Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Indacaterol 150 μg via the Concept1 dry- inhaler · 1 trial · 1 indication
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose for each treatment.
| Arm | Type | Description |
|---|---|---|
| Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg | EXPERIMENTAL | In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo | EXPERIMENTAL | In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg | EXPERIMENTAL | In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg | EXPERIMENTAL | In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Name | Type | Description |
|---|---|---|
| Indacaterol 150 μg via the Concept1 dry-powder inhaler | DRUG | Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler. |
| Indacaterol 60 μg via the Simoon dry-powder inhaler | DRUG | Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler. |
| Indacaterol 120 μg via the Simoon dry-powder inhaler | DRUG | Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler. |
| Placebo to indacaterol via the Concept1 dry-powder inhaler | DRUG | Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler. |
Inclusion criteria: * Patients with persistent asthma with a forced expiratory volume in 1 second (FEV1) ≥ 50% * Patients using inhaled corticosteroid (with or without long-acting beta agonist) Exclusion criteria: * Asthma exacerbations in previous 6 months * Chronic obstructive pulmonary disease...
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|---|---|---|---|---|
| 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 |
Indacaterol 150 μg via the Concept1 dry-powder inhaler is an investigational small molecule therapy being studied for asthma. It delivers a fixed 150 microgram dose of indacaterol through the Concept1 dry-powder inhaler device. It is in Phase 2 clinical development and is being developed by Novartis AG.
It is being studied as a treatment for asthma, a respiratory condition. The Phase 2 trial enrolled adults aged 18 years and older with asthma in Germany, the Netherlands, and the United Kingdom. It is investigational and has not been established as a marketed asthma treatment.
Indacaterol targets ADRB2, the beta-2 adrenergic receptor, and acts as an agonist at that receptor. This receptor target class is consistent with its development as a bronchodilator therapy delivered by inhalation for asthma. The drug is a small molecule administered through the Concept1 dry-powder inhaler.
Novartis AG, which trades under the ticker NVS, is the developer of indacaterol 150 μg via the Concept1 dry-powder inhaler. The company sponsored the Phase 2 asthma study of the drug. Novartis is the sole developer named for this specific inhaler presentation.
Indacaterol 150 μg via the Concept1 dry-powder inhaler is in Phase 2 development for asthma. It is investigational and is not an approved product. The single Phase 2 trial has been completed, and no active trials are currently listed for this inhaler presentation.
One Phase 2 trial has studied indacaterol 150 μg via the Concept1 dry-powder inhaler: NCT01012739, titled Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices. It was a completed, randomized, double-blind, controlled study that enrolled 35 adults with asthma in Germany, the Netherlands, and the United Kingdom.