Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
fresolimumab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| fresolimumab 1 mg/kg total body weight | EXPERIMENTAL | - |
| fresolimumab 4 mg/kg total body weight | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| fresolimumab | DRUG | 1 mg/kg total body weight administered intravenous (IV) |
| Placebo | DRUG | Placebo administered to match active treatment group |
Inclusion Criteria: * The patient's renal biopsy is consistent with the diagnosis of primary Focal Segmental Glomerulosclerosis (FSGS) including all histological subtypes. * The patient has an eGFR ≥ 30 mL/min/1.73 m2 * The patient has a urinary total protein:creatinine ratio ≥ 3 mg protein/mg crea...
Fresolimumab is an investigational drug being studied for the treatment of primary focal segmental glomerulosclerosis (FSGS), a kidney disorder. It is being developed for patients with steroid-resistant primary FSGS. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Fresolimumab is a monoclonal antibody that targets transforming growth factor beta (TGF-beta). By neutralizing TGF-beta, it aims to reduce the fibrosis and scarring in the kidneys that characterize primary focal segmental glomerulosclerosis. This mechanism is being evaluated in clinical trials for its potential to slow disease progression.
Fresolimumab is being developed by Sanofi, a global biopharmaceutical company. Sanofi is conducting clinical trials to evaluate the safety and efficacy of fresolimumab in patients with primary focal segmental glomerulosclerosis. The company is listed on the stock exchange under the ticker symbol SNY.
Fresolimumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of primary focal segmental glomerulosclerosis, with a completed Phase 2 trial involving 36 participants.
Fresolimumab has been studied in a Phase 2 clinical trial with the identifier NCT01665391. This trial was a randomized, double-blind, placebo-controlled study that evaluated fresolimumab in patients with steroid-resistant primary focal segmental glomerulosclerosis. The trial enrolled 36 participants and has been completed.
Fresolimumab is also known by other names, including GC1008. It is a monoclonal antibody that targets TGF-beta. Researchers and clinicians may refer to it by either name, but they refer to the same investigational drug being developed by Sanofi for primary focal segmental glomerulosclerosis.