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
Existing / approved use
Documented · FDA, WHO, ChEMBLApproved 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 MRSA, E. coli 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 evidenceClinical
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.
Docking
Computational · nothing measuredAutoDock 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 measuredOther 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.
- Ozanimod HydrochlorideExisting use: Multiple sclerosis, Relapsing-remitting multiple sclerosis, Ulcerative colitis66.8% AI-predicted activityagainst MRSA7 registered studies
- Micafungin SodiumExisting use: Candidiasis66.8% AI-predicted activityagainst MRSA50+ registered studies
- AbemaciclibExisting use: Breast cancer, Breast carcinoma, Breast neoplasm and 3 more66.4% AI-predicted activityagainst MRSA50+ registered studies
- RisperidoneExisting use: Aggressive behavior, Autism, Bipolar disorder and 4 more66.4% AI-predicted activityagainst MRSA50+ registered studies
- Lazertinib MesylateExisting use: Non-small cell lung carcinoma66.1% AI-predicted activityagainst MRSANo documented evidence found
- Desmopressin AcetateExisting use: Central diabetes insipidus, Diabetes insipidus, Enuresis and 5 more65.8% AI-predicted activityagainst MRSA50+ registered studies
- Terazosin HydrochlorideExisting use: Benign prostatic hyperplasia65.8% AI-predicted activityagainst MRSA41 registered studies
- VemurafenibExisting use: Cancer, Cutaneous melanoma, Melanoma and 2 more65.8% AI-predicted activityagainst MRSA50+ registered studies
- Caspofungin AcetateExisting use: Aspergillosis, Candidemia, Candidiasis and 1 more65.5% AI-predicted activityagainst MRSA50+ registered studies
- VenetoclaxExisting use: Cancer, Chronic lymphocytic leukemia, Neoplasm65.5% AI-predicted activityagainst MRSA50+ registered studies
- Larotrectinib SulfateExisting use: Abdominal Neoplasms, Cancer, Metastasis and 1 more65.4% AI-predicted activityagainst MRSA5 registered studies
- SirolimusExisting use: Adenoma sebaceum, Angiofibroma, Cancer and 5 more65.2% AI-predicted activityagainst MRSA50+ registered studies
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 RhinitisInterventionazelastine/fluticasone 137/50 mcg nasal spray; Dymista™PhasePhase 2Registry statusCompletedStudy 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 RhinitisInterventionAzelastine hydrochloride (BAYR9258); PlaceboPhasePhase 3Registry statusCompletedCorneal 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; KeratoconusInterventionNot recordedPhaseNot recordedRegistry statusUnknownDYmista 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 RhinitisInterventionAzelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT; Azelastine Hydrochloride 0.137 MG/ACTUAT; Fluticasone Propionate 0.05 MG/ACTUATPhasePhase 3Registry statusCompletedEffects 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; AllergyInterventionAzelastine-Fluticasone Nasal; PlacebosPhasePhase 4Registry statusTerminatedMP-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 RhinitisInterventionAzelastine hydrochloride + fluticasone propionate nasal spray; Placebos; fluticasone propionate nasal spray + loratadinePhasePhase 4Registry statusCompletedComparative 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 RhinitisInterventionAzelastine Hydrochloride/Fluticasone Propionate Nasal Spray; Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray; Placebo nasal sprayPhasePhase 3Registry statusCompletedClinical 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 RhinitisInterventionAzelastine hydrochloride and Fluticasone propionate; Dymista™; PlaceboPhasePhase 3Registry statusUnknownEfficacy 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 RhinitisInterventionMolo 1 (also referred as GSP 301-2 NS); Molo 2 (also referred as GSP 301-1 NS); Placebo nasal spray; DYMISTA nasal spray +1 morePhasePhase 2Registry statusCompletedA 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 RhinitisInterventionAzelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray; Dymista™ Nasal Spray; PlaceboPhasePhase 2Registry statusUnknownSafety 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 RhinitisInterventionazelastine hydrochloride and fluticasone propionate; Dymista vehiclePhasePhase 3Registry statusCompletedSafety 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 RhinitisIntervention205.5 mcg of azelastine hydrochloride; 137 mcg of azelastine hydrochloridePhasePhase 4Registry statusCompletedEfficacy 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 RhinitisInterventionmometasone furoate plus azelastine HCl; mometasone furoate; azelastine HClPhasePhase 3Registry statusCompletedAzelastine 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 RhinitisInterventionAzelastine , fluticasone; Fluticasone propionatePhasePhase 4Registry statusWithdrawnSingle 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 RhinitisInterventionAzelastine, Fluticasone; Azelastine mono; AzelastinePhasePhase 1Registry statusCompleted