NDAORALTABLET, EXTENDED RELEASE
Approved
Dec 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
15
Data completeness
5/8 — Partial
NEXICLON XR (clonidine) by Athena Bioscience is adrenergic alpha2-agonists [moa]. Approved for attention deficit hyperactivity disorder, hypertension. First approved in 2009.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEXICLON XR is an extended-release oral tablet formulation of clonidine, a central alpha-2 adrenergic agonist approved in 2009. It treats Attention Deficit Hyperactivity Disorder (ADHD) and hypertension by stimulating alpha-adrenergic receptors in the brain stem to reduce sympathetic outflow and lower blood pressure and improve attention. The mechanism involves decreased peripheral resistance, reduced heart rate, and modulation of catecholamine and renin activity.
Peak5.3 years to LOE
Product is in peak commercial phase with stable market position; brand teams are focused on maintaining market share against generic and alternative mechanisms rather than growth expansion.
Mechanism of Action
Adrenergic alpha2-Agonists
Pharmacologic Class:
Central alpha-2 Adrenergic Agonist
Indications (2)
Clinical Trials (15)
Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer.
Started Feb 2021
190 enrolled
Chemoradiotherapy-Induced Severe Oral Mucositis
Clonidine for Analgesia to Preterm Infants During Neonatal Intensive Care
Started Apr 2018
40 enrolled
Intensive Care, NeonatalAnalgesiaHypnotics and Sedatives
Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants
Started Apr 2017
49 enrolled
Asphyxia Neonatorum
Efficacy, Safety and Pharmacokinetic Study of Intravenous Clonidine Versus Midazolam for Sedation in Paediatric Patients
Started May 2016
28 enrolled
Sedation in Intensive Care
Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers
Started Sep 2015
36 enrolled
Healthy
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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.