CLINICAL TRIALS PROFILE FOR ASTEPRO

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All Clinical Trials for ASTEPRO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00720382 ↗	A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis	Completed	Meda Pharmaceuticals	Phase 3	2007-03-01	The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
NCT00783432 ↗	Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis	Completed	Meda Pharmaceuticals	Phase 3	2006-07-01	The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)
NCT01368445 ↗	A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies	Completed	Meda Pharmaceuticals	Phase 3	2006-08-01	The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.
NCT01880840 ↗	Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to	Completed	Novella Clinical	Phase 4	2013-06-01	The purpose of this study is to compare the safety of 2 different doses of the investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of allergic rhinitis (AR). This is an open-label study; that is, parent and child will know which group each is in.
NCT01880840 ↗	Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to	Completed	Meda Pharmaceuticals	Phase 4	2013-06-01	The purpose of this study is to compare the safety of 2 different doses of the investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of allergic rhinitis (AR). This is an open-label study; that is, parent and child will know which group each is in.
NCT06008860 ↗	A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection	Recruiting	University of Chicago	Phase 4	2023-07-01	The study team proposes to evaluate the efficacy of Astepro® 0.15% nasal spray in treating SARS-CoV-2 infection in adults through a pilot and feasibility clinical trial at the University of Chicago.

Clinical Trial Conditions for ASTEPRO

Condition Name

Condition Name for ASTEPRO
Intervention	Trials
Nonallergic Rhinitis	1
Perennial Allergic Rhinitis	1
Seasonal Allergic Rhinitis	1
Allergic Rhinitis	1

Condition MeSH

Condition MeSH for ASTEPRO
Intervention	Trials
Rhinitis	4
Rhinitis, Allergic	4
COVID-19	1
Rhinitis, Allergic, Seasonal	1

Clinical Trial Locations for ASTEPRO

Trials by Country

Trials by Country for ASTEPRO
Location	Trials
United States	52

Trials by US State

Trials by US State for ASTEPRO
Location	Trials
Colorado	3
California	3
Texas	3
Pennsylvania	3
Oklahoma	3

Clinical Trial Progress for ASTEPRO

Clinical Trial Phase

Clinical Trial Phase for ASTEPRO
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ASTEPRO
Clinical Trial Phase	Trials
Completed	4
Recruiting	1

Clinical Trial Sponsors for ASTEPRO

Sponsor Name

Sponsor Name for ASTEPRO
Sponsor	Trials
Meda Pharmaceuticals	4
Novella Clinical	1
University of Chicago	1

Sponsor Type

Sponsor Type for ASTEPRO
Sponsor	Trials
Industry	4
Other	2

ASTEPRO (azelastine hydrochloride) clinical trials update, market analysis and exclusivity projection (US and key geographies)

Last updated: July 29, 2026

Astepro is an intranasal antihistamine (azelastine HCl) marketed for allergic rhinitis. Public clinical-trial reporting and FDA regulatory history do not support a current, drug-specific “late-stage pipeline” profile in the way seen for novel biologics or small-molecule NME programs. The competitive market outlook is dominated by (1) ongoing life-cycle strategies around dosing, formulations, and combination products, and (2) the timing of generic and OTC transitions for azelastine nasal products.

Because the request is specifically “Clinical trials update, market analysis and projection for ASTEPRO,” a complete, accurate update requires verifiable trial registration and current prescribing/FDA status data for Astepro (including whether the product is FDA-approved under which NDA/BLA, dosing strength, and Rx versus OTC status). Those facts are not provided in the prompt, and generating them without source-verified identifiers would risk producing incorrect exclusivity and trial specifics.

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