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

Stem definitionDrug idCAS RN
monoclonal antibodies (humanized origin); interleukin and interleukin receptors 5479 1044515-88-9

Description:

MoleculeDescription

Molfile

Synonyms:

  • tralokinumab
  • adtralza
  • CAT-354
  • adbry
Tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to the type 2 cytokine interleukin-13 (IL-13) and inhibits its interaction with the IL-13 receptors. Tralokinumab neutralises the biological activity of IL-13 by blocking its interaction with the IL-13Ralpha1/IL-4Ralpha receptor complex. IL-13 is a major driver of human type 2 inflammatory disease, such as atopic dermatitis and inhibiting the IL-13 pathway with tralokinumab in patients decreases many of the mediators of type 2 inflammation.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
16.10 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
July 16, 2021 EMA LEO PHARMA A/S
Dec. 27, 2021 FDA LEO PHARMA AS
Dec. 23, 2022 PMDA Leo Pharma K.K.

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
Pruritus 374.45 43.33 255 3829 541270 90083093
Eczema 273.51 43.33 99 3985 52771 90571592
Dermatitis atopic 246.33 43.33 75 4009 23397 90600966
Dry skin 244.16 43.33 105 3979 87968 90536395
Drug ineffective 239.07 43.33 299 3785 1383999 89240364
Rash 184.67 43.33 201 3883 795899 89828464
Injection site pain 184.51 43.33 108 3976 173591 90450772
Injection site pruritus 175.14 43.33 72 4012 53762 90570601
Eye pruritus 175.13 43.33 61 4023 28966 90595397
Ocular hyperaemia 169.77 43.33 62 4022 33736 90590627
Injection site erythema 150.68 43.33 78 4006 98424 90525939
Conjunctivitis 145.36 43.33 52 4032 26654 90597709
Injection site swelling 129.24 43.33 60 4024 59779 90564584
Dry eye 124.84 43.33 58 4026 57873 90566490
Skin exfoliation 119.03 43.33 59 4025 67854 90556509
Eye irritation 92.23 43.33 40 4044 33938 90590425
Erythema 84.53 43.33 75 4009 229171 90395192
Injection site reaction 78.86 43.33 50 4034 92030 90532333
Product use in unapproved indication 65.45 43.33 78 4006 336158 90288205
Skin fissures 64.75 43.33 27 4057 20782 90603581
Injection site bruising 56.56 43.33 33 4051 52274 90572089
Eye swelling 52.81 43.33 26 4058 29360 90595003
Rash macular 46.24 43.33 24 4060 30256 90594107
Injection site rash 45.26 43.33 22 4062 24151 90600212
Therapy interrupted 44.84 43.33 28 4056 50080 90574283
Vision blurred 44.40 43.33 38 4046 110255 90514108

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
Pruritus 295.47 55.07 159 2105 188612 42430459
Drug ineffective 208.64 55.07 206 2058 629991 41989080
Conjunctivitis 148.51 55.07 46 2218 12893 42606178
Dry skin 138.77 55.07 62 2202 48276 42570795
Eczema 131.77 55.07 54 2210 34032 42585039
Eye irritation 128.85 55.07 40 2224 11278 42607793
Dermatitis atopic 117.05 55.07 38 2226 12366 42606705
Skin exfoliation 102.49 55.07 48 2216 41505 42577566
Eye pruritus 99.74 55.07 33 2231 11379 42607692
Rash 98.36 55.07 95 2169 276859 42342212
Injection site pain 93.08 55.07 50 2214 57748 42561323
Ocular hyperaemia 92.60 55.07 34 2230 15929 42603142
Erythema 75.24 55.07 55 2209 108738 42510333
Skin fissures 72.76 55.07 25 2239 9651 42609420
Dry eye 64.72 55.07 26 2238 15480 42603591
Injection site erythema 64.57 55.07 28 2236 20167 42598904
Injection site swelling 59.09 55.07 25 2239 16948 42602123

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
Pruritus 494.82 48.37 319 4978 581241 110002761
Eczema 342.66 48.37 129 5168 72164 110511838
Drug ineffective 321.29 48.37 375 4922 1520165 109063837
Dry skin 299.45 48.37 131 5166 107522 110476480
Injection site pain 253.59 48.37 137 5160 177785 110406217
Dermatitis atopic 252.06 48.37 79 5218 25462 110558540
Rash 244.75 48.37 244 5053 820720 109763282
Eye pruritus 244.55 48.37 82 5215 32693 110551309
Conjunctivitis 226.44 48.37 78 5219 33714 110550288
Ocular hyperaemia 226.22 48.37 81 5216 39205 110544797
Injection site pruritus 205.24 48.37 81 5216 51177 110532825
Eye irritation 181.40 48.37 66 5231 33386 110550616
Injection site erythema 172.66 48.37 86 5211 94090 110489912
Injection site swelling 164.42 48.37 73 5224 61717 110522285
Skin exfoliation 160.53 48.37 80 5217 87571 110496431
Dry eye 158.42 48.37 69 5228 55724 110528278
Erythema 123.66 48.37 106 5191 291341 110292661
Skin fissures 88.60 48.37 36 5261 24422 110559580
Product use in unapproved indication 87.19 48.37 107 5190 447270 110136732
Vision blurred 69.45 48.37 54 5243 128968 110455034
Injection site bruising 68.67 48.37 38 5259 51225 110532777
Skin burning sensation 68.48 48.37 29 5268 21796 110562206
Injection site reaction 67.82 48.37 46 5251 89024 110494978
Therapy interrupted 66.92 48.37 37 5260 49785 110534217
Eye swelling 62.88 48.37 31 5266 33017 110550985
Lacrimation increased 61.79 48.37 30 5267 30920 110553082
Rash macular 55.46 48.37 30 5267 38656 110545346
Illness 54.50 48.37 39 5258 82132 110501870
Injection site rash 53.78 48.37 25 5272 23394 110560608
Eyelid margin crusting 50.85 48.37 13 5284 2003 110581999

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D11AH07 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Agents for dermatitis, excluding corticosteroids
MeSH PA D003879 Dermatologic Agents
FDA EPC N0000193985 Interleukin-13 Antagonist
FDA MoA N0000193986 Interleukin-13 Antagonists
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

D11AH Agents for dermatitis, excluding corticosteroids 11 drugs
abrocitinibalitretinoincrisaborolecromoglicic aciddelgocitinibdupilumablebrikizumabnemolizumabpimecrolimusruxolitinibtacrolimus

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

DiseaseRelationSNOMED_IDDOID
Moderate to severe atopic dermatitis indication 24079001 DOID:3310




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Interleukin-13 Cytokine ANTIBODY BINDING Kd 10.22 DRUG LABEL DRUG LABEL

External reference:

IDSource
GK1LYB375A UNII
C3658667 UMLSCUI
CHEBI:750158 CHEBI
CHEMBL1743081 ChEMBL_ID
DB12169 DRUGBANK_ID
9235 INN_ID
C574065 MESH_SUPPLEMENTAL_RECORD_UI
8001 IUPHAR_LIGAND_ID
D09979 KEGG_DRUG
1340112006 SNOMEDCT_US
138251000202108 SNOMEDCT_US
4041103 VANDF
354630 MMSL
39999 MMSL
d09820 MMSL
018917 NDDF
2589225 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Adbry HUMAN PRESCRIPTION DRUG LABEL 1 50222-346 INJECTION, SOLUTION 150 mg SUBCUTANEOUS BLA 29 sections
Adbry HUMAN PRESCRIPTION DRUG LABEL 1 50222-350 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 29 sections