umeclidinium 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
muscarinic receptors agonists/antagonists 4816 869113-09-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • incruse
  • umeclidinium
  • GSK573719A
  • umeclidinium bromide
a long-acting antimuscarinic agent with similar affinity to the subtypes of muscarinic receptors M1 to M5, in the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation
  • Molecular weight: 428.60
  • Formula: C29H34NO2
  • CLOGP: 1.60
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 29.46
  • ALOGS: -7.38
  • ROTB: 8

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
55 mcg Inhal.powder

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 1.23 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 35.95 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.11 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 19 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 18, 2013 FDA GLAXOSMITHKLINE
July 4, 2014 PMDA GLAXOSMITHKLINE K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Wheezing 369.62 23.30 172 6204 61875 50536873
Obstructive airways disorder 291.40 23.30 99 6277 15553 50583195
Asthma 256.48 23.30 152 6224 89185 50509563
Nasal polyps 228.32 23.30 55 6321 2499 50596249
Full blood count abnormal 194.17 23.30 82 6294 23306 50575442
Cough 172.32 23.30 180 6196 241084 50357664
Sleep disorder due to a general medical condition 166.55 23.30 54 6322 7317 50591431
Dyspnoea 151.45 23.30 256 6120 547352 50051396
Sputum discoloured 149.09 23.30 58 6318 13337 50585411
Therapeutic product effect incomplete 139.16 23.30 105 6271 91410 50507338
Productive cough 113.85 23.30 75 6301 52619 50546129
Asthma-chronic obstructive pulmonary disease overlap syndrome 108.05 23.30 22 6354 453 50598295
Salpingo-oophorectomy unilateral 105.20 23.30 22 6354 519 50598229
Sputum increased 101.35 23.30 27 6349 1840 50596908
Sinusitis fungal 100.80 23.30 25 6351 1281 50597467
Osteoporosis 99.66 23.30 65 6311 44814 50553934
Respiratory symptom 98.99 23.30 28 6348 2386 50596362
Loss of personal independence in daily activities 96.81 23.30 76 6300 69974 50528774
Dyspnoea exertional 94.17 23.30 66 6310 51167 50547581
Hiatus hernia 94.04 23.30 46 6330 18298 50580450
Embolism venous 93.28 23.30 27 6349 2498 50596250
Total lung capacity increased 93.26 23.30 21 6355 706 50598042
Gastrooesophageal reflux disease 93.07 23.30 77 6299 76351 50522397
Female genital tract fistula 83.36 23.30 27 6349 3639 50595109
Diastolic dysfunction 81.08 23.30 29 6347 5273 50593475
Emphysema 72.45 23.30 31 6345 9062 50589686
Venous pressure jugular increased 71.19 23.30 16 6360 533 50598215
Chronic obstructive pulmonary disease 69.55 23.30 56 6320 53379 50545369
Kyphosis 69.31 23.30 21 6355 2274 50596474
Oedema peripheral 63.08 23.30 88 6288 157873 50440875
Chronic sinusitis 62.69 23.30 25 6351 6120 50592628
Rhinitis allergic 62.20 23.30 26 6350 7174 50591574
Chest discomfort 61.95 23.30 67 6309 92655 50506093
Disease recurrence 59.56 23.30 35 6341 20046 50578702
Tricuspid valve incompetence 59.44 23.30 30 6346 12740 50586008
Bronchiectasis 59.40 23.30 28 6348 10255 50588493
Diverticulum 55.53 23.30 27 6349 10587 50588161
Sarcoidosis 53.23 23.30 21 6355 4996 50593752
Eczema 53.10 23.30 34 6342 22668 50576080
Rectal prolapse 52.80 23.30 16 6360 1733 50597015
Hysterectomy 50.29 23.30 23 6353 7867 50590881
Iron deficiency anaemia 49.03 23.30 29 6347 16805 50581943
Upper-airway cough syndrome 48.52 23.30 23 6353 8527 50590221
Pneumococcal infection 47.98 23.30 11 6365 401 50598347
Sleep apnoea syndrome 46.74 23.30 32 6344 23836 50574912
Bundle branch block left 45.57 23.30 20 6356 6210 50592538
Cardiac murmur 43.46 23.30 23 6353 10761 50587987
Sputum purulent 43.26 23.30 12 6364 951 50597797
Lung neoplasm malignant 40.76 23.30 25 6351 15459 50583289
Candida infection 40.16 23.30 29 6347 23494 50575254
Osteoarthritis 39.66 23.30 46 6330 68560 50530188
Chorea 39.35 23.30 12 6364 1328 50597420
Tooth injury 34.17 23.30 10 6366 961 50597787
Nicotine dependence 33.32 23.30 9 6367 646 50598102
Blood test abnormal 31.65 23.30 19 6357 11300 50587448
Secondary immunodeficiency 28.02 23.30 9 6367 1179 50597569
Fungal infection 27.98 23.30 26 6350 29939 50568809
Pulmonary embolism 25.69 23.30 46 6330 101658 50497090
Pneumonia respiratory syncytial viral 24.22 23.30 7 6369 643 50598105
Respiratory gas exchange disorder 23.59 23.30 6 6370 340 50598408

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 373.81 34.60 164 5526 33685 29535152
Wheezing 328.31 34.60 149 5541 33091 29535746
Obstructive airways disorder 323.61 34.60 109 5581 10907 29557930
Therapeutic product effect incomplete 322.63 34.60 155 5535 39150 29529687
Full blood count abnormal 244.00 34.60 96 5594 14917 29553920
Bronchial wall thickening 220.39 34.60 49 5641 1003 29567834
Appendicolith 197.27 34.60 57 5633 3423 29565414
Pulmonary function test abnormal 168.05 34.60 45 5645 2037 29566800
Right atrial hypertrophy 157.19 34.60 33 5657 509 29568328
Appendicitis 145.54 34.60 57 5633 8722 29560115
Bronchiectasis 135.25 34.60 50 5640 6535 29562302
Bronchial secretion retention 132.39 34.60 33 5657 1120 29567717
Right ventricular hypertrophy 132.17 34.60 33 5657 1128 29567709
Loss of personal independence in daily activities 126.87 34.60 72 5618 25368 29543469
Obstruction 115.61 34.60 33 5657 1893 29566944
Aortic valve stenosis 111.16 34.60 33 5657 2175 29566662
Cardiogenic shock 105.70 34.60 58 5632 19132 29549705
Cough 104.59 34.60 125 5565 126602 29442235
Productive cough 103.28 34.60 68 5622 31191 29537646
Stress 96.93 34.60 57 5633 21433 29547404
Dyspnoea 94.84 34.60 199 5491 326533 29242304
Diastolic dysfunction 84.31 34.60 33 5657 5031 29563806
Sleep disorder due to a general medical condition 83.89 34.60 29 5661 3117 29565720
Intervertebral disc degeneration 83.07 34.60 33 5657 5231 29563606
Chest X-ray abnormal 82.29 34.60 30 5660 3764 29565073
Ascites 69.44 34.60 57 5633 36562 29532275
Pulmonary function test decreased 68.84 34.60 27 5663 4136 29564701
Sleep apnoea syndrome 67.28 34.60 42 5648 17557 29551280
Blood test abnormal 66.90 34.60 29 5661 5720 29563117
Abdominal distension 64.02 34.60 60 5630 45851 29522986
Osteoporosis 63.29 34.60 34 5656 10735 29558102
Blood immunoglobulin E increased 59.96 34.60 20 5670 1927 29566910
Benign prostatic hyperplasia 57.92 34.60 33 5657 11677 29557160
Pleural thickening 57.03 34.60 13 5677 298 29568539
Hypoacusis 56.58 34.60 35 5655 14388 29554449
Hyponatraemia 52.80 34.60 65 5625 67568 29501269
Gout 49.12 34.60 34 5656 16877 29551960
Eosinophil count increased 48.21 34.60 25 5665 7344 29561493
Inspiratory capacity abnormal 46.45 34.60 9 5681 90 29568747
Breath sounds abnormal 46.02 34.60 22 5668 5435 29563402
Gastrooesophageal reflux disease 45.49 34.60 42 5648 31454 29537383
Multiple organ dysfunction syndrome 45.02 34.60 58 5632 63058 29505779
Ocular discomfort 42.83 34.60 15 5675 1674 29567163
Chest discomfort 42.16 34.60 48 5642 45935 29522902
Ventricular fibrillation 41.73 34.60 30 5660 15803 29553034
Iron deficiency 41.08 34.60 17 5673 2988 29565849
Dyspnoea exertional 40.26 34.60 42 5648 36448 29532389
Constipation 38.09 34.60 74 5616 114086 29454751
Asthma-chronic obstructive pulmonary disease overlap syndrome 36.93 34.60 11 5679 732 29568105

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Obstructive airways disorder 559.25 23.66 192 10797 22993 64464750
Wheezing 557.07 23.66 272 10717 80307 64407436
Asthma 452.47 23.66 250 10739 94975 64392768
Full blood count abnormal 357.34 23.66 148 10841 29609 64458134
Therapeutic product effect incomplete 309.79 23.66 202 10787 103280 64384463
Cough 234.50 23.66 272 10717 301876 64185867
Appendicolith 199.60 23.66 56 10933 3413 64484330
Productive cough 197.31 23.66 134 10855 73069 64414674
Bronchial wall thickening 192.21 23.66 48 10941 1859 64485884
Bronchiectasis 182.08 23.66 74 10915 14066 64473677
Pulmonary function test abnormal 177.15 23.66 50 10939 3114 64484629
Nasal polyps 174.78 23.66 51 10938 3578 64484165
Dyspnoea 172.42 23.66 377 10612 718297 63769446
Diastolic dysfunction 162.52 23.66 60 10929 8815 64478928
Right atrial hypertrophy 160.96 23.66 33 10956 512 64487231
Loss of personal independence in daily activities 156.72 23.66 116 10873 72338 64415405
Osteoporosis 155.42 23.66 94 10895 41986 64445757
Sleep disorder due to a general medical condition 141.01 23.66 53 10936 8181 64479562
Sputum discoloured 140.31 23.66 66 10923 17790 64469953
Gastrooesophageal reflux disease 136.27 23.66 113 10876 83030 64404713
Right ventricular hypertrophy 131.90 23.66 33 10956 1287 64486456
Asthma-chronic obstructive pulmonary disease overlap syndrome 126.90 23.66 31 10958 1094 64486649
Appendicitis 124.93 23.66 56 10933 13513 64474230
Dyspnoea exertional 120.36 23.66 100 10889 73630 64414113
Sleep apnoea syndrome 116.24 23.66 69 10920 29763 64457980
Bronchial secretion retention 110.67 23.66 33 10956 2494 64485249
Obstruction 102.51 23.66 33 10956 3215 64484528
Blood test abnormal 99.09 23.66 47 10942 12896 64474847
Aortic valve stenosis 91.40 23.66 33 10956 4547 64483196
Chest discomfort 90.38 23.66 105 10884 116001 64371742
Salpingo-oophorectomy unilateral 89.44 23.66 20 10969 476 64487267
Respiratory symptom 84.16 23.66 28 10961 3025 64484718
Cardiogenic shock 81.67 23.66 57 10932 32370 64455373
Sinusitis fungal 77.85 23.66 23 10966 1683 64486060
Total lung capacity increased 77.27 23.66 19 10970 689 64487054
Female genital tract fistula 75.76 23.66 25 10964 2633 64485110
Upper-airway cough syndrome 73.79 23.66 34 10955 8736 64479007
Hiatus hernia 72.13 23.66 44 10945 19913 64467830
Sputum increased 71.82 23.66 26 10963 3609 64484134
Chest X-ray abnormal 69.33 23.66 30 10959 6651 64481092
Benign prostatic hyperplasia 69.29 23.66 33 10956 9132 64478611
Embolism venous 68.97 23.66 25 10964 3482 64484261
Chronic obstructive pulmonary disease 68.65 23.66 72 10917 70976 64416767
Intervertebral disc degeneration 60.83 23.66 34 10955 13086 64474657
Pulmonary function test decreased 60.53 23.66 27 10962 6434 64481309
Ascites 60.19 23.66 63 10926 61938 64425805
Eczema 56.27 23.66 44 10945 29676 64458067
Stress 56.08 23.66 60 10929 60474 64427269
Kyphosis 54.42 23.66 19 10970 2374 64485369
Venous pressure jugular increased 53.17 23.66 16 10973 1247 64486496
Blood immunoglobulin E increased 52.50 23.66 21 10968 3823 64483920
Chronic sinusitis 48.61 23.66 23 10966 6269 64481474
Rectal prolapse 48.25 23.66 16 10973 1710 64486033
Abdominal distension 46.81 23.66 69 10920 95925 64391818
Hypoacusis 46.18 23.66 37 10952 25830 64461913
Rhinitis allergic 46.01 23.66 24 10965 8054 64479689
Gout 45.58 23.66 34 10955 21379 64466364
Hysterectomy 43.67 23.66 20 10969 5065 64482678
Emphysema 43.25 23.66 28 10961 14041 64473702
Eosinophil count increased 43.17 23.66 28 10961 14084 64473659
Inspiratory capacity abnormal 41.99 23.66 8 10981 83 64487660
Sputum purulent 40.92 23.66 13 10976 1213 64486530
Multiple organ dysfunction syndrome 39.84 23.66 66 10923 101347 64386396
Tricuspid valve incompetence 38.45 23.66 28 10961 16975 64470768
Diverticulum 37.49 23.66 25 10964 13173 64474570
Sinusitis 37.33 23.66 79 10910 145849 64341894
Pneumococcal infection 37.16 23.66 11 10978 810 64486933
Sarcoidosis 37.13 23.66 19 10970 6127 64481616
Oedema peripheral 36.61 23.66 98 10891 210219 64277524
Drug interaction 35.49 23.66 9 10980 362074 64125669
Breath sounds abnormal 35.32 23.66 23 10966 11646 64476097
Cardiac failure congestive 34.92 23.66 72 10917 130508 64357235
Disease recurrence 32.33 23.66 33 10956 31477 64456266
Iron deficiency anaemia 32.20 23.66 28 10961 21861 64465882
Ventricular fibrillation 32.07 23.66 29 10960 23831 64463912
Chorea 31.09 23.66 12 10977 1988 64485755
Bundle branch block left 30.92 23.66 20 10969 10014 64477729
Pleural thickening 30.86 23.66 13 10976 2697 64485046
Iron deficiency 28.98 23.66 17 10972 7160 64480583
Systolic dysfunction 28.78 23.66 13 10976 3189 64484554
Toxicity to various agents 28.75 23.66 13 10976 363500 64124243
Nicotine dependence 28.70 23.66 9 10980 805 64486938
Osteoarthritis 28.68 23.66 44 10945 63292 64424451
Bronchial hyperreactivity 28.44 23.66 12 10977 2500 64485243
Cardiac murmur 28.34 23.66 20 10969 11543 64476200
Drug ineffective 27.92 23.66 64 10925 840183 63647560
Tooth injury 27.86 23.66 10 10979 1353 64486390
Diaphragmatic disorder 27.41 23.66 10 10979 1418 64486325
Constipation 26.85 23.66 93 10896 229244 64258499
Hyponatraemia 26.68 23.66 70 10919 148269 64339474
Bronchopulmonary aspergillosis allergic 26.17 23.66 10 10979 1612 64486131
Ocular discomfort 26.02 23.66 13 10976 3986 64483757
Asthenia 25.91 23.66 21 10968 428023 64059720
Seasonal allergy 25.81 23.66 19 10970 11707 64476036
Neutropenia 25.39 23.66 5 10984 239619 64248124
Lung neoplasm malignant 24.85 23.66 24 10965 21424 64466319

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R03AL03 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL08 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BB07 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Anticholinergics
FDA MoA N0000175370 Cholinergic Antagonists
FDA EPC N0000175574 Anticholinergic
CHEBI has role CHEBI:48876 muscarinic antagonists

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic obstructive lung disease indication 13645005 DOID:3083
Chronic bronchitis indication 63480004 DOID:6132
Pulmonary emphysema indication 87433001
Asthma indication 195967001 DOID:2841




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION RE44874 March 23, 2023 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION RE44874 March 23, 2023 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION RE44874 March 23, 2023 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA; AND ASTHMA
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 9, 2020 RX POWDER INHALATION RE44874 March 23, 2023 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA; AND ASTHMA
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION 8309572 April 27, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
EQ 62.5MCG BASE/INH INCRUSE ELLIPTA GLAXO GRP ENGLAND N205382 April 30, 2014 RX POWDER INHALATION 8309572 April 27, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 8309572 April 27, 2025 METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 9, 2020 RX POWDER INHALATION 8309572 April 27, 2025 METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION 7439393 May 21, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 7439393 May 21, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 7439393 May 21, 2025 MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 18 YRS AND OLDER, OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 9, 2020 RX POWDER INHALATION 7439393 May 21, 2025 MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 18 YRS AND OLDER, OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION 8183257 July 27, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
EQ 62.5MCG BASE/INH INCRUSE ELLIPTA GLAXO GRP ENGLAND N205382 April 30, 2014 RX POWDER INHALATION 8183257 July 27, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 8183257 July 27, 2025 METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA INHALATION
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 8183257 July 27, 2025 METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 9, 2020 RX POWDER INHALATION 8183257 July 27, 2025 METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION 8511304 June 14, 2027 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 8511304 June 14, 2027 METHOD OF DISPENSING A COMBINATION MEDICAMENT PRODUCT FROM CLAIMED DELIVERY DEVICE, FOR EXAMPLE FOR THE TREATMENT OF ASTHMA OR COPD
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 9, 2020 RX POWDER INHALATION 8511304 June 14, 2027 METHOD OF DISPENSING A COMBINATION MEDICAMENT PRODUCT FROM CLAIMED DELIVERY DEVICE, FOR EXAMPLE FOR THE TREATMENT OF ASTHMA OR COPD
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION 11090294 Nov. 29, 2030 MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 11090294 Nov. 29, 2030 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) COMPRISING THE ONCE PER DAY ADMINISTRATION OF TRELEGY ELLIPTA, 100 MCG FLUTICASONE FUROATE/62.5 MCG UMECLIDINIUM/25 MCG VILANTEROL

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION June 9, 2022 ADDITIONAL INFORMATION ADDED TO THE LABELING BASED ON SAFETY AND EFFICACY DATA FROM THE IMPACT TRIAL
EQ 62.5MCG BASE/INH INCRUSE ELLIPTA GLAXO GRP ENGLAND N205382 April 30, 2014 RX POWDER INHALATION June 9, 2022 ADDITIONAL INFORMATION ADDED TO THE LABELING BASED ON SAFETY AND EFFICACY DATA FROM THE IMPACT TRIAL
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION Sept. 9, 2023 MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 9, 2020 RX POWDER INHALATION Sept. 9, 2023 NEW STRENGTH

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 10.22 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Muscarinic acetylcholine receptor M4 GPCR ANTAGONIST Ki 10.30 IUPHAR
Muscarinic acetylcholine receptor M5 GPCR ANTAGONIST Ki 9.90 IUPHAR
Muscarinic acetylcholine receptor M1 GPCR Ki 9.80 SCIENTIFIC LITERATURE
Muscarinic acetylcholine receptor M2 GPCR Ki 9.82 SCIENTIFIC LITERATURE

External reference:

IDSource
D10180 KEGG_DRUG
4033108 VANDF
4033109 VANDF
CHEBI:79040 CHEBI
CHEMBL1187833 ChEMBL_ID
C573971 MESH_SUPPLEMENTAL_RECORD_UI
7354 IUPHAR_LIGAND_ID
DB09076 DRUGBANK_ID
GE2T1418SV UNII
11519070 PUBCHEM_CID
1487512 RXNORM
d08187 MMSL
015344 NDDF
015345 NDDF
706898002 SNOMEDCT_US
706899005 SNOMEDCT_US
715611006 SNOMEDCT_US
C3661274 UMLSCUI
CHEMBL523299 ChEMBL_ID
9551 INN_ID
869185-19-3 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Anoro Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 0173-0869 POWDER 62.50 ug RESPIRATORY (INHALATION) NDA 27 sections
Incruse Ellipta HUMAN PRESCRIPTION DRUG LABEL 1 0173-0873 AEROSOL, POWDER 62.50 ug ORAL NDA 27 sections
Incruse Ellipta HUMAN PRESCRIPTION DRUG LABEL 1 0173-0873 AEROSOL, POWDER 62.50 ug ORAL NDA 27 sections
Trelegy Ellipta HUMAN PRESCRIPTION DRUG LABEL 3 0173-0887 POWDER 62.50 ug RESPIRATORY (INHALATION) NDA 27 sections
Trelegy Ellipta HUMAN PRESCRIPTION DRUG LABEL 3 0173-0887 POWDER 62.50 ug RESPIRATORY (INHALATION) NDA 27 sections
Trelegy Ellipta HUMAN PRESCRIPTION DRUG LABEL 3 0173-0893 POWDER 62.50 ug RESPIRATORY (INHALATION) NDA 27 sections
Trelegy Ellipta HUMAN PRESCRIPTION DRUG LABEL 3 0173-0893 POWDER 62.50 ug RESPIRATORY (INHALATION) NDA 27 sections