NDAORALSOLUTION
Approved
Oct 2025
Lifecycle
Launch
Competitive Pressure
0/100
Data completeness
4/8 — Partial
JAVADIN (clonidine hydrochloride oral) by R-Pharm US is alpha-adrenoreceptors in the brain. Approved for hypertension in adult patients to lower blood pressure, hypertension. First approved in 2025.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JAVADIN is a clonidine hydrochloride oral solution approved by the FDA on October 23, 2025, for the treatment of hypertension in adult patients. It works by stimulating alpha-adrenoreceptors in the brain stem to reduce sympathetic nervous system outflow, thereby decreasing peripheral resistance, heart rate, and blood pressure. Clonidine is an established antihypertensive agent with a well-understood central nervous system mechanism of action.
Launch16.1 years to LOE
Very early-stage launch product with zero current Medicare Part D data; team building and initial market penetration phase underway.
Mechanism of Action
alpha-adrenoreceptors in the brain. Clonidine is not a central nervous system stimulant. Clonidine is a known antihypertensive agent. By stimulating alpha-adrenoreceptors in the brain stem, clonidine reduces sympathetic outflow from the central nervous system and decreases peripheral resistance,…
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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.