PARLODEL (bromocriptine mesylate) · ESJAY PHARMA
Parlodel (bromocriptine mesylate) is indicated for the treatment of hyperprolactinemia-associated dysfunctions, including amenorrhea, galactorrhea, infertility, and hypogonadism. It is used to treat prolactin-secreting adenomas and may be used to reduce tumor mass prior to surgical adenectomy. Additionally, Parlodel is indicated for acromegaly (as monotherapy or adjunctive to irradiation or surgery) and for the management of signs and symptoms of idiopathic or postencephalitic Parkinson’s disease, particularly as an adjunct to levodopa to manage "end of dose failure" or levodopa tolerance.
How PARLODEL Works
Bromocriptine is a semi-synthetic ergot alkaloid that acts as a potent dopamine D2 receptor agonist and a partial D1 receptor antagonist. It inhibits the secretion of prolactin from the anterior pituitary by stimulating D2 receptors on lactotroph cells. In patients with acromegaly, it paradoxically suppresses the release of growth hormone. In the treatment of Parkinson’s disease, bromocriptine directly stimulates postsynaptic dopamine receptors in the corpus striatum, helping to compensate for the deficiency of endogenous dopamine.
Details
- Status
- Prescription
- First Approved
- 1978-06-28
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
PARLODEL Approval History
What PARLODEL Treats
8 indicationsPARLODEL is approved for 8 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperprolactinemia
- Amenorrhea
- Galactorrhea
- Infertility
- Hypogonadism
- Prolactin-Secreting Adenoma
- Acromegaly
- Parkinson's Disease
PARLODEL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02078440 | VS-PEDS BA-2010 | Ph 1 | completed | Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects |
Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PARLODEL FDA Label Details
Indications & Usage
FDA Label (PDF)INDICATIONS & USAGE Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocripti...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.