Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formatris 24µg · 1 trial · 1 indication
The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.
| Arm | Type | Description |
|---|---|---|
| 24 µg Formoterol Novolizer | EXPERIMENTAL | 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| 12µg Formoterol Novolizer | EXPERIMENTAL | 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| 24 µg Formoterol Aerolizer | ACTIVE_COMPARATOR | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 |
| 12µg Formoterol Aerolizer | ACTIVE_COMPARATOR | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2 |
| Name | Type | Description |
|---|---|---|
| Formatris 24µg | DRUG | 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| Formatris 12µg | DRUG | 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| Foradil P 24µg | DRUG | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 |
| Foradil P 12µg | DRUG | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2 |
Inclusion Criteria: 1. Male or female patients aged from 18 to 60 years (inclusive). 2. Patients with asthma indicated by * history of asthma symptoms and * airway hyperresponsiveness to methacholine with a provocation concentration of methacholine that cause a 20% decrease in FEV1 (PC20) ≤8...
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 | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, 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 |
Formatris 24µg is an investigational small molecule therapy being developed for the treatment of asthma. It is a respiratory medicine delivered by inhalation. The drug is in Phase 2 clinical development and has been studied in adult patients with asthma. It is not yet approved for commercial use.
Formatris 24µg is being developed by Viatris Inc., a pharmaceutical company traded on the Nasdaq under the ticker symbol VTRS. Viatris is responsible for the clinical program evaluating the drug in asthma.
Formatris 24µg is in Phase 2 clinical development. One Phase 2 trial has been completed, and there are currently no active trials listed for this drug. It remains an investigational product and has not been approved by the FDA.
Formatris 24µg has been evaluated in one completed Phase 2 trial, NCT01256086, titled Relative Potency of Formoterol Novolizer 12 µg Compared to Formoterol Aerolizer 12 µg. The trial enrolled 44 adults with asthma in the United States and used a randomized, double-blind, active-controlled design.
No, Formatris 24µg is not FDA approved. It is an investigational drug in Phase 2 clinical development for asthma. Approval would require successful completion of later-stage trials and regulatory review.