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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.

  • The Role of Phosphodiesterase Inhibitors in Incretin Secretion

    NCT02363335 · start 2015-02-13

    Registered record
    Registry ID
    NCT02363335
    Conditions
    Healthy Volunteers
    Interventions
    Placebo; Roflumilast/Sitagliptin; Sitagliptin; Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2015-02-13
    Completion
    2016-09-19
    Enrolment
    29

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

    ConditionHealthy Volunteers
    InterventionPlacebo; Roflumilast/Sitagliptin; Sitagliptin; Roflumilast
    PhasePhase 1
    Registry statusCompleted

  • Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

    NCT01745848 · start 2013-02

    Registered record
    Registry ID
    NCT01745848
    Conditions
    Chronic Obstructive Pulmonary Disease
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2013-02
    Completion
    2016-06-30
    Enrolment
    26

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

    ConditionChronic Obstructive Pulmonary Disease
    InterventionRoflumilast
    PhasePhase 4
    Registry statusCompleted

  • Roflumilast Plus Montelukast in Adults With Severe Asthma

    NCT01765192 · start 2013-02

    Registered record
    Registry ID
    NCT01765192
    Conditions
    Asthma
    Interventions
    Roflumilast; Roflumilast placebo; Montelukast
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2013-02
    Completion
    2013-10
    Enrolment
    64

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

    ConditionAsthma
    InterventionRoflumilast; Roflumilast placebo; Montelukast
    PhasePhase 2
    Registry statusCompleted

  • Post Marketing Surveillance of Roflumilast in Korea

    NCT02068456 · start 2012-09-18

    Registered record
    Registry ID
    NCT02068456
    Conditions
    Chronic Obstructive Pulmonary Disease
    Interventions
    Roflumilast
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2012-09-18
    Completion
    2017-04-26
    Enrolment
    1,837

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

    ConditionChronic Obstructive Pulmonary Disease
    InterventionRoflumilast
    PhaseNot recorded
    Registry statusCompleted

  • Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes

    NCT01664624 · start 2012-07

    Registered record
    Registry ID
    NCT01664624
    Conditions
    Type 2 Diabetes
    Interventions
    Roflumilast; Alogliptin; Exenatide; Placebo to roflumilast; Placebo to alogliptin
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2012-07
    Completion
    2012-11
    Enrolment
    40

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

    ConditionType 2 Diabetes
    InterventionRoflumilast; Alogliptin; Exenatide; Placebo to roflumilast +1 more
    PhasePhase 1
    Registry statusCompleted

  • Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients

    NCT01580748 · start 2012-05

    Registered record
    Registry ID
    NCT01580748
    Conditions
    Symptomatic Bronchiectasis
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Unknown
    Start
    2012-05
    Completion
    2013-01
    Enrolment
    25

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

    ConditionSymptomatic Bronchiectasis
    InterventionRoflumilast
    PhasePhase 2
    Registry statusUnknown

  • Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease

    NCT01595750 · start 2012-05

    Registered record
    Registry ID
    NCT01595750
    Conditions
    Chronic Obstructive Pulmonary Disease
    Interventions
    Roflumilast 500; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2012-05
    Completion
    2012-08
    Enrolment
    150

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

    ConditionChronic Obstructive Pulmonary Disease
    InterventionRoflumilast 500; Placebo
    PhasePhase 4
    Registry statusUnknown

  • Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

    NCT01443845 · start 2011-09-30

    Registered record
    Registry ID
    NCT01443845
    Conditions
    COPD; COPD Exacerbation; Lung Diseases; Respiratory Disorders; Pulmonary Disease; Chronic Obstructive Lung Diseases; Chronic Obstructive Airway Disease
    Interventions
    Roflumilast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2011-09-30
    Completion
    2016-01-31
    Enrolment
    2,354

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

    ConditionCOPD; COPD Exacerbation; Lung Diseases; Respiratory Disorders +3 more
    InterventionRoflumilast; Placebo
    PhasePhase 4
    Registry statusCompleted

  • Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects

    NCT01354782 · start 2011-05

    Registered record
    Registry ID
    NCT01354782
    Conditions
    Chronic Obstructive Pulmonary Disease
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2011-05
    Completion
    2011-09
    Enrolment
    32

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

    ConditionChronic Obstructive Pulmonary Disease
    InterventionRoflumilast
    PhasePhase 1
    Registry statusCompleted

  • A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:

    NCT01313494 · start 2011-03

    Registered record
    Registry ID
    NCT01313494
    Conditions
    COPD
    Interventions
    Roflumilast; Placebo; Salbutamol
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2011-03
    Completion
    2012-05
    Enrolment
    626

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

    ConditionCOPD
    InterventionRoflumilast; Placebo; Salbutamol
    PhasePhase 3
    Registry statusCompleted

  • Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

    NCT00297102 · start 2006-02

    Registered record
    Registry ID
    NCT00297102
    Conditions
    Chronic Obstructive Pulmonary Disease (COPD)
    Interventions
    Roflumilast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2006-02
    Completion
    2008-09
    Enrolment
    1,523

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

    ConditionChronic Obstructive Pulmonary Disease (COPD)
    InterventionRoflumilast; Placebo
    PhasePhase 3
    Registry statusCompleted

  • Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)

    NCT00242320 · start 2005-08

    Registered record
    Registry ID
    NCT00242320
    Conditions
    COPD
    Interventions
    Roflumilast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2005-08
    Completion
    2007-08
    Enrolment
    551

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

    ConditionCOPD
    InterventionRoflumilast; Placebo
    PhasePhase 3
    Registry statusCompleted

  • A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma

    NCT01365533 · start 2004-12

    Registered record
    Registry ID
    NCT01365533
    Conditions
    Allergic Asthma
    Interventions
    Roflumilast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2004-12
    Completion
    2005-07
    Enrolment
    48

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

    ConditionAllergic Asthma
    InterventionRoflumilast; Placebo
    PhasePhase 2
    Registry statusCompleted

  • The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)

    NCT00108823 · start 2004-10

    Registered record
    Registry ID
    NCT00108823
    Conditions
    Chronic Obstructive Pulmonary Disease, COPD
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2004-10
    Completion
    Not recorded
    Enrolment
    550

    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 Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).

    NCT00242307 · start 2004-05-01

    Registered record
    Registry ID
    NCT00242307
    Conditions
    Bronchial Asthma
    Interventions
    Roflumilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2004-05-01
    Completion
    2007-06-01
    Enrolment
    450

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

    ConditionBronchial Asthma
    InterventionRoflumilast
    PhasePhase 2 / Phase 3
    Registry statusCompleted