Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Saroglitazar Magnesium · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Saroglitazar Magnesium 1 mg | EXPERIMENTAL | Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 months). |
| Name | Type | Description |
|---|---|---|
| Saroglitazar Magnesium 1 mg | DRUG | Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in the open label extension program |
Inclusion Criteria: 1. Must provide written informed consent and agree to comply with the trial protocol 2. Participated and completed SARO.21.001, the double-blind treatment phase study Exclusion Criteria: 1. Consumption of 2 standard drinks per day if male and 1 standard drink per day if female...
Saroglitazar Magnesium is an investigational small molecule being developed for Primary Biliary Cholangitis, a chronic liver disease. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with this condition to evaluate its safety and efficacy.
Saroglitazar Magnesium is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting clinical trials to evaluate the drug for the treatment of Primary Biliary Cholangitis.
Saroglitazar Magnesium is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The ongoing Phase 3 trial is an open-label extension study designed to assess the long-term effects of the drug in patients with Primary Biliary Cholangitis.
Saroglitazar Magnesium is being studied in a Phase 3 open-label extension trial with the identifier NCT06427395. This trial enrolls approximately 102 participants with Primary Biliary Cholangitis and is active but not recruiting. The study is being conducted in the United States, Argentina, and Turkey.
Yes, Saroglitazar Magnesium is also known as Saroglitazar Magnesium 1 mg. Both names refer to the same investigational drug being developed for Primary Biliary Cholangitis. The 1 mg designation indicates the dosage strength used in clinical studies.