daclatasvir

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ
Vd (Volume of distribution)	0.67 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	13.50 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	700 mg/mL	Bocci G, Oprea TI, Benet LZ

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	3.833		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	28.249		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	15.101	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	3.420	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	3.090	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	8.270	%	High	1
herg	hERG pIC50	4.758	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	1.766	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	6.194	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	3.360	%	High	1
kinase-safety-class	ACVR2B,GRK2,PDK1,PDK2,PDK4,PRKDC	6
kinase-selectivity-class	ACVR2B,CLK2,CLK4,MAP3K21,PDK1	5
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	28.840		High	0.85
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	38.637		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	7.603		High	1
mppb	Mouse plasma protein binding (% unbound)	1.880		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	77.983		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pppb	Pig plasma protein binding (% unbound)	5.500	%	High	1
rat-kpuu-brain	Rat brain Kpuu	0.002	%	High	0.85
rh-clint	Rat hepatocyte intrinsic clearance	5.224	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	17.980	%	High	1
rppb	Rat plasma protein binding (% unbound)	1.670	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	19.454	uM	High	1

Date	Agency	Company	Orphan
July 24, 2015	FDA	BRISTOL MYERS SQUIBB
June 27, 2014	EMA

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
Hepatocellular carcinoma	340.94	29.86	62	3457	2366	90622562
Hepatitis C	249.39	29.86	55	3464	5605	90619323
Ascites	150.97	29.86	60	3459	47680	90577248
Genotype drug resistance test positive	142.34	29.86	23	3496	426	90624502
Hepatic encephalopathy	124.75	29.86	38	3481	13734	90611194
Hepatic failure	101.88	29.86	43	3476	39685	90585243
Fatigue	76.42	29.86	149	3370	1153874	89471054
Headache	65.11	29.86	118	3401	862628	89762300
Viral mutation identified	63.88	29.86	15	3504	2010	90622918
Oesophageal varices haemorrhage	62.91	29.86	14	3505	1478	90623450
Virologic failure	62.48	29.86	15	3504	2209	90622719
Liver transplant	61.87	29.86	15	3504	2302	90622626
Hepatic cirrhosis	50.17	29.86	31	3488	63222	90561706
Hepatitis B reactivation	49.29	29.86	14	3505	3960	90620968
Renal impairment	48.71	29.86	37	3482	105384	90519544
Jaundice	45.08	29.86	23	3496	32494	90592434
Fibrosis	43.71	29.86	14	3505	5938	90618990
Drug interaction	39.44	29.86	51	3468	276402	90348526
Anaemia	36.81	29.86	56	3463	352746	90272182
Alanine aminotransferase increased	34.81	29.86	32	3487	118306	90506622
Pulmonary arterial hypertension	34.78	29.86	18	3501	26169	90598759
Drug resistance	32.24	29.86	18	3501	30431	90594497
Hepatitis B DNA increased	31.69	29.86	6	3513	284	90624644
Treatment failure	29.93	29.86	47	3472	303881	90321047

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
Hepatocellular carcinoma	1029.18	26.52	237	5807	7957	42607334
Hepatitis C	737.56	26.52	189	5855	9944	42605347
Genotype drug resistance test positive	700.96	26.52	125	5919	1079	42614212
Treatment failure	469.75	26.52	211	5833	62413	42552878
Liver transplant	219.02	26.52	55	5989	2636	42612655
Viral mutation identified	151.61	26.52	43	6001	3288	42612003
Hepatic encephalopathy	144.02	26.52	62	5982	16380	42598911
Fatigue	109.33	26.52	209	5835	435432	42179859
Hepatic cirrhosis	108.94	26.52	54	5990	19648	42595643
Virologic failure	105.88	26.52	34	6010	3960	42611331
Ascites	103.17	26.52	76	5968	56602	42558689
Headache	101.99	26.52	146	5898	239223	42376068
Drug ineffective	99.79	26.52	251	5793	629946	41985345
Hepatic failure	90.10	26.52	60	5984	38040	42577251
Therapeutic embolisation	78.01	26.52	16	6028	302	42614989
Hepatic cancer	77.59	26.52	33	6011	8447	42606844
Hyperbilirubinaemia	67.65	26.52	40	6004	20595	42594696
Insomnia	60.53	26.52	79	5965	118174	42497117
Hepatitis B reactivation	59.74	26.52	23	6021	4555	42610736
Genital herpes simplex	52.91	26.52	10	6034	121	42615170
Biliary colic	48.35	26.52	14	6030	1150	42614141
Varices oesophageal	46.71	26.52	19	6025	4346	42610945
Hepatitis C RNA increased	44.45	26.52	10	6034	296	42614995
Oesophageal varices haemorrhage	43.10	26.52	17	6027	3590	42611701
Abdominal cavity drainage	40.46	26.52	10	6034	447	42614844
Genital herpes	39.97	26.52	11	6033	751	42614540
Hepatorenal syndrome	39.61	26.52	15	6029	2839	42612452
Jaundice	38.76	26.52	35	6009	34554	42580737
Hepatitis C RNA positive	38.33	26.52	8	6036	165	42615126
Peritonitis bacterial	32.50	26.52	17	6027	6898	42608393
Embolism	31.38	26.52	18	6026	8745	42606546
Hepatic neoplasm	28.56	26.52	11	6033	2180	42613111
Transcatheter arterial chemoembolisation	27.78	26.52	4	6040	6	42615285

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daclatasvir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products:

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
Hepatocellular carcinoma	1250.95	25.20	259	8414	9621	110571005
Hepatitis C	871.10	25.20	201	8472	12372	110568254
Genotype drug resistance test positive	595.35	25.20	102	8571	1304	110579322
Hepatic encephalopathy	268.52	25.20	96	8577	28160	110552466
Liver transplant	257.82	25.20	62	8611	4527	110576099
Ascites	238.51	25.20	125	8548	92683	110487943
Viral mutation identified	224.21	25.20	55	8618	4364	110576262
Treatment failure	213.08	25.20	175	8498	277059	110303567
Hepatic failure	160.74	25.20	87	8586	68652	110511974
Fatigue	157.16	25.20	313	8360	1215645	109364981
Virologic failure	136.64	25.20	38	8635	4914	110575712
Headache	124.36	25.20	236	8437	882141	109698485
Hepatic cirrhosis	108.46	25.20	67	8606	67559	110513067
Hyperbilirubinaemia	101.22	25.20	49	8624	30622	110550004
Therapeutic embolisation	95.40	25.20	19	8654	571	110580055
Hepatic cancer	95.06	25.20	35	8638	11121	110569505
Hepatitis B reactivation	92.61	25.20	31	8642	7453	110573173
Oesophageal varices haemorrhage	79.58	25.20	25	8648	4920	110575706
Hepatitis C RNA increased	76.20	25.20	15	8658	424	110580202
Varices oesophageal	74.12	25.20	26	8647	7189	110573437
Renal impairment	70.13	25.20	80	8593	188365	110392261
Jaundice	66.52	25.20	47	8626	59189	110521437
Insomnia	65.37	25.20	108	8565	360482	110220144
Abdominal cavity drainage	54.73	25.20	13	8660	898	110579728
Drug ineffective	53.07	25.20	247	8426	1520293	109060333
Hepatorenal syndrome	52.77	25.20	18	8655	4579	110576047
Hepatitis B DNA increased	50.32	25.20	12	8661	843	110579783
Anaemia	45.64	25.20	119	8554	546967	110033659
Portal hypertensive gastropathy	45.20	25.20	13	8660	1895	110578731
Genital herpes simplex	44.84	25.20	10	8663	522	110580104
Peritonitis bacterial	41.42	25.20	19	8654	10514	110570112
Hepatectomy	37.71	25.20	8	8665	330	110580296
Biliary colic	37.60	25.20	14	8659	4583	110576043
Fibrosis	37.17	25.20	16	8657	7626	110573000
Drug interaction	34.93	25.20	102	8571	500081	110080545
Hepatitis C RNA positive	34.11	25.20	7	8666	245	110580381
Genital herpes	33.30	25.20	11	8662	2536	110578090
Hydrocholecystis	33.18	25.20	8	8665	589	110580037
Acute leukaemia	32.49	25.20	10	8663	1839	110578787
Hepatic neoplasm	32.45	25.20	12	8661	3855	110576771
Liver transplant rejection	32.29	25.20	12	8661	3906	110576720
Mesenteric vein thrombosis	31.74	25.20	10	8663	1985	110578641
Renal disorder	31.25	25.20	28	8645	49451	110531175
Embolism	30.91	25.20	18	8655	16271	110564355
Pulmonary arterial hypertension	30.13	25.20	23	8650	32545	110548081
Alanine aminotransferase increased	27.94	25.20	51	8622	183722	110396904
Transcatheter arterial chemoembolisation	27.38	25.20	4	8669	16	110580610
Nausea	26.30	25.20	176	8497	1235514	109345112
Liver disorder	26.23	25.20	43	8630	142200	110438426
Renal failure	26.14	25.20	56	8617	226518	110354108

Source	Code	Description
ATC	J05AP07	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
ATC	J05AP58	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA MoA	N0000190107	Organic Anion Transporting Polypeptide 1B1 Inhibitors
FDA MoA	N0000190108	Organic Anion Transporting Polypeptide 1B3 Inhibitors
FDA MoA	N0000190113	Breast Cancer Resistance Protein Inhibitors
FDA EPC	N0000191256	Hepatitis C Virus NS5A Inhibitor
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:35441	antiinfective agent
CHEBI has role	CHEBI:36044	antiviral drug
CHEBI has role	CHEBI:64951	anti-HBV agent
CHEBI has role	CHEBI:83799	nonstructural protein 5A inhibitor

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.05	acidic
pKa2	12.44	acidic
pKa3	12.88	acidic
pKa4	13.27	acidic
pKa5	6.51	Basic
pKa6	5.91	Basic

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 30MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	8900566	Aug. 8, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS
EQ 30MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	8900566	Aug. 8, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
EQ 30MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	9421192	Aug. 8, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS
EQ 30MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	9421192	Aug. 8, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
EQ 60MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	8900566	Aug. 8, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS
EQ 60MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	8900566	Aug. 8, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
EQ 60MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	9421192	Aug. 8, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS
EQ 60MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	9421192	Aug. 8, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
EQ 90MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	April 13, 2016	DISCN	TABLET	ORAL	9421192	Aug. 8, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS
EQ 90MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	April 13, 2016	DISCN	TABLET	ORAL	9421192	Aug. 8, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
EQ 30MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	8642025	Aug. 11, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS
EQ 30MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	8642025	Aug. 11, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
EQ 60MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	8642025	Aug. 11, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS
EQ 60MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	8642025	Aug. 11, 2027	METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
EQ 30MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	8629171	June 13, 2031	METHOD OF INHIBITING HEPATITIS C VIRUS
EQ 60MG BASE	DAKLINZA	BRISTOL-MYERS SQUIBB	N206843	July 24, 2015	DISCN	TABLET	ORAL	8629171	June 13, 2031	METHOD OF INHIBITING HEPATITIS C VIRUS

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	4.53	CHEMBL
Genome polyprotein	Polyprotein		POLG_HCVBK	INHIBITOR	EC50	11.05	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Genome polyprotein	Polyprotein		POLG_HCVH	INHIBITOR	EC50	10.30	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Nonstructural protein 5A	Unclassified		Q5L478_9HEPC		IC50	10.64	CHEMBL

ID	Source
D10065	KEGG_DRUG
4034682	VUID
N0000191739	NUI
4034682	VANDF
CHEMBL2023898	ChEMBL_ID
CHEMBL2303621	ChEMBL_ID
C549273	MESH_SUPPLEMENTAL_RECORD_UI
11266	IUPHAR_LIGAND_ID
1009119-65-6	SECONDARY_CAS_RN
DB09102	DRUGBANK_ID
1606217	RXNORM
229788	MMSL
30519	MMSL
d08285	MMSL
015679	NDDF
1172356004	SNOMEDCT_US
712519008	SNOMEDCT_US
714014007	SNOMEDCT_US
C3252090	UMLSCUI
CHEBI:83800	CHEBI
9483	INN_ID
25154714	PUBCHEM_CID
LI2427F9CI	UNII