Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Carvedilol · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Carvedilol | EXPERIMENTAL | Carvedilol Tablets 25 mg of Dr Reddys Laboratories Limited |
| Coreg | ACTIVE_COMPARATOR | Coreg Tablets 25 mg of GlaxoSmithKline |
| Name | Type | Description |
|---|---|---|
| Carvedilol | DRUG | Carvedilol Tablets 25 mg |
Inclusion Criteria: Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc. Website, Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in or...
Carvedilol is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed. Carvedilol is an antagonist that targets the alpha-1 adrenergic receptors ADRA1A, ADRA1B, and ADRA1D, as well as the beta-adrenergic receptors ADRB1, ADRB2, and ADRB3.
Carvedilol targets six adrenergic receptors: ADRA1A, ADRA1B, ADRA1D, ADRB1, ADRB2, and ADRB3. It acts as an antagonist at these targets. By blocking both alpha-1 and beta-adrenergic receptors, Carvedilol is classified as a small molecule with dual receptor antagonist activity.
Carvedilol is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is running Phase 1 bioequivalence studies of Carvedilol 25 mg film-coated tablets as part of its development program for this asset.
Carvedilol is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The program is not approved, and it remains investigational. Both completed studies were bioequivalence studies of Carvedilol 25 mg film-coated tablets conducted in healthy volunteers.
Carvedilol has been evaluated in two completed Phase 1 bioequivalence trials. NCT01064180 studied Carvedilol 25 mg film-coated tablets under fed conditions with 24 healthy volunteers. NCT01064154 studied the same tablets under fasting conditions with 36 healthy volunteers. Both trials enrolled adults aged 18 years and older and were active-controlled.
Carvedilol is the active ingredient in the Dr. Reddy's Laboratories Ltd product candidate, which is formulated as 25 mg film-coated tablets. The Phase 1 program evaluated bioequivalence of these tablets under fed and fasting conditions, indicating the development focus is on a generic or comparable formulation of carvedilol.