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omidenepag isopropyl 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| prostaglandins receptors agonists, non-prostanoids | 5312 | 1187451-19-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| 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:
| 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 |
| 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
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 | 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.002% | OMLONTI | OCUVEX THERAP | N215092 | Sept. 22, 2022 | RX | 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 | AGONIST | EC50 | 8.08 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| 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:
| 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 | 84826-002 | SOLUTION/ DROPS | 0.02 mg | OPHTHALMIC | NDA | 27 sections |