Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04531083 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1: PF-04531083 | ACTIVE_COMPARATOR | - |
| Cohort 2: PF-04531083 | ACTIVE_COMPARATOR | - |
| cohort 1 | EXPERIMENTAL | - |
| cohort 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-04531083 | DRUG | Dosed as a tablet in 100mg strengths. Dosage in the first cohort will be 300mg twice daily for 3 days followed by 200mg twice daily for 11 days |
| simvastatin | DRUG | Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study. |
Inclusion Criteria: * Young * Healthy volunteers Exclusion Criteria: * Elderly volunteers * Patients with any existing medical conditions considered likely to impinge on study execution
Top 4 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Retatrutide, LY3016859, LY3556050, LY3526318, LY3857210 |
| Fortress Biotech, Inc. | FBIO | 1 | PHASE3 | Tramadol |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | MK-6916 |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
PF-04531083 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for chronic pain. It is a Phase 1 clinical candidate and has not been approved for any indication. Two Phase 1 trials of the drug have been completed, both in Belgium, with a combined enrollment of 48 participants.
PF-04531083 targets SCN10A, a sodium channel, and is classified as a blocker of that target. By blocking SCN10A, the drug is designed to interfere with pain signaling. This mechanism is being explored in the chronic pain setting, though the compound remains in Phase 1 development.
PF-04531083 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program for this small molecule candidate in chronic pain. The compound is also referred to in some study records as PF-04531083 100mg, reflecting a dose strength used in testing.
PF-04531083 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two Phase 1 trials have been completed, and no active trials are currently listed for this candidate.
Two completed Phase 1 trials have evaluated PF-04531083: NCT01119235, which examined the tablet form and blood concentrations of PF-04531083 after oral dosing in healthy volunteers, and NCT01103739, which explored the effect of PF-04531083 on blood concentrations of simvastatin and its main acid metabolite when co-administered. Both enrolled 24 participants in Belgium.