Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
75 µg indacaterol · 1 trial · 1 indication
Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
| Arm | Type | Description |
|---|---|---|
| 75 µg Indacaterol (LB) + Placebo (PoS) | EXPERIMENTAL | 75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. |
| 75 µg Indacaterol (PoS) + Placebo (LB) | EXPERIMENTAL | 75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| 37.5 µg Indacaterol (PoS) + Placebo (LB) | EXPERIMENTAL | 37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| Placebo (LB) and Placebo (PoS) | EXPERIMENTAL | Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| Name | Type | Description |
|---|---|---|
| 75 µg indacaterol maleate (LB) | DRUG | 75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| 75 µg indacaterol maleate (PoS) | DRUG | 75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. |
| 37.5 µg indacaterol maleate (PoS) | DRUG | 37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. |
| placebo to indacaterol (LB) | DRUG | Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| placebo to indacaterol (PoS) | DRUG | Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. |
Inclusion Criteria: * Male and female patients with asthma * Aged 18 or above * Patients using inhaled corticosteroid (with or without long acting beta agonist) * Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist Exclusion Criteria: * Asthma exacerbations in ...
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 |
75 µg indacaterol is an investigational small molecule being studied for the treatment of asthma. It is a formulation of indacaterol maleate delivered via the Concept 1 device. Development is at Phase 2, and it has not been approved for any indication.
75 µg indacaterol is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this formulation for asthma.
75 µg indacaterol is in Phase 2 clinical development for asthma. One Phase 2 trial has been completed, and no active trials are currently listed. It remains an investigational product and is not approved for commercial use.
75 µg indacaterol has been evaluated in one completed Phase 2 trial, NCT01484197, titled "A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device." The trial enrolled 36 participants with asthma in Germany and the United Kingdom.