NDAORALTABLET
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
4/8 — Partial
DOSTINEX (cabergoline) by Pfizer is d2 receptors. First approved in 1996.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DOSTINEX (cabergoline) is an oral ergot-derived dopamine D2 receptor agonist approved in 1996 for treating hyperprolactinemia and acromegaly. It works by directly inhibiting prolactin secretion from pituitary lactotrophs, with high selectivity for D2 receptors and minimal off-target binding. The drug is indicated for patients with elevated prolactin levels or growth hormone excess.
LOE Approaching
As LOE approaches, brand team size is expected to contract; focus shifts from growth initiatives to lifecycle management and defensive positioning.
Mechanism of Action
D2 receptors. Results of in vitro studies demonstrate that cabergoline exerts a direct inhibitory effect on the secretion of prolactin by rat pituitary lactotrophs. Cabergoline decreased serum prolactin levels in reserpinized rats. Receptor-binding studies indicate that cabergoline has low affinity…
Pharmacologic Class:
Ergot Derivative
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Cabergoline for the Treatment of Chronic Pain Due to Endometriosis
Started Dec 2019
129 enrolled
Endometriosis
Cabergoline Combined Hydroxychloroquine/Chloroquine to Treat Resistant Prolactinomas
Started Oct 2018
30 enrolled
Resistance, DiseaseProlactinoma
Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease
Started Mar 2014
68 enrolled
Cushings Disease
Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
Started Nov 2010
22,014 enrolled
Parkinson's DiseaseHyperprolactinemia
Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly
Started Mar 2006
20 enrolled
Acromegaly
Worked on DOSTINEX at Pfizer? Share your interview experience or compensation data (+7 days Pro)
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.