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Apremilast

FDA-approved product (tablet, oral), marketed as Apremilast, Otezla, Otezla Xr.

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

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Behcet's syndrome
  • Immune system disease
  • Oral ulcer
  • Psoriasis
  • Psoriasis vulgaris
  • Psoriatic arthritis
  • Pustulosis palmaris et plantaris

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

WHO therapeutic group
Selective immunosuppressants
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. It was surfaced computationally for further investigation; it is not an established treatment for this infection.

AI-predicted activity

AI prediction · nothing measured
  • MRSA36.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • E. coli35.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae26.1% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis60.0% 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)

-6.9 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.4 kcal/mol

0better fit →-12

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

-6.8 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.8 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 Apremilast 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.

  • Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)

    NCT03616561 · start 2018-02-23

    Registered record
    Registry ID
    NCT03616561
    Conditions
    Nail Psoriasis
    Interventions
    Apremilast
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2018-02-23
    Completion
    2020-07-23
    Enrolment
    45

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

    ConditionNail Psoriasis
    InterventionApremilast
    PhaseNot recorded
    Registry statusCompleted
  • An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema

    NCT03160248 · start 2017-07-05

    Registered record
    Registry ID
    NCT03160248
    Conditions
    Nummular Eczema; Eczema; Dermatitis Eczema; Nummular Dermatitis
    Interventions
    Apremilast; Placebo Oral Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2017-07-05
    Completion
    2021-09-15
    Enrolment
    31

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

    ConditionNummular Eczema; Eczema; Dermatitis Eczema; Nummular Dermatitis
    InterventionApremilast; Placebo Oral Tablet
    PhasePhase 2
    Registry statusCompleted
  • A Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium

    NCT03096990 · start 2017-04-21

    Registered record
    Registry ID
    NCT03096990
    Conditions
    Arthritis, Psoriatic
    Interventions
    apremilast
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2017-04-21
    Completion
    2018-12-27
    Enrolment
    106

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

    ConditionArthritis, Psoriatic
    Interventionapremilast
    PhaseNot recorded
    Registry statusCompleted
  • A Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis

    NCT03022617 · start 2017-01

    Registered record
    Registry ID
    NCT03022617
    Conditions
    Psoriatic Nail; Psoriasis Vulgaris; Psoriasis
    Interventions
    Apremilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2017-01
    Completion
    2022-09-29
    Enrolment
    12

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

    ConditionPsoriatic Nail; Psoriasis Vulgaris; Psoriasis
    InterventionApremilast
    PhasePhase 4
    Registry statusCompleted
  • Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

    NCT02802735 · start 2016-06-22

    Registered record
    Registry ID
    NCT02802735
    Conditions
    Pharmacokinetics
    Interventions
    Apremilast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2016-06-22
    Completion
    2016-08-05
    Enrolment
    28

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

    ConditionPharmacokinetics
    InterventionApremilast; Placebo
    PhasePhase 1
    Registry statusCompleted
  • A Study of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions

    NCT02626793 · start 2015-08-03

    Registered record
    Registry ID
    NCT02626793
    Conditions
    Psoriasis
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2015-08-03
    Completion
    2018-06-14
    Enrolment
    391

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

    ConditionPsoriasis
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted
  • Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

    NCT02289417 · start 2015-01-08

    Registered record
    Registry ID
    NCT02289417
    Conditions
    Ulcerative Colitis
    Interventions
    Apremilast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2015-01-08
    Completion
    2019-06-03
    Enrolment
    170

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

    ConditionUlcerative Colitis
    InterventionApremilast; Placebo
    PhasePhase 2
    Registry statusCompleted
  • Apremilast Pregnancy Exposure Registry

    NCT02775500 · start 2014-11

    Registered record
    Registry ID
    NCT02775500
    Conditions
    Psoriatic Arthritis; Psoriasis
    Interventions
    apremilast
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Active not recruiting
    Start
    2014-11
    Completion
    2025-07
    Enrolment
    233

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

    ConditionPsoriatic Arthritis; Psoriasis
    Interventionapremilast
    PhaseNot recorded
    Registry statusActive not recruiting
  • Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men

    NCT02236988 · start 2014-01-07

    Registered record
    Registry ID
    NCT02236988
    Conditions
    Healthy Volunteers
    Interventions
    Apremilast Immediate Release; Apremilast Modified Release 1; Apremilast Modified Release 2; Apremilast Modified Release 3; Apremilast Modified Release 4; Apremilast Modified Release 5; Apremilast Modified Release 6; Apremilast Modified Release 8; Apremilast Modified Release 9; Apremilast Modified Release 11; Apremilast Modified Release 12; Apremilast Modified Release 13; Apremilast Modified Release 14
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-01-07
    Completion
    2014-09-11
    Enrolment
    80

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

    ConditionHealthy Volunteers
    InterventionApremilast Immediate Release; Apremilast Modified Release 1; Apremilast Modified Release 2; Apremilast Modified Release 3 +9 more
    PhasePhase 1
    Registry statusCompleted
  • Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis

    NCT01988103 · start 2013-07-09

    Registered record
    Registry ID
    NCT01988103
    Conditions
    Psoriasis; Psoriatic Arthritis; Psoriasis Arthropatica
    Interventions
    Apremilast; Apremilast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2013-07-09
    Completion
    2015-12-15
    Enrolment
    254

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

    ConditionPsoriasis; Psoriatic Arthritis; Psoriasis Arthropatica
    InterventionApremilast; Apremilast; Placebo
    PhasePhase 2
    Registry statusCompleted
  • Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

    NCT01690299 · start 2012-10-01

    Registered record
    Registry ID
    NCT01690299
    Conditions
    Psoriasis; Psoriatic Arthritis
    Interventions
    Apremilast; Etanercept; Placebo tablet; Placebo injection
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-10-01
    Completion
    2016-04-04
    Enrolment
    250

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

    ConditionPsoriasis; Psoriatic Arthritis
    InterventionApremilast; Etanercept; Placebo tablet; Placebo injection
    PhasePhase 3
    Registry statusCompleted
  • Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults

    NCT01634191 · start 2012-02-01

    Registered record
    Registry ID
    NCT01634191
    Conditions
    Healthy Volunteer
    Interventions
    Apremilast
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2012-02-01
    Completion
    2012-04-01
    Enrolment
    36

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

    ConditionHealthy Volunteer
    InterventionApremilast
    PhasePhase 1
    Registry statusCompleted
  • Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.

    NCT01232283 · start 2010-11-22

    Registered record
    Registry ID
    NCT01232283
    Conditions
    Plaque Psoriasis
    Interventions
    Apremilast; Placebo; Topical or Phototherapy Therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2010-11-22
    Completion
    2016-11-30
    Enrolment
    413

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

    ConditionPlaque Psoriasis
    InterventionApremilast; Placebo; Topical or Phototherapy Therapy
    PhasePhase 3
    Registry statusCompleted
  • A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease

    NCT00866359 · start 2009-08-01

    Registered record
    Registry ID
    NCT00866359
    Conditions
    Behcet Syndrome
    Interventions
    Apremilast (CC-10004); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2009-08-01
    Completion
    2012-05-01
    Enrolment
    111

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

    ConditionBehcet Syndrome
    InterventionApremilast (CC-10004); Placebo
    PhasePhase 2
    Registry statusCompleted
  • Spondylitis Trial of Apremilast for Better Rheumatic Therapy

    NCT00944658 · start 2009-08

    Registered record
    Registry ID
    NCT00944658
    Conditions
    Ankylosing Spondylitis
    Interventions
    Apremilast; Placebo (sugar pill)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2009-08
    Completion
    2011-01
    Enrolment
    38

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

    ConditionAnkylosing Spondylitis
    InterventionApremilast; Placebo (sugar pill)
    PhasePhase 2
    Registry statusCompleted