Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN7544 · 3 trials · 3 indications
Only for Cohort B
| Arm | Type | Description |
|---|---|---|
| REGN7544 | EXPERIMENTAL | - |
| Placebo (PB) | PLACEBO_COMPARATOR | - |
| Low Dose | EXPERIMENTAL | Randomized 1:1:1 |
| High Dose | EXPERIMENTAL | Randomized 1:1:1 |
| Matching Placebo | PLACEBO_COMPARATOR | Randomized 1:1:1 |
| IV Dose Level 1 | EXPERIMENTAL | Randomized 6:2 for single ascending IV dose |
| IV Dose Level 2 | EXPERIMENTAL | Randomized 6:2 for single ascending IV dose |
| IV Dose Level 3 | EXPERIMENTAL | Randomized 6:2 for single ascending IV dose |
| IV Dose Level 4 | EXPERIMENTAL | Randomized 6:2 for single ascending IV dose |
| IV Dose Level 5 | EXPERIMENTAL | Randomized 6:2 for single ascending IV dose |
| IV Dose Level 6 | EXPERIMENTAL | Randomized 6:2 for single ascending IV dose |
| SC Dose Level 1 | EXPERIMENTAL | Randomized 6:2 for single ascending SC dose |
| SC Dose Level 2 | EXPERIMENTAL | Randomized 6:2 for single ascending SC dose |
| SC Dose Level 3 | EXPERIMENTAL | Randomized 6:2 for single ascending SC dose |
| Optional Cohort 1 | EXPERIMENTAL | Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV or SC and will not exceed highest dose level |
| Optional Cohort 2 | EXPERIMENTAL | Randomized 6:2 Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV o SC and will not exceed highest dose level |
| Name | Type | Description |
|---|---|---|
| REGN7544 | DRUG | Administered per the protocol |
| PB | DRUG | Administered per the protocol |
| Placebo | DRUG | SC administration |
| Matching Placebo | DRUG | Solution for single ascending IV or SC administration per the protocol |
Key Inclusion Criteria: 1. Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period 2. Sepsis-induced hypotension that has not responded to Intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Art...
REGN7544 is an investigational small molecule being studied for sepsis-induced hypotension and postural orthostatic tachycardia syndrome (POTS), as well as in healthy volunteers. It is a natriuretic peptide receptor 1 (NPR1) antagonist. The drug is being developed by Regeneron Pharmaceuticals and is currently in clinical trials.
REGN7544 targets natriuretic peptide receptor 1 (NPR1). As an NPR1 antagonist, it is being studied for its potential effects on conditions involving blood pressure regulation, including sepsis-induced hypotension and postural orthostatic tachycardia syndrome (POTS).
REGN7544 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational small molecule in multiple patient populations.
REGN7544 has completed Phase 1 and Phase 2 clinical trials. A Phase 1 study in healthy volunteers and Phase 2 studies in patients with postural orthostatic tachycardia syndrome (POTS) and sepsis-induced hypotension have all been completed. The drug remains investigational and is not yet approved.
REGN7544 has been studied in three completed clinical trials: NCT05970718, a Phase 1 safety study in healthy volunteers; NCT06593600, a Phase 2 study in patients with postural orthostatic tachycardia syndrome (POTS); and NCT06608901, a Phase 2 study in patients with sepsis-induced hypotension.
Yes, REGN7544 is a natriuretic peptide receptor 1 (NPR1) antagonist. This mechanism is being investigated for its potential to modulate blood pressure in conditions such as sepsis-induced hypotension and postural orthostatic tachycardia syndrome (POTS).