Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BROMOCRIPTINE, USP · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Metoclopramide Hydrochloride Injection Sandoz Standard 5mg/mL (10mg/2mL)and BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg |
| 2 | ACTIVE_COMPARATOR | Metoclopramide Hydrochloride Injection Sandoz Standard 5mg/mL (10mg/2mL) and Parlodel® (bromocriptine mesylate) capsules, USP 5 mg |
| Name | Type | Description |
|---|---|---|
| BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg | DRUG | 4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection |
| Parlodel® (bromocriptine mesylate) capsules, USP 5 mg | DRUG | 4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection |
Inclusion Criteria: * Healthy adult male or female volunteers, 18-45 years of age. * Subjects will be continuous non-smokers for at least 3 months prior to the first dose or consistent moderate smokers (fewer than 10 cigarettes per day) for at least 3 months prior to the first dosing. * Weighi...
BROMOCRIPTINE, USP is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is currently in Phase 1 clinical development, with two completed Phase 1 trials in healthy volunteers. The specific therapeutic indication for this development program has not been disclosed.
BROMOCRIPTINE, USP targets the dopamine receptors DRD2, DRD3, and DRD4. It acts as an agonist at these receptors, meaning it activates them. This mechanism is characteristic of dopamine receptor agonists used in various clinical settings.
BROMOCRIPTINE, USP is being developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of this drug candidate.
BROMOCRIPTINE, USP is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication.
BROMOCRIPTINE, USP has been studied in two completed Phase 1 trials: NCT00650520, which evaluated 2.5 mg bromocriptine mesylate tablets in 119 healthy volunteers in Canada, and NCT00649168, which evaluated 5 mg bromocriptine mesylate capsules in 120 healthy volunteers in Canada.