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

Stem definitionDrug idCAS RN
beta3-adrenoreceptor agonists 4382 223673-61-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • YM178
  • myrbetriq
  • mirabegron
a beta-3 adrenergic agonist, relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity
  • Molecular weight: 396.51
  • Formula: C21H24N4O2S
  • CLOGP: 1.32
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 4
  • TPSA: 100.27
  • ALOGS: -4.98
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 23.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 13.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.29 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 28, 2012 FDA APGDI

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
Blepharospasm 196.87 12.50 75 21715 5921 63461311
Taste disorder 160.34 12.50 83 21707 13579 63453653
Urinary retention 160.09 12.50 110 21680 30191 63437041
Urinary tract infection 141.91 12.50 293 21497 264391 63202841
Blood pressure increased 123.83 12.50 209 21581 161853 63305379
Intentional product misuse 114.34 12.50 122 21668 60795 63406437
Memory impairment 112.78 12.50 158 21632 104100 63363132
Epilepsy 110.38 12.50 84 21706 26981 63440251
Urinary incontinence 89.92 12.50 80 21710 31934 63435298
Fall 78.87 12.50 304 21486 392030 63075202
Toxicity to various agents 71.99 12.50 3 21787 247247 63219985
Migraine 68.11 12.50 125 21665 103221 63364011
Drug dispensed to wrong patient 53.90 12.50 14 21776 308 63466924
Hypertension 53.24 12.50 213 21577 279090 63188142
Off label use 53.17 12.50 404 21386 674058 62793174
Residual urine volume increased 52.39 12.50 10 21780 47 63467185
Multiple sclerosis relapse 51.66 12.50 73 21717 48405 63418827
Multiple sclerosis 51.42 12.50 52 21738 24320 63442912
Contraindicated product administered 51.23 12.50 7 21783 217641 63249591
Gastrooesophageal reflux disease 51.21 12.50 106 21684 95533 63371699
Cystitis 50.22 12.50 77 21713 54914 63412318
Hypoaesthesia 49.15 12.50 148 21642 168245 63298987
Dry mouth 46.10 12.50 90 21700 77773 63389459
Paraesthesia 43.97 12.50 136 21654 156830 63310402
Bladder pain 42.17 12.50 19 21771 2289 63464943
Kidney infection 40.97 12.50 45 21745 23131 63444101
Pemphigus 40.74 12.50 7 21783 183719 63283513
Abdominal pain upper 39.74 12.50 158 21632 206286 63260946
Pollakiuria 38.93 12.50 48 21742 27889 63439343
Maternal exposure during pregnancy 38.02 12.50 14 21776 220048 63247184
Antineutrophil cytoplasmic antibody increased 36.73 12.50 9 21781 155 63467077
Sinonasal obstruction 36.62 12.50 10 21780 268 63466964
Scleral discolouration 36.25 12.50 11 21779 432 63466800
Therapeutic product effect decreased 35.61 12.50 11 21779 193176 63274056
Exposure during pregnancy 34.32 12.50 6 21784 155541 63311691
Micturition urgency 33.08 12.50 27 21763 9584 63457648
Muscular weakness 31.49 12.50 103 21687 122250 63344982
Treatment failure 30.64 12.50 15 21775 199028 63268204
Anal incontinence 30.54 12.50 30 21760 13546 63453686
Gait disturbance 30.40 12.50 134 21656 183044 63284188
On and off phenomenon 30.05 12.50 14 21776 1821 63465411
Anxiety disorder 29.50 12.50 18 21772 4032 63463200
Pericarditis 29.19 12.50 5 21785 131574 63335658
Sputum retention 29.00 12.50 10 21780 592 63466640
Systemic lupus erythematosus 28.89 12.50 18 21772 208900 63258332
Intercepted medication error 28.68 12.50 10 21780 612 63466620
Bladder disorder 28.43 12.50 24 21766 8922 63458310
Swelling 27.95 12.50 32 21758 275346 63191886
Synovitis 27.41 12.50 15 21775 186903 63280329
Glossodynia 26.75 12.50 14 21776 178862 63288370
Dermatitis atopic 26.70 12.50 24 21766 9700 63457532
Lip disorder 26.51 12.50 12 21778 1462 63465770
Urinary tract disorder 26.50 12.50 15 21775 2926 63464306
Vitamin D deficiency 26.35 12.50 28 21762 13864 63453368
Vascular stenosis 25.49 12.50 8 21782 352 63466880
Palpitations 24.71 12.50 90 21700 112680 63354552
Hand deformity 24.56 12.50 12 21778 159445 63307787
Rheumatoid arthritis 24.16 12.50 31 21759 253788 63213444
Dementia 24.13 12.50 31 21759 18763 63448469
Discomfort 23.72 12.50 14 21776 167360 63299872
Balance disorder 23.47 12.50 73 21717 84349 63382883
Lymphocyte count decreased 23.01 12.50 39 21751 30218 63437014
Disease progression 22.60 12.50 7 21783 122751 63344481
Dysuria 22.44 12.50 41 21749 33697 63433535
Schizophrenia 22.40 12.50 22 21768 9930 63457302
Infusion related reaction 22.33 12.50 31 21759 245490 63221742
Nocturia 22.17 12.50 20 21770 8121 63459111
Drug hypersensitivity 22.04 12.50 46 21744 310641 63156591
Arthropathy 22.01 12.50 29 21761 234763 63232469
Feeling drunk 21.77 12.50 15 21775 4127 63463105
Arrhythmia 21.25 12.50 43 21747 38097 63429135
Lip swelling 20.98 12.50 38 21752 31025 63436207
Idiopathic orbital inflammation 20.83 12.50 6 21784 196 63467036
Haemorrhoids 20.19 12.50 31 21759 22119 63445113
Product blister packaging issue 20.17 12.50 6 21784 220 63467012
Tender joint count 20.04 12.50 6 21784 225 63467007
Clubbing 19.91 12.50 7 21783 439 63466793
Dizziness 19.81 12.50 230 21560 429695 63037537
Rheumatoid factor positive 19.18 12.50 3 21787 84403 63382829
Anti-cyclic citrullinated peptide antibody positive 19.06 12.50 8 21782 116204 63351028
Metastatic neoplasm 18.99 12.50 14 21776 4281 63462951
Wound 18.79 12.50 17 21773 163246 63303986
Lung neoplasm malignant 18.63 12.50 28 21762 19605 63447627
Pharyngeal mass 18.40 12.50 6 21784 299 63466933
Thrombocytopenia 18.30 12.50 15 21775 151142 63316090
Loefgren syndrome 18.20 12.50 5 21785 137 63467095
Neutropenia 18.11 12.50 20 21770 174985 63292247
Product packaging quantity issue 18.11 12.50 9 21781 1350 63465882
Hypertensive crisis 17.75 12.50 24 21766 15262 63451970
Dyskinesia 17.74 12.50 36 21754 31966 63435266
Constipation 17.72 12.50 135 21655 224808 63242424
Pyrexia 16.72 12.50 94 21696 470384 62996848
Duodenal ulcer perforation 16.00 12.50 5 21785 87204 63380028
Hypothyroidism 15.89 12.50 41 21749 42591 63424641
Mouth swelling 15.65 12.50 13 21777 4727 63462505
Hypersensitivity 15.63 12.50 50 21740 292635 63174597
Steroid diabetes 15.49 12.50 8 21782 1300 63465932
Product use in unapproved indication 14.96 12.50 109 21681 178971 63288261
Urine albumin/creatinine ratio decreased 14.95 12.50 4 21786 99 63467133
Diabetic ketosis 14.93 12.50 5 21785 271 63466961
Dyspepsia 14.89 12.50 72 21718 102124 63365108
Magnetic resonance imaging head abnormal 14.80 12.50 9 21781 2004 63465228
Persistent genital arousal disorder 14.75 12.50 5 21785 281 63466951
Conjunctival discolouration 14.69 12.50 4 21786 106 63467126
Hyperventilation 14.67 12.50 14 21776 6102 63461130
Angina pectoris 14.54 12.50 32 21758 30046 63437186
Allergy to arthropod bite 14.31 12.50 5 21785 308 63466924
VIIth nerve injury 14.25 12.50 4 21786 119 63467113
Sleep apnoea syndrome 14.09 12.50 31 21759 29102 63438130
Wrong patient received product 14.03 12.50 9 21781 2198 63465034
Febrile neutropenia 14.03 12.50 12 21778 118437 63348795
Cystitis interstitial 13.94 12.50 8 21782 1600 63465632
Pancreatitis necrotising 13.48 12.50 8 21782 1704 63465528
Hyperlipidaemia 13.29 12.50 24 21766 19547 63447685
Blister 13.24 12.50 15 21775 129799 63337433
COVID-19 13.24 12.50 75 21715 113028 63354204
Concussion 13.07 12.50 16 21774 9228 63458004
Muscle atrophy 13.03 12.50 14 21776 7019 63460213
Neurogenic bladder 12.96 12.50 10 21780 3275 63463957
Breast disorder 12.92 12.50 9 21781 2521 63464711
Muscle tightness 12.79 12.50 18 21772 11882 63455350

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
Urinary retention 180.79 16.41 115 9131 36173 34911512
Hallucination 117.41 16.41 102 9144 51396 34896289
Fall 81.60 16.41 171 9075 202714 34744971
Confusional state 56.07 16.41 120 9126 144040 34803645
Intentional product misuse 50.05 16.41 61 9185 45550 34902135
Urinary tract infection 46.13 16.41 81 9165 84000 34863685
Platypnoea 45.04 16.41 8 9238 32 34947653
Nocturia 44.97 16.41 30 9216 10180 34937505
Urinary incontinence 42.16 16.41 37 9209 18837 34928848
Micturition urgency 40.93 16.41 24 9222 6501 34941184
Phaeochromocytoma malignant 39.51 16.41 8 9238 72 34947613
Delusion 39.22 16.41 30 9216 12605 34935080
Blood pressure increased 32.65 16.41 72 9174 88030 34859655
Arrhythmia 31.59 16.41 43 9203 35765 34911920
Dementia 30.80 16.41 27 9219 13721 34933964
Gait disturbance 29.78 16.41 68 9178 85072 34862613
Bone marrow oedema 26.50 16.41 9 9237 663 34947022
Pollakiuria 24.35 16.41 28 9218 19646 34928039
Constipation 23.84 16.41 85 9161 136897 34810788
Spinal cord haemorrhage 23.72 16.41 7 9239 326 34947359
Prescribed underdose 22.99 16.41 19 9227 8914 34938771
Blood pressure systolic increased 22.45 16.41 29 9217 22923 34924762
Drug ineffective 21.98 16.41 200 9046 456551 34491134
Oesophageal dilatation 21.85 16.41 6 9240 215 34947470
Dysuria 21.55 16.41 31 9215 27121 34920564
Extradural haematoma 21.51 16.41 9 9237 1180 34946505
Hypertensive crisis 21.25 16.41 18 9228 8733 34938952
On and off phenomenon 20.61 16.41 11 9235 2486 34945199
Toxicity to various agents 20.44 16.41 14 9232 200348 34747337
Cerebral infarction 19.85 16.41 30 9216 27425 34920260
Hallucination, visual 19.83 16.41 24 9222 17767 34929918
Device dislocation 19.75 16.41 15 9231 6234 34941451
Embedded device 19.45 16.41 6 9240 325 34947360
Head injury 19.43 16.41 24 9222 18136 34929549
Dropped head syndrome 19.13 16.41 5 9241 148 34947537
Cystitis interstitial 18.46 16.41 5 9241 170 34947515
Dyskinesia oesophageal 18.34 16.41 4 9242 53 34947632
Blood pressure abnormal 18.31 16.41 16 9230 8090 34939595
Orthostatic hypotension 18.28 16.41 28 9218 25891 34921794
Heart rate abnormal 17.79 16.41 9 9237 1822 34945863
Vasoplegia syndrome 17.67 16.41 9 9237 1847 34945838
Hypertonic bladder 17.64 16.41 9 9237 1855 34945830
Perineal pain 17.43 16.41 7 9239 826 34946859
Oesophageal obstruction 16.93 16.41 6 9240 502 34947183
Product use complaint 16.78 16.41 8 9238 1424 34946261
Blood prolactin decreased 16.48 16.41 5 9241 256 34947429

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
Urinary retention 196.73 12.25 155 25260 56475 79662498
Urinary tract infection 144.62 12.25 289 25126 274223 79444750
Fall 136.67 12.25 402 25013 487227 79231746
Blepharospasm 129.68 12.25 54 25361 5797 79713176
Taste disorder 108.85 12.25 66 25349 15757 79703216
Urinary incontinence 102.88 12.25 93 25322 40816 79678157
Memory impairment 84.76 12.25 138 25277 111596 79607377
Toxicity to various agents 84.58 12.25 16 25399 421524 79297449
Hallucination 70.65 12.25 110 25305 85635 79633338
Blood pressure increased 69.54 12.25 185 25230 211175 79507798
Gait disturbance 58.76 12.25 172 25243 207334 79511639
Migraine 54.42 12.25 99 25316 87394 79631579
Cystitis 54.05 12.25 75 25340 52657 79666316
Micturition urgency 51.33 12.25 38 25377 12603 79706370
Epilepsy 50.98 12.25 64 25351 40796 79678177
Bladder pain 49.88 12.25 21 25394 2316 79716657
Pollakiuria 49.04 12.25 60 25355 37257 79681716
Residual urine volume increased 48.41 12.25 9 25406 39 79718934
Multiple sclerosis relapse 45.93 12.25 65 25350 46468 79672505
Drug dispensed to wrong patient 44.06 12.25 14 25401 692 79718281
Hypoaesthesia 43.61 12.25 141 25274 179211 79539762
Platypnoea 43.55 12.25 8 25407 32 79718941
On and off phenomenon 43.30 12.25 21 25394 3219 79715754
Hypertension 43.10 12.25 214 25201 330778 79388195
Kidney infection 40.46 12.25 42 25373 21809 79697164
Confusional state 38.87 12.25 202 25213 317795 79401178
Phaeochromocytoma malignant 38.02 12.25 8 25407 72 79718901
Dysuria 37.35 12.25 62 25353 50889 79668084
Muscular weakness 36.95 12.25 124 25291 160605 79558368
Multiple sclerosis 34.55 12.25 39 25376 22243 79696730
Intentional product misuse 34.02 12.25 86 25329 95079 79623894
Arrhythmia 33.95 12.25 66 25349 61206 79657767
Dry mouth 33.00 12.25 81 25334 87938 79631035
Nocturia 32.23 12.25 30 25385 13651 79705322
Dementia 31.35 12.25 39 25376 24620 79694353
Sinonasal obstruction 31.10 12.25 9 25406 323 79718650
Paraesthesia 29.64 12.25 123 25292 176200 79542773
Scleral discolouration 29.55 12.25 10 25405 603 79718370
Gastrooesophageal reflux disease 29.07 12.25 86 25329 104160 79614813
Thrombocytopenia 27.95 12.25 26 25389 265233 79453740
Delusion 27.09 12.25 33 25382 20390 79698583
Anal incontinence 25.15 12.25 30 25385 18138 79700835
Hypertonic bladder 25.04 12.25 16 25399 4185 79714788
Antineutrophil cytoplasmic antibody increased 24.84 12.25 7 25408 228 79718745
Abdominal pain upper 24.49 12.25 138 25277 223681 79495292
Constipation 24.35 12.25 164 25251 282886 79436087
Balance disorder 24.26 12.25 78 25337 98779 79620194
Lip disorder 23.74 12.25 11 25404 1523 79717450
Dizziness 23.18 12.25 263 25152 526178 79192795
Head injury 22.86 12.25 42 25373 37327 79681646
Therapeutic product effect decreased 22.61 12.25 12 25403 163851 79555122
Dyskinesia oesophageal 22.53 12.25 5 25410 59 79718914
Exposure during pregnancy 22.13 12.25 3 25412 101129 79617844
Vascular stenosis 21.99 12.25 8 25407 598 79718375
Hypertensive crisis 21.97 12.25 30 25385 20740 79698233
Palpitations 21.80 12.25 89 25326 126521 79592452
Urinary tract disorder 21.68 12.25 14 25401 3728 79715245
Cystitis interstitial 21.66 12.25 10 25405 1373 79717600
Tender joint count 21.07 12.25 6 25409 203 79718770
Contraindicated product administered 21.06 12.25 12 25403 157526 79561447
Feeling drunk 21.01 12.25 15 25400 4704 79714269
Sputum retention 20.58 12.25 9 25406 1088 79717885
Product blister packaging issue 20.50 12.25 6 25409 224 79718749
Coma 19.77 12.25 4 25411 100645 79618328
Idiopathic orbital inflammation 19.76 12.25 6 25409 255 79718718
Hallucination, visual 19.04 12.25 36 25379 32693 79686280
Product use complaint 18.74 12.25 11 25404 2472 79716501
Spinal cord haemorrhage 18.70 12.25 7 25408 567 79718406
Intercepted medication error 18.67 12.25 8 25407 921 79718052
Feeling abnormal 18.64 12.25 100 25315 159099 79559874
Loefgren syndrome 18.57 12.25 5 25410 137 79718836
Orthostatic hypotension 18.26 12.25 49 25366 56115 79662858
Pharyngeal mass 18.23 12.25 6 25409 332 79718641
Prescribed underdose 17.84 12.25 33 25382 29481 79689492
Multiple organ dysfunction syndrome 17.81 12.25 8 25407 120238 79598735
Bladder disorder 17.66 12.25 18 25397 9147 79709826
Treatment failure 17.61 12.25 17 25398 170469 79548504
Intentional medical device removal by patient 17.43 12.25 6 25409 381 79718592
Maternal exposure during pregnancy 17.41 12.25 11 25404 136527 79582446
Clubbing 17.20 12.25 7 25408 708 79718265
Lymphocyte count decreased 17.17 12.25 43 25372 47246 79671727
Pericarditis 16.97 12.25 6 25409 104230 79614743
Neutropenia 16.95 12.25 42 25373 287668 79431305
Bone marrow oedema 16.78 12.25 9 25406 1702 79717271
Dysstasia 16.74 12.25 31 25384 27715 79691258
Amnesia 16.61 12.25 51 25364 63006 79655967
Oesophageal dilatation 16.48 12.25 6 25409 449 79718524
COVID-19 16.43 12.25 96 25319 157578 79561395
Cardio-respiratory arrest 16.42 12.25 7 25408 108503 79610470
Hyperventilation 16.11 12.25 16 25399 7883 79711090
Pemphigus 15.76 12.25 6 25409 99576 79619397
Hip fracture 15.67 12.25 32 25383 30729 79688244
Leukopenia 15.39 12.25 9 25406 116504 79602469
Allergy to arthropod bite 15.29 12.25 5 25410 271 79718702
Persistent genital arousal disorder 15.20 12.25 5 25410 276 79718697
Disease progression 15.17 12.25 22 25393 184340 79534633
Breast disorder 15.14 12.25 9 25406 2072 79716901
Pyrexia 15.08 12.25 141 25274 678568 79040405
Febrile neutropenia 14.99 12.25 32 25383 230967 79488006
Infusion related reaction 14.86 12.25 32 25383 230205 79488768
Discomfort 14.84 12.25 11 25404 125606 79593367
Extradural haematoma 14.82 12.25 10 25405 2866 79716107
Urine albumin/creatinine ratio decreased 14.67 12.25 4 25411 115 79718858
Lip swelling 14.64 12.25 37 25378 40874 79678099
Dyskinesia 14.49 12.25 39 25376 44734 79674239
Synovitis 14.47 12.25 16 25399 150718 79568255
Somatic dysfunction 14.46 12.25 3 25412 25 79718948
Perineal pain 14.42 12.25 7 25408 1075 79717898
Drug hypersensitivity 14.41 12.25 48 25367 298868 79420105
Dropped head syndrome 14.24 12.25 5 25410 337 79718636
Blood pressure abnormal 14.09 12.25 22 25393 17147 79701826
Insomnia 13.86 12.25 129 25286 245041 79473932
Product use in unapproved indication 13.79 12.25 131 25284 250228 79468745
Concussion 13.66 12.25 16 25399 9487 79709486
Product dose omission issue 13.38 12.25 129 25286 247408 79471565
Freezing phenomenon 13.20 12.25 8 25407 1906 79717067
Muscle spasticity 12.96 12.25 24 25391 21451 79697522
Urine analysis abnormal 12.92 12.25 13 25402 6507 79712466
Magnetic resonance imaging head abnormal 12.91 12.25 9 25406 2717 79716256
Dementia with Lewy bodies 12.89 12.25 6 25409 840 79718133
VIIth nerve injury 12.80 12.25 4 25411 187 79718786
Rheumatoid arthritis 12.61 12.25 30 25385 208440 79510533
Impaired quality of life 12.60 12.25 19 25396 14367 79704606
Sensory loss 12.60 12.25 18 25397 12973 79706000
Lower urinary tract symptoms 12.41 12.25 4 25411 207 79718766
Diabetic ketosis 12.39 12.25 5 25410 495 79718478
Overdose 12.39 12.25 25 25390 184181 79534792
Acute kidney injury 12.36 12.25 106 25309 519298 79199675
Open fracture 12.34 12.25 5 25410 500 79718473
Blood bilirubin increased 12.26 12.25 3 25412 66229 79652744

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G04BD12 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
UROLOGICALS
Drugs for urinary frequency and incontinence
MeSH PA D018663 Adrenergic Agents
MeSH PA D000322 Adrenergic Agonists
MeSH PA D058667 Adrenergic beta-3 Receptor Agonists
MeSH PA D000318 Adrenergic beta-Agonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D064804 Urological Agents
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000185007 Adrenergic beta3-Agonists
FDA EPC N0000185008 beta3-Adrenergic Agonist
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000190114 Cytochrome P450 3A Inhibitors
CHEBI has role CHEBI:35522 beta-adrenergic agonists

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Bladder muscle dysfunction - overactive indication 236633002
Hypertensive disorder contraindication 38341003 DOID:10763




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.32 acidic
pKa2 8.7 Basic
pKa3 4.93 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 8835474 Nov. 4, 2023 FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL RE44872 Nov. 4, 2023 FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 8835474 Nov. 4, 2023 FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL RE44872 Nov. 4, 2023 FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 8772315 Oct. 30, 2028 USE IN COMBINATION WITH THE MUSCARINIC ANTAGONIST SOLIFENACIN SUCCINATE FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 8772315 Oct. 30, 2028 USE IN COMBINATION WITH THE MUSCARINIC ANTAGONIST SOLIFENACIN SUCCINATE FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 10842780 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 10842780 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
8MG/ML MYRBETRIQ GRANULES APGDI N213801 March 25, 2021 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 10058536 March 31, 2036 TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER BY ADMINISTRATION OF AN EXTENDED-RELEASE SUSPENSION FORMULATION OF MIRABEGRON

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL March 25, 2024 TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL March 25, 2024 TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
8MG/ML MYRBETRIQ GRANULES APGDI N213801 March 25, 2021 RX FOR SUSPENSION, EXTENDED RELEASE ORAL March 25, 2024 NEW PRODUCT
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL Sept. 25, 2024 PEDIATRIC EXCLUSIVITY
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL Sept. 25, 2024 PEDIATRIC EXCLUSIVITY
8MG/ML MYRBETRIQ GRANULES APGDI N213801 March 25, 2021 RX FOR SUSPENSION, EXTENDED RELEASE ORAL Sept. 25, 2024 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Beta-3 adrenergic receptor GPCR AGONIST EC50 7.65 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE

External reference:

IDSource
D09535 KEGG_DRUG
4031804 VANDF
CHEBI:65349 CHEBI
H6U PDB_CHEM_ID
CHEMBL2095212 ChEMBL_ID
C520025 MESH_SUPPLEMENTAL_RECORD_UI
7445 IUPHAR_LIGAND_ID
8907 INN_ID
DB08893 DRUGBANK_ID
MVR3JL3B2V UNII
1300786 RXNORM
191568 MMSL
28616 MMSL
d07876 MMSL
014540 NDDF
703803006 SNOMEDCT_US
703804000 SNOMEDCT_US
C2983812 UMLSCUI
9865528 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-2601 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-2601 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-2601 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-2602 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-2602 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-2602 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-5020 GRANULE, FOR SUSPENSION, EXTENDED RELEASE 8 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-5020 GRANULE, FOR SUSPENSION, EXTENDED RELEASE 8 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-5020 GRANULE, FOR SUSPENSION, EXTENDED RELEASE 8 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 55154-8712 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 55154-8712 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 55154-8713 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 55154-8713 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 70518-2435 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 70518-2435 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 70518-2435 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 70518-3158 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 70518-3158 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL NDA 27 sections