Umeclidinium

Umeclidinium is a 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.

• Umeclidinium ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Umeclidinium ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).ICD-10: J44.9

• Umeclidinium ELLIPTA is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins [see Warnings and Precautions ( 5.3 )] • Hypersensitivity to umeclidinium or any of the excipients [see Warnings and Precautions ( 5.3 ), Description ( 11 )] • Severe hypersensitivity to milk proteins. ( 4 ) • Hypersensitivity to any ingredient.contraindicated

The recommended dosage of Umeclidinium ELLIPTA for maintenance treatment of COPD is 1 actuation (umeclidinium 62.5 mcg) once daily by oral inhalation. • Umeclidinium ELLIPTA should be used at the same time every day. Do not use Umeclidinium ELLIPTA more than 1 time every 24 hours. • No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment [see Clinical Pharmacology ( 12.3 )] . • For oral inhalation only. ( 2 ) • Maintenance treatment of COPD: 1 actuation of Umeclidinium ELLIPTA once daily administered by oral inhalation. ( 2 )

• Do not initiate in acutely deteriorating COPD. Do not use to treat acute symptoms. ( 5.1 ) • If paradoxical bronchospasm occurs, discontinue Umeclidinium ELLIPTA and institute alternative therapy. ( 5.2 ) • Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.4 ) • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.5 ) 5.1 Deterioration of Disease and Acute Episodes Umeclidinium ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD. Umeclidinium ELLIPTA has not been studied in subjects with acutely deteriorating COPD. The initiation of Umeclidinium ELLIPTA in this setting is not appropriate. Umeclidinium ELLIPTA should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Umeclidinium ELLIPTA has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta 2 -agonist. If Umeclidinium ELLIPTA no longer controls symptoms of bronchoconstriction; the patient’s inhaled, short-acting beta 2 -agonist becomes less effective; or the patient needs more short-acting beta 2 -agonist than usual, these may be markers of deterioration of disease.

The following adverse reactions are described in greater detail in other sections: • Paradoxical bronchospasm [see Warnings and Precautions ( 5.2 )] • Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.4 )] • Worsening of urinary retention [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence ≥2% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the 8 clinical trials conducted to support initial approval of Umeclidinium ELLIPTA, a total of 1,663 subjects with COPD (mean age: 62.7 years; 89% white; 65% male across all treatments, including placebo) received at least 1 inhalation dose of umeclidinium at doses of 62.5 or 125 mcg. In the 4 randomized, double-blind, placebo- or active-controlled, efficacy clinical trials, 1,185 subjects received umeclidinium for up to 24 weeks, of which 487 subjects received the recommended dose of umeclidinium 62.5 mcg. In a 12-month, randomized, double-blind, placebo-controlled, long-term safety trial, 227 subjects received umeclidinium 125 mcg for up to 52 weeks [see Clinical Studies ( 14 )] .

8.1 Pregnancy Risk Summary There are insufficient data on the use of umeclidinium in pregnant women to inform a drug‑associated risk. Umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effect on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled dose (MRHDID). (See Data.) The estimated risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: In separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 50 and 200 times the MRHDID, respectively (on an AUC basis at maternal inhalation doses up to 278 mcg/kg/day in rats and at maternal subcutaneous doses up to 180 mcg/kg/day in rabbits). No evidence of teratogenic effects was observed in either species.

Metabolism

Linear pharmacokinetics was observed for umeclidinium (62.5 to 500 mcg). Absorption Umeclidinium plasma levels may not predict therapeutic effect.

High doses of umeclidinium may lead to anticholinergic signs and symptoms. Treatment of overdosage consists of discontinuation of Umeclidinium ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy.

• Dec 18, 2013NDANDA203975Glaxosmithkline
• Apr 30, 2014NDANDA205382Glaxo Grp England
• Sep 18, 2017NDANDA209482Glaxosmithkline

1. 1Dyspnoea8,84214%
2. 2Drug Ineffective5,4518.6%
3. 3Wrong Technique In Device Usage Process5,1568.2%
4. 4Cough4,3276.9%
5. 5Product Dose Omission Issue4,2186.7%
6. 6Product Complaint4,1346.5%
7. 7Death3,0304.8%
8. 8Pneumonia3,0224.8%
9. 9Asthma2,4073.8%
10. 10Chronic Obstructive Pulmonary Disease2,4013.8%
11. 11Fatigue2,0513.2%
12. 12Off Label Use1,9543.1%
13. 13Headache1,9023.0%
14. 14Product Use In Unapproved Indication1,8592.9%
15. 15Condition Aggravated1,6882.7%

The 10 most recently updated of 114 ClinicalTrials.gov registrations naming Umeclidinium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Immuno-inflammatory Response of Erdosteine in COPD
  Not yet recruiting · Interventional · 30 enrolled · Pierachille Santus, MD, PhD
  NCT07329946updated 2026-04-29
• Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD
  Suspended · Interventional · 100 enrolled · Medical University of Bialystok
  NCT07541378updated 2026-04-21
• VENTURI (VENTilation Using Respiratory Imaging)
  Recruiting · Phase 2 · Interventional · 20 enrolled · University of Alabama at Birmingham
  NCT07282886updated 2026-04-13
• Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
  Active not recruiting · Phase 4 · Interventional · 1,366 enrolled · GlaxoSmithKline
  NCT06372496updated 2026-03-24
• Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study
  Completed · Phase 4 · Interventional · 22 enrolled · Thammasat University
  NCT06905483updated 2026-02-02
• 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
  Completed · Phase 4 · Interventional · 463 enrolled · GlaxoSmithKline
  NCT05535972updated 2025-12-11
• Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations
  Completed · Phase 4 · Interventional · 80 enrolled · Baylor Research Institute
  NCT05292053updated 2025-11-21
• A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
  Recruiting · Phase 3 · Interventional · 292 enrolled · GlaxoSmithKline
  NCT05757102updated 2025-10-07
• 129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation
  Not yet recruiting · Phase 4 · Interventional · 60 enrolled · Western University, Canada
  NCT07192016updated 2025-09-25
• Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators
  Recruiting · Phase 4 · Interventional · 72 enrolled · University of Tennessee Graduate School of Medicine
  NCT07133880updated 2025-08-27

Frequently asked questions

How does Umeclidinium work?

Umeclidinium is a 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.

What is Umeclidinium used for?

According to FDA labeling, Umeclidinium carries indications including: Umeclidinium ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Umeclidinium ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Umeclidinium?

Umeclidinium is classified as Anticholinergic, Cholinergic Antagonists, Cholinergic Muscarinic Antagonists, Bronchodilation.

What are the brand names for Umeclidinium?

Umeclidinium is marketed under brand names including Anoro, Incruse, Trelegy.

What are the contraindications for Umeclidinium?

Umeclidinium labeling lists contraindications including: Umeclidinium ELLIPTA is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins [see Warnings and Precautions ( 5.3 )] • Hypersensitivity to umeclidinium or any of the excipients [see Warnings and Precautions ( 5.3 ), Description ( 11 )] • Severe hypersensitivity to milk proteins. ( 4 ) • Hypersensitivity to any ingredient.. Always consult the full prescribing information and a clinician.