

    Registered record
    Registry ID
    NCT06677788
    Conditions
    Non-Alcoholic Steatohepatitis (NASH)
    Interventions
    Roflumilast 500 Mcg Oral Tablet; Vitamin E capsule
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2022-04-01
    Completion
    2024-10-15
    Enrolment
    55

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

    ConditionNon-Alcoholic Steatohepatitis (NASH)
    InterventionRoflumilast 500 Mcg Oral Tablet; Vitamin E capsule
    PhasePhase 2
    Registry statusCompleted

  • Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

    NCT05028582 · start 2021-08-24

    Registered record
    Registry ID
    NCT05028582
    Conditions
    Scalp Psoriasis
    Interventions
    Roflumilast Foam 0.3%; Vehicle Foam
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-08-24
    Completion
    2022-06-03
    Enrolment
    432

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

    ConditionScalp Psoriasis
    InterventionRoflumilast Foam 0.3%; Vehicle Foam
    PhasePhase 3
    Registry statusCompleted

  • Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

    NCT04845620 · start 2021-04-07

    Registered record
    Registry ID
    NCT04845620
    Conditions
    Atopic Dermatitis Eczema
    Interventions
    Roflumilast Cream 0.05%; Vehicle Cream
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-04-07
    Completion
    2023-06-01
    Enrolment
    652

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

    ConditionAtopic Dermatitis Eczema
    InterventionRoflumilast Cream 0.05%; Vehicle Cream
    PhasePhase 3
    Registry statusCompleted

  • Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

    NCT04773600 · start 2021-02-24

    Registered record
    Registry ID
    NCT04773600
    Conditions
    Atopic Dermatitis Eczema
    Interventions
    Roflumilast Cream; Vehicle cream
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-02-24
    Completion
    2022-09-29
    Enrolment
    683

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

    ConditionAtopic Dermatitis Eczema
    InterventionRoflumilast Cream; Vehicle cream
    PhasePhase 3
    Registry statusCompleted

  • Efficacy of Roflumilast in the Treatment of Psoriasis

    NCT04549870 · start 2021-01-01

    Registered record
    Registry ID
    NCT04549870
    Conditions
    Psoriasis
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2021-01-01
    Completion
    2022-12-12
    Enrolment
    46

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

    ConditionPsoriasis
    InterventionRoflumilast
    PhasePhase 2
    Registry statusCompleted

  • Roflumilast in Non-CF Bronchiectasis Study (2019)

    NCT04322929 · start 2020-11-12

    Registered record
    Registry ID
    NCT04322929
    Conditions
    Non-cystic Fibrosis Bronchiectasis
    Interventions
    Roflumilast Oral Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2020-11-12
    Completion
    2024-11-30
    Enrolment
    42

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

    ConditionNon-cystic Fibrosis Bronchiectasis
    InterventionRoflumilast Oral Tablet
    PhasePhase 2
    Registry statusCompleted

  • Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial

    NCT04069312 · start 2020-02-11

    Registered record
    Registry ID
    NCT04069312
    Conditions
    Chronic Obstructive Pulmonary Disease Severe; Chronic Bronchitis
    Interventions
    Roflumilast; Azithromycin
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2020-02-11
    Completion
    2026-03-01
    Enrolment
    1,032

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

    ConditionChronic Obstructive Pulmonary Disease Severe; Chronic Bronchitis
    InterventionRoflumilast; Azithromycin
    PhasePhase 3
    Registry statusCompleted

  • Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

    NCT04211363 · start 2019-12-20

    Registered record
    Registry ID
    NCT04211363
    Conditions
    Chronic Plaque Psoriasis
    Interventions
    Roflumilast 0.3% cream; Vehicle Cream
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-12-20
    Completion
    2020-11-16
    Enrolment
    439

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

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

  • Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis

    NCT04090294 · start 2019-10-01

    Registered record
    Registry ID
    NCT04090294
    Conditions
    Bronchiectasis
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Unknown
    Start
    2019-10-01
    Completion
    2020-11
    Enrolment
    35

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

    ConditionBronchiectasis
    InterventionRoflumilast
    PhaseEarly phase 1
    Registry statusUnknown

  • Exercise as an Immune Adjuvant for Allogeneic Cell Therapies

    NCT06643221 · start 2018-01-24

    Registered record
    Registry ID
    NCT06643221
    Conditions
    Leukemia; Hematopoetic Stem Cell Transplantation; Donor Lymphocyte Infusion; CAR T-Cell Therapy; Lymphoma; Cell Therapy
    Interventions
    Exercise; Isoproterenol; Placebo; Bisoprolol Fumarate Tablet 10 mg; Nadolol (1 x 80 mg) Tablets (Invamed, Inc); Carvedilol 50 mg; Roflumilast 500 Mcg Oral Tablet
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Recruiting
    Start
    2018-01-24
    Completion
    2031-05-31
    Enrolment
    200

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

    ConditionLeukemia; Hematopoetic Stem Cell Transplantation; Donor Lymphocyte Infusion; CAR T-Cell Therapy +2 more
    InterventionExercise; Isoproterenol; Placebo; Bisoprolol Fumarate Tablet 10 mg +3 more
    PhaseEarly phase 1
    Registry statusRecruiting

  • A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients

    NCT02671942 · start 2016-03

    Registered record
    Registry ID
    NCT02671942
    Conditions
    Chronic Obstructive Pulmonary Disease
    Interventions
    Roflumilast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2016-03
    Completion
    2018-06-13
    Enrolment
    55

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

    ConditionChronic Obstructive Pulmonary Disease
    InterventionRoflumilast; Placebo
    PhasePhase 2
    Registry statusTerminated