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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.

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.

  • The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)

    NCT00076076 · start 2003-12

    Registered record
    Registry ID
    NCT00076076
    Conditions
    Asthma
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2003-12
    Completion
    2005-06
    Enrolment
    822

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

    ConditionAsthma
    InterventionRoflumilast
    PhasePhase 3
    Registry statusCompleted
  • OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

    NCT00076089 · start 2003-12

    Registered record
    Registry ID
    NCT00076089
    Conditions
    Chronic Obstructive Pulmonary Disease; COPD
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2003-12
    Completion
    2005-12
    Enrolment
    1,100

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

    ConditionChronic Obstructive Pulmonary Disease; COPD
    InterventionRoflumilast
    PhasePhase 3
    Registry statusCompleted
  • Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

    NCT00073177 · start 2003-11

    Registered record
    Registry ID
    NCT00073177
    Conditions
    Asthma
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2003-11
    Completion
    Not recorded
    Enrolment
    819

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

    ConditionAsthma
    InterventionRoflumilast
    PhasePhase 3
    Registry statusCompleted
  • Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

    NCT00062582 · start 2003-06

    Registered record
    Registry ID
    NCT00062582
    Conditions
    Chronic Obstructive Pulmonary Disease; COPD
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2003-06
    Completion
    Not recorded
    Enrolment
    1,000

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

    ConditionChronic Obstructive Pulmonary Disease; COPD
    InterventionRoflumilast
    PhasePhase 3
    Registry statusCompleted
  • Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

    NCT00430729 · start 2003-01

    Registered record
    Registry ID
    NCT00430729
    Conditions
    Chronic Obstructive Pulmonary Disease; COPD
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2003-01
    Completion
    Not recorded
    Enrolment
    1,100

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

    ConditionChronic Obstructive Pulmonary Disease; COPD
    InterventionRoflumilast
    PhasePhase 3
    Registry statusCompleted