Catapres

(clonidine)

ApprovedSmall molecule

Clonidine is used to treat high blood pressure by helping blood vessels relax and reducing heart rate. It is also used to help manage ADHD symptoms in children and to reduce hot flashes in menopausal women.[2] Catapres is currently approved and in use across 41 indications[4].[1]

Catapres is one of 755 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

145

Total Trials

Active Trials

754

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseApproved

Low Back PainActive, not recruiting

Musculoskeletal System DiseaseApproved

Migraine DisorderActive, not recruiting

Cocaine AbuseApproved

Atopic EczemaApproved

RadiculopathyActive, not recruiting

Heroin DependenceApproved

GlaucomaActive, not recruiting

Substance Withdrawal SyndromeActive, not recruiting

Cardiovascular DiseaseApproved

Approved

Low Back PainPreclinical

Active, not recruiting

Musculoskeletal System DiseaseApproved

Approved

Migraine DisorderApproved

Active, not recruiting

Cocaine AbuseApproved

Approved

Atopic EczemaApproved

Approved

RadiculopathyPreclinical

Active, not recruiting

Heroin DependenceApproved

Approved

GlaucomaApproved

Active, not recruiting

Substance Withdrawal SyndromePreclinical

Active, not recruiting

Showing 10 of 40 indications

Competition

Competitive Landscape

198 competitors in Heart Failure

#DrugCompanyPhaseTrials

Catapres

Boehringer Ingelheim

Approved

1 2

Bayer Aspirin

Bayer

Preclinical

2 3

Brethine

Sanofi

Preclinical

1 4

Medrol

Pfizer

Preclinical

1 5

Amidate

Pfizer

Preclinical

1 6

Activase

Zemplar

Adriamycin

Savaysa

Xifaxan

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Hypertension

NCT05416840

Post-ApprovalNot yet recruiting

Effectiveness

NCT07044609

Post-ApprovalActive, not recruiting

Neonatal Abstinence Syndrome

NCT03092011

Q2 2027

Not yet recruiting

Emergency

NCT07913308

Q3 2027

Post-ApprovalRecruiting

Clonidine

NCT07313371

Q4 2027

Post-ApprovalActive, not recruiting

Spinal Anesthesia

NCT03121261

Clinical

Trials by Indication[1]

Hypertension9 trials

A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy

Withdrawn·—·N/A·NCT00329511

Treatment Targets for Chronic Hypertension in Pregnancy

Withdrawn·WWeill Medical College of Cornell University·Phase 1/2·NCT00194974

Resistant Hypertension Optimal Treatment

Unknown status·IInstituto do Coracao·Phase 4·NCT01643434·2,000 enrolled

Show 6 more trials

Vascular Dysfunction in Human Obesity Hypertension

Terminated·GGary L. Pierce·Phase 2·NCT01983462·33 enrolled

Matão Controlling Hypertension (MatCH Study): Rationale and Design

Unknown status·CCentro Neurológico de Pesquisa e Reabiitação, Brazil·Phase 1·NCT03147092·15,000 enrolled

Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension

Not yet recruiting·JJing Liu·Phase 4·NCT05416840·92 enrolled

Treatment of Supine Hypertension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223717·152 enrolled

Black Education and Treatment of Hypertension (BEAT HTN)

Completed·—·Phase 4·NCT00661895·99 enrolled

Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02177461·374 enrolled

Clonidine8 trials

Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

Withdrawn·JJames Martins·N/A·NCT00585871

Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)

Completed·UUniversity of Cincinnati·Phase 2·NCT00414921·30 enrolled

Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder

Recruiting·UUniversity of Sao Paulo General Hospital·Phase 4·NCT07313371·36 enrolled

Show 5 more trials

Use of Transdermal Clonidine in Trauma Patients

Terminated·MMemorial Health University Medical Center·Phase 4·NCT01139996·22 enrolled

An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study

Terminated·MMclean Hospital·Phase 4·NCT03065933·5 enrolled

The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients

Completed·CCHU de Charleroi·N/A·NCT00356226·64 enrolled

Effect of Clonidine on Responses to Imagery Scripts

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00318760·92 enrolled

Clonidine for Neurocognitive Sequelae

Withdrawn·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 1/2·NCT00166686

Delirium6 trials

The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients

Unknown status·DDeventer Ziekenhuis·Phase 3·NCT01876355·115 enrolled

Efficacy of Dexmedetomidine Versus Clonidine to Control Delirium in Patients Undergoing CABG

Completed·—·N/A·NCT03477994·147 enrolled

Dexmedetomidine or Clonidine Infusion for Prevention of Delirium After Open Heart Surgery

Recruiting·OOslo University Hospital·Phase 4·NCT05029050·900 enrolled

Show 3 more trials

The Oslo Study of Clonidine in Elderly Patients With Delirium

Terminated·OOslo University Hospital·Phase 2·NCT01956604·20 enrolled

Clonidine to Prevent Delirium After Electroconvulsive Therapy.

Recruiting·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT04828226·130 enrolled

Clonidine vs. Dexmedetomidine in Agitated Delirium in Intensive Care Patients

Unknown status·EErasme University Hospital·Phase 4·NCT04758936·50 enrolled

Spinal Anesthesia4 trials

Comparison of Different Doses of Clonidine to Fentanyl as an Adjuvant to Bupivacaine 0.5% for Spinal Anesthesia

Withdrawn·PPravara Institute of Medical Sciences University·N/A·NCT01205204

Prophylactic Mirtazapine or Clonidine for Post-spinal Anesthesia Shivering

Completed·—·Phase 4·NCT03679052·300 enrolled

Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Unknown status·UUniversity Hospital, Montpellier·Phase 4·NCT01075490·120 enrolled

Show 1 more trial

The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia

Active, not recruiting·UUniversity Hospital Dubrava·Phase 4·NCT03121261·60 enrolled

Sedation4 trials

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

Terminated·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT02509273·28 enrolled

Premedication in Children: a Clinical Trial Comparing Oral Ketamine and Oral Clonidine With Respect to Sedation Level and Opioid Consumption in Pediatrics Undergoing Elective Lower Abdominal Day-case Surgery.

Recruiting·—·N/A·NCT07461376·84 enrolled

Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children

Completed·HHamilton Health Sciences Corporation·Phase 4·NCT00959062·50 enrolled

Show 1 more trial

Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

Completed·MMedical University of Graz·Phase 4·NCT04026074·50 enrolled

89 more indications

Neonatal Abstinence Syndrome4 trials

Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

Terminated·HHennepin County Medical Center, Minneapolis·Phase 4·NCT03762317·10 enrolled

Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

Completed·UUniversity of Tennessee Medical Center·Phase 2·NCT03670160·25 enrolled

Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy

Active, not recruiting·TThe Cooper Health System·Phase 4·NCT03092011·69 enrolled

Show 1 more trial

Clonidine for Neonatal Abstinence Syndrome Study

Terminated·—·N/A·NCT01175668·68 enrolled

Cesarean Section4 trials

Transversus Abdominis Plane (TAP) Block for Cesarean Section

Completed·UUniversity of Washington·N/A·NCT01015807·90 enrolled

Efficacy of Intrathecal Clonidine Versus Neostigmine as Adjuvants to Bupivacaine on Postoperative Maternal and Fetal Outcomes After Elective Cesarean Section

Unknown status·—·Phase 1·NCT05943613·111 enrolled

Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section

Completed·QQazvin University Of Medical Sciences·Phase 1/2·NCT01425658·90 enrolled

Show 1 more trial

Intrathecal Clonidine in Cesarean Section May Lead to Worse Blood Gas Results in the Newborns

Completed·UUniversity of Sao Paulo General Hospital·N/A·NCT02550444·64 enrolled

Epidural Analgesia3 trials

Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor

Unknown status·—·Phase 4·NCT03018171·268 enrolled

Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia

Completed·GGrace Lim, MD, MS·Phase 2·NCT05487196·88 enrolled

Systematic Clonidine for Epidural Analgesia in Labour

Completed·UUniversity Hospital, Clermont-Ferrand·Phase 4·NCT00983125·124 enrolled

Dexmedetomidine3 trials

Dexmedetomidine Versus Clonidine in TAP Block

Completed·—·Phase 2/3·NCT03155646·90 enrolled

Use of Clonidine to Prevent Withdrawal Following Prolonged Dexmedetomidine Infusions

Completed·JJoseph D. Tobias··NCT02404077·712 enrolled

Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT05575219·128 enrolled

Buprenorphine2 trials

Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00295308·208 enrolled

Buprenorphine in the Emergency Department

Completed·—·Phase 4·NCT03174067·26 enrolled

Premedication2 trials

Premedication by Clonidine Intranasal in Pediatric Surgery

Completed·UUniversity Hospital, Lille·Phase 3·NCT03725930·90 enrolled

Clonidine Versus Midazolam for Premedication

Completed·UUniversity Hospital Schleswig-Holstein·N/A·NCT00638729·60 enrolled

Nerve Block2 trials

Clonidine for Infra-orbital Nerve Block During Pediatric Cleft Lip Revision Surgeries

Unknown status·—·N/A·NCT05790044·86 enrolled

Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT02740127·52 enrolled

Neuropathic Pain2 trials

Clonidine Versus Adenosine to Treat Neuropathic Pain

Completed·WWake Forest University Health Sciences·Phase 2·NCT00349921·24 enrolled

Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain

Completed·WWake Forest University Health Sciences·Phase 2·NCT00350532·43 enrolled

Treatment2 trials

NAS Treatment - Opiate Versus Non-Opiate

Completed·HHenrietta Bada·Phase 4·NCT01734551·31 enrolled

Comparison of Keppra and Clonidine in the Treatment of Tics

Completed·—·Phase 4·NCT00370838·12 enrolled

Blood Pressure2 trials

Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

Completed·TThe George Institute·N/A·NCT00226096·404 enrolled

Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure

Completed·TThe Center for Clinical Research, Winston-Salem, NC·Phase 2·NCT01297335·10 enrolled

Fecal Incontinence2 trials

A Placebo-Controlled Study of Clonidine for Fecal Incontinence.

Completed·MMayo Clinic·Phase 2·NCT00884832·44 enrolled

A Study of Colesevelam in Fecal Incontinence

Completed·MMayo Clinic·Phase 3·NCT02628626·88 enrolled

Postoperative Pain Control2 trials

Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine

Completed·SSt Joseph University, Beirut, Lebanon·Phase 4·NCT01902108·225 enrolled

Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Replacement

Withdrawn·RRush University Medical Center·Phase 4·NCT03119038

Bupivacaine2 trials

Adjuvants for Bupivacaine in Brachial Plexus Block in Pediatrics

Unknown status·—·N/A·NCT06180941·70 enrolled

Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery.

Unknown status·—·Phase 4·NCT04530903·30 enrolled

Total Knee Arthroplasty2 trials

Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)

Completed·TTowson Orthopaedic Associates·N/A·NCT01042093·160 enrolled

Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty

Terminated·VVirginia Commonwealth University·Phase 4·NCT02570503·64 enrolled

Agitation2 trials

Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

Completed·RRigshospitalet, Denmark·Phase 4·NCT02361476·379 enrolled

Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.

Completed·PProfessor Fernando Figueira Integral Medicine Institute·Phase 3·NCT02181543·30 enrolled

Intraocular Pressure2 trials

Effects of Intravenous Clonidine on Ocular Blood Flow and Intraocular Pressure

Completed·MMedical University of Vienna·Phase 4·NCT00279253·12 enrolled

Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia

Completed·FFederal University of Minas Gerais·Phase 2·NCT02733757·80 enrolled

Adductor Canal Block2 trials

Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03704376·125 enrolled

Addition of Clonidine to Ropivacaine in Adductor Canal Block

Unknown status·UUniversity of Vermont·Phase 4·NCT03057015·80 enrolled

Drug Abuse1 trial

Medications Development for Drug Abuse Disorders

Completed·JJohns Hopkins University·Phase 1/2·NCT01188421·106 enrolled

Hyperalgesia1 trial

Epidural Clonidine for Postoperative Hyperalgesia

Withdrawn·—·Phase 3·NCT00417443

Prospective1 trial

Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial

Completed·HHospices Civils de Lyon·Phase 3·NCT00437996·85 enrolled

Breast Cancer1 trial

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients

Recruiting·UUniversity of Arkansas·Phase 2·NCT01530373·110 enrolled

Coronary Artery Bypass1 trial

The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass

Completed·FFederal University of Juiz de Fora·Phase 4·NCT01619436·46 enrolled

Popliteal Nerve Block1 trial

Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery

Terminated·UUniversity of Alabama at Birmingham·Phase 1/2·NCT01986751·14 enrolled

Autism Spectrum Disorder1 trial

Clonidine for Sleep Disturbances in Children With Autism Spectrum Disorder

Withdrawn·OOhio State University·Phase 2·NCT02812368

Femoral Nerve Block1 trial

Clonidine in Femoral Nerve Block Surgery in Children

Withdrawn·NNationwide Children's Hospital·Phase 2·NCT01293149

Breakthrough Pain1 trial

Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain

Completed·—·Phase 4·NCT01846221·101 enrolled

Elective1 trial

IINB vs. QLB for Elective Open Inguinal Herniorrhaphy

Completed·WWake Forest University Health Sciences·Phase 2·NCT03007966·60 enrolled

Schizophrenia1 trial

Will Decreased Noradrenergic Activity Normalize Information Processing in Patients With Schizophrenia?

Completed·BBirte Glenthoj·N/A·NCT00206986·40 enrolled

Completed·HHenrietta Bada·Phase 3·NCT03396588·120 enrolled

Withdrawal Syndrome1 trial

Pregabalin for Opiate Withdrawal Syndrome

Completed·SSt. Petersburg Bekhterev Research Psychoneurological Institute·Phase 4·NCT03017430·100 enrolled

Pectoral Nerve1 trial

Double-blind Study to Assess effectIveness of Pectoral Nerves Block After Breast Surgery on Piritramide Consumption

Completed·JJules Bordet Institute·Phase 3·NCT02655965·54 enrolled

Hot flashes1 trial

A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats

Active, not recruiting· Astellas logo

Astellas··NCT06049797·999 enrolled

Intraoperative1 trial

Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

Completed·RRichard Beringer·Phase 3·NCT02324413·45 enrolled

Cardiac Surgery1 trial

Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery

Completed·FFederal University of São Paulo·Phase 2·NCT01597427·29 enrolled

Psilocybin1 trial

Consciousness, Psilocybin, and Well-Being

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT05592379·6 enrolled

Attention Deficit Hyperactivity Disorder1 trial

Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children

Completed·UUniversity of Cincinnati·Phase 3·NCT00031395·122 enrolled

Stress Response1 trial

The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism

Completed·VVilnius University·N/A·NCT02362256·60 enrolled

Caudal Anesthesia1 trial

Clonidine and Morphine in Caudal Anesthesia

Completed·FFederal University of Minas Gerais·Phase 1/2·NCT00672347·80 enrolled

Knee Arthroplasty1 trial

A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty

Completed·KKootenai Health·Phase 4·NCT02543801·239 enrolled

Osteoarthritis1 trial

Effectiveness of Ultrasound Guided Adductor Canal Block on Chronic Pain in Knee Osteoarthritis

Completed·MMensur Salihovic··NCT02695654·77 enrolled

Propranolol1 trial

Efficacy of Clonidine and Propranolol in Dentistry (AAA)

Unknown status·—·Phase 2·NCT01784250·60 enrolled

Perioperative Pain1 trial

Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain

Terminated·—·Phase 3·NCT03537612·15 enrolled

Tics1 trial

Anesthetics in Rhytidoplasty - A Comparison Study

Completed·MMercy Facial Plastic Surgery Center·N/A·NCT02410460·30 enrolled

Orthopedic Surgery1 trial

Oral Clonidine & Gabapentin: Improving Recovery and Pain Management After Outpatient With Major Orthopedic Surgery

Withdrawn·—·Phase 4·NCT01112878

Hyperemesis Gravidarum1 trial

Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

Completed·AA.O.U. Città della Salute e della Scienza·Phase 3·NCT01559012·13 enrolled

Post-Traumatic Stress Disorder1 trial

Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin

Suspended·—·Phase 2·NCT05360953·53 enrolled

Opioid1 trial

The Relationships Between the Noradrenergic, Opioid and Pain System

Withdrawn·RRambam Health Care Campus·N/A·NCT01851486

Cannabis Dependence1 trial

Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia

Terminated·MMclean Hospital·Phase 2/3·NCT01598896·12 enrolled

Opioid Dependence1 trial

Improving Treatment Outcomes for Prescription Opioid Dependence

Completed·UUniversity of Arkansas·Phase 2/3·NCT02543944·117 enrolled

Intensive Care1 trial

Clonidine for Analgesia to Preterm Infants During Neonatal Intensive Care

Completed·RRegion Skane··NCT04928651·40 enrolled

Treatment Resistant Depression1 trial

Treatment Resistant Depression (Pilot)

Completed·WWashington University School of Medicine·N/A·NCT01179009·20 enrolled

Cataract1 trial

Assessment of the Effect of Clonidine for Cataract Surgery

Unknown status·FFederal University of São Paulo·Phase 2·NCT01677351·40 enrolled

Endometriosis1 trial

Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis

Completed·UUniversity of Aarhus·Phase 4·NCT05560230·120 enrolled

Opioid Withdrawal1 trial

Utility of Olanzapine in the Treatment of Opioid Withdrawal in the ED

Completed·HHennepin Healthcare Research Institute·N/A·NCT02643355·70 enrolled

Caesarean Section1 trial

Dexmedetomidine Versus Clonidine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section

Completed·—·N/A·NCT03770013·150 enrolled

Parkinson's Disease1 trial

Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:

Completed·HHospices Civils de Lyon·Phase 2·NCT03552068·38 enrolled

Anxiety1 trial

The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children

Terminated·TThe University of Texas Medical Branch, Galveston·N/A·NCT00580151·9 enrolled

Pilot Study1 trial

Pilot Study for the NorCAPITAL Trial

Completed·OOslo University Hospital·N/A·NCT01507701·5 enrolled

Sickle Cell Disease1 trial

Clonidine With Morphine in Patient Controlled Analgesia Pump in Vaso-Occlusive Crisis in Sickle Cell Disease Patient

Unknown status·—·Phase 4·NCT05848531·40 enrolled

Pregnancy1 trial

Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG)

Completed·UUniversity Hospital, Limoges·Phase 3·NCT02563821·37 enrolled

Methamphetamine1 trial

Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA)

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT01136278·16 enrolled

Chronic Fatigue Syndrome1 trial

The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial

Completed·OOslo University Hospital·Phase 2·NCT01040429·120 enrolled

High Blood Pressure1 trial

Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure

Completed·IInstituto Materno Infantil Prof. Fernando Figueira·Phase 4·NCT01761916·90 enrolled

Humans1 trial

Sympathetic Regulation of Large Artery Stiffness in Humans With ISH

Completed·UUniversity of Iowa·Phase 1·NCT04423627·100 enrolled

Effectiveness1 trial

A Study to Assess the Effectiveness and Safety of Clonidine Extended-Release OnydaTM XR in Children With ADHD and ODD

Not yet recruiting·LLas Vegas Medical Research, LLC DBA Vector Clinical Trials·Phase 4·NCT07044609·162 enrolled

Diabetic Neuropathy1 trial

Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy

Completed·AArcion Therapeutics Inc·Phase 2·NCT00695565·180 enrolled

Shivering1 trial

Clonidine Versus Granisetron for Shivering Prevension

Unknown status·ZZagazig University·Phase 2·NCT06031090·186 enrolled

Encephalopathy1 trial

Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia

Completed·JJohns Hopkins University·Phase 1/2·NCT01862250·13 enrolled

Dialysis Patients1 trial

Transdermal Clonidine in Chronic Hemodialysis Patients

Unknown status·PPeking University People's Hospital·N/A·NCT02545530·45 enrolled

Heart Failure1 trial

Using Clonidine to Improve Leg Weakness in People With Heart Failure

Completed·UUniversity of California, Los Angeles·Phase 4·NCT00858845·11 enrolled

Opioid Free Anesthesia1 trial

OFA - Opioid Free Anesthesia

Unknown status·UUniversity of Parma·Phase 4·NCT03124082·64 enrolled

Medication1 trial

Novel Medications for Opiate Detoxification - 4

Completed·YYale University·Phase 2·NCT00000279

Radiculopathy1 trial

Epidural Clonidine for Lumbosacral Radiculopathy

Terminated·MMayo Clinic·N/A·NCT00588354·26 enrolled

Rectus Sheath Block1 trial

Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination

Terminated·MMihaela Visoiu·N/A·NCT02439281·50 enrolled

Infiltration1 trial

The Effect of Buccal Infiltration Administration of Clonidine on the Success Rate of Inferior Alveolar Nerve Block

Withdrawn·UUniversity of California, San Francisco·Phase 4·NCT04186299

Type 2 Diabetes1 trial

Nephropathy In Type 2 Diabetes and Cardio-renal Events

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT00535925·850 enrolled

Abdominal Surgery1 trial

The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children

Completed·—·Phase 2·NCT00130091·120 enrolled

Intrusive Memories1 trial

Influence of the Noradrenergic System on the Formation of Intrusive Memories

Completed·—·N/A·NCT02541071·118 enrolled

Atopic Dermatitis1 trial

Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function

Completed·UUniversity of Minnesota·Phase 1·NCT02268448·8 enrolled

Low back pain1 trial

Epidural Clonidine Versus Corticosteroid for Low Back Pain

Terminated·WWest Virginia University·N/A·NCT02239627·16 enrolled

Emergency1 trial

Comparison of Intravenously Administered Dexmedetomidine Versus Clonidine Versus No Alpha-2 Agonist on Emergence Delirium, PACU Length of Stay, and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: A Prospective Observational Study

Not yet recruiting·UUniversitair Ziekenhuis Brussel··NCT07913308·150 enrolled

Psychological1 trial

Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study

Not yet recruiting·UUniversity of Wisconsin, Madison·Phase 1·NCT07360301·120 enrolled

Cesarean Delivery1 trial

Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery

Recruiting·CColumbia University·Approved·NCT07567495·150 enrolled

Critical Illness1 trial

Alpha 2 Agonists for Sedation to Produce Better Outcomes From Critical Illness (A2B Trial): A Randomised, Parallel-group, Allocation Concealed, Controlled, Open, Phase 3 Pragmatic Clinical and Cost- Effectiveness Trial With Internal Pilot

Completed·UUniversity of Edinburgh·Phase 3·NCT03653832·1,404 enrolled

Tachycardia1 trial

Treatment of Orthostatic Intolerance

Active, not recruiting·SSatish R. Raj·Preclinical·NCT00262470·150 enrolled

Emergence Delirium1 trial

The PREVENT AGITATION Trial II - Children ≤1 Year

Recruiting·RRigshospitalet, Denmark·Preclinical·NCT05091242·336 enrolled

Unspecified3 trials

Hip Scope Fascia-iliaca (FI) Block Study

Completed·TThe Hawkins Foundation·Phase 4·NCT02365961·84 enrolled

Exparel vs Exparel Plus ACB in TKAs

Withdrawn·TThe Hawkins Foundation·Phase 4·NCT02365727

Assessment of Regional Anesthetic Blockade Using Non-Invasive Surface Electromyogram (EMG)

Completed·NNationwide Children's Hospital·Preclinical·NCT06287151·80 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

CATAPRES

NDA NDA017407

Oct 10, 1984

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Oct 10, 1984

CATAPRES-TTS-1

NDA NDA018891

Sep 18, 1985

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Oct 14, 1987

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

May 11, 1988

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

May 11, 1988

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Jul 21, 1988

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Oct 27, 1988

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Dec 7, 1988

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Apr 18, 1989

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Dec 13, 1989

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Aug 17, 1992

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Nov 24, 1992

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Feb 19, 1993

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Jun 9, 1995

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Jul 23, 1996

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Jul 23, 1996

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Sep 6, 1996

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Sep 6, 1996

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Oct 2, 1996

DURACLON

NDA NDA020615

Oct 3, 1997

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Sep 22, 1998

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Aug 30, 1999

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Aug 13, 2004

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Apr 13, 2006

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Sep 30, 2009

JENLOGA

NDA NDA022331

Nov 13, 2009

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Dec 3, 2009

NEXICLON XR

NDA NDA022500

Dec 3, 2009

CLONIDINE

NDA NDA022499

Apr 28, 2010

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

May 31, 2012

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Feb 1, 2023

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

May 24, 2024

ONYDA XR

NDA NDA217645

Oct 23, 2025

JAVADIN

NDA NDA220256

Dec 4, 2025

CATAPRES-TTS-3, CATAPRES-TTS-1, CATAPRES-TTS-2

NDA NDA018891

Jul 28, 2026

QLONILIK

NDA NDA221094

Sources

References

[1]
ClinicalTrials.gov — 145 trial records for clonidine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Catapres drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — clonidine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for clonidine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA221094). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Catapres. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-2 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Boehringer Ingelheim

Patent Landscape[6]

Patent Cliff

Apr 17, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8337890Apr 17, 2027

8623409Sep 8, 2031

12576032Jul 28, 2041

11918689Jul 28, 2041

12721837Jul 15, 2042

3 more patents

12440474Jul 15, 2042

12233049Jul 15, 2042

12551466Aug 21, 2045

Catapres

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Hypertension9 trials

Clonidine8 trials

Delirium6 trials

Spinal Anesthesia4 trials

Sedation4 trials

Neonatal Abstinence Syndrome4 trials

Cesarean Section4 trials

Epidural Analgesia3 trials

Dexmedetomidine3 trials

Buprenorphine2 trials

Premedication2 trials

Nerve Block2 trials

Neuropathic Pain2 trials

Treatment2 trials

Blood Pressure2 trials

Fecal Incontinence2 trials

Postoperative Pain Control2 trials

Bupivacaine2 trials

Total Knee Arthroplasty2 trials

Agitation2 trials

Intraocular Pressure2 trials

Adductor Canal Block2 trials

Drug Abuse1 trial

Hyperalgesia1 trial

Prospective1 trial

Breast Cancer1 trial

Coronary Artery Bypass1 trial

Popliteal Nerve Block1 trial

Autism Spectrum Disorder1 trial

Femoral Nerve Block1 trial

Breakthrough Pain1 trial

Elective1 trial

Schizophrenia1 trial

Dexamethasone1 trial

Septic Shock1 trial

Injury1 trial

Withdrawal Syndrome1 trial

Pectoral Nerve1 trial

Hot flashes1 trial

Intraoperative1 trial

Cardiac Surgery1 trial

Psilocybin1 trial

Attention Deficit Hyperactivity Disorder1 trial

Stress Response1 trial

Caudal Anesthesia1 trial

Knee Arthroplasty1 trial

Osteoarthritis1 trial

Propranolol1 trial

Perioperative Pain1 trial

Tics1 trial

Orthopedic Surgery1 trial

Hyperemesis Gravidarum1 trial

Post-Traumatic Stress Disorder1 trial

Opioid1 trial

Cannabis Dependence1 trial

Opioid Dependence1 trial

Intensive Care1 trial

Treatment Resistant Depression1 trial

Cataract1 trial

Endometriosis1 trial

Opioid Withdrawal1 trial

Caesarean Section1 trial

Parkinson's Disease1 trial

Anxiety1 trial

Pilot Study1 trial

Sickle Cell Disease1 trial

Pregnancy1 trial

Methamphetamine1 trial

Chronic Fatigue Syndrome1 trial

High Blood Pressure1 trial

Humans1 trial