Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TEV-56248 · 3 trials · 1 indication
Baseline values are averaged on day 1 to get a single value. Area under the effect curve will be calculated using measurements collected between zero and 6 hours after dosing. Baseline-adjusted post-dose FEV1 AUEC0-6h for visits on Day 1 and at Week 4 will be calculated using the trapezoidal rule.
| 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. |
| Fp/ABS eMDPI | EXPERIMENTAL | Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module |
| Fp eMDPI | ACTIVE_COMPARATOR | Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI) |
| ABS eMDPI | ACTIVE_COMPARATOR | Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI) |
| Placebo eMDPI | PLACEBO_COMPARATOR | - |
| 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/ABS | DRUG | Inhalation powder |
| FP | DRUG | Inhalation powder |
| ABS | DRUG | Inhalation powder |
| Placebo | DRUG | 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...
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 |
TEV-56248 is an investigational inhaled therapy being developed for the treatment of asthma. It is a fixed-dose combination product studied in patients aged 4 years and older, including adolescents and adults. It is not currently approved for commercial use and remains in clinical development.
TEV-56248 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating the asset in asthma, including the Phase 3 trials currently recruiting participants across multiple countries.
TEV-56248 is in Phase 3 clinical development for asthma. Two Phase 3 trials are currently recruiting, and one Phase 1 pharmacokinetic study in children aged 4 to 11 years has been completed. The program has enrolled approximately 3,454 participants across three trials to date.
TEV-56248 has been studied in three registered trials. NCT06664619 is a recruiting Phase 3 trial in participants 12 years and older, NCT06052267 is a recruiting Phase 3 trial evaluating asthma exacerbation prevention, and NCT06290102 is a completed Phase 1 pharmacokinetic and safety study in children aged 4 to 11 years.