Data updated: May 26, 2026
NEXICLON XR (clonidine)
Adrenergic alpha2-Agonists
Trial Activity: Declining 8 active trials
Cardiovascular
Approved 2009-12-03
NEXICLON XR is indicated for the treatment of Hypertension.
Source: FDA Label • ROSEMONT
Development Insights
Oslo University Hospital conducting 3 trials (5%)
88 indications explored (Broad Platform)
→ neonatal abstinence syndrome (5 trials)
→ delirium (3 trials)
→ psychedelic experiences (2 trials)
1
Indication
--
Phase 3 Trials
16
Years on Market
Details
- Status
- Prescription
- First Approved
- 2009-12-03
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
NEXICLON XR 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
4 FDA actions from 2009 to 2010
What NEXICLON XR Treats
1 indicationsNEXICLON XR 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
NEXICLON XR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in NEXICLON XR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NEXICLON XR treats. First-in-class if their pivotal trials read out positive.
Baxdrostat CIN-107 ✓ Won — Ph3 readout
AstraZeneca CYP11B2 · small-molecule selective aldosterone synthase inhibitor · 4 Phase 3 trials
Lorundrostat MLS-101 ✓ Won — Ph3 readout
Mineralys Therapeutics Inc. CYP11B2 · small-molecule selective aldosterone synthase inhibitor · 2 Phase 3 trials
Zilebesiran ALN-AGT01
Alnylam Pharmaceuticals AGT · GalNAc-conjugated siRNA (RNAi therapeutic) · 1 Phase 3 trial
Drugs Similar to NEXICLON XR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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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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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
NEXICLON XR FDA Label Details
Indications & Usage
FDA Label (PDF)NEXICLON XR is indicated for the treatment of Hypertension.
View full patent landscape →
2 OB patents · 2 families ·
75 international docs across 15 countries
Pro Intelligence Preview
Deep insights for NEXICLON XR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 8 active patents
Trial Analysis
- • 66 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment