ivabradine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
bradycardic agents 3312 155974-00-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • corlanor
  • corlentor
  • ivabradine hydrochloride
  • ivabradine
  • coraxan
  • procoralan
  • ivabradine HCl
Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarisation.
  • Molecular weight: 468.59
  • Formula: C27H36N2O5
  • CLOGP: 3.07
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 0
  • TPSA: 60.47
  • ALOGS: -4.36
  • ROTB: 10

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 4 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.46 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 1.66 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 10.27 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.28 % Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 20, 2019 PMDA Ono Pharmaceutical Co., Ltd.
April 15, 2015 FDA AMGEN INC
Oct. 25, 2005 EMA Les Laboratoires Servier

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
Off label use 464.61 18.76 453 7174 473973 50123524
Photopsia 154.52 18.76 46 7581 3920 50593577
Drug interaction 128.57 18.76 154 7473 199467 50398030
Torsade de pointes 105.41 18.76 46 7581 11789 50585708
Electrocardiogram QT prolonged 104.95 18.76 76 7551 51810 50545687
Bradycardia 96.63 18.76 79 7548 64347 50533150
Palpitations 77.85 18.76 83 7544 94423 50503074
Cardiac failure 73.87 18.76 73 7554 75967 50521530
First trimester pregnancy 72.13 18.76 10 7617 8 50597489
Syncope 70.29 18.76 82 7545 102920 50494577
Ischaemic stroke 63.91 18.76 36 7591 15912 50581585
Cardiac failure chronic 56.56 18.76 21 7606 3542 50593955
Congestive cardiomyopathy 54.22 18.76 23 7604 5495 50592002
Chest pain 53.97 18.76 96 7531 176786 50420711
Crush syndrome 52.46 18.76 10 7617 119 50597378
Apallic syndrome 51.00 18.76 13 7614 620 50596877
Myoglobin blood increased 50.36 18.76 15 7612 1278 50596219
Dizziness 48.84 18.76 138 7489 346231 50251266
Ventricular fibrillation 48.26 18.76 26 7601 10533 50586964
Language disorder 45.57 18.76 15 7612 1773 50595724
Bundle branch block left 45.22 18.76 21 7606 6209 50591288
Drug effective for unapproved indication 43.86 18.76 15 7612 1994 50595503
Ventricular tachycardia 43.40 18.76 28 7599 15793 50581704
Pain 41.16 18.76 18 7609 578885 50018612
Heart rate decreased 41.01 18.76 38 7589 36459 50561038
Acute kidney injury 40.38 18.76 99 7528 227959 50369538
Sensorimotor disorder 40.14 18.76 10 7617 434 50597063
Pneumobilia 34.56 18.76 7 7620 116 50597381
Dyspnoea 33.71 18.76 167 7460 547441 50050056
Sinus bradycardia 30.53 18.76 21 7606 13162 50584335
Heart rate increased 30.31 18.76 47 7580 77203 50520294
Genital rash 30.15 18.76 8 7619 447 50597050
Hyperparathyroidism secondary 29.16 18.76 10 7617 1340 50596157
Shock haemorrhagic 28.54 18.76 17 7610 8327 50589170
Visual impairment 27.43 18.76 42 7585 68233 50529264
Lactic acidosis 26.89 18.76 29 7598 33326 50564171
Anaemia folate deficiency 26.13 18.76 6 7621 183 50597314
Hyperphosphataemia 25.97 18.76 10 7617 1861 50595636
Mitral valve incompetence 25.26 18.76 21 7606 17450 50580047
Tachycardia 25.20 18.76 50 7577 99713 50497784
Drug ineffective 25.14 18.76 54 7573 819279 49778218
Lordosis 23.85 18.76 6 7621 271 50597226
Third trimester pregnancy 23.40 18.76 3 7624 0 50597497
Second trimester pregnancy 23.40 18.76 3 7624 0 50597497
Angina pectoris 23.30 18.76 24 7603 26164 50571333
Tuberculosis of central nervous system 23.16 18.76 6 7621 305 50597192
Hypotension 23.16 18.76 83 7544 235386 50362111
Gastrointestinal tract adenoma 22.88 18.76 6 7621 320 50597177
Femoral neck fracture 22.39 18.76 14 7613 7476 50590021
Alopecia 22.00 18.76 5 7622 245042 50352455
Atrial tachycardia 21.32 18.76 9 7618 2123 50595374
Oliguria 21.20 18.76 14 7613 8202 50589295
Serotonin syndrome 20.82 18.76 22 7605 24691 50572806
Pneumonia fungal 20.76 18.76 11 7616 4309 50593188
Orthopnoea 20.53 18.76 12 7615 5677 50591820
Lupus myocarditis 20.06 18.76 4 7623 61 50597436
Gastric antral vascular ectasia 19.84 18.76 6 7621 538 50596959
Sinus arrest 19.80 18.76 8 7619 1690 50595807
Osteochondrosis 19.41 18.76 7 7620 1087 50596410
Nasopharyngitis 19.31 18.76 3 7624 192924 50404573

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
Cardiac failure 245.68 19.46 191 8009 79096 29487231
Bradycardia 115.80 19.46 115 8085 65514 29500813
Computerised tomogram coronary artery abnormal 114.83 19.46 23 8177 185 29566142
Hypotension 108.31 19.46 193 8007 194161 29372166
Photopsia 89.79 19.46 29 8171 1744 29564583
Cardiac failure chronic 76.87 19.46 37 8163 6430 29559897
Dyspnoea at rest 69.47 19.46 28 8172 3186 29563141
Ischaemic cardiomyopathy 69.27 19.46 33 8167 5605 29560722
N-terminal prohormone brain natriuretic peptide increased 60.30 19.46 22 8178 1910 29564417
Dyspnoea 59.75 19.46 212 7988 326520 29239807
Oesophageal obstruction 57.97 19.46 15 8185 406 29565921
Sinus bradycardia 56.66 19.46 37 8163 11566 29554761
Torsade de pointes 52.75 19.46 29 8171 6632 29559695
Bezoar 52.32 19.46 16 8184 803 29565524
Left ventricular enlargement 51.47 19.46 15 8185 637 29565690
Ventricular arrhythmia 50.68 19.46 25 8175 4579 29561748
Electrocardiogram abnormal 47.55 19.46 28 8172 7294 29559033
Ventricular extrasystoles 47.45 19.46 32 8168 10550 29555777
Blood pressure systolic decreased 45.69 19.46 22 8178 3822 29562505
Venous pressure jugular increased 45.55 19.46 14 8186 715 29565612
Oedema peripheral 42.92 19.46 91 8109 103466 29462861
Ejection fraction decreased 41.83 19.46 35 8165 15943 29550384
Base excess decreased 41.15 19.46 10 8190 208 29566119
Glomerular filtration rate decreased 41.03 19.46 30 8170 11236 29555091
Cardiomyopathy 39.97 19.46 33 8167 14754 29551573
Atrial tachycardia 38.83 19.46 16 8184 1925 29564402
Blood potassium increased 38.16 19.46 32 8168 14619 29551708
Oxygen consumption decreased 37.37 19.46 9 8191 180 29566147
Venous pressure jugular decreased 37.02 19.46 7 8193 40 29566287
Ventricular dysfunction 36.40 19.46 18 8182 3313 29563014
Dermatitis exfoliative generalised 35.60 19.46 17 8183 2899 29563428
Pulmonary oedema 35.38 19.46 51 8149 42684 29523643
Hyperkalaemia 35.29 19.46 62 8138 61330 29504997
Brain natriuretic peptide increased 35.11 19.46 19 8181 4211 29562116
Ventricular tachycardia 35.06 19.46 37 8163 22537 29543790
Asthma-chronic obstructive pulmonary disease overlap syndrome 32.97 19.46 11 8189 732 29565595
Bronchial wall thickening 32.90 19.46 12 8188 1040 29565287
Urticaria chronic 32.03 19.46 7 8193 89 29566238
Drug interaction 31.62 19.46 123 8077 197262 29369065
Acute kidney injury 30.81 19.46 150 8050 265117 29301210
Angina pectoris 30.33 19.46 38 8162 27812 29538515
Palpitations 30.09 19.46 41 8159 32563 29533764
Ventricular enlargement 29.36 19.46 9 8191 455 29565872
Sinus arrest 29.19 19.46 12 8188 1435 29564892
Death 28.32 19.46 32 8168 342052 29224275
Blood creatinine increased 27.69 19.46 68 8132 85034 29481293
ECG signs of myocardial ischaemia 27.17 19.46 7 8193 186 29566141
Bronchial hyperreactivity 26.14 19.46 11 8189 1395 29564932
Left ventricular dilatation 26.12 19.46 9 8191 661 29565666
Presyncope 26.11 19.46 27 8173 16062 29550265
Hypertrophy 25.40 19.46 8 8192 443 29565884
Dyspnoea exertional 25.16 19.46 40 8160 36450 29529877
Non-compaction cardiomyopathy 25.09 19.46 5 8195 39 29566288
Tracheal atresia 24.37 19.46 4 8196 8 29566319
Body mass index increased 24.21 19.46 9 8191 823 29565504
Eosinophilia 23.75 19.46 30 8170 22131 29544196
Syncope 23.33 19.46 62 8138 81309 29485018
Tricuspid valve incompetence 23.24 19.46 19 8181 8375 29557952
Mean cell haemoglobin decreased 23.15 19.46 10 8190 1351 29564976
Cardiac ventricular thrombosis 23.15 19.46 9 8191 930 29565397
Blood chloride increased 22.01 19.46 12 8188 2697 29563630
Pulmonary function test abnormal 22.01 19.46 11 8189 2071 29564256
Lichenoid keratosis 21.57 19.46 11 8189 2159 29564168
Oesophageal haemorrhage 21.36 19.46 9 8191 1144 29565183
Ventricular fibrillation 21.18 19.46 24 8176 15809 29550518
Blood luteinising hormone increased 21.10 19.46 5 8195 93 29566234
Breath sounds abnormal 20.93 19.46 15 8185 5442 29560885
Low cardiac output syndrome 20.58 19.46 7 8193 494 29565833
Congestive cardiomyopathy 20.47 19.46 16 8184 6614 29559713
Cardiac hypertrophy 20.37 19.46 8 8192 850 29565477
Contraindicated product administered 20.00 19.46 25 8175 18241 29548086
Carbon dioxide decreased 19.82 19.46 9 8191 1370 29564957
Blood follicle stimulating hormone increased 19.74 19.46 5 8195 124 29566203
Diastolic dysfunction 19.61 19.46 14 8186 5050 29561277

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
Off label use 381.36 16.62 589 14421 632217 63851505
Cardiac failure 293.28 16.62 244 14766 132129 64351593
Bradycardia 192.08 16.62 183 14827 118036 64365686
Photopsia 177.32 16.62 59 14951 4655 64479067
Torsade de pointes 148.29 16.62 75 14935 17288 64466434
Drug interaction 132.19 16.62 272 14738 361811 64121911
Cardiac failure chronic 126.69 16.62 55 14955 8986 64474736
Computerised tomogram coronary artery abnormal 118.83 16.62 23 14987 185 64483537
Hypotension 110.47 16.62 261 14749 380713 64103009
Palpitations 83.64 16.62 112 14898 104376 64379346
Sinus bradycardia 83.52 16.62 57 14953 22836 64460886
Dyspnoea 79.10 16.62 353 14657 718321 63765401
Electrocardiogram QT prolonged 77.54 16.62 94 14916 79354 64404368
Ventricular tachycardia 77.37 16.62 64 14946 34201 64449521
Syncope 75.30 16.62 133 14877 157502 64326220
Ischaemic cardiomyopathy 71.73 16.62 34 14976 6804 64476918
Acute kidney injury 69.72 16.62 246 14764 448994 64034728
N-terminal prohormone brain natriuretic peptide increased 64.46 16.62 26 14984 3533 64480189
Ventricular fibrillation 63.32 16.62 49 14961 23811 64459911
First trimester pregnancy 62.99 16.62 9 15001 4 64483718
Ventricular extrasystoles 60.06 16.62 42 14968 17487 64466235
Left ventricular enlargement 57.93 16.62 16 14994 668 64483054
Atrial tachycardia 57.64 16.62 24 14986 3535 64480187
Chest pain 56.96 16.62 151 14859 235829 64247893
Congestive cardiomyopathy 55.83 16.62 33 14977 10311 64473411
Dizziness 55.42 16.62 222 14788 429941 64053781
Ischaemic stroke 54.90 16.62 49 14961 28986 64454736
Ventricular arrhythmia 54.58 16.62 29 14981 7386 64476336
Angina pectoris 53.46 16.62 59 14951 45022 64438700
Dyspnoea at rest 53.03 16.62 27 14983 6302 64477420
Pain 51.18 16.62 33 14977 553478 63930244
Oesophageal obstruction 50.68 16.62 15 14995 804 64482918
Glomerular filtration rate decreased 49.34 16.62 39 14971 19533 64464189
ECG signs of myocardial ischaemia 47.70 16.62 12 14998 347 64483375
Ejection fraction decreased 47.57 16.62 45 14965 28662 64455060
Bundle branch block left 46.42 16.62 29 14981 10005 64473717
Crush syndrome 44.26 16.62 10 15000 180 64483542
Hyperkalaemia 42.76 16.62 81 14929 101048 64382674
Apallic syndrome 41.48 16.62 13 14997 846 64482876
Bezoar 39.57 16.62 16 14994 2187 64481535
Base excess decreased 37.66 16.62 10 15000 359 64483363
Blood pressure systolic decreased 37.08 16.62 24 14986 8796 64474926
Venous pressure jugular increased 36.56 16.62 13 14997 1250 64482472
Brain natriuretic peptide increased 35.15 16.62 22 14988 7611 64476111
Sinus arrest 34.36 16.62 16 14994 3074 64480648
Blood potassium increased 34.30 16.62 36 14974 25944 64457778
Asthma-chronic obstructive pulmonary disease overlap syndrome 34.17 16.62 12 14998 1113 64482609
Body mass index increased 33.73 16.62 13 14997 1566 64482156
Venous pressure jugular decreased 33.63 16.62 7 15003 84 64483638
Cardiomyopathy 33.24 16.62 35 14975 25321 64458401
Language disorder 33.14 16.62 15 14995 2702 64481020
Mitral valve incompetence 33.03 16.62 35 14975 25503 64458219
Myoglobin blood increased 32.98 16.62 15 14995 2732 64480990
Tricuspid valve incompetence 32.74 16.62 29 14981 16974 64466748
Oxygen consumption decreased 32.46 16.62 9 15001 381 64483341
Dermatitis exfoliative generalised 32.26 16.62 19 14991 5897 64477825
Electrocardiogram abnormal 32.14 16.62 26 14984 13455 64470267
Presyncope 31.76 16.62 40 14970 35049 64448673
Eosinophilia 30.70 16.62 41 14969 38035 64445687
Sensorimotor disorder 30.11 16.62 10 15000 783 64482939
Ventricular enlargement 29.85 16.62 9 15001 514 64483208
Oedema peripheral 29.79 16.62 112 14898 210205 64273517
Ventricular dysfunction 28.93 16.62 17 14993 5253 64478469
Blood creatinine increased 28.84 16.62 83 14927 135699 64348023
Drug effective for unapproved indication 28.70 16.62 15 14995 3693 64480029
Pneumobilia 28.43 16.62 7 15003 185 64483537
Bronchial hyperreactivity 27.91 16.62 13 14997 2499 64481223
Febrile neutropenia 27.89 16.62 5 15005 187652 64296070
Rash 27.61 16.62 40 14970 458509 64025213
Diastolic dysfunction 27.49 16.62 20 14990 8855 64474867
Osteochondrosis 27.40 16.62 11 14999 1476 64482246
Mean cell haemoglobin decreased 27.21 16.62 15 14995 4107 64479615
Urticaria chronic 26.78 16.62 8 15002 443 64483279
Non-compaction cardiomyopathy 25.97 16.62 5 15005 39 64483683
Rheumatoid arthritis 25.24 16.62 4 15006 164290 64319432
Bronchial wall thickening 24.76 16.62 11 14999 1896 64481826
Orthopnoea 24.75 16.62 19 14991 9115 64474607
Lactic acidosis 24.48 16.62 48 14962 61362 64422360
Heart rate decreased 24.37 16.62 45 14965 55022 64428700
Dyspnoea paroxysmal nocturnal 24.24 16.62 11 14999 1993 64481729
Dyspnoea exertional 23.98 16.62 53 14957 73677 64410045
Nasopharyngitis 23.75 16.62 8 15002 196065 64287657
Sinusitis 23.71 16.62 3 15007 145925 64337797
Vertigo 23.38 16.62 46 14964 58965 64424757
Infusion related reaction 23.14 16.62 5 15005 164462 64319260
Abdominal discomfort 22.86 16.62 7 15003 182315 64301407
Hypertrophy 22.67 16.62 8 15002 752 64482970
Completed suicide 22.63 16.62 12 14998 224402 64259320
Pulmonary function test abnormal 22.23 16.62 12 14998 3152 64480570
Feeling abnormal 22.20 16.62 75 14935 133527 64350195
Third trimester pregnancy 22.10 16.62 3 15007 0 64483722
Second trimester pregnancy 22.10 16.62 3 15007 0 64483722
Anaemia folate deficiency 21.88 16.62 6 15004 244 64483478
Pulmonary oedema 21.68 16.62 53 14957 78621 64405101
Genital rash 21.63 16.62 8 15002 861 64482861
Alopecia 21.43 16.62 6 15004 165684 64318038
Cardiac ventricular thrombosis 21.07 16.62 9 15001 1411 64482311
Joint swelling 21.02 16.62 12 14998 215370 64268352
Arthralgia 20.81 16.62 45 14965 442215 64041507
Acute coronary syndrome 20.72 16.62 24 14986 19286 64464436
Hepatic enzyme increased 20.33 16.62 3 15007 129940 64353782
Lordosis 20.25 16.62 6 15004 323 64483399
Oesophageal haemorrhage 20.13 16.62 9 15001 1575 64482147
Intentional overdose 20.08 16.62 56 14954 89888 64393834
Hyperparathyroidism secondary 19.69 16.62 10 15000 2320 64481402
Blood pressure decreased 19.57 16.62 54 14956 86145 64397577
Drug hypersensitivity 19.54 16.62 16 14994 237799 64245923
Kyphosis 19.44 16.62 10 15000 2383 64481339
Musculoskeletal stiffness 18.92 16.62 3 15007 123203 64360519
Tuberculosis of central nervous system 18.79 16.62 6 15004 415 64483307
Low cardiac output syndrome 18.62 16.62 7 15003 788 64482934
Arrhythmia 18.28 16.62 39 14971 52905 64430817
Haematoma 18.25 16.62 36 14974 46214 64437508
Blood luteinising hormone increased 18.17 16.62 5 15005 206 64483516
Gastrointestinal tract adenoma 18.06 16.62 6 15004 470 64483252
Blood chloride increased 17.61 16.62 12 14998 4791 64478931
Product prescribing error 17.11 16.62 30 14980 35239 64448483
Infection 17.06 16.62 11 14999 184869 64298853
Femoral neck fracture 17.03 16.62 15 14995 8709 64475013
Cardiac failure acute 17.01 16.62 20 14990 16324 64467398
Lupus myocarditis 16.94 16.62 4 15006 88 64483634
International normalised ratio decreased 16.94 16.62 14 14996 7464 64476258
Heart rate increased 16.92 16.62 56 14954 98619 64385103
Platelet count decreased 16.86 16.62 9 15001 167702 64316020
Blood follicle stimulating hormone increased 16.73 16.62 5 15005 277 64483445

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C01EB17 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
OTHER CARDIAC PREPARATIONS
Other cardiac preparations
ATC C07FX05 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents, other combinations
ATC C07FX06 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents, other combinations
MeSH PA D002317 Cardiovascular Agents
FDA EPC N0000191544 Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker
FDA MoA N0000191546 Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists
CHEBI has role CHEBI:38147 cardiotonic drugs

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

DiseaseRelationSNOMED_IDDOID
Chronic heart failure indication 48447003
Angina pectoris indication 194828000




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.45 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 5MG BASE CORLANOR AMGEN INC N206143 April 15, 2015 RX TABLET ORAL 7361649 Feb. 22, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
EQ 5MG BASE CORLANOR AMGEN INC N206143 April 15, 2015 RX TABLET ORAL 7361650 Feb. 22, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
EQ 5MG BASE CORLANOR AMGEN INC N206143 April 15, 2015 RX TABLET ORAL 7879842 Feb. 22, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
EQ 7.5MG BASE CORLANOR AMGEN INC N206143 April 15, 2015 RX TABLET ORAL 7361649 Feb. 22, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
EQ 7.5MG BASE CORLANOR AMGEN INC N206143 April 15, 2015 RX TABLET ORAL 7361650 Feb. 22, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
EQ 7.5MG BASE CORLANOR AMGEN INC N206143 April 15, 2015 RX TABLET ORAL 7879842 Feb. 22, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
5MG/5ML (1MG/ML) CORLANOR AMGEN INC N209964 April 22, 2019 RX SOLUTION ORAL 7361649 Feb. 22, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
5MG/5ML (1MG/ML) CORLANOR AMGEN INC N209964 April 22, 2019 RX SOLUTION ORAL 7361650 Feb. 22, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
5MG/5ML (1MG/ML) CORLANOR AMGEN INC N209964 April 22, 2019 RX SOLUTION ORAL 7879842 Feb. 22, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
EQ 5MG BASE CORLANOR AMGEN INC N206143 April 15, 2015 RX TABLET ORAL 7867996 Dec. 12, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
EQ 7.5MG BASE CORLANOR AMGEN INC N206143 April 15, 2015 RX TABLET ORAL 7867996 Dec. 12, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE
5MG/5ML (1MG/ML) CORLANOR AMGEN INC N209964 April 22, 2019 RX SOLUTION ORAL 7867996 Dec. 12, 2026 A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
5MG/5ML (1MG/ML) CORLANOR AMGEN INC N209964 April 22, 2019 RX SOLUTION ORAL April 22, 2022 NEW PRODUCT
5MG/5ML (1MG/ML) CORLANOR AMGEN INC N209964 April 22, 2019 RX SOLUTION ORAL Oct. 22, 2022 PEDIATRIC EXCLUSIVITY
5MG/5ML (1MG/ML) CORLANOR AMGEN INC N209964 April 22, 2019 RX SOLUTION ORAL April 22, 2026 INDICATED FOR THE TREATMENT OF STABLE SYMPTOMATIC HEART FAILURE DUE TO DILATED CARDIOMYOPATHY (DCM) IN PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER, WHO ARE IN SINUS RHYTHM WITH AN ELEVATED HEART RATE
5MG/5ML (1MG/ML) CORLANOR AMGEN INC N209964 April 22, 2019 RX SOLUTION ORAL Oct. 22, 2026 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 1 Ion channel BLOCKER IC50 5.70 IUPHAR DRUG LABEL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 2 Ion channel BLOCKER UNKNOWN DRUG LABEL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 3 Ion channel BLOCKER IC50 5.70 IUPHAR DRUG LABEL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 Ion channel EC50 5.37 CHEMBL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 1 Ion channel EC50 5.35 CHEMBL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 2 Ion channel EC50 5.34 CHEMBL

External reference:

IDSource
D07165 KEGG_DRUG
148849-67-6 SECONDARY_CAS_RN
4034416 VANDF
C0257190 UMLSCUI
CHEBI:85969 CHEBI
CHEMBL471737 ChEMBL_ID
CHEMBL2145077 ChEMBL_ID
D000077550 MESH_DESCRIPTOR_UI
DB09083 DRUGBANK_ID
2357 IUPHAR_LIGAND_ID
7523 INN_ID
3H48L0LPZQ UNII
132999 PUBCHEM_CID
1649479 RXNORM
20884 MMSL
233849 MMSL
d05706 MMSL
011156 NDDF
011157 NDDF
420906000 SNOMEDCT_US
421228002 SNOMEDCT_US
421692002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Corlanor HUMAN PRESCRIPTION DRUG LABEL 1 55513-800 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
Corlanor HUMAN PRESCRIPTION DRUG LABEL 1 55513-800 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
Corlanor HUMAN PRESCRIPTION DRUG LABEL 1 55513-810 TABLET, FILM COATED 7.50 mg ORAL NDA 31 sections
Corlanor HUMAN PRESCRIPTION DRUG LABEL 1 55513-810 TABLET, FILM COATED 7.50 mg ORAL NDA 31 sections
Corlanor HUMAN PRESCRIPTION DRUG LABEL 1 55513-813 SOLUTION 5 mg ORAL NDA 31 sections
Corlanor HUMAN PRESCRIPTION DRUG LABEL 1 55513-813 SOLUTION 5 mg ORAL NDA 31 sections
Corlanor HUMAN PRESCRIPTION DRUG LABEL 1 70518-3309 TABLET, FILM COATED 5 mg ORAL NDA 33 sections