Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Montelukast chewable · 1 trial · 1 indication
Pharmacokinetics
Pharmacokinetics
| Arm | Type | Description |
|---|---|---|
| A(reference)/B(test) | EXPERIMENTAL | initial administration of reference and cross-over to test |
| B(test)/A(reference) | EXPERIMENTAL | initial administration of test and cross-over to reference |
| Name | Type | Description |
|---|---|---|
| Montelukast 5 mg chewable tablets | DRUG | Reference product |
Inclusion Criteria: Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice. Healthy, between 18 and 50 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; he...
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 |
Montelukast chewable is a small molecule drug developed by GSK plc for asthma. It is a chewable tablet formulation, specifically montelukast 5 mg chewable tablets, and is taken orally. It is currently in Phase 1 clinical development.
Montelukast chewable is used for asthma. It is being developed as a chewable tablet formulation for this respiratory condition. The drug is in Phase 1 development, and its only listed trial enrolled adults with asthma.
Montelukast chewable targets CYSLTR1, the cysteinyl leukotriene receptor 1. It acts as an antagonist at this receptor. By blocking CYSLTR1, the drug interferes with leukotriene-mediated signaling, which is relevant to asthma pathophysiology.
Montelukast chewable is developed by GSK plc, which trades under the ticker GSK. GSK is the company responsible for the development of this chewable tablet formulation of montelukast.
Montelukast chewable is in Phase 1 clinical development. It is investigational and has not been approved. The development program includes one completed Phase 1 trial, and no active trials are listed.
Montelukast chewable has been studied in one completed Phase 1 trial, NCT01863654, titled Bioequivalence Study of Montelukast 5 mg Chewable. It enrolled 32 healthy adult volunteers, was randomized and controlled, and evaluated bioequivalence in participants aged 18 years and older.