Intranasal Dexmedetomidine

ApprovedSmall molecule

BBaudax Bio

Intranasal Dexmedetomidine is one of 124 small molecule programs targeting Sedation. It is currently in Approved.

Indications

Total Trials

Active Trials

123

Competitors

Pipeline

Status by Indication[3][1]

Indication

DeliriumActive, not recruiting

Coronary Artery BypassActive, not recruiting

CataractActive, not recruiting

Autism Spectrum DisorderActive, not recruiting

DeliriumApproved

Active, not recruiting

Coronary Artery BypassPhase 1

Active, not recruiting

CataractPhase 3

Active, not recruiting

Autism Spectrum DisorderPreclinical

Active, not recruiting

Competition

Competitive Landscape

219 competitors in Cataract

#DrugCompanyPhaseTrials

Intranasal Dexmedetomidine

BBaudax Bio

Approved

1 2

Isopto Carpine

AAdvanz Pharma

Phase 3

1 3

Clobetasol Propionate

Bayer

Phase 3

3 4

Mapracorat

Bayer

Phase 3

4 5

Ripasudil

KKowa Research Institute, Inc.

Phase 3

2 6

XG-102

XXigen SA

Phase 3

2 7

Midalozam

Idorsia Pharmaceuticals Ltd.

Phase 3

2 8

Zolymbus

AbbVie

Preclinical

—9

Neurontin

VViatris Specialty LLC

Preclinical

3 10

Kenalog

BBassett Healthcare

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1/2Not yet recruiting

Sedation

NCT07180095

Q4 2027

N/ANot yet recruiting

Autism Spectrum Disorder

NCT07324057

Clinical

Trials by Indication[1]

Sedation6 trials

The Effect of Age on the Median Effective Dose (ED50) of Intranasal Dexmedetomidine for Rescue Sedation Following Failed Sedation With Oral Chloral Hydrate During Magnetic Resonance Imaging

Completed·GGuangzhou Women and Children's Medical Center·Phase 4·NCT02253199·120 enrolled

Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures

Completed·—··NCT03220880·578 enrolled

A Study to Assess the Analgesia and Sedation Using Intranasal Dexmedetomidine in Third Molar Surgery Under Local Anaesthesia

Completed·TThe University of Hong Kong·Phase 3·NCT01132794

Show 3 more trials

Children of Age 2-6years Undergoing Elective Surgery Will be Divided Into Two Groups Randomly. This Study Aims to Evaluate if Intranasal Dexmedetomidine is Better Than Intranasal Ketamine in Producing Sedation and Reducing Parent Separation Anxiety Before Surgery.

Not yet recruiting·LLiaquat National Hospital & Medical College·Phase 1/2·NCT07180095·60 enrolled

Intranasal Dexmedetomidine Sedation for Ophthalmic Examinations in Children

Unknown status·SSun Yat-sen University·N/A·NCT02077712·60 enrolled

Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment

Completed·NNourhan M.Aly·Phase 2/3·NCT04237532·42 enrolled

Dexmedetomidine5 trials

IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED

Recruiting·UUniversity of Oklahoma·Phase 4·NCT05934669·90 enrolled

Effectiveness of Intranasal Dexmedetomidine Premedication in Child Intubation

Completed·IIndonesia University·Phase 3·NCT06991647·40 enrolled

Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room

Withdrawn·NNationwide Children's Hospital·Phase 2·NCT05057689

Show 2 more trials

Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of Endoscopic Sinus Surgery

Unknown status·KKafrelsheikh University·Phase 4·NCT06081933·54 enrolled

Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT03293277·48 enrolled

Postoperative Analgesia3 trials

Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery

Completed·BBaudax Bio·Phase 2·NCT02284243·168 enrolled

Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy

Terminated·BBaudax Bio·Phase 2·NCT02169336·95 enrolled

Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy

Withdrawn·MMansoura University·N/A·NCT03742180

Cataract1 trial

Intranasal Dexmedetomidine on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery

Recruiting·SSuez Canal University·Phase 3·NCT07080229·126 enrolled

Hypotensive Anesthesia1 trial

Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS

Completed·—·Phase 4·NCT05604599·60 enrolled

6 more indications

Autism Spectrum Disorder1 trial

The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavioral Changes in Children With Autism Spectrum Disorder

Not yet recruiting·SSun Fei·N/A·NCT07324057·234 enrolled

Delirium1 trial

Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

Completed·IIndonesia University·Phase 4·NCT04263844·66 enrolled

Pediatric Patients1 trial

ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study

Completed·GGuangzhou Women and Children's Medical Center·Phase 4·NCT02780427·320 enrolled

Intranasal Administration1 trial

Bioavailability of Dexmedetomidine After Intranasal Administration

Completed·UUniversity of Turku·Phase 1·NCT00837187·7 enrolled

Intravenous1 trial

Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants

Unknown status·UUniversity of Sao Paulo General Hospital·Phase 3·NCT04621110·60 enrolled

Coronary Artery Bypass1 trial

Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft.

Not yet recruiting·MMinia University·Phase 1·NCT06741566·150 enrolled

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Intranasal Dexmedetomidine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Intranasal Dexmedetomidine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Intranasal Dexmedetomidine. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Baudax Bio company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: BBaudax Bio

Intranasal Dexmedetomidine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2027

Trials by Indication[1]

Sedation6 trials

Dexmedetomidine5 trials

Postoperative Analgesia3 trials

Cataract1 trial

Hypotensive Anesthesia1 trial

Autism Spectrum Disorder1 trial

Delirium1 trial

Pediatric Patients1 trial

Intranasal Administration1 trial

Intravenous1 trial

Coronary Artery Bypass1 trial

References

Drug Info

Quick Facts

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