Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
0.5% Roflumilast · 1 trial · 1 indication
Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity.
| Arm | Type | Description |
|---|---|---|
| 0.5% Roflumilast Cream | EXPERIMENTAL | Roflumilast 0.5%, cream, topically, twice daily for up to 15 days. |
| Vehicle Cream | PLACEBO_COMPARATOR | Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days. |
| Name | Type | Description |
|---|---|---|
| 0.5% Roflumilast Cream | DRUG | Roflumilast 0.5% cream |
| Vehicle Cream | DRUG | Roflumilast formulation vehicle |
Inclusion Criteria: 1. Is male or female between 18 to 65 years of age, inclusive, with atopic dermatitis (AD) meeting Hanifin and Rajka's criteria. 2. Has lesional skin areas of moderate severity characterized by modified local SCORing Atopic Dermatitis (SCORAD) of at least 4, with an erythema sco...
Top 20 of 25 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 9 | PHASE3 | Upadacitinib, corticosteroids |
| Pfizer Inc. | PFE | 11 | PHASE3 | Abrocitinib |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Lebrikizumab, Corticosteroid |
| Sanofi SA Sponsored ADR | SNY | 13 | PHASE3 | Amlitelimab |
| Regeneron Pharmaceuticals, Inc. | REGN | 4 | PHASE3 | Dupilumab |
| Incyte Corporation | INCY | 3 | PHASE3 | Ruxolitinib, Vehicle |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof, 1%, Vehicle |
| Apogee Therapeutics, Inc. | APGE | 3 | PHASE2 | APG777 |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | GIA632 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE2 | Soquelitinib |
| Nektar Therapeutics | NKTR | 1 | PHASE2 | Rezpegaldesleukin |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE2 | Barzolvolimab |
| Evommune, Inc. | EVMN | 1 | PHASE2 | EVO756 |
| Sunshine Biopharma Incorporated | SBFM | 3 | PHASE3 | 611, corticosteroid |
| Aclaris Therapeutics, Inc. | ACRS | 1 | PHASE2 | ATI-045 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-914 |
| Turn Therapeutics Inc. | TTRX | 1 | PHASE2 | GX-03 |
| Arcutis Biotherapeutics Inc | ARQT | 1 | PHASE1 | ARQ-234 |
0.5% Roflumilast is an investigational small molecule being studied for the treatment of atopic dermatitis, a form of eczema. It is applied topically and is currently in Phase 2 clinical development. The drug has not been approved by regulatory authorities and remains under investigation for this dermatological condition.
0.5% Roflumilast is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical research to evaluate the safety and efficacy of this topical formulation for atopic dermatitis.
0.5% Roflumilast is in Phase 2 clinical development for atopic dermatitis. It is an investigational drug, meaning it has not received FDA approval and is not yet available for commercial use. The Phase 2 trial has been completed, and the drug remains under evaluation for this indication.
0.5% Roflumilast was studied in a Phase 2 clinical trial identified as NCT01856764, titled "Topical Roflumilast in Adults With Atopic Dermatitis." This completed trial enrolled 40 participants in Germany and was randomized, double-blind, and placebo-controlled. The study included adults aged 18 years and older.
0.5% Roflumilast is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for atopic dermatitis. The completed clinical trial, NCT01856764, evaluated its safety and efficacy, but regulatory approval has not been granted, and the drug is not yet available for prescription use.