Approval Probability
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ADX-102 1% Dermal · 1 trial · 1 indication
Change from baseline using the Visual Index Ichthyosis Severity (VIIS) Scaling Score (0 = least, 4 = most), where a higher value represents a worse outcome, in ADX-102 treated patients
| Arm | Type | Description |
|---|---|---|
| ADX-102 1% Topical Dermal Cream (reproxalap) | EXPERIMENTAL | - |
| Vehicle of ADX-102 Topical Dermal Cream | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ADX-102 1% Topical Dermal Cream (reproxalap) | DRUG | ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months. |
| Vehicle of ADX-102 Topical Dermal Cream | DRUG | Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months. |
Inclusion Criteria: * Subject is aged 3 years or older * Subject has a genetically-confirmed diagnosis of SLS. * Subject has active ichthyosis that is Grade 2 or higher on the Visual Index Ichthyosis Severity (VIIS) score. * Females of child-bearing potential: Negative pregnancy test at Screening a...
ADX-102 1% Dermal is an investigational small molecule being developed for the treatment of Sjogren-Larsson Syndrome, a rare genetic disorder. It is a topical formulation applied to the skin. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
ADX-102 1% Dermal is being developed by Aldeyra Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALDX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Sjogren-Larsson Syndrome.
ADX-102 1% Dermal is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 3 trial for this drug has been completed, and the results will determine whether further development or regulatory submission is pursued.
ADX-102 1% Dermal has been studied in one Phase 3 clinical trial, identified as NCT03445650, titled 'RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)'. This randomized, double-blind, placebo-controlled trial enrolled 11 participants in the United States and has been completed.
ADX-102 1% Dermal is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Sjogren-Larsson Syndrome. The completed Phase 3 trial, NCT03445650, evaluated the drug in 11 patients, but regulatory approval has not been granted.