Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ponesimod · 2 trials · 2 indications
Proportion of participants achieving clinical remission at Week 16.
Safety will be assessed based on frequency of treatment-emergent adverse events and serious adverse events, and frequency of clinically notable abnormal vital signs, blood chemistry, hematology, urology, and ECGs
| Arm | Type | Description |
|---|---|---|
| Ponesimod (VSP-128) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Ponesimod | EXPERIMENTAL | Ponesimod |
| Name | Type | Description |
|---|---|---|
| Ponesimod | DRUG | Ponesimod administered orally once daily. Participants are randomized 2:1 to Ponesimod or placebo during a 16-week double-blind period. A 14-day titration is followed by a stable dose daily from Day 15 through end of treatment. Participants may enter a 36-week open-label extension receiving Ponesimod. |
| Placebo | DRUG | Matching placebo administered orally once daily during a 16-week double-blind period (2:1 randomization). A mock 14-day titration is used to maintain blinding. Participants may enter a 36-week open-label extension receiving Ponesimod. |
Inclusion Criteria: * Male and female subjects aged 18-75 years * Able to provide written informed consent * Diagnosis of ulcerative colitis for ≥90 days prior to screening * Three-component Mayo score of 5-9 with endoscopy subscore ≥2 and rectal bleeding subscore ≥1 * History of inadequate respons...
Ponesimod is an investigational small molecule being developed for moderate-to-severe chronic plaque psoriasis and ulcerative colitis (UC). It is currently in Phase 3 clinical trials for both indications. The drug is not yet approved by the FDA and remains in clinical development.
Ponesimod targets the S1PR1 receptor, acting as an agonist. This mechanism is being studied for its potential effects in treating moderate-to-severe chronic plaque psoriasis and ulcerative colitis. The drug is currently in Phase 3 clinical trials for these conditions.
Ponesimod is being developed by Vanda Pharmaceuticals Inc., a company traded under the ticker VNDA. The drug is currently in Phase 3 clinical trials for moderate-to-severe chronic plaque psoriasis and ulcerative colitis.
Ponesimod is in Phase 3 clinical development. It is being studied in two separate Phase 3 trials: one for moderate-to-severe chronic plaque psoriasis and another for moderately to severely active ulcerative colitis. Both trials are currently recruiting participants.
Ponesimod is being evaluated in two Phase 3 trials. NCT07362017 is an open-label study in moderate-to-severe chronic plaque psoriasis with 300 participants. NCT07686081 is a study in moderately to severely active ulcerative colitis with 150 participants. Both trials are recruiting in the United States.
Yes, Ponesimod is also known as VSP-128. This alternative name appears in the clinical trial for ulcerative colitis, NCT07686081, which evaluates the efficacy and safety of Ponesimod (VSP-128) in patients with moderately to severely active disease.