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AMR Drug RepurposingSmart Screeningresearch prototype

Azelastine Hydrochloride

FDA-approved product (spray, metered, nasal), marketed as Astelin, Astepro, Astepro Allergy and 5 more.

Registered studies
48
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Allergic conjunctivitis
  • Allergic disease
  • Allergic rhinitis
  • Eye allergy
  • Nasal congestion
  • Rhinitis, Allergic, Perennial
  • Seasonal allergic rhinitis
  • Vasomotor rhinitis

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

WHO therapeutic group
Antiallergic agents, excl. corticosteroids; Other antihistamines for systemic use; Other antiallergics
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, MRSA and E. coli. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA57.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli42.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae22.0% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis59.8% 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

48registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

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

Open Azelastine Hydrochloride 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)

-5.8 kcal/mol

0better fit →-12

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

-6.4 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.0 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 Azelastine Hydrochloride 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.

  • A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergic Rhinitis

    NCT06051786 · start 2020-08-20

    Registered record
    Registry ID
    NCT06051786
    Conditions
    Allergic Rhinitis
    Interventions
    azelastine/fluticasone 137/50 mcg nasal spray; Dymista™
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2020-08-20
    Completion
    2021-07-20
    Enrolment
    136

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

    ConditionAllergic Rhinitis
    Interventionazelastine/fluticasone 137/50 mcg nasal spray; Dymista™
    PhasePhase 2
    Registry statusCompleted

  • Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis

    NCT04264637 · start 2020-02-03

    Registered record
    Registry ID
    NCT04264637
    Conditions
    Allergic Rhinitis
    Interventions
    Azelastine hydrochloride (BAYR9258); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2020-02-03
    Completion
    2021-03-17
    Enrolment
    110

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

    ConditionAllergic Rhinitis
    InterventionAzelastine hydrochloride (BAYR9258); Placebo
    PhasePhase 3
    Registry statusCompleted

  • Corneal Biomechanical Changes of Allergic Conjunctivitis

    NCT04299399 · start 2019-11-10

    Registered record
    Registry ID
    NCT04299399
    Conditions
    Conjunctivitis, Allergic; Keratoconus
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2019-11-10
    Completion
    2021-06-30
    Enrolment
    100

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

    ConditionConjunctivitis, Allergic; Keratoconus
    InterventionNot recorded
    PhaseNot recorded
    Registry statusUnknown

  • DYmista NAsal Spray in CHInese Patients

    NCT03599791 · start 2018-06-29

    Registered record
    Registry ID
    NCT03599791
    Conditions
    Allergic Rhinitis
    Interventions
    Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT; Azelastine Hydrochloride 0.137 MG/ACTUAT; Fluticasone Propionate 0.05 MG/ACTUAT
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-06-29
    Completion
    2019-09-24
    Enrolment
    900

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

    ConditionAllergic Rhinitis
    InterventionAzelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT; Azelastine Hydrochloride 0.137 MG/ACTUAT; Fluticasone Propionate 0.05 MG/ACTUAT
    PhasePhase 3
    Registry statusCompleted

  • Effects of Intranasal Fluticasone Plus Azelastine on Airway Inflammation in Patients With Asthma & Allergic Rhinitis

    NCT02953106 · start 2017-01-20

    Registered record
    Registry ID
    NCT02953106
    Conditions
    Asthma, Allergic; Rhinitis,Allergic; Allergy
    Interventions
    Azelastine-Fluticasone Nasal; Placebos
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2017-01-20
    Completion
    2018-09-10
    Enrolment
    7

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

    ConditionAsthma, Allergic; Rhinitis,Allergic; Allergy
    InterventionAzelastine-Fluticasone Nasal; Placebos
    PhasePhase 4
    Registry statusTerminated

  • MP-AzeFlu Allergen Chamber - Onset of Action Study

    NCT03004131 · start 2017-01-07

    Registered record
    Registry ID
    NCT03004131
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    Azelastine hydrochloride + fluticasone propionate nasal spray; Placebos; fluticasone propionate nasal spray + loratadine
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2017-01-07
    Completion
    2017-03-29
    Enrolment
    82

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

    ConditionSeasonal Allergic Rhinitis
    InterventionAzelastine hydrochloride + fluticasone propionate nasal spray; Placebos; fluticasone propionate nasal spray + loratadine
    PhasePhase 4
    Registry statusCompleted

  • Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis

    NCT02230696 · start 2014-08

    Registered record
    Registry ID
    NCT02230696
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray; Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray; Placebo nasal spray
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2014-08
    Completion
    2015-02
    Enrolment
    951

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

    ConditionSeasonal Allergic Rhinitis
    InterventionAzelastine Hydrochloride/Fluticasone Propionate Nasal Spray; Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray; Placebo nasal spray
    PhasePhase 3
    Registry statusCompleted

  • Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™

    NCT02249663 · start 2014-08

    Registered record
    Registry ID
    NCT02249663
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    Azelastine hydrochloride and Fluticasone propionate; Dymista™; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Unknown
    Start
    2014-08
    Completion
    Not recorded
    Enrolment
    1,535

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

    ConditionSeasonal Allergic Rhinitis
    InterventionAzelastine hydrochloride and Fluticasone propionate; Dymista™; Placebo
    PhasePhase 3
    Registry statusUnknown

  • Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)

    NCT03444506 · start 2014-01-27

    Registered record
    Registry ID
    NCT03444506
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    Molo 1 (also referred as GSP 301-2 NS); Molo 2 (also referred as GSP 301-1 NS); Placebo nasal spray; DYMISTA nasal spray; PATANASE nasal spray
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2014-01-27
    Completion
    2014-02-28
    Enrolment
    180

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

    ConditionSeasonal Allergic Rhinitis
    InterventionMolo 1 (also referred as GSP 301-2 NS); Molo 2 (also referred as GSP 301-1 NS); Placebo nasal spray; DYMISTA nasal spray +1 more
    PhasePhase 2
    Registry statusCompleted

  • A Study Comparing the Bioequivalence of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray (Apotex, Inc.) to That of Dymista™ Nasal Spray (Meda Pharmaceuticals, Inc.) in the Treatment of Seasonal Allergic Rhinitis

    NCT02279563 · start 2013-12

    Registered record
    Registry ID
    NCT02279563
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray; Dymista™ Nasal Spray; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Unknown
    Start
    2013-12
    Completion
    Not recorded
    Enrolment
    595

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

    ConditionSeasonal Allergic Rhinitis
    InterventionAzelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray; Dymista™ Nasal Spray; Placebo
    PhasePhase 2
    Registry statusUnknown

  • Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)

    NCT01915823 · start 2013-07

    Registered record
    Registry ID
    NCT01915823
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    azelastine hydrochloride and fluticasone propionate; Dymista vehicle
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2013-07
    Completion
    Not recorded
    Enrolment
    348

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

    ConditionSeasonal Allergic Rhinitis
    Interventionazelastine hydrochloride and fluticasone propionate; Dymista vehicle
    PhasePhase 3
    Registry statusCompleted

  • Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR

    NCT01880840 · start 2013-06

    Registered record
    Registry ID
    NCT01880840
    Conditions
    Allergic Rhinitis
    Interventions
    205.5 mcg of azelastine hydrochloride; 137 mcg of azelastine hydrochloride
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2013-06
    Completion
    2014-08
    Enrolment
    191

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

    ConditionAllergic Rhinitis
    Intervention205.5 mcg of azelastine hydrochloride; 137 mcg of azelastine hydrochloride
    PhasePhase 4
    Registry statusCompleted

  • Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis

    NCT01470053 · start 2011-03

    Registered record
    Registry ID
    NCT01470053
    Conditions
    Perennial Allergic Rhinitis
    Interventions
    mometasone furoate plus azelastine HCl; mometasone furoate; azelastine HCl
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2011-03
    Completion
    2012-11
    Enrolment
    347

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

    ConditionPerennial Allergic Rhinitis
    Interventionmometasone furoate plus azelastine HCl; mometasone furoate; azelastine HCl
    PhasePhase 3
    Registry statusCompleted

  • Azelastine Fluticasone Combination vs. Fluticasone

    NCT00845598 · start 2010-08

    Registered record
    Registry ID
    NCT00845598
    Conditions
    Allergic Rhinitis
    Interventions
    Azelastine , fluticasone; Fluticasone propionate
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Withdrawn
    Start
    2010-08
    Completion
    2011-08
    Enrolment
    0

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

    ConditionAllergic Rhinitis
    InterventionAzelastine , fluticasone; Fluticasone propionate
    PhasePhase 4
    Registry statusWithdrawn

  • Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays

    NCT01190852 · start 2010-08

    Registered record
    Registry ID
    NCT01190852
    Conditions
    Allergic Rhinitis
    Interventions
    Azelastine, Fluticasone; Azelastine mono; Azelastine
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2010-08
    Completion
    2010-10
    Enrolment
    30

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

    ConditionAllergic Rhinitis
    InterventionAzelastine, Fluticasone; Azelastine mono; Azelastine
    PhasePhase 1
    Registry statusCompleted