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Also known as diquafosol tetrasodium (INS365) ophthalmic solution
diquafosol tetrasodium · 7 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 2 | PLACEBO_COMPARATOR | - |
| Arm 1 | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Diquafosol tetrasodium ophthalmic solution, 2% | DRUG | One to two drops in each eye QID for 6 weeks |
| Placebo | DRUG | One to two drops in each eye QID for 6 weeks |
| Non-preserved saline solution (Placebo) | DRUG | 1-2 drops administered in each eye 4 times a day for 6 weeks |
| diquafosol tetrasodium (INS365) Ophthalmic Solution | DRUG | - |
Inclusion Criteria: * Have best corrected visual acuity in both eyes of at least +0.7 or better * Central corneal staining of 3 on the NEI scale * If female, are non-pregnant or non-lactating * Have a history of dry eye disease in both eyes * Have normal lid anatomy Exclusion Criteria: * Unable t...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-319 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Bausch Health Companies Inc. | BHC | 1 | PHASE2 | BL1107 |
Diquafosol tetrasodium is an investigational ophthalmic small molecule being developed for the treatment of dry eye disease. It is formulated as a 2% ophthalmic solution and is administered as an eye drop. The drug is currently in Phase 3 clinical development, with seven completed trials in dry eye disease.
Diquafosol tetrasodium targets the purinergic receptors P2RY6, P2RY1, P2RY2, and P2RY4, where it acts as an agonist. By activating these receptors, it is designed to stimulate tear secretion and support ocular surface hydration in dry eye disease.
Diquafosol tetrasodium is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is responsible for the clinical development program of the ophthalmic solution for dry eye disease.
Diquafosol tetrasodium is in Phase 3 clinical development for dry eye disease. It is an investigational therapy and has not been approved by the FDA. Seven clinical trials have been completed, including Phase 2 and Phase 3 studies, with no active trials currently listed.
Diquafosol tetrasodium has been studied in seven completed clinical trials, including Phase 3 trials NCT00831662 and NCT00600288, and Phase 2 trials NCT00680108 and NCT00679718. These trials enrolled a total of 2,603 participants and evaluated the ophthalmic solution in dry eye disease.
Yes, diquafosol tetrasodium is also known as INS365. The ophthalmic solution is referred to as diquafosol tetrasodium (INS365) ophthalmic solution, 2%, and related variations. INS365 was the earlier code name used in Phase 2 studies of the compound.