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

Stem definition	Drug id	CAS RN
bradycardic agents	3312	155974-00-8

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
10	mg	O

ADMET properties:

Property	Value	Reference
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 µM/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:

Date	Agency	Company
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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
Chronic heart failure	indication	48447003
Angina pectoris	indication	194828000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.45	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 1	Ion channel	O60741	HCN1_HUMAN	BLOCKER	IC50	5.70	IUPHAR	DRUG LABEL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 2	Ion channel	Q9UL51	HCN2_HUMAN	BLOCKER			UNKNOWN	DRUG LABEL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 3	Ion channel	Q9P1Z3	HCN3_HUMAN	BLOCKER	IC50	5.70	IUPHAR	DRUG LABEL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4	Ion channel	Q9Y3Q4	HCN4_HUMAN		EC50	5.37	CHEMBL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 1	Ion channel		HCN1_MOUSE		EC50	5.35	CHEMBL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 2	Ion channel		HCN2_MOUSE		EC50	5.34	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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