Asmanex Hfa

(Mometasone)

ApprovedSmall molecule

Asmanex Hfa is one of 233 small molecule programs targeting Chronic Rhinosinusitis Without Nasal Polyps. It is currently in Approved.

Indications

Total Trials

Active Trials

232

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Chronic Rhinosinusitis Without Nasal PolypsActive, not recruiting

SinusitisApproved

Rhinitis, Allergic, PerennialApproved

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Otitis Media With EffusionActive, not recruiting

Allergic RhinitisActive, not recruiting

Chronic RhinosinusitisActive, not recruiting

PsoriasisActive, not recruiting

AsthmaActive, not recruiting

Sickle Cell DiseaseApproved

Chronic Rhinosinusitis Without Nasal PolypsApproved

Active, not recruiting

SinusitisApproved

Approved

Rhinitis, Allergic, PerennialApproved

Approved

Chronic Obstructive Pulmonary DiseasePhase 3

Active, not recruiting

Otitis Media With EffusionPhase 3

Active, not recruiting

Allergic RhinitisPhase 3

Active, not recruiting

Chronic RhinosinusitisApproved

Active, not recruiting

PsoriasisApproved

Active, not recruiting

AsthmaApproved

Active, not recruiting

Sickle Cell DiseaseApproved

Approved

Showing 10 of 11 indications

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Asmanex Hfa

PPerrigo Company

Approved

15 2

Dupixent

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

30 3

Atrovent

Boehringer Ingelheim

Preclinical

5 4

Arcoxia

Tylenol

1 6

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 7

DUPIXENT

Regeneron

Preclinical

1 8

Blood Withdrawn

Emergent BioSolutions

Preclinical

1 9

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 10

Spiriva

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalRecruiting

Rhinitis, Allergic

NCT06436534

Clinical

Trials by Indication[1]

Asthma15 trials

A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma

Terminated·JJohns Hopkins University·Phase 4·NCT00461812·33 enrolled

A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)

Completed·OOrganon and Co·Phase 3·NCT00442117·180 enrolled

A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)

Completed·OOrganon and Co·Phase 4·NCT01471340·11,744 enrolled

Show 12 more trials

A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)

Completed·OOrganon and Co·Phase 2·NCT01502371·583 enrolled

Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)

Completed·OOrganon and Co·Phase 4·NCT00394355·566 enrolled

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00383552·746 enrolled

A Study of the Equivalent Effectiveness of 400 mcg Mometasone Furoate Using Two Different Dry Powder Inhalers in Moderate Asthmatics (Study P04828)

Completed·OOrganon and Co·Phase 4·NCT00521599·672 enrolled

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00381485·834 enrolled

Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED)

Completed·OOrganon and Co·Phase 2·NCT00635882·93 enrolled

Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)

Completed·OOrganon and Co·Phase 3·NCT00379288·404 enrolled

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00383240·781 enrolled

Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)

Completed·OOrganon and Co·Phase 3·NCT00424008·722 enrolled

A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)

Completed·OOrganon and Co·Phase 2·NCT01258803·92 enrolled

Acute Effect of Mometasone on Beta-adrenergic Airway and Airway Vascular Relaxation in Severe Asthma

Completed·UUniversity of Miami·N/A·NCT01210170·22 enrolled

Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)

Completed·OOrganon and Co·Phase 3·NCT01566149·49 enrolled

Allergic Rhinitis5 trials

A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)

Completed·OOrganon and Co·Phase 3·NCT00783224·351 enrolled

Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431)

Completed·OOrganon and Co·Phase 4·NCT00783237·340 enrolled

Study to Assess the Effects of Allergic Rhinitis and Co-administration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02154334·47 enrolled

Show 2 more trials

Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis

Withdrawn·EEMS·Phase 3·NCT02953379

Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis

Withdrawn·EEMS·Phase 3·NCT02953366

Seasonal Allergic Rhinitis3 trials

Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

Terminated·UUniversity of Chicago·Phase 4·NCT00361439·17 enrolled

Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280)

Completed·OOrganon and Co·Phase 4·NCT00070707·188 enrolled

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

Completed· Novartis logo

Novartis·Phase 3·NCT05311475·669 enrolled

Psoriasis1 trial

Elocon vs Fluticasone in Localized Psoriasis (P03197)

Completed·OOrganon and Co·Phase 4·NCT00763529·245 enrolled

Budesonide1 trial

Mometasone vs Budesonide in CRS With Polyposis

Terminated·UUniversité de Sherbrooke·Phase 3·NCT03323866·36 enrolled

10 more indications

Chronic Obstructive Pulmonary Disease1 trial

Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00383721·1,196 enrolled

COPD1 trial

Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00383435·1,055 enrolled

Local Anesthetic1 trial

A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff

Completed·—·N/A·NCT04085744·91 enrolled

Sinusitis1 trial

Response of the Airway in Sinusitis and Asthma

Completed·MMedical University of Lodz·Phase 4·NCT03011632·150 enrolled

Chronic Rhinosinusitis Without Nasal Polyps1 trial

Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Terminated·NNorthwestern University·Phase 4·NCT01676415·9 enrolled

Chronic Rhinosinusitis1 trial

Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

Completed·WWashington University School of Medicine·Phase 4·NCT03705793·53 enrolled

Otitis Media With Effusion1 trial

Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children

Completed·HHormozgan University of Medical Sciences·Phase 3·NCT02541760·143 enrolled

Patient Preference1 trial

Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01401465·327 enrolled

Rhinitis, Allergic1 trial

A Randomized, Double-blind, Placebo-controlled, Single-center Clinical Trial of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis

Recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Preclinical·NCT06436534·50 enrolled

Unspecified2 trials

Clinical Equivalence Study of Mometasone Nasal Spray

Completed·AActavis Inc.·Phase 3·NCT01850823·880 enrolled

Inhaled Mometasone to Promote Reduction in Vasoocclusive Events 2

Completed·JJeffrey Glassberg·Phase 2·NCT03758950·80 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 30, 1987

ELOCON

NDA NDA019543

May 6, 1987

ELOCON

NDA NDA019625

Mar 30, 1989

ELOCON

NDA NDA019796

Oct 1, 1997

NASONEX

NDA NDA020762

Feb 1, 2008

ASMANEX TWISTHALER

NDA NDA021067

Dec 8, 2017

SINUVA

NDA NDA209310

Aug 12, 2019

ASMANEX HFA

NDA NDA205641

Mar 17, 2022

NASONEX 24HR ALLERGY

NDA NDA215712

Sources

References

[1]
ClinicalTrials.gov — 36 trial records for Mometasone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mometasone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Mometasone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215712). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Asmanex Hfa. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Perrigo Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: PPerrigo Company

Patent Landscape[5]

Patent Cliff

Nov 29, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9585681Apr 4, 2026

7544192Nov 29, 2026

8025635Jun 12, 2027

10357640Oct 3, 2031

8763222Feb 8, 2032

2 more patents

10406332Mar 13, 2034

10232152Nov 24, 2034

Asmanex Hfa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Asthma15 trials

Allergic Rhinitis5 trials

Seasonal Allergic Rhinitis3 trials

Psoriasis1 trial

Budesonide1 trial

Chronic Obstructive Pulmonary Disease1 trial

COPD1 trial

Local Anesthetic1 trial

Sinusitis1 trial

Chronic Rhinosinusitis Without Nasal Polyps1 trial

Chronic Rhinosinusitis1 trial

Otitis Media With Effusion1 trial

Patient Preference1 trial

Rhinitis, Allergic1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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