Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC). URSO 250 and URSO Forte (ursodiol) tablets are bile acids indicated for the treatment of patients with primary biliary cholangitis. ( 1 ) FDA label
Ursodiol · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on AUC0-72
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
| Arm | Type | Description |
|---|---|---|
| Ursodiol (test) First | EXPERIMENTAL | Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg dosed in second period. |
| Urso Forte™ (reference) First | ACTIVE_COMPARATOR | Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period. |
| Name | Type | Description |
|---|---|---|
| Ursodiol | DRUG | Ursodiol Tablets, 500 mg |
| Urso Forte™ | DRUG | Urso Forte™ Tablets, 500 mg |
Inclusion Criteria: * Healthy, non-smoking male and female subjects, 18 years of age or older. * BMI ≥ 19 and ≤ 30. * Negative for: 1. HIV. 2. Hepatitis B surface antigen and Hepatitis C antibody. 3. Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodia...
Ursodiol is a small molecule drug developed by Teva Pharmaceutical Industries Limited. It is currently in Phase 1 clinical development. The specific medical conditions it is being studied for have not been disclosed. It has been evaluated in two completed Phase 1 trials involving healthy adult volunteers.
Ursodiol targets NR1H4, also known as the farnesoid X receptor, and acts as an agonist at this receptor. Agonist activity at NR1H4 means the drug activates the receptor to trigger a biological response. This target class places Ursodiol among compounds that modulate NR1H4 signaling.
Ursodiol is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical trials evaluating this small molecule drug. The company holds the development program for Ursodiol as it advances through Phase 1 testing.
Ursodiol is in Phase 1 clinical development. It is an investigational drug and is not approved for any indication based on the available development information. The program has completed two Phase 1 trials and currently has no active trials listed.
Ursodiol has been studied in two completed Phase 1 trials. NCT00909753 evaluated Ursodiol 500 mg tablets under fed conditions in 92 healthy volunteers in Canada. NCT00909610 evaluated Ursodiol 500 mg tablets under fasting conditions in 80 healthy volunteers in Canada. Both trials enrolled adults aged 18 and older.
Ursodiol is being studied in Phase 1 clinical development, and the specific indications have not been disclosed. The completed trials enrolled healthy adult volunteers rather than patients with a defined disease, which is typical of early-phase pharmacokinetic and bioavailability studies. No approved indication is established for this development program.