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Mometasone

Phase 4FDA approved

Perennial Allergic Rhinitis | Small molecule | Respiratory |Organon & Co.|Trials Updated: May 10, 2024

Mometasone development status

FDA approval on record Nov 18, 1998 as Nasonex
Approval holderOrganon Llc
ApplicationNDA020762
Highest phase Phase 4 (NCT00783237)
Phase scored for OGNPhase 3
Registered trials 7 across 4 sponsors since Oct 2003

Mometasone target and mechanism

ModalitySmall molecule

Also known as SCH 032088, Nasonex

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials2
Total Enrollment485

FDA Designations

No designations recorded

Mometasone clinical trials

Mometasone · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00783224A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)Perennial Allergic Rhinitis
COMPLETED351 Analytics
PHASE3COMPLETED
A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)
Perennial Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks
Baseline to 2 weeks of treatment

The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.

Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)
Baseline and 2 weeks

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.

Secondary Endpoints

Change From Baseline in Daytime Asthma Symptom Score
Baseline and 2 weeks
Change From Baseline in Nighttime Asthma Symptom Score
Baseline and 2 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Mometasone Furoate Placebo (PLAMF)PLACEBO_COMPARATORPlacebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
Fluticasone Propionate Placebo (PLAFP)PLACEBO_COMPARATORPlacebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
Mometasone Furoate (MF)EXPERIMENTALMometasone furoate nasal spray 200 μg/day(QD)
Fluticasone Propionate (FP)ACTIVE_COMPARATORFluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
1ACTIVE_COMPARATORmometasone
2PLACEBO_COMPARATORmontelukast followed by placebo; or placebo followed by montelukast.

Interventions

NameTypeDescription
Placebo for MFDRUGPlacebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
Placebo for FPDRUGPlacebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
MometasoneDRUGMometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
FluticasoneDRUGFluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
Comparator: mometasoneDRUGmometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)
Comparator: montelukastDRUGmontelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)
Comparator: placebo (unspecified)DRUGPlacebo (Placebo once-daily, for approximately 2 weeks)
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: Patients with perennial allergic rhinitis meeting all of the followings. * Patients with symptoms of perennial allergic rhinitis, the severity of which is moderate or severer according to the severity grading provided in the "Guidelines for the Management of Allergic Rhinitis i...

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Frequently asked questions about Mometasone

What is mometasone used for?

Mometasone is a small molecule corticosteroid used for asthma and perennial allergic rhinitis. In asthma, it is studied as an inhaled corticosteroid, and in perennial allergic rhinitis, it is studied as a nasal spray. It is being developed by Organon & Co. (OGN) and is currently in clinical development.

Who makes mometasone?

Mometasone is being developed by Organon & Co., which trades under the ticker OGN. The company is conducting clinical trials of mometasone for respiratory conditions including asthma and perennial allergic rhinitis.

What phase is mometasone in?

Mometasone is in Phase 2 clinical development for asthma, based on a completed Phase 2 trial. It has also been studied in a completed Phase 3 trial for perennial allergic rhinitis. The drug is investigational and not yet approved.

What clinical trials is mometasone in?

Mometasone has one completed Phase 2 trial, NCT00666679, which studied inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone in 134 patients with chronic asthma. It also has a completed Phase 3 trial, NCT00783224, comparing mometasone furoate nasal spray with fluticasone propionate nasal spray in 351 patients with perennial allergic rhinitis.

Is mometasone the same as mometasone furoate?

Mometasone is the drug name, and mometasone furoate is a specific form used in the nasal spray studied for perennial allergic rhinitis. The clinical trials reference mometasone furoate nasal spray, indicating that mometasone furoate is a formulation of mometasone.