Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TEV-56248 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| TEV-56248 Low Dose | EXPERIMENTAL | Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms. |
| TEV-56248 High Dose | EXPERIMENTAL | Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms. |
| Albuterol sulfate | ACTIVE_COMPARATOR | Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms. |
| Sequence ABC | EXPERIMENTAL | - |
| Sequence BCA | EXPERIMENTAL | - |
| Sequence CAB | EXPERIMENTAL | - |
| Sequence ACB | EXPERIMENTAL | - |
| Sequence BAC | EXPERIMENTAL | - |
| Sequence CBA | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TEV-56248 | DRUG | Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder. |
| Albuterol sulfate | DRUG | Oral inhalation powder |
| Fp MDPI | DRUG | Pharmaceutical form: Dry powder Route of administration: Oral inhalation |
Inclusion Criteria: * The participant has a documented diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines. * The participant has a documented history of at least 1 severe clinical asthma exacerbation (CAE) ending within the past 12 month. * The participant is using any pr...
TEV-56248 is an investigational small molecule being developed for the treatment of asthma. It is a fixed-dose combination of fluticasone propionate and albuterol sulfate, intended to prevent asthma exacerbations. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
TEV-56248 combines fluticasone propionate, a corticosteroid that reduces airway inflammation, with albuterol sulfate, a bronchodilator that relaxes airway muscles. This dual mechanism aims to both control inflammation and provide rapid relief of bronchoconstriction in patients with asthma.
TEV-56248 is being developed by Teva Pharmaceutical Industries Limited, a global pharmaceutical company traded on the NYSE under the ticker TEVA. Teva is conducting clinical trials to evaluate the safety and efficacy of this fixed-dose combination for asthma.
TEV-56248 is in Phase 3 clinical development for asthma. The most advanced trial, NCT06052267, is a Phase 3 study evaluating the fixed-dose combination's effectiveness in preventing asthma exacerbations. This trial is currently recruiting participants, indicating the drug is still investigational and not yet approved.
TEV-56248 has two clinical trials. NCT06052267 is a Phase 3 study testing the fixed-dose combination's effectiveness in preventing asthma exacerbations, with an enrollment of 2,700 participants across multiple countries. NCT06290102 is a completed Phase 1 study evaluating the pharmacokinetic profile and safety of the combination in children aged 4 to 11.
TEV-56248 is a fixed-dose combination of fluticasone propionate and albuterol sulfate. It is not the same as either drug alone; rather, it combines both active ingredients into a single product. This combination is being studied to provide both anti-inflammatory and bronchodilator effects in a single inhaler for asthma management.