All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
prostaglandins receptors agonists, non-prostanoids	5312	1187451-19-9

Description:

Molecule

Description

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: OFM Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Sept. 22, 2022	FDA	SANTEN
Sept. 21, 2018	PMDA	Santen Pharmaceutical Co., Ltd.

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:

Source	Code	Description
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

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

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	5.4	Basic
pKa2	2.94	Basic
pKa3	0.55	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.002%	OMLONTI	SANTEN	N215092	Sept. 22, 2022	DISCN	SOLUTION	OPHTHALMIC	10179127	Jan. 8, 2035	METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002%	OMLONTI	SANTEN	N215092	Sept. 22, 2022	DISCN	SOLUTION	OPHTHALMIC	10702511	Jan. 8, 2035	METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002%	OMLONTI	SANTEN	N215092	Sept. 22, 2022	DISCN	SOLUTION	OPHTHALMIC	11197849	Jan. 8, 2035	METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002%	OMLONTI	SANTEN	N215092	Sept. 22, 2022	DISCN	SOLUTION	OPHTHALMIC	9415038	Jan. 8, 2035	METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002%	OMLONTI	SANTEN	N215092	Sept. 22, 2022	DISCN	SOLUTION	OPHTHALMIC	RE48183	Jan. 8, 2035	METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
0.002%	OMLONTI	SANTEN	N215092	Sept. 22, 2022	DISCN	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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.002%	OMLONTI	SANTEN	N215092	Sept. 22, 2022	DISCN	SOLUTION	OPHTHALMIC	Sept. 22, 2027	NEW CHEMICAL ENTITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Prostaglandin E2 receptor EP2 subtype	GPCR	P43116	PE2R2_HUMAN	AGONIST	EC50	8.08		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE

External reference:

ID	Source
G0G0H52U6K	UNII
1187451-41-7	SECONDARY_CAS_RN
C5139819	UMLSCUI
CHEMBL4297666	ChEMBL_ID
44230999	PUBCHEM_CID
DB15071	DRUGBANK_ID
CHEMBL3707245	ChEMBL_ID
D10966	KEGG_DRUG
10315	IUPHAR_LIGAND_ID
019188	NDDF
019189	NDDF
10214	INN_ID
2612690	RXNORM
39780	MMSL
C000632951	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Omlonti	HUMAN PRESCRIPTION DRUG LABEL	1	65086-002	SOLUTION/ DROPS	0.02 mg	OPHTHALMIC	NDA	27 sections
Omlonti	HUMAN PRESCRIPTION DRUG LABEL	1	65086-002	SOLUTION/ DROPS	0.02 mg	OPHTHALMIC	NDA	27 sections