Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. FDA label
Propranolol · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Propranolol Hydrochloride Extended-Release Capsules 160 mg |
| 2 | ACTIVE_COMPARATOR | Inderal® LA Capsules 160 mg |
| Name | Type | Description |
|---|---|---|
| Propranolol Hydrochloride Extended-Release Capsules 160 mg | DRUG | 160mg, single dose fed |
| Inderal® LA Capsules 160 mg | DRUG | 160mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have a negative serum (Beta HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administ...
Propranolol Hydrochloride Extended-Release Capsules 160 mg is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is an extended-release oral capsule formulation of propranolol hydrochloride. The specific indication being studied is undisclosed, and the program is in Phase 1 clinical development.
Propranolol targets ADRB2 and ADRB1, the beta-2 and beta-1 adrenergic receptors. It acts as an antagonist at these receptors, meaning it blocks their activation. This receptor-blocking activity underlies the drug's classification as a beta-adrenergic antagonist small molecule.
Viatris Inc., which trades under the ticker VTRS, is the developer of Propranolol Hydrochloride Extended-Release Capsules 160 mg. The company is responsible for the clinical development program for this extended-release formulation.
Propranolol Hydrochloride Extended-Release Capsules 160 mg is in Phase 1 clinical development. It is an investigational formulation, and the two recorded Phase 1 trials have both been completed. No active trials are currently listed for this program.
Two completed Phase 1 trials are registered for Propranolol Hydrochloride Extended-Release Capsules 160 mg: NCT00647816, a fasting study, and NCT00647608, a food study. Both compared the extended-release capsules with Inderal LA Capsules 160 mg in healthy adult volunteers in the United States, enrolling 100 and 98 participants respectively.
Propranolol Hydrochloride Extended-Release Capsules 160 mg is also known as Propranolol Hydrochloride Extended-Release Capsules 160 mg, and its Phase 1 trials used Inderal LA Capsules 160 mg as the active comparator. The trials were designed as fasting and food studies comparing the two formulations in healthy volunteers.