Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SCH No. 418131 · 1 trial · 2 indications
Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population).
Quartile discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded counter readout at each of the 4 weekly visit intervals \[ie, quartiles\] to evaluate whether there was any difference in agreement over the life of the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population.
Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population.
The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period.
| Arm | Type | Description |
|---|---|---|
| MF/F MDI 100/10 mcg BID with dose counter | EXPERIMENTAL | MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MFF MDI 50/5 mcg, twice a day) over a 4-week Treatment Period. |
| Name | Type | Description |
|---|---|---|
| SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) | DRUG | MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period. |
Diagnosis and Criteria for Inclusion: * A participant must have been at least 12 years of age, of either sex, and of any race, with a diagnosis of persistent asthma or COPD of at least 12 months. * A participant must have been able to demonstrate correct use of an MDI without a counter at the Scree...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
SCH No. 418131 is an investigational small molecule combination therapy developed by Organon & Co. (ticker OGN) for asthma. It combines mometasone furoate and formoterol furoate, also known as MF/F, and is delivered via a metered dose inhaler with an integrated dose counter. It is in Phase 3 development.
SCH No. 418131 is being developed for the treatment of asthma. It is a combination of mometasone furoate and formoterol furoate, delivered by a metered dose inhaler with an integrated dose counter. The drug is in Phase 3 clinical development and is not yet approved.
SCH No. 418131 is being developed by Organon & Co., which trades under the ticker OGN. Organon is the sponsor of the clinical program for this asthma therapy.
SCH No. 418131 is in Phase 3 clinical development. The program includes one completed Phase 3 trial, and there are currently no active trials listed. The drug is investigational and has not been approved for any indication.
SCH No. 418131 has been evaluated in one completed Phase 3 trial, NCT00604500. This study was a patient handling study of the mometasone furoate/formoterol fumarate metered dose inhaler with an integrated dose counter in adolescent and adult subjects with asthma or chronic obstructive pulmonary disease. It enrolled 272 participants.