Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
R348, 0.2% · 3 trials · 2 indications
Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.
| Arm | Type | Description |
|---|---|---|
| R348 Ophthalmic Solution, 0.2% | ACTIVE_COMPARATOR | R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day |
| R348 Ophthalmic Solution, 0.5% | ACTIVE_COMPARATOR | R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day |
| Placebo | PLACEBO_COMPARATOR | Placebo Ophthalmic Solution 2 drops per eye twice a day |
| R348 Ophthalmic Solution, 1.0% | ACTIVE_COMPARATOR | R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. |
| Name | Type | Description |
|---|---|---|
| R348 Ophthalmic Solution, 0.2% | DRUG | R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day |
| R348 Ophthalmic Solution, 0.5% | DRUG | R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day |
| Placebo Ophthalmic Solution | OTHER | Placebo Ophthalmic Solution 2 drops per eye twice a day |
| Placebo | DRUG | Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. |
| R348 Ophthalmic Solution, 1.0% | DRUG | R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose |
Inclusion Criteria: * Received an Allogeneic hematologic stem cell transplantation at least 3 months prior. * Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening of dry eye symptoms for at least 1 month prior. * Use of over-the-counter and/or prescription eye drop...
R348, 0.2% is an investigational small molecule being studied for the treatment of Keratoconjunctivitis Sicca, also known as dry eye disease, and Chronic Graft-versus-host Disease. It is developed by Rigel Pharmaceuticals, Inc. and is currently in clinical development, though it has not been approved by regulatory authorities.
R348, 0.2% is a small molecule developed by Rigel Pharmaceuticals, Inc. for use in immunology-related conditions. The specific molecular target of R348, 0.2% has not been disclosed in available information, so its exact mechanism of action is not publicly detailed.
R348, 0.2% is developed by Rigel Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RIGL. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for ophthalmic conditions.
R348, 0.2% is in Phase 2 clinical development. It has completed two Phase 2 trials and one Phase 1 trial. The drug is investigational and has not received FDA approval, as it is still undergoing clinical evaluation for safety and efficacy.
R348, 0.2% has completed three clinical trials: NCT01733992, a Phase 1 study in dry eye disease; NCT01900249, a Phase 2 study in Keratoconjunctivitis Sicca; and NCT02040623, a Phase 2 study in Chronic Graft-versus-host Disease. All trials were completed in the United States.
R348, 0.2% is also known as R932348. Clinical trial records for the drug list R932348 as the active ingredient name, with R348, 0.2% referring to the concentration of the ophthalmic solution being studied.