Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR446597 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part I - SAR446597 open-label (OL) | EXPERIMENTAL | Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants. |
| Part II - SAR446597 Dose A | EXPERIMENTAL | Participants will receive SAR at a dose specified for each arm. |
| Part II - SAR446597 Dose B | EXPERIMENTAL | Participants will receive SAR at a dose specified for each arm. |
| Part II - Sham control | SHAM_COMPARATOR | Participants will receive Sham at a dose specified for each arm. |
| Name | Type | Description |
|---|---|---|
| SAR446597 | DRUG | Intravitreal injection |
| Sham Comparator | DRUG | Sham injection |
Inclusion Criteria: * 60 years old or above * Participants with diagnosis of GA secondary to age-related macular degeneration (AMD) * Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal o...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
SAR446597 is an investigational small molecule being developed for geographic atrophy, a form of age-related macular degeneration. It is administered as a one-time intravitreal injection. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
SAR446597 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical trials for the treatment of geographic atrophy.
SAR446597 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to expedite the development and review of therapies for serious conditions.
SAR446597 is being studied in a Phase 1 clinical trial with the identifier NCT07215234. This trial is recruiting participants with geographic atrophy secondary to age-related macular degeneration. The study is randomized, double-blind, and sham-controlled, with an enrollment of 104 participants across the United States and Australia.
SAR446597 is the only name provided for this drug. It is not known to be the same as any other drug. The drug is a small molecule being developed by Sanofi for geographic atrophy.