NDAORALTABLETPriority Review
Approved
Jun 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
5/8 — Partial
Priority Review
PARLODEL (bromocriptine mesylate) by Aurobindo Pharma is clinical pharmacology bromocriptine mesylate is a dopamine receptor agonist, which activates post-synaptic dopamine receptors. Approved for dysfunctions associated with hyperprolactinemia including amenorrhea with, without galactorrhea, infertility and 7 more indications. First approved in 1978.
Drug data last refreshed 23h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Parlodel (bromocriptine mesylate) is an oral dopamine receptor agonist approved in 1978 for treating hyperprolactinemia-related disorders and Parkinson's disease. It works by activating dopamine receptors in the pituitary and brain to suppress prolactin secretion and restore motor control. The drug addresses amenorrhea, infertility, galactorrhea, prolactin-secreting adenomas, acromegaly, and parkinsonian symptoms.
LOE Approaching
Product is in loss-of-exclusivity phase with limited commercial runway; career opportunities centered on manufacturing and supply chain optimization rather than market expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Bromocriptine mesylate is a dopamine receptor agonist, which activates post-synaptic dopamine receptors. The dopaminergic neurons in the tuberoinfundibular process modulate the secretion of prolactin from the anterior pituitary by secreting a prolactin inhibitory factor…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.