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dexmedetomidine

Generic: DEXMEDETOMIDINE HYDROCHLORIDE·Brand: DEXMEDETOMIDINE HYDROCHLORIDE, Dexased, Dexdomitor, Dexmedesed, Dexmedvet, IGALMI, Igalmi, PRECEDEX, Precedex, Sedexodine, Sileo·Code: BXCL501

dexmedetomidine: developed by 2 companies · 21 clinical trials tracked · 1 FDA decision.

dexmedetomidine evidence translation

What we can confirm

1 FDA record · 21 tracked trials

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about dexmedetomidine, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 3 study sponsors
Development Pipeline (3)
CompanyPhase
BioXcel Therapeutics, Inc. (BTAI)
Agitation,Psychomotor; Agitation
Phase 2
DR REDDYS LABORATORIES LTD (RDY)Approved
DR REDDYS LABORATORIES LTD (RDY)Approved
Clinical Trials (21)showing 10 most recent

An Alpha2-adrenoceptor Agonist to Reduce Locus Coeruleus Activity During Sleep in Adults With Insomnia Disorder: a Pilot Randomised Placebo-controlled Cross-over Study

NCT07392177·Phase 2·GHRS
Recruiting

Primary endpoint: Electrographic (EEG) signatures

InterventionalRandomizedquadruple15 targetStarted 2026-08Completion 2027-031 site · AustraliaWoolcock Institute of Medical Research

Evaluation of an Opioid-Free Approach in Sedation Method Selection in Endoscopy Units: A Prospective Randomized Observational Double-Blind Comparison of Dexmedetomidine (Opioid-Free) and Remifentanil-Dexmedetomidine (Opioid-Based) Combination

Not yet recruiting

Primary endpoint: Incidence of Opioid-Related Adverse Symptoms

InterventionalRandomizedquadruple80 targetStarted 2026-06Completion 2028-02Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With a Sublingual Formulation of Dexmedetomidine (BXCL501)

NCT06943404·Phase 2
Recruiting

Primary endpoint: Change in ASD Score

InterventionalRandomizedquadruple100 targetStarted 2026-02Completion 2026-093 sites · United StatesUniversity of North Carolina, Chapel Hill

Dexmedetomidine Versus Fentanyl-Midazolam Combination to Attenuate the Stress Response in Laparoscopic Cholecystectomy

NCT07425444·Phase 4·CGTX
Not yet recruiting

Primary endpoint: Hemodynamics

InterventionalRandomizeddouble50 targetStarted 2026-02Completion 2027-04Assiut University

A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guided Infraclavicular Block

NCT07249827·Phase 2
Completed

Primary endpoint: Motor block duration

InterventionalRandomizedquadruple69 enrolledStarted 2025-12Completion 2026-061 site · CanadaMcGill University Health Centre/Research Institute of the McGill University Health Centre

Differences in C-Reactive Protein Levels Between Traumatic Brain Injury Patients Receiving Dexmedetomidine and Those Not Receiving Dexmedetomidine Undergoing Craniotomy at Prof. Dr. Margono Soekarjo Regional General Hospital, Purwokerto

NCT07406555·Phase 4·CGTX
Completed

Primary endpoint: Change in C-Reactive Protein (CRP) Levels

InterventionalRandomizedtriple25 enrolledStarted 2025-10Completion 2025-111 site · IndonesiaUniversitas Jenderal Soedirman

Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants: a Randomized Controlled Multicenter Trial - DEXPRE

NCT06878703·Phase 3·CRNX
Recruiting

Primary endpoint: Time, measured in minutes, is evaluated from the discontinuation of the experimental treatment (either dexmedetomidine-based or midazolam-based sedation) to extubation.

InterventionalRandomizedquadruple380 targetStarted 2025-10Completion 2029-101 site · FranceAssistance Publique - Hôpitaux de Paris

Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm: Outpatient Follow-up of Mental Health INDices (SDATE OF MIND)

Recruiting

Primary endpoint: Post-traumatic stress disorder symptoms

Observational70 targetStarted 2025-03Completion 2028-061 site · CanadaOttawa Heart Institute Research Corporation

Dexmedetomidine as an Adjuvant to Bupivacaine in Bilateral Pectoral Nerve Blocks for Postoperative Pain Control After Cardiac Surgeries: A Randomized Controlled Trial

NCT06453681·Phase 4·CGTX
Completed

Primary endpoint: The duration of analgesia

InterventionalRandomizedquadruple60 enrolledStarted 2024-08Completion 2025-052 sites · EgyptKasr El Aini Hospital

Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

NCT06281977·Phase 3·GHRS
Recruiting

Primary endpoint: The primary outcome is a composite of the following: 1. All-cause in-hospital death AND/OR 2. Any in-hospital ventricular arrhythmia requiring treatment after study drug initiation.

InterventionalRandomizedtriple192 targetStarted 2024-05Completion 2027-082 sites · Canada, United StatesOttawa Heart Institute Research Corporation
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha 2 adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. (1.1) • Sedation of non-intubated adult patients prior to and/or during surgical and other proce(RDY)FDA ↗
ANDA220315UNKNOWNStandardOtherInjectable

Frequently asked questions

Who is developing dexmedetomidine?

dexmedetomidine is being developed by BioXcel Therapeutics, Inc., DR REDDYS LABORATORIES LTD.

How many clinical trials involve dexmedetomidine?

BioSniper tracks 21 clinical trials involving dexmedetomidine.

What is dexmedetomidine's latest FDA decision?

The most recent tracked FDA decision for dexmedetomidine is Approval for 1 INDICATIONS AND USAGE Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha 2 adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. (1.1) • Sedation of non-intubated adult patients prior to and/or during surgical and other proce, dated February 25, 2026.