Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as REGN1033 (SAR391786), GDF8
REGN1033 · 1 trial · 1 indication
The primary endpoint in the study is the percent change in total lean body mass measured by DEXA (dual energy X-ray absorptiometry) from baseline (day 1) to week 12 (day 85).
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Dosing regimen 1 |
| Group 2 | EXPERIMENTAL | Dosing regimen 2 |
| Group 3 | EXPERIMENTAL | Dosing regimen 3 |
| Group 4 | EXPERIMENTAL | Dosing regimen 4 |
| Name | Type | Description |
|---|---|---|
| REGN1033 (SAR391786) | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: 1. Men and women aged 70 years and older (all women participating in the study must be postmenopausal) 2. Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions 3. Ability to follow a walking program 4. ...
REGN1033 was developed as an investigational treatment for sarcopenia, the age-related loss of muscle mass and strength. It was studied in adults aged 70 years and older. REGN1033 has not been approved for any indication and remains an investigational therapy rather than an available treatment option.
REGN1033 targets GDF8, also known as myostatin, a protein that limits skeletal muscle growth. By binding myostatin, the monoclonal antibody was designed to remove that inhibitory signal and potentially support muscle mass. Myostatin inhibition is the mechanism explored in its sarcopenia program.
REGN1033 was developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. The compound is also referenced as SAR391786, reflecting a collaboration with Sanofi. Regeneron is the developer associated with the sarcopenia clinical program for this monoclonal antibody.
REGN1033 reached Phase 2 clinical development for sarcopenia. That Phase 2 study has been completed, and no trials are currently active. REGN1033 is not FDA approved and remains an investigational agent, so it is not commercially available for any indication.
REGN1033 was evaluated in one Phase 2 trial, NCT01963598, titled Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia. The completed study enrolled 253 participants across the United States, France, the Netherlands, and Spain, and used a randomized, double-blind, controlled design.
Yes, REGN1033 and SAR391786 are the same investigational antibody. REGN1033 is Regeneron's designation, while SAR391786 is the Sanofi code used under the companies' collaboration. Both names refer to the anti-myostatin monoclonal antibody studied in the Phase 2 sarcopenia trial NCT01963598.