Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-05335810 Dose A · 1 trial · 1 indication
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Cohort 5 | EXPERIMENTAL | - |
| Cohort 6 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-05335810 Dose A | BIOLOGICAL | Single SC Injection |
| PF-05335810 Dose B | BIOLOGICAL | Single Subcutaneous Injection(s) |
| Placebo | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-04950615 Dose A | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-05335810 Dose C | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-04950615 | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-05335810 Dose D | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-05335810 Dose E | BIOLOGICAL | Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months. |
Inclusion Criteria: * On stable daily doses of a statin for 45 days prior to receiving study treatment. * Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization. Exclusion Criteria: * History of a cardiovascular or cerebrovascular event or ...
Top 12 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 4 | PHASE3 | Enlicitide |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Inclisiran, Pelacarsen, DII235, QCZ484 |
| AstraZeneca PLC | AZN | 3 | PHASE3 | AZD0780, Laroprovstat, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 5 | PHASE3 | Plozasiran, zodasiran, VSA003 |
| Ionis Pharmaceuticals, Inc. | IONS | 2 | PHASE3 | Olezarsen, ION775 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE2 | Alirocumab |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Solbinsiran |
| MediciNova, Inc. | MNOV | 1 | PHASE2 | MN-001 |
| Verve Therapeutics, Inc. | VERV | 4 | PHASE2 | VERVE-102, VERVE-201 |
| NewAmsterdam Pharma Company N.V. | NAMS | 1 | PHASE1 | Obicetrapib |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| Esperion Therapeutics, Inc. | ESPR | 1 | - | Bempedoic acid+ Ezetimibe |
PF-05335810 Dose A is an investigational monoclonal antibody developed by Pfizer, Inc. (PFE) for hypercholesterolemia, a condition of elevated cholesterol in the blood. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial. It is not an approved therapy.
PF-05335810 Dose A is being developed for hypercholesterolemia, the metabolic condition marked by high cholesterol levels. Its only recorded clinical study enrolled hypercholesterolemic adults, not healthy volunteers. The drug remains investigational and has no approved indication.
Pfizer, Inc. (ticker PFE) is the developer of PF-05335810 Dose A. Pfizer sponsored the Phase 1 study of the monoclonal antibody in hypercholesterolemic subjects, which was conducted in the United States.
PF-05335810 Dose A is in Phase 1 clinical development. Its single recorded trial, NCT01720537, was a completed Phase 1 study. The drug is investigational and has not been approved for any use.
PF-05335810 Dose A has been studied in one trial, NCT01720537, titled A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects. It was a completed Phase 1 randomized, double-blind, controlled trial that enrolled 133 participants aged 18 years and older in the United States.