NDAINHALATIONPOWDER
Approved
Apr 2014
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
INCRUSE ELLIPTA (umeclidinium) by GSK is long-acting muscarinic antagonist, which is often referred to as an anticholinergic. First approved in 2014.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INCRUSE ELLIPTA is an inhaled long-acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD). It works by blocking M3 receptors on airway smooth muscle to produce bronchodilation lasting over 24 hours. The drug is delivered as a dry powder via the ELLIPTA inhaler device.
$0.456BPart D
LOE ApproachingStable
1.2 years to LOEProduct is in late-stage lifecycle with approximately 1.3 years until loss of exclusivity; commercial teams are likely focused on defending market share against generic/biosimilar entry and optimizing existing customer base rather than expansion.
Mechanism of Action
long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptors at the smooth muscle leading to bronchodilation. The…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Safety and Efficacy of Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI) in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Started Jun 2023
229 enrolled
Pulmonary Disease, Chronic Obstructive
To Evaluate Real-World Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol (FF/UMEC/VI) in a Single Inhaler (Trelegy Ellipta) in Participants With Symptomatic COPD
Started Oct 2022
463 enrolled
Pulmonary Disease, Chronic Obstructive
Efficacy and Safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Chinese Participants With Inadequately Controlled Asthma
Started Jul 2021
359 enrolled
Asthma
A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol
Started Feb 2021
11,316 enrolled
Pulmonary Disease, Chronic Obstructive
Effectiveness of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) Using the Connected Inhaler System (CIS) as Compared With Fluticasone Proprionate/ Salmeterol (FP/SAL) Plus Tiotropium (TIO) in Inadequately Controlled Asthma
Started Jan 2019
0Asthma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.