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
BA (Bioavailability) 0.07 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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 1121.66 38.88 278 3657 30179 63454908
Weight decreased 424.92 38.88 243 3692 276555 63208532
Diarrhoea 383.33 38.88 328 3607 715038 62770049
Flatulence 208.59 38.88 79 3856 34623 63450464
Low density lipoprotein increased 202.63 38.88 52 3883 6305 63478782
Diet noncompliance 148.45 38.88 25 3910 368 63484719
Nausea 120.17 38.88 199 3736 854272 62630815
Abdominal pain upper 109.12 38.88 95 3840 206349 63278738
Inappropriate schedule of product administration 99.16 38.88 68 3867 103897 63381190
Product dose omission issue 83.95 38.88 87 3848 234226 63250861
Blood cholesterol increased 70.12 38.88 53 3882 93979 63391108
Product administered to patient of inappropriate age 58.55 38.88 17 3918 3251 63481836
Abdominal distension 54.12 38.88 44 3891 86571 63398516
Liver function test increased 50.19 38.88 29 3906 32782 63452305
Non-high-density lipoprotein cholesterol increased 44.85 38.88 8 3927 167 63484920

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 494.43 54.04 125 1764 16848 34938194
Weight decreased 345.41 54.04 173 1716 176128 34778914
Diarrhoea 205.64 54.04 167 1722 389745 34565297
Flatulence 125.55 54.04 46 1843 21152 34933890
Diet noncompliance 122.51 54.04 19 1870 187 34954855
Low density lipoprotein increased 110.53 54.04 29 1860 4407 34950635
Product dose omission issue 94.72 54.04 66 1823 119645 34835397
Abdominal discomfort 64.21 54.04 40 1849 59795 34895247
Blood cholesterol increased 60.46 54.04 27 1862 20516 34934526

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 1263.86 41.38 316 4395 37246 79702431
Weight decreased 538.38 41.38 304 4407 354894 79384783
Diarrhoea 449.86 41.38 385 4326 880104 78859573
Flatulence 264.09 41.38 98 4613 42626 79697051
Low density lipoprotein increased 222.25 41.38 59 4652 8563 79731114
Nausea 151.07 41.38 229 4482 956967 78782710
Abdominal pain upper 126.69 41.38 105 4606 223714 79515963
Diet noncompliance 113.97 41.38 21 4690 556 79739121
Product dose omission issue 101.88 41.38 97 4614 247440 79492237
Inappropriate schedule of product administration 97.72 41.38 73 4638 133555 79606122
Product administered to patient of inappropriate age 88.09 41.38 26 4685 5527 79734150
Blood cholesterol increased 80.29 41.38 54 4657 83666 79656011
Alanine aminotransferase increased 73.10 41.38 67 4644 162503 79577174
Abdominal discomfort 68.50 41.38 79 4632 250648 79489029
Non-high-density lipoprotein cholesterol increased 64.71 41.38 12 4699 329 79739348
Abdominal distension 63.10 41.38 54 4657 119596 79620081
Aspartate aminotransferase increased 56.26 41.38 54 4657 138587 79601090
Liver function test increased 54.01 41.38 32 4679 39741 79699936
Very low density lipoprotein increased 50.09 41.38 9 4702 206 79739471
Hepatic enzyme increased 43.96 41.38 54 4657 182556 79557121

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