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Sedation

18
Pipeline Programs
10
Companies
18
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
4
1
10
3
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Pfizer
PRECEDEXApproved
dexmedetomidine hydrochloride
Pfizer
injection1999

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
9 programs
1
1
4
1
DexmedetomidinePhase 41 trial
DA-9501Phase 3
DexmedetomidinePhase 31 trial
DexmedetomidinePhase 3
Dexmedetomidine hydrochloridePhase 3
+4 more programs
Active Trials
NCT06085573Completed111Est. Jun 2025
NCT01378988Completed5Est. Aug 2011
NCT01159262Completed36Est. Aug 2011
+2 more trials
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
midazolamPhase 4
Maruishi Pharmaceutical
4 programs
3
DA-9501Phase 31 trial
DexmedetomidinePhase 31 trial
Dexmedetomidine hydrochloridePhase 31 trial
Dexmedetomidine HydrochlorideN/A1 trial
Active Trials
NCT04040439Completed111Est. Aug 2022
NCT01438931Completed162Est. Mar 2012
NCT00526760Completed80Est. Jun 2008
+1 more trials
Sedana Medical
Sedana MedicalSweden - Danderyd
4 programs
3
IsofluranePhase 31 trial
IsofluranePhase 31 trial
MidazolamPhase 31 trial
IsofluraneN/A1 trial
Active Trials
NCT07457593Available
NCT05327296Completed282Est. Nov 2024
NCT05312385Completed277Est. Oct 2024
+1 more trials
Paion
PaionGermany - Aachen
1 program
1
A. CNS 7056Phase 21 trial
Active Trials
NCT01145222Completed162Est. Oct 2010
Sichuan Haisco Pharmaceutical
1 program
1
HSK3486 0.1-0.2 /0.3 mg / kg groupPhase 21 trial
Active Trials
NCT04147416Completed39Est. Jul 2020
Talphera
TalpheraCA - San Mateo
1 program
1
Sublingual Sufentanil/Triazolam NanoTab™Phase 21 trial
Active Trials
NCT00894699Completed40Est. Sep 2009
Autonomous Therapeutics
1 program
CiprofolN/A
Eisai
EisaiChina - Liaoning
1 program
fospropofol disodium Subgroup 1 Lower DosePHASE_41 trial
Active Trials
NCT01127438Completed153Est. Jun 2011
GSK
GSKLONDON, United Kingdom
1 program
midazolamPHASE_41 trial
Active Trials
NCT00158873Completed224

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Eisaifospropofol disodium Subgroup 1 Lower Dose
PfizerDexmedetomidine
GSKmidazolam
Sedana MedicalIsoflurane
Sedana MedicalIsoflurane
Sedana MedicalMidazolam
Maruishi PharmaceuticalDA-9501
Maruishi PharmaceuticalDexmedetomidine hydrochloride
PfizerDexmedetomidine
Maruishi PharmaceuticalDexmedetomidine
PfizerMidazolam
Sichuan Haisco PharmaceuticalHSK3486 0.1-0.2 /0.3 mg / kg group
PfizerDexmedetomidine
PaionA. CNS 7056
TalpheraSublingual Sufentanil/Triazolam NanoTab™

Showing 15 of 17 trials with date data

Clinical Trials (18)

Total enrollment: 2,070 patients across 18 trials

NCT01127438Eisaifospropofol disodium Subgroup 1 Lower Dose

A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations

Start: Apr 2010Est. completion: Jun 2011153 patients
Phase 4Completed
NCT00409344PfizerDexmedetomidine

Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms

Start: Jan 2007Est. completion: Jan 20080
Phase 4Terminated

Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects

Start: Sep 2004224 patients
Phase 4Completed

Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)

Start: Jun 2022Est. completion: Nov 2024282 patients
Phase 3Completed

Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)

Start: Apr 2022Est. completion: Oct 2024277 patients
Phase 3Completed

Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old

Start: Jan 2021Est. completion: Jan 202394 patients
Phase 3Completed

Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation

Start: Jul 2011Est. completion: Mar 2012162 patients
Phase 3Completed
NCT01438957Maruishi PharmaceuticalDexmedetomidine hydrochloride

Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation

Start: Jun 2011Est. completion: Nov 2011119 patients
Phase 3Completed
NCT00875550PfizerDexmedetomidine

Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects

Start: Jan 2010Est. completion: Jan 2011175 patients
Phase 3Completed

Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects

Start: Oct 2007Est. completion: Jun 200880 patients
Phase 3Completed

Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

Start: Jul 2010Est. completion: Aug 201136 patients
Phase 2/3Completed
NCT04147416Sichuan Haisco PharmaceuticalHSK3486 0.1-0.2 /0.3 mg / kg group

A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation

Start: Nov 2019Est. completion: Jul 202039 patients
Phase 2Completed
NCT01378988PfizerDexmedetomidine

Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months

Start: Jun 2011Est. completion: Aug 20115 patients
Phase 2Completed
NCT01145222PaionA. CNS 7056

Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy

Start: May 2010Est. completion: Oct 2010162 patients
Phase 2Completed
NCT00894699TalpheraSublingual Sufentanil/Triazolam NanoTab™

A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure

Start: Jun 2009Est. completion: Sep 200940 patients
Phase 2Completed

Expanded Access for Inhaled Isoflurane Delivered Via the Sedaconda ACD-S for Sedation of Difficult-to-Sedate Adult Mechanically Ventilated Intensive Care Unit Patients

N/AAvailable
NCT06085573PfizerDexmedetomidine Hydrochloride

A Study to Learn About the Study Medicine - Precedex in Children From Japan.

Start: Oct 2023Est. completion: Jun 2025111 patients
N/ACompleted
NCT04040439Maruishi PharmaceuticalDexmedetomidine Hydrochloride

Precedex Special Investigation (in Pediatric Patients)

Start: Jul 2019Est. completion: Aug 2022111 patients
N/ACompleted

Phase Legend

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

Key Insights

10 late-stage (Phase 3) programs, potential near-term approvals
10 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.