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

Stem definitionDrug idCAS RN
microsomal triglyceride transfer protein (MTP) inhibitors 4721 182431-12-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lomitapide
  • juxtapid
  • BMS-201038
  • lomitapide mesylate
  • lojuxta
  • lomitapide mesilate
  • BMS201038
  • BMS 201038
an anticholesteremic agent and microsomal triglycide transfer protein inhibitor
  • Molecular weight: 693.73
  • Formula: C39H37F6N3O2
  • CLOGP: 6.69
  • LIPINSKI: 2
  • HAC: 5
  • HDO: 2
  • TPSA: 61.44
  • ALOGS: -6.89
  • ROTB: 12
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
40 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 16.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 39.70 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 21, 2012 FDA AEGERION

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
Therapy cessation 1109.30 37.46 278 3566 25733 50575547
Weight decreased 427.03 37.46 242 3602 221003 50380277
Diarrhoea 370.94 37.46 323 3521 588153 50013127
Flatulence 205.57 37.46 79 3765 29379 50571901
Low density lipoprotein increased 198.26 37.46 52 3792 5594 50595686
Diet noncompliance 152.38 37.46 25 3819 249 50601031
Abdominal pain upper 113.76 37.46 95 3749 159214 50442066
Inappropriate schedule of product administration 109.51 37.46 68 3776 71763 50529517
Nausea 106.57 37.46 190 3654 705208 49896072
Blood cholesterol increased 85.95 37.46 53 3791 55162 50546118
Product dose omission issue 84.98 37.46 86 3758 183752 50417528
Product administered to patient of inappropriate age 58.78 37.46 17 3827 2613 50598667
Abdominal distension 52.93 37.46 44 3800 72859 50528421
Non-high-density lipoprotein cholesterol increased 45.12 37.46 8 3836 130 50601150
Liver function test increased 43.43 37.46 26 3818 25580 50575700
Abdominal discomfort 41.86 37.46 68 3776 231573 50369707

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
Therapy cessation 495.74 60.00 125 1732 14337 29558333
Weight decreased 346.43 60.00 173 1684 150732 29421938
Diarrhoea 207.01 60.00 167 1690 332531 29240139
Flatulence 126.90 60.00 46 1811 17663 29555007
Diet noncompliance 124.46 60.00 19 1838 141 29572529
Low density lipoprotein increased 109.89 60.00 29 1828 3875 29568795
Product dose omission issue 98.73 60.00 66 1791 96317 29476353
Abdominal discomfort 66.89 60.00 40 1817 47863 29524807
Blood cholesterol increased 63.72 60.00 27 1830 15568 29557102

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
Therapy cessation 1252.25 42.61 316 4260 32173 64461983
Weight decreased 545.69 42.61 303 4273 285436 64208720
Diarrhoea 444.65 42.61 380 4196 722324 63771832
Flatulence 263.88 42.61 98 4478 35568 64458588
Low density lipoprotein increased 217.86 42.61 59 4517 7681 64486475
Nausea 137.97 42.61 218 4358 785582 63708574
Abdominal pain upper 132.52 42.61 105 4471 174925 64319231
Diet noncompliance 116.54 42.61 21 4555 404 64493752
Inappropriate schedule of product administration 110.06 42.61 73 4503 92213 64401943
Product dose omission issue 104.65 42.61 96 4480 194651 64299505
Blood cholesterol increased 96.79 42.61 54 4522 50012 64444144
Product administered to patient of inappropriate age 88.22 42.61 26 4550 4575 64489581
Abdominal discomfort 77.37 42.61 79 4497 182243 64311913
Non-high-density lipoprotein cholesterol increased 68.62 42.61 12 4564 193 64493963
Alanine aminotransferase increased 67.76 42.61 65 4511 138966 64355190
Abdominal distension 64.86 42.61 54 4522 95940 64398216
Aspartate aminotransferase increased 50.90 42.61 52 4524 119736 64374420
Liver function test increased 50.70 42.61 30 4546 30940 64463216
Very low density lipoprotein increased 50.50 42.61 9 4567 162 64493994
Hepatic enzyme increased 49.13 42.61 53 4523 129890 64364266

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C10AX12 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
Other lipid modifying agents
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000186778 Microsomal Triglyceride Transfer Protein Inhibitors
FDA EPC N0000186779 Microsomal Triglyceride Transfer Protein Inhibitor
CHEBI has role CHEBI:35821 anticholesteremic drugs
CHEBI has role CHEBI:72298 microsomal triglyceride transfer protein inhibitor

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

DiseaseRelationSNOMED_IDDOID
Familial hypercholesterolemia - homozygous indication 238078005




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.28 acidic
pKa2 13.97 acidic
pKa3 8.71 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 10MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 10016404 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 10MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 10555938 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 10MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 8618135 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 10MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9265758 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 10MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9364470 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 10MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9433617 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 10MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9861622 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 20MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 10016404 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 20MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 10555938 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 20MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 8618135 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 20MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9265758 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 20MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9364470 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 20MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9433617 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 20MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9861622 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 30MG BASE JUXTAPID AMRYT N203858 April 23, 2015 RX CAPSULE ORAL 10016404 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 30MG BASE JUXTAPID AMRYT N203858 April 23, 2015 RX CAPSULE ORAL 10555938 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 30MG BASE JUXTAPID AMRYT N203858 April 23, 2015 RX CAPSULE ORAL 8618135 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 30MG BASE JUXTAPID AMRYT N203858 April 23, 2015 RX CAPSULE ORAL 9265758 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 30MG BASE JUXTAPID AMRYT N203858 April 23, 2015 RX CAPSULE ORAL 9364470 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 30MG BASE JUXTAPID AMRYT N203858 April 23, 2015 RX CAPSULE ORAL 9433617 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 30MG BASE JUXTAPID AMRYT N203858 April 23, 2015 RX CAPSULE ORAL 9861622 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 40MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 10016404 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 40MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 10555938 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 40MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 8618135 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 40MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 9265758 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 40MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 9364470 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 40MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 9433617 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 40MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 9861622 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 5MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 10016404 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 5MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 10555938 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 5MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 8618135 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 5MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9265758 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 5MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9364470 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 5MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9433617 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 5MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 9861622 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 60MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 10016404 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 60MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 10555938 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 60MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 8618135 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 60MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 9265758 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 60MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 9364470 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 60MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 9433617 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 60MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 9861622 March 7, 2025 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 10MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 7932268 Aug. 19, 2027 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 20MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 7932268 Aug. 19, 2027 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 30MG BASE JUXTAPID AMRYT N203858 April 23, 2015 RX CAPSULE ORAL 7932268 Aug. 19, 2027 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 40MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 7932268 Aug. 19, 2027 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 5MG BASE JUXTAPID AMRYT N203858 Dec. 21, 2012 RX CAPSULE ORAL 7932268 Aug. 19, 2027 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
EQ 60MG BASE JUXTAPID AMRYT N203858 April 23, 2015 DISCN CAPSULE ORAL 7932268 Aug. 19, 2027 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Microsomal triglyceride transfer protein large subunit Cytosolic other INHIBITOR IC50 8.10 WOMBAT-PK CHEMBL

External reference:

IDSource
D09637 KEGG_DRUG
4032035 VUID
N0000186142 NUI
202914-84-9 SECONDARY_CAS_RN
4032035 VANDF
C2827241 UMLSCUI
CHEBI:72297 CHEBI
CHEMBL354541 ChEMBL_ID
CHEMBL2105662 ChEMBL_ID
DB08827 DRUGBANK_ID
C473731 MESH_SUPPLEMENTAL_RECORD_UI
7439 IUPHAR_LIGAND_ID
9120 INN_ID
82KUB0583F UNII
9853053 PUBCHEM_CID
1364478 RXNORM
196706 MMSL
29025 MMSL
30485 MMSL
d07939 MMSL
014810 NDDF
014811 NDDF
716228008 SNOMEDCT_US
716229000 SNOMEDCT_US
864003008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Juxtapid HUMAN PRESCRIPTION DRUG LABEL 1 76431-105 CAPSULE 5 mg ORAL NDA 33 sections
Juxtapid HUMAN PRESCRIPTION DRUG LABEL 1 76431-105 CAPSULE 5 mg ORAL NDA 33 sections
Juxtapid HUMAN PRESCRIPTION DRUG LABEL 1 76431-110 CAPSULE 10 mg ORAL NDA 33 sections
Juxtapid HUMAN PRESCRIPTION DRUG LABEL 1 76431-110 CAPSULE 10 mg ORAL NDA 33 sections
Juxtapid HUMAN PRESCRIPTION DRUG LABEL 1 76431-120 CAPSULE 20 mg ORAL NDA 33 sections
Juxtapid HUMAN PRESCRIPTION DRUG LABEL 1 76431-120 CAPSULE 20 mg ORAL NDA 33 sections
Juxtapid HUMAN PRESCRIPTION DRUG LABEL 1 76431-130 CAPSULE 30 mg ORAL NDA 33 sections
Juxtapid HUMAN PRESCRIPTION DRUG LABEL 1 76431-130 CAPSULE 30 mg ORAL NDA 33 sections