Omidenepag isopropyl
As of the edition of 20 October 2026, Omidenepag isopropyl is a small molecule: marketed, first approved in 2018 (JP); acts on PTGER2; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Omlonti
- First approved
- 21 September 2018 (JP)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Ocuvex Therapeutics; 2 holders in all
- Registered trials
- 13, 0 stopped early
- Disease areas
- Eye
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by Ocuvex Therapeutics.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Omidenepag isopropyl.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PTGER2 | Prostaglandin E2 receptor EP2 subtype | P43116 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 7 | 7 | 0 | 0 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Santen Pharmaceutical | Applicant and Lead sponsor of trials | 2012 to now |
| Ocuvex Therapeutics | Acquired holder | 2025 to now |