> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/umeclidinium-2b71ac68-52ec-4163-963e-d2f7e2cfa063
> Record changed: 2026-10-13

# Umeclidinium

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

First approval year

2013

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

## Development status

**First approval year**

2013

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

**Drug name**

Umeclidinium

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

**Molecular weight**

428.6

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

**Structure (SMILES)**

OC(c1ccccc1)(c1ccccc1)C12CC\[N+\](CCOCc3ccccc3)(CC1)CC2

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

### Other names (27)

- gsk 573719
- GSK-573719
- gsk573719
- GSK573719
- GSK573719 (INHALATION POWDER)
- GSK573719 1000 μg
- GSK573719 125 mcg (one strip)
- GSK573719 125 mcg(two strips)
- GSK573719 125mcg
- GSK573719 250 μg
- GSK573719 250mcg
- GSK573719 500 μg
- GSK573719 500mcg
- GSK573719 62.5 mcg (one strip)
- GSK573719 62.5 mcg(two strips)
- umeclidinium
- Umeclidinium
- UMECLIDINIUM \[USAN\]
- UMECLIDINIUM \[VANDF\]
- Umeclidinium \[WHO-DD\]
- umeclidinium cation
- Umeclidinium cation
- umeclidinium ion
- Umeclidinium ion
- umeclidinium usan

And 2 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- R03BB07

**ChEMBL ID**

CHEMBL1187833

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

**InChIKey**

FVTWTVQXNAJTQP-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1187833)

**PubChem compound IDs**

- 11519070

**FDA ingredient codes (UNII)**

- GE2T1418SV

### CAS registry numbers (2)

- 869113-09-7
- 869185-19-3

### RxNorm IDs (RxCUI) (2)

- 1487512
- 1487514

## Regulatory information

### United States

**Applicant**

GLAXOSMITHKLINE

**Approval date**

18 Dec 2013

**Application number**

NDA203975

### European Union

**Status**

Authorised

**Status date**

20 Mar 2017

**Authorisation date**

20 Mar 2017

**Approved indications**

Rolufta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

**Product number**

EMEA/H/C/004654

**Authorisation holder**

GlaxoSmithKline Trading Services Limited

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

No

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Pulmonary Disease, Chronic Obstructive

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/rolufta-ellipta)

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

umeclidinium

**Type**

Synthetic organic

**Drug name stem**

\-clidinium; -ium

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- topical

### Mechanisms of action (5)

- **Action**  
Antagonist

**Action type**  
Antagonist

**Target**  
M2 receptor

**Gene symbol**  
CHRM2

**Protein identifier**  
P08172

**Median affinity**

9.82

**Affinity units**  
pKi
- **Action**  
Antagonist

**Action type**  
Antagonist

**Target**  
M4 receptor

**Gene symbol**  
CHRM4

**Protein identifier**  
P08173

**Median affinity**

10.3

**Affinity units**  
pKi
- **Action**  
Antagonist

**Action type**  
Antagonist

**Target**  
M5 receptor

**Gene symbol**  
CHRM5

**Protein identifier**  
P08912

**Median affinity**

9.9

**Affinity units**  
pKi
- **Action**  
Antagonist

**Action type**  
Antagonist

**Target**  
M1 receptor

**Gene symbol**  
CHRM1

**Protein identifier**  
P11229

**Median affinity**

9.8

**Affinity units**  
pKi
- **Action**  
Antagonist

**Action type**  
Antagonist

**Target**  
M3 receptor

**Gene symbol**  
CHRM3

**Protein identifier**  
P20309

**Median affinity**

10.22

**Affinity units**  
pKi

### Open Targets mechanisms

- **Mechanism**  
Muscarinic acetylcholine receptor M3 antagonist

**Action type**  
Antagonist

**Target**  
Muscarinic acetylcholine receptor M3

### DrugCentral mechanisms (3)

- **Action type**  
Antagonist

**Gene symbol**  
CHRM4

**Protein identifier**  
P08173

**Organism**  
Homo sapiens

**Target development level**  
Clinical
- **Action type**  
Antagonist

**Gene symbol**  
CHRM5

**Protein identifier**  
P08912

**Organism**  
Homo sapiens

**Target development level**  
Clinical
- **Action type**  
Antagonist

**Gene symbol**  
CHRM3

**Protein identifier**  
P20309

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (3)

- **Condition**  
Pulmonary Disease, Chronic Obstructive

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000341

**Subject identifier**  
D029424
- **Condition**  
Hyperhidrosis

**Highest recorded phase**  
2

**Condition identifier**  
HP:0000975

**Subject identifier**  
D006945
- **Condition**  
Asthma

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0004979

**Subject identifier**  
D001249

### Open Targets indications (7)

- **Condition identifier**  
EFO\_0000341
- **Condition identifier**  
HP\_0000975

**Highest recorded phase**  
1
- **Condition identifier**  
HP\_0002094

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0004979

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004979

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005002

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005249

### Reported adverse events (40)

- **Event**  
angle closure glaucoma

**Reports**  
3

**Reporting signal score**

8.19215
- **Event**  
asthma

**Reports**  
52

**Reporting signal score**

143.291
- **Event**  
blood count abnormal

**Reports**  
19

**Reporting signal score**

58.4348
- **Event**  
blood immunoglobulin e increased

**Reports**  
3

**Reporting signal score**

9.41919
- **Event**  
blood test abnormal

**Reports**  
5

**Reporting signal score**

11.3502
- **Event**  
bronchial wall thickening

**Reports**  
2

**Reporting signal score**

8.12474
- **Event**  
bronchiectasis

**Reports**  
5

**Reporting signal score**

13.6079
- **Event**  
bronchospasm

**Reports**  
8

**Reporting signal score**

16.8602
- **Event**  
bronchospasm paradoxical

**Reports**  
3

**Reporting signal score**

15.7172
- **Event**  
chest discomfort

**Reports**  
10

**Reporting signal score**

9.6496
- **Event**  
choking

**Reports**  
4

**Reporting signal score**

8.77955
- **Event**  
chronic obstructive pulmonary disease

**Reports**  
20

**Reporting signal score**

48.1409
- **Event**  
cough

**Reports**  
41

**Reporting signal score**

60.1426
- **Event**  
diarrhoea

**Reports**  
1

**Reporting signal score**

7.12035
- **Event**  
dyspepsia

**Reports**  
10

**Reporting signal score**

12.9626
- **Event**  
dyspnoea

**Reports**  
59

**Reporting signal score**

65.3154
- **Event**  
dyspnoea exertional

**Reports**  
6

**Reporting signal score**

7.84987
- **Event**  
gastrooesophageal reflux disease

**Reports**  
11

**Reporting signal score**

15.8938
- **Event**  
glaucoma

**Reports**  
8

**Reporting signal score**

19.4055
- **Event**  
halo vision

**Reports**  
3

**Reporting signal score**

12.7882
- **Event**  
lethargy

**Reports**  
9

**Reporting signal score**

10.4816
- **Event**  
loss of personal independence in daily activities

**Reports**  
5

**Reporting signal score**

7.45475
- **Event**  
lung hyperinflation

**Reports**  
2

**Reporting signal score**

7.82244
- **Event**  
mouth swelling

**Reports**  
4

**Reporting signal score**

11.7295
- **Event**  
obstructive airways disorder

**Reports**  
17

**Reporting signal score**

58.8277

And 15 more, listed on the interactive page.

### Trial references (41)

- NCT00475436  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00475436)
- NCT00515502  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00515502)
- NCT00732472  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00732472)
- NCT00976144  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00976144)
- NCT01030965  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01030965)
- NCT01110018  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01110018)
- NCT01128634  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01128634)
- NCT01313637  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01313637)
- NCT01316887  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01316887)
- NCT01316900  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01316900)
- NCT01316913  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01316913)
- NCT01323660  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01323660)
- NCT01328444  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01328444)
- NCT01362257  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01362257)
- NCT01372410  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01372410)
- NCT01376388  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01376388)
- NCT01387230  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01387230)
- NCT01521377  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01521377)
- NCT01521390  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01521390)
- NCT01571999  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01571999)
- NCT01577680  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01577680)
- NCT01636713  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01636713)
- NCT01702363  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01702363)
- NCT01716520  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01716520)
- NCT01777334  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01777334)

And 16 more, listed on the interactive page.

## Dosing

**Dose**

1 actuation (umeclidinium 62.5 mcg)

**Route**

Inhalation

**How often**

Once daily

### Conditions of use (2)

- Do not use more than 1 time every 24 hours
- Use at the same time every day

## Chemical properties

**Hydrogen bond acceptors**

2

**Hydrogen bond donors**

1

**Polar surface area**

29.46

**Calculated partition coefficient (ALogP)**

5.14

**Calculated partition coefficient (XLogP)**

4.7

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

8

**Heavy atoms**

32

**Molecular formula**

C29H34NO2+

**Monoisotopic mass**

428.258954327

**Natural product**

Yes

## Evidence counts

**Recorded assays**

54

**Active assays**

14

### Active assay types (2)

- Confirmatory
- Other

## Related records

### Trials (149)

- 24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease
- 24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease
- 28-day Repeat Dose Study of GSK573719
- A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD
- A 24-week Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 125/25 mcg and 62.5/25mcg Inhalation Powder Compared With Placebo in Subjects With COPD
- A 6-month Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade
- A Bioequivalence Study Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions
- A Bioequivalence Study Between Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions
- A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade (BREATH-PK250-CC)
- A Clinical Study Evaluating the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients
- A Clinical Study of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease
- A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Participants
- A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
- A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease.
- A Clinical Trial Comparing TQC3927 Inhaled Powder With Glycopyrronium Bromide and Formoterol Inhaled Aerosol (Biovoping® Lingchang®) for the Treatment of Chronic Obstructive Pulmonary Disease
- A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma
- A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease
- A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy

### In development for (2)

- [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Phase 2
- [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Phase 3

### Targets (1)

- [CHRM3](https://trialight.com/data/target/chrm3-0610da06-d23d-5bc0-b133-4b5bb330f58e.md) Muscarinic acetylcholine receptor M3 antagonist

---

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