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ICU Sedation

5
Pipeline Programs
4
Companies
2
Clinical Trials
1
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
3
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

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

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Orion PharmaDexmedetomidine
Maruishi PharmaceuticalDexmedetomidine hydrochloride

Clinical Trials (2)

Total enrollment: 123 patients across 2 trials

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

Start: Mar 2017Est. completion: May 201860 patients
Phase 4Completed
NCT02757625Maruishi PharmaceuticalDexmedetomidine hydrochloride

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

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

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & 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.