CLONIDINE HYDROCHLORIDE

Post-LOE

clonidine

Gen Pharmaceuticals

ANDAINJECTIONINJECTABLE

Approved

Oct 2013

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

CLONIDINE HYDROCHLORIDE (clonidine) by Gen Pharmaceuticals is mechanism of action epidurally administered clonidine produces dose-dependent analgesia not antagonized by opiate antagonists. Approved for combination with opiates for the treatment of severe pain in cancer patients. First approved in 2013.

Drug data last refreshed 21h ago

Mechanism of Action

Mechanism of Action Epidurally administered clonidine produces dose-dependent analgesia not antagonized by opiate antagonists. The analgesia is limited to the body regions innervated by the spinal segments where analgesic concentrations of clonidine are present. Clonidine is thought to produce…

Indications (1)

combination with opiates for the treatment of severe pain in cancer patients

Clinical Trials (15)

NCT04648020Phase 2/3Terminated

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

NCT04928651N/ACompleted

Clonidine for Analgesia to Preterm Infants During Neonatal Intensive Care

Started Apr 2018

40 enrolled

Intensive Care, NeonatalAnalgesiaHypnotics and Sedatives

NCT03177980N/ACompleted

Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants

Started Apr 2017

49 enrolled

Asphyxia Neonatorum

NCT02509273Phase 3Terminated

Efficacy, Safety and Pharmacokinetic Study of Intravenous Clonidine Versus Midazolam for Sedation in Paediatric Patients

Started May 2016

28 enrolled

Sedation in Intensive Care

NCT02548806Phase 1Completed

Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers

Started Sep 2015

36 enrolled

Healthy

Worked on CLONIDINE HYDROCHLORIDE at Gen Pharmaceuticals? 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.