JAVADIN™ (clonidine hydrochloride) oral solution is the first and only FDA-approved, immediate-release, ready-to-use oral liquid formulation of clonidine to treat hypertension in adult patients. The drug is intended to reduce blood pressure and reduce the risk of fatal and non-fatal cardiovascular events, such as stroke and myocardial infarction.
Ronald Scarboro, CEO of Azurity Pharmaceuticals, stated that JAVADIN maintenance is a breakthrough in hypertension treatment for patients and healthcare personnel. According to him, the oral solution is more suitable for patients who have difficulty swallowing tablets or capsules easily since there is no need to cut tablets, prepare compounds, or use transdermal patches. Scarboro added that Azurity is committed to developing accessible and innovative dosing therapies that can be easily administered and made more readily available to the patient.
A study cited by Azurity reported that over one-third of adult primary care patients reported difficulty swallowing tablets and capsules. Of these, 58.8% adjusted their medications through splitting, crushing, or breaking capsules, which may alter the effectiveness and safety of drugs.
Ajay Singh, Chief Scientific Officer of Azurity Pharmaceuticals, emphasized the rapid onset and unique mechanism of action of JAVADIN. He observed that JAVADIN reduces the blood pressure within 30 to 60 minutes of administration. JAVADIN is also centrally acting, unlike many other antihypertensive agents, by stimulation of alpha-adrenoreceptors located in the brain (peripheral action). The effect of this mechanism is a decrease in peripheral and renal vascular resistance, decreased heart rate, and decreased blood pressure.
JAVADIN is a clear, colorless oral solution with a berry flavor, containing clonidine at a concentration of 0.1 mg (0.02 mg/mL) per 5 mL dose. The formulation can be administered either alone or in conjunction with other antihypertensive agents, which offers a wide range of treatment opportunities. It must, however, not be administered to patients who are known to be hypersensitive to clonidine. JAVADIN™ will be commercially available in the market by the end of 2025.
JAVADIN is prescribed for the management of hypertension in adults by reducing elevated blood pressure levels. This reduction helps decrease the risk of fatal and nonfatal cardiovascular events, usually strokes and myocardial infarction. Such advantages have been proven in controlled trials of antihypertensive medication of extremely diverse pharmacologic classes. However, risk reduction with JAVADIN itself has not yet been shown in controlled trials. The medication can be administered as a single medication or with other antihypertensives.
Through this approval, Azurity Pharmaceuticals continues its mission to develop ready-to-use therapeutic solutions that would increase medication access, compliance, and safety for patients who need tailored hypertension management.
Reference: Azurity Pharmaceuticals. Azurity Pharmaceuticals Announces FDA Approval of JAVADINTM (clonidine hydrochloride) Oral Solution. Published Oct 24, 2025. Accessed Oct 29, 2025. Azurity Pharmaceuticals Announces FDA Approval of JAVADINTM (clonidine hydrochloride) Oral Solution
