TheraRadar
Data updated: May 26, 2026

CLONIDINE

Cardiovascular Approved 2009-08-18

CLONIDINE is indicated for the treatment of Hypertension.

Source: FDA Label • TRIS PHARMA INC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2009-08-18
Routes
ORAL, TRANSDERMAL
Dosage Forms
SUSPENSION, EXTENDED RELEASE, SYSTEM

Companies

TRIS PHARMA INC Teva DIFGEN PHARMS Viatris Dr. Reddy's
Active Ingredient: CLONIDINE

CLONIDINE Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
35 FDA actions from 2009 to 2025
Jun 2025 SUPPL
Label · Labeling
Sep 2023 SUPPL
Label · Labeling
May 2015 SUPPL
Label · Labeling

What CLONIDINE Treats

1 indications

CLONIDINE is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
Source: FDA Label

CLONIDINE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

JAVADIN
AZURITY
2025 3 indic.
SDAMLO
BRILLIAN PHARMA
2025 4 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CLONIDINE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ACEBUTOLOL HYDROCHLORIDE
ACEBUTOLOL HYDROCHLORIDE
1 shared
PHARMOBEDIENT
Shared indications:
Hypertension
ALDACTONE
SPIRONOLACTONE
1 shared
Pfizer
Shared indications:
Hypertension
ALISKIREN HEMIFUMARATE
ALISKIREN HEMIFUMARATE
1 shared
PH HEALTH
Shared indications:
Hypertension
View all 20 similar drugs Pro
📋

Clinical Trial Registry

65 trials
Trial Sponsor ID Phase Status Title
NCT07567495 ACYY0438 Ph 4 not yet recruiting Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
NCT03121261 070219812014 Ph 4 active not recruiting The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia
NCT07360301 2025-1861 SMPH | Psychiatry, Protocol Version 12/18/25 Ph 1 not yet recruiting Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
NCT01530373 132500 Ph 2 recruiting Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
NCT07313371 86251324.2.0000.0068 Ph 4 recruiting Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder
NCT03725930 CLONIPREM 2016_37 2017-003638-10 Ph 3 completed Premedication by Clonidine Intranasal in Pediatric Surgery
NCT03552068 ID-CLO 69HCL18_0135 2019-000165-20 Ph 2 completed Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:
NCT05360953 ClonDO Ph 2 suspended Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin
NCT04828226 ECaTa BECD-3-21 Ph 4 completed Clonidine to Prevent Delirium After Electroconvulsive Therapy.
NCT03396588 No-POPPY results posted 11-0534-F34 1R01DA043519-01 Ph 3 completed Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
NCT05592379 CoPE Pilot 2022-0746 A532017, Protocol Version 10/2/2024 Ph 1 completed Consciousness, Psilocybin, and Well-Being
NCT05487196 results posted STUDY22030095 Ph 2 completed Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
NCT03092011 16-144 Ph 4 active not recruiting Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
NCT03653832 A2B AC18022 HTA 16/93/01, 2018-001650-98 Ph 3 completed Alpha 2 Agonists for Sedation to Produce Better Outcomes From Critical Illness (A2B Trial)
NCT05560230 CLONIPAIN 2022064017 Ph 4 completed Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis
NCT03537612 RCT CAN1701 Ph 3 terminated Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain
NCT02628626 results posted 15-005986 R01DK078924, UL1RR024150 Ph 3 completed A Study of Colesevelam in Fecal Incontinence
NCT01983462 VANISH results posted 201307779 Ph 2 terminated Vascular Dysfunction in Human Obesity Hypertension
NCT04186299 19-28605 Ph 4 withdrawn The Effect of Buccal Infiltration Administration of Clonidine on the Success Rate of Inferior Alveolar Nerve Block
NCT03762317 results posted NAS Ph 4 terminated Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome
NCT02268448 DERM-2006-15390 Ph 1 completed Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function
NCT02543944 GBN results posted 203970 R01DA039088 Ph 2, Ph 3 completed Improving Treatment Outcomes for Prescription Opioid Dependence
NCT02570503 results posted HM20004125 Ph 4 terminated Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
NCT02740127 results posted 2014-0990 NCI-2016-00860 Ph 3 completed Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis
NCT03670160 results posted UHS-OB-0001 Ph 2 completed Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
NCT02655965 DESIGN IJB-SUR-DESIGN-2015 2015-005574-38, CE2483 Ph 3 completed Double-blind Study to Assess effectIveness of Pectoral Nerves Block After Breast Surgery on Piritramide Consumption
NCT02733757 results posted CAAE - 03409512.2.0000.5149 Ph 2 completed Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia
NCT03155646 TAP block Ph 2, Ph 3 completed Dexmedetomidine Versus Clonidine in TAP Block
NCT03017430 BRPI-PGBL-OW01 Ph 4 completed Pregabalin for Opiate Withdrawal Syndrome
NCT04026074 2 Ph 4 completed Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.
NCT02543801 results posted IRB2022 Ph 4 completed A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
NCT02365961 results posted Pro00038232 Ph 4 completed Hip Scope Fascia-iliaca (FI) Block Study
NCT02361476 results posted H - 2 - 2014 - 072 Ph 4 completed Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?
NCT02563821 PCEA-IMG I14032 (PCEA-IMG) Ph 3 completed Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG)
NCT02509273 CloSed1 CLON01 2014-003582-24 Ph 3 terminated Efficacy, Safety and Pharmacokinetic Study of Intravenous Clonidine Versus Midazolam for Sedation in Paediatric Patients
NCT01956604 LUCID 2013-000815-26 2013-000815-26 Ph 2 terminated The Oslo Study of Clonidine in Elderly Patients With Delirium
NCT03679052 R 48 / 2018 Ph 4 completed Prophylactic Mirtazapine or Clonidine for Post-spinal Anesthesia Shivering
NCT01598896 DCCS results posted 2010P-002262 Brain and Behavior Research Ph 2, Ph 3 terminated Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia
NCT01846221 results posted AAAL4101 Ph 4 completed Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
NCT02181543 U1111-1157-8852 Ph 3 completed Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
NCT01734551 NAS results posted 11-0534 Ph 4 completed NAS Treatment - Opiate Versus Non-Opiate
NCT01856517 CATACHOC 2011PPRC01TURC Ph 2, Ph 3 terminated Upregulation of Alpha-1 Receptors Upon Septic Shock?
NCT01188421 results posted NIDA-018125 NA_00037871, R01DA018125 Ph 1, Ph 2 completed Medications Development for Drug Abuse Disorders
NCT01139996 results posted MHUMC-2010-04-02 Ph 4 terminated Use of Transdermal Clonidine in Trauma Patients
NCT03174067 BED BED2013 Ph 4 completed Buprenorphine in the Emergency Department
NCT02812368 2016H0181 Ph 2 withdrawn Clonidine for Sleep Disturbances in Children With Autism Spectrum Disorder
NCT01986751 results posted F130625002 Ph 1, Ph 2 terminated Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery
NCT01297335 results posted 1461 Clonidine 1461 Ph 2 completed Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure
NCT02365727 Pro00034356 Ph 4 withdrawn Exparel vs Exparel Plus ACB in TKAs
NCT01902108 CLON-POBPC Ph 4 completed Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine

Showing 50 of 65 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CLONIDINE FDA Label Details

Indications & Usage

FDA Label (PDF)

CLONIDINE is indicated for the treatment of Hypertension.

Looking for the branded version?

NEXICLON XR

Full clinical data, patents, trials, and competitive landscape for clonidine.

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Data Sources

FDA Approval: NDA022499 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.