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Molecule

Omidenepag isopropyl

Prostaglandin E2 Receptor Agonist
Available on requestCold chain
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Omidenepag isopropyl is a prostaglandin E2 receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. It is available as eye drops for ophthalmic use. MedsAcross supplies Omidenepag isopropyl for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Prostaglandin E2 Receptor Agonist, Prostaglandin E2 Receptor Agonists
US FDA first approval
22 September 2022
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Ophthalmic
Dosage forms
Eye drops
Identifiers
UNII G0G0H52U6KCAS 1187451-19-9DrugBank DB15071Q27896252

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Source: US FDA prescribing information

How it works

Omidenepag is a relatively selective EP2 receptor agonist which decreases intraocular pressure (IOP). The exact mechanism of action is unknown at this time. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

Source: US FDA prescribing information

Dosing overview

The recommended dosage is one drop in the affected eye(s) once daily in the evening. Recommended Dosage The recommended dosage is one drop in the affected eye(s) once daily in the evening.

Source: US FDA prescribing information

Warnings and precautions

Pigmentation. Eyelash changes. Ocular Inflammation. Macular Edema Pigmentation Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is a prodrug of omidenepag, a relatively selective EP2 receptor agonist. Pigmentation is expected to increase as long as omidenepag isopropyl ophthalmic solution is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of Omlonti, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes are likely to be reversible in most patients. Patients who receive prostaglandin analogs, including Omlonti, should be informed of the possibility of increased pigmentation, including permanent changes. The long-term effects of increased pigmentation are not known.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Pigmentation Eyelash Changes Ocular Inflammation Macular Edema The most common adverse reactions with incidence ≥ 1% are conjunctival hyperemia (9%), photophobia (5%), vision blurred (4%), dry eye (3%), instillation site pain (3%), eye pain (2%), ocular hyperemia (2%), punctate keratitis (2%), headache (2%), eye irritation (1%), and visual impairment (1%).

Source: US FDA prescribing information

Storage

Store unopened bottle (s) in the refrigerator at 2°C to 8°C (36°F to 46°F). Once a bottle is opened for use, it can be stored for up to 31 days at up to 30°C (86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Omidenepag isopropyl, sorted by availability.

MedicineManufacturerRegisterAvailability
Omlonti 0.02 mg/mL eye dropsOphthalmic Cold chainOcuvex TherapeuticsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 22 September 2022Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Omidenepag isopropyl available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Omidenepag isopropyl and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Omidenepag isopropyl have?

The catalogue lists 1 brand names for Omidenepag isopropyl, including Omlonti.

Is Omidenepag isopropyl approved by the US FDA?

Yes. The US FDA first approved Omidenepag isopropyl on 22 September 2022, according to Drugs@FDA.

Does Omidenepag isopropyl need cold chain shipping?

At least one listed presentation of Omidenepag isopropyl must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. Omlonti prescribing information (Ocuvex Therapeutics). U.S. National Library of Medicine, DailyMed. Retrieved 21 April 2025

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