Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN22044 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Intravenous (IV) Cohorts | EXPERIMENTAL | - |
| Subcutaneous (SC) Cohorts | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| REGN22044 | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol |
Key Inclusion Criteria: 1\. Is judged by the investigator to be in good health as described in the protocol Key Exclusion Criteria: 1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, a...
REGN22044 is an investigational small molecule being developed by Regeneron Pharmaceuticals, Inc. It is in Phase 1 clinical development and is currently being studied in healthy adult volunteers. Regeneron has not publicly disclosed the specific disease or condition the drug is intended to treat.
REGN22044 is made and developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is running the first-in-human study of the compound and holds the development program.
REGN22044 is in Phase 1 development. It has not been approved by the FDA and remains an investigational drug. Its only registered clinical study to date is a first-in-human Phase 1 trial, and no later-stage trials have been recorded.
REGN22044 is being studied in one clinical trial, NCT07526116, titled a first-in-human study to assess safety, tolerability and pharmacokinetics of a single dose of REGN22044 in healthy adults. The trial is recruiting, is randomized, double-blind and controlled, and is expected to enroll 88 participants in Belgium.
The REGN22044 Phase 1 trial, NCT07526116, enrolls healthy adult volunteers of any sex who are 18 years of age or older. Participants receive a single dose of the study drug, and the trial is being conducted in Belgium.
No. REGN22044 is an investigational small molecule in Phase 1 clinical development and has not been approved by the FDA. It is being evaluated only in a first-in-human safety, tolerability and pharmacokinetics study in healthy volunteers.