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ICU Sedation

6
Pipeline Programs
4
Companies
2
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
2
4
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Pfizer
DEXMEDETOMIDINE HYDROCHLORIDEApproved
dexmedetomidine hydrochloride
Pfizer
injection2014
Pfizer
PRECEDEXApproved
dexmedetomidine hydrochloride
Pfizer
injection1999

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
1 program
1
1
Dexmedetomidine hydrochloridePhase 31 trial
Active Trials
NCT02757625Completed63Est. May 2017
Orion
OrionUK - Cambridge
1 program
1
DexmedetomidinePhase 41 trial
Active Trials
NCT03813277Completed60Est. May 2018
Orion Pharma
Orion PharmaUK - Reading
1 program
1
DexmedetomidinePhase 4
Maruishi Pharmaceutical
1 program
1
Dexmedetomidine hydrochloridePhase 3

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
OrionDexmedetomidine
PfizerDexmedetomidine hydrochloride

Clinical Trials (2)

Total enrollment: 123 patients across 2 trials

NCT03813277OrionDexmedetomidine

Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU

Start: Mar 2017Est. completion: May 201860 patients
Phase 4Completed
NCT02757625PfizerDexmedetomidine hydrochloride

Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit

Start: Jul 2016Est. completion: May 201763 patients
Phase 3Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

ICU Sedation | Pipeline & Competitive Landscape | Formulate