Skip to content
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 E. coli, 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
  • 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.

  • Thermosensitive Gel Nasal Spray With Stem Cell Exosomes, Mupirocin, and DNase I for Chronic Sinusitis

    NCT07635433 · start 2026-07-01

    Registered record
    Registry ID
    NCT07635433
    Conditions
    Chronic Rhinosinusitis With Nasal Polyps
    Interventions
    Exosomes (hUC-MSC-Exo); Mupirocin; DNase I; Placebo Gel Matrix
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Not yet recruiting
    Start
    2026-07-01
    Completion
    2027-06-30
    Enrolment
    108

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

    ConditionChronic Rhinosinusitis With Nasal Polyps
    InterventionExosomes (hUC-MSC-Exo); Mupirocin; DNase I; Placebo Gel Matrix
    PhaseEarly phase 1
    Registry statusNot yet recruiting

  • Thermosensitive Gel Nasal Spray With Exosomes, Azelastine, and Interferon for Acute Phase of Chronic Sinusitis

    NCT07635459 · start 2026-07-01

    Registered record
    Registry ID
    NCT07635459
    Conditions
    Chronic Rhinosinusitis Without Polyps
    Interventions
    Exosomes, Azelastine, and Interferon alpha-2b; Azelastine and Interferon alpha-2b; Placebo Gel Matrix
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Not yet recruiting
    Start
    2026-07-01
    Completion
    2027-06-30
    Enrolment
    108

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

    ConditionChronic Rhinosinusitis Without Polyps
    InterventionExosomes, Azelastine, and Interferon alpha-2b; Azelastine and Interferon alpha-2b; Placebo Gel Matrix
    PhaseEarly phase 1
    Registry statusNot yet recruiting

  • Dymista in Chinese Adolescents

    NCT07597473 · start 2026-05-08

    Registered record
    Registry ID
    NCT07597473
    Conditions
    Allergic Rhinitis Due to Allergens
    Interventions
    Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Recruiting
    Start
    2026-05-08
    Completion
    2027-03
    Enrolment
    100

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

    ConditionAllergic Rhinitis Due to Allergens
    InterventionTreatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate
    PhasePhase 4
    Registry statusRecruiting

  • Azelastine Allergen Chamber - Onset of Action Study

    NCT06126952 · start 2023-10-30

    Registered record
    Registry ID
    NCT06126952
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair); Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray; Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2023-10-30
    Completion
    2024-03-18
    Enrolment
    84

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

    ConditionSeasonal Allergic Rhinitis
    InterventionTreatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair); Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray; Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
    PhasePhase 2
    Registry statusCompleted

  • Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis

    NCT05887843 · start 2023-06-08

    Registered record
    Registry ID
    NCT05887843
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    Mometasone + Azelastine; Mometasone Furoate; Azelastine Hydrochloride
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2023-06-08
    Completion
    2023-09-08
    Enrolment
    38

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

    ConditionSeasonal Allergic Rhinitis
    InterventionMometasone + Azelastine; Mometasone Furoate; Azelastine Hydrochloride
    PhasePhase 1
    Registry statusTerminated

  • Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction

    NCT06800274 · start 2023-04-21

    Registered record
    Registry ID
    NCT06800274
    Conditions
    Allergic Conjunctivitis; Dry Eye Disease (DED)
    Interventions
    NAAGA (N-acetyl-aspartyl-glutamate) 49 mg/mL; azelastine hydrochloride 0.05%
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2023-04-21
    Completion
    2024-03-28
    Enrolment
    134

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

    ConditionAllergic Conjunctivitis; Dry Eye Disease (DED)
    InterventionNAAGA (N-acetyl-aspartyl-glutamate) 49 mg/mL; azelastine hydrochloride 0.05%
    PhasePhase 4
    Registry statusCompleted

  • Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray

    NCT06180083 · start 2023-03-24

    Registered record
    Registry ID
    NCT06180083
    Conditions
    Seasonal Allergic Rhinitis; Perennial Allergic Rhinitis
    Interventions
    Azelastine Hydrochloride/ Fluticasone propionate nasal spray; 'DYMISTA' NASAL SPRAY
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2023-03-24
    Completion
    2023-07-05
    Enrolment
    56

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

    ConditionSeasonal Allergic Rhinitis; Perennial Allergic Rhinitis
    InterventionAzelastine Hydrochloride/ Fluticasone propionate nasal spray; 'DYMISTA' NASAL SPRAY
    PhasePhase 1
    Registry statusCompleted

  • A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients

    NCT06212973 · start 2023-03-13

    Registered record
    Registry ID
    NCT06212973
    Conditions
    Seasonal Allergic Conjunctivitis
    Interventions
    Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln; Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2023-03-13
    Completion
    2023-11-02
    Enrolment
    266

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

    ConditionSeasonal Allergic Conjunctivitis
    InterventionEpinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln; Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln
    PhasePhase 3
    Registry statusCompleted

  • INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION

    NCT07415278 · start 2022-12-01

    Registered record
    Registry ID
    NCT07415278
    Conditions
    Allergic Rhinitis
    Interventions
    Fluticasone propionate nasal spray; Fluticasone propionate-azelastine nasal spray
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Active not recruiting
    Start
    2022-12-01
    Completion
    2026-10-30
    Enrolment
    61

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

    ConditionAllergic Rhinitis
    InterventionFluticasone propionate nasal spray; Fluticasone propionate-azelastine nasal spray
    PhasePhase 4
    Registry statusActive not recruiting

  • Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis

    NCT05311475 · start 2022-04-04

    Registered record
    Registry ID
    NCT05311475
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    Mometasone; Azelastine; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2022-04-04
    Completion
    2023-06-20
    Enrolment
    669

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

    ConditionSeasonal Allergic Rhinitis
    InterventionMometasone; Azelastine; Placebo
    PhasePhase 3
    Registry statusCompleted

  • Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients

    NCT05158972 · start 2021-10-27

    Registered record
    Registry ID
    NCT05158972
    Conditions
    Allergic Rhinitis
    Interventions
    Dymista
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2021-10-27
    Completion
    2023-10-24
    Enrolment
    924

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

    ConditionAllergic Rhinitis
    InterventionDymista
    PhaseNot recorded
    Registry statusCompleted

  • Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients

    NCT04729517 · start 2021-04-20

    Registered record
    Registry ID
    NCT04729517
    Conditions
    Allergic Rhinitis Due to Allergens
    Interventions
    AI201901; Azelastine Hydrochloride
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-04-20
    Completion
    2023-05-02
    Enrolment
    210

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

    ConditionAllergic Rhinitis Due to Allergens
    InterventionAI201901; Azelastine Hydrochloride
    PhasePhase 3
    Registry statusCompleted

  • To Investigate Drug-drug Interaction and Relative Bioavailability Between the FDC AzelastineHCL/Beclomethasone Dipropionate Nasal Spray, & Beclomethasone Dipropionate Nasal Spray in the Test Vehicle, and RinoClenil® Nasal Spray

    NCT04817800 · start 2021-03-25

    Registered record
    Registry ID
    NCT04817800
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2021-03-25
    Completion
    2021-04-10
    Enrolment
    48

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

    ConditionSeasonal Allergic Rhinitis
    Intervention140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)
    PhasePhase 1 / Phase 2
    Registry statusCompleted

  • Allergic Rhinitis Combination Pharmacotherapy Efficacy Study

    NCT04601324 · start 2020-12-15

    Registered record
    Registry ID
    NCT04601324
    Conditions
    Allergic Rhinitis
    Interventions
    Fluticasone Propionate; Azelastine hydrochloride and fluticasone propionate; Rupatadine
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Withdrawn
    Start
    2020-12-15
    Completion
    2021-07-01
    Enrolment
    0

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

    ConditionAllergic Rhinitis
    InterventionFluticasone Propionate; Azelastine hydrochloride and fluticasone propionate; Rupatadine
    PhasePhase 4
    Registry statusWithdrawn

  • Dymista Allergen Chamber - Onset of Action Study

    NCT04652245 · start 2020-12-14

    Registered record
    Registry ID
    NCT04652245
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3; Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5; Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5; Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2020-12-14
    Completion
    2021-12-13
    Enrolment
    216

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

    ConditionSeasonal Allergic Rhinitis
    InterventionTreatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3; Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5; Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5; Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3
    PhasePhase 4
    Registry statusCompleted