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Also known as Rambazole, R115866
Talarozole · 4 trials · 3 indications
PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Talarozole |
| B | ACTIVE_COMPARATOR | Talarozole 1.0 mg |
| C | ACTIVE_COMPARATOR | Talarozole 2.0 mg |
| D | PLACEBO_COMPARATOR | Talarozole matching Placebo |
| Name | Type | Description |
|---|---|---|
| Talarozole | DRUG | Oral Dose 1.0 mg once daily |
| Differin™, 0.1% adapalene gel | DRUG | Topical Application (20 mg) |
Inclusion Criteria: * Male subject * Presence of moderate to severe facial acne vulgaris: having a minimum of 15 papules and/or pustules and at least 2 nodulocystic lesions * In good general health and free of any disease state or physical condition which, in the investigator's opinion, might have ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE2 | Acne mRNA vaccine |
| Sagimet Biosciences Inc. Class A | SGMT | 2 | PHASE3 | Denifanstat, TVB-3567 |
| Hoth Therapeutics, Inc. | HOTH | 1 | PHASE2 | HT-001 |
Talarozole is an investigational small molecule developed by GSK plc for dermatology indications, including acne, cutaneous inflammation, and psoriasis. It has been studied in Phase 2 clinical trials. Talarozole is not approved and remains in clinical development.
Talarozole targets CYP26A1 and acts as an inhibitor of this enzyme. By inhibiting CYP26A1, talarozole is designed to modulate retinoic acid metabolism, which is relevant to inflammatory skin conditions such as acne and psoriasis.
Talarozole is developed by GSK plc, which trades under the ticker GSK. GSK has sponsored the clinical trials of talarozole in dermatology indications including acne, cutaneous inflammation, and psoriasis.
Talarozole is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The completed studies include Phase 1 and Phase 2 trials in acne, psoriasis, and cutaneous inflammation.
Talarozole has been studied in completed trials including NCT00725439 in facial acne, NCT00725348 and NCT00716144 in plaque psoriasis, and NCT00719121 in cutaneous inflammation. These trials enrolled a total of 195 participants across Belgium, the Netherlands, Germany, Ireland, Russia, and the United Kingdom.
Yes, Talarozole is also known as R115866. Clinical trial records for talarozole list it under the code R115866, including studies in facial acne and plaque psoriasis. The names refer to the same investigational compound.