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mometasone furoate combination MDI 200/

Phase 3

Asthma | Small molecule | Respiratory |Organon & Co.|Last Updated: May 20, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment404
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00379288Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)PHASE3 COMPLETED 404Jun 1, 2006Nov 1, 2007May 20, 2024 -
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Study Endpoints
Primary Endpoints
The Number of All Randomized Subjects Reporting Adverse Events (AEs).
1 year

AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MF/F 200/10 mcg BIDEXPERIMENTAL -
MF/F 400/10 mcg BIDEXPERIMENTAL -
F/SC 250/50 mcg BIDACTIVE_COMPARATOR -
F/SC 500/50 mcg BIDACTIVE_COMPARATOR -
Interventions
NameTypeDescription
mometasone furoate combination MDI 200/10 mcg BIDDRUGMF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
mometasone furoate combination MDI 400/10 mcg BIDDRUGMF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
Fluticasone/Salmeterol 250/50 mcg BIDDRUGF/SC 250/50 twice daily for 1 year
Fluticasone/Salmeterol 500/50 mcg BIDDRUGF/SC 500/50 twice daily for 1 year
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects of either sex and any race, at least 12 years of age, with a diagnosis of asthma of at least 12 months. * Use of medium or high daily dose of ICS (alone or in combination with long-acting beta-agonist \[LABA\]) for at least 12 weeks prior to Screening and have been on...

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