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

Stem definitionDrug idCAS RN
prostaglandins receptors agonists, non-prostanoids 5312 1187451-19-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • omidenepag isopropyl
  • omidenepag
  • DE-117
  • eybelis
  • omlonti
Omidenepag isopropyl is a prodrug that is converted by hydrolysis to omidenepag, the active form that it is thought to lower ophthalmic pressure via a dual mechanism of action, increasing both the trabecular outfow facility and the uveoscleral outfow as a result of EP2 receptor stimulation, thereby promoting aqueous outfow.
  • Molecular weight: 520.61
  • Formula: C26H28N6O4S
  • CLOGP: 3.04
  • LIPINSKI: 1
  • HAC: 10
  • HDO: 1
  • TPSA: 119.31
  • ALOGS: -4.51
  • ROTB: 11
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,ITK,JAK2,MAP3K21,MAP3K7,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PRKDC,SIK2,SIK3,STK33,TEK,TTK 39
kinase-selectivity-class AXL 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Sept. 21, 2018 PMDA Santen Pharmaceutical Co., Ltd.
Sept. 22, 2022 FDA SANTEN

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC S01EX06 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIGLAUCOMA PREPARATIONS AND MIOTICS
Other antiglaucoma preparations
FDA EPC N0000194041 Prostaglandin E2 Receptor Agonist
FDA MoA N0000194042 Prostaglandin E2 Receptor Agonists
CHEBI has role CHEBI:39456 antiglaucoma drug
CHEBI has role CHEBI:35674 antihypertensive agent

Related Drugs by ATC class:

S01EX Other antiglaucoma preparations 4 drugs
dapiprazoleguanethidinenetarsudilripasudil

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

DiseaseRelationSNOMED_IDDOID
Ocular hypertension indication 4210003 DOID:9282
Glaucoma indication 23986001 DOID:1686




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.4 Basic
pKa2 2.94 Basic
pKa3 0.55 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.002% OMLONTI OCUVEX THERAP N215092 Sept. 22, 2022 RX SOLUTION OPHTHALMIC 10179127 Jan. 8, 2035 METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002% OMLONTI OCUVEX THERAP N215092 Sept. 22, 2022 RX SOLUTION OPHTHALMIC 10702511 Jan. 8, 2035 METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002% OMLONTI OCUVEX THERAP N215092 Sept. 22, 2022 RX SOLUTION OPHTHALMIC 11197849 Jan. 8, 2035 METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002% OMLONTI OCUVEX THERAP N215092 Sept. 22, 2022 RX SOLUTION OPHTHALMIC 11793798 Jan. 8, 2035 METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002% OMLONTI OCUVEX THERAP N215092 Sept. 22, 2022 RX SOLUTION OPHTHALMIC 12295946 Jan. 8, 2035 METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002% OMLONTI OCUVEX THERAP N215092 Sept. 22, 2022 RX SOLUTION OPHTHALMIC 9415038 Jan. 8, 2035 METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002% OMLONTI OCUVEX THERAP N215092 Sept. 22, 2022 RX SOLUTION OPHTHALMIC RE48183 Jan. 8, 2035 METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002% OMLONTI OCUVEX THERAP N215092 Sept. 22, 2022 RX SOLUTION OPHTHALMIC 12290511 Dec. 27, 2038 METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002% OMLONTI OCUVEX THERAP N215092 Sept. 22, 2022 RX SOLUTION OPHTHALMIC 11666563 July 16, 2039 METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.002% OMLONTI OCUVEX THERAP N215092 Sept. 22, 2022 RX SOLUTION OPHTHALMIC Sept. 22, 2027 NEW CHEMICAL ENTITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin E2 receptor EP2 subtype GPCR AGONIST EC50 8.08 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE

External reference:

IDSource
G0G0H52U6K UNII
1187451-41-7 SECONDARY_CAS_RN
4044439 VANDF
4044440 VANDF
C5139819 UMLSCUI
CHEBI:757127 CHEBI
CHEMBL4297666 ChEMBL_ID
44230999 PUBCHEM_CID
DB15071 DRUGBANK_ID
CHEMBL3707245 ChEMBL_ID
D10966 KEGG_DRUG
C000632951 MESH_SUPPLEMENTAL_RECORD_UI
10214 INN_ID
361706 MMSL
39780 MMSL
019188 NDDF
019189 NDDF
10315 IUPHAR_LIGAND_ID
2612690 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Omlonti HUMAN PRESCRIPTION DRUG LABEL 1 65086-002 SOLUTION/ DROPS 0.02 mg OPHTHALMIC NDA 27 sections
Omlonti HUMAN PRESCRIPTION DRUG LABEL 1 84826-002 SOLUTION/ DROPS 0.02 mg OPHTHALMIC NDA 27 sections