Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 | ACTIVE_COMPARATOR | Talarozole 0.5 mg |
| 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 Capsule Once Daily |
| Differin™, 0.1% adapalene gel | DRUG | Topical Application (20 mg) |
Inclusion Criteria: * Plaque Psoriasis with PASI greater than or equal to 10 * Male or a female who was NOT of childbearing potential (i.e., post- menopausal for greater than 12 months or had a complete hysterectomy); Exclusion Criteria: * Spontaneously improving or rapidly deteriorating plaque p...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | 1% Clascoterone |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE1 | Acne mRNA vaccine |
| Hoth Therapeutics, Inc. | HOTH | 1 | PHASE2 | HT-001 2%, HT-001 1%, HT-001 0.5% |
| Sagimet Biosciences Inc. Class A | SGMT | 1 | PHASE1 | TVB-3567 |
| Bausch Health Companies Inc. | BHC | 1 | - | clindamycin, adapalene and benzoyl peroxide |
Talarozole is an investigational small molecule being developed by GSK plc for dermatology conditions including psoriasis, acne, and cutaneous inflammation. It is currently in Phase 2 clinical development and is not approved by the FDA.
Talarozole targets the retinoic acid metabolism pathway, specifically inhibiting the enzyme CYP26, which is involved in the breakdown of retinoic acid. By blocking this enzyme, talarozole increases retinoic acid levels in the skin, which may help treat conditions like psoriasis and acne.
Talarozole is being developed by GSK plc, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol GSK. The drug is currently in Phase 2 clinical trials for dermatological indications.
Talarozole is in Phase 2 clinical development. It has completed two Phase 2 trials for psoriasis and acne, as well as a Phase 1 trial for cutaneous inflammation. The drug is still investigational and has not received FDA approval.
Talarozole has completed several clinical trials, including NCT00716144 (Phase 2, plaque psoriasis, 176 participants), NCT00719121 (Phase 1, cutaneous inflammation, 12 participants), NCT00725348 (Phase 2, plaque psoriasis, 19 participants), and NCT00725439 (Phase 2, facial acne, 16 participants). All trials are completed.
Yes, Talarozole is also known as R115866. Clinical trials for the drug have used the name R115866, including studies for plaque psoriasis, cutaneous inflammation, and facial acne. Both names refer to the same investigational compound.