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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 |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 2 | PHASE3 | Vonaprument (ANX007) |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Genentech, Inc. | RHHBY | 1 | PHASE2 | OpRegen |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
SAR446597 is an investigational small molecule developed by Sanofi for geographic atrophy, a progressive form of retinal degeneration. It is administered as a one-time intravitreal injection into the eye and is currently in Phase 1 clinical development. It has received Fast Track designation from the FDA.
SAR446597 is being studied for the treatment of geographic atrophy secondary to age-related macular degeneration. Geographic atrophy is an advanced form of dry AMD that causes irreversible loss of retinal tissue and central vision. The drug is given as a single intravitreal injection and remains investigational.
SAR446597 is developed by Sanofi, a global pharmaceutical company listed on the Nasdaq under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the drug in geographic atrophy.
SAR446597 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 1 trial is currently recruiting participants.
SAR446597 is being evaluated in a single Phase 1 trial, NCT07215234, titled A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration. The trial is randomized, double-blind, sham-controlled, and recruiting in the United States, Australia, and the United Kingdom.
No, SAR446597 is not FDA approved. It is an investigational drug in Phase 1 clinical development for geographic atrophy. The FDA has granted it Fast Track designation, which is intended to expedite the review of drugs that treat serious conditions and fill an unmet medical need.