Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
U0267 · 1 trial · 1 indication
Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
| Arm | Type | Description |
|---|---|---|
| U0267 Foam | EXPERIMENTAL | U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. |
| Vehicle foam | PLACEBO_COMPARATOR | Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body. |
| Name | Type | Description |
|---|---|---|
| U0267 | DRUG | All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). |
| Vehicle | DRUG | All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). |
Inclusion Criteria: * Male or female subjects at least 12 years old and in good general health. * Mild to moderate plaque-type psoriasis Exclusion Criteria: * Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulatio...
Top 12 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 11 | PHASE3 | JNJ-77242113, Ustekinumab, Guselkumab |
| Bristol-Myers Squibb Company | BMY | 14 | PHASE3 | Deucravacitinib |
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Risankizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE3 | Zasocitinib |
| Alumis Inc. | ALMS | 2 | PHASE3 | Envudeucitinib |
| Oruka Therapeutics, Inc. | ORKA | 4 | PHASE2 | ORKA-002, ORKA-001 |
| Can-Fite Biopharma Ltd | CANF | 1 | PHASE3 | Piclidenoson |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Ponesimod |
| Novartis AG Sponsored ADR | NVS | 4 | - | Secukinumab |
| Bausch Health Companies Inc. | BHC | 2 | - | Brodalumab |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-8644 |
U0267 is an investigational small molecule developed by GSK plc for the treatment of plaque-type psoriasis, a chronic inflammatory skin condition. It is being studied as a topical therapy in a Phase 3 clinical program. U0267 has not been approved by the FDA and remains in clinical development.
U0267 is being developed by GSK plc, the global pharmaceutical company listed on the New York Stock Exchange under the ticker GSK. GSK is the sponsor of the clinical program evaluating U0267 in plaque-type psoriasis.
U0267 is in Phase 3 clinical development for plaque-type psoriasis. One Phase 3 trial has been completed, and no active trials are currently listed. U0267 is investigational and has not received FDA approval.
U0267 has been evaluated in one completed Phase 3 trial, NCT00688519, titled "Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies." The trial enrolled 336 participants in the United States, was randomized, double-blind, and placebo-controlled, and included subjects aged 12 years and older.
No, U0267 is not FDA approved. It is an investigational small molecule in Phase 3 clinical development for plaque-type psoriasis, sponsored by GSK plc. The only listed trial, NCT00688519, has been completed, and no active trials are currently reported.