TheraRadar
Data updated: Jun 17, 2026

AMIDATE (etomidate)

Trial Activity: Mature 1 active trials
Other Approved 1982-09-07

AMIDATE is indicated by intravenous injection for the induction of general anesthesia. When considering use of AMIDATE, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ).

Source: FDA Label • Pfizer
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Vanderbilt University Medical Center conducting 1 trials (7%)
26 indications explored (Broad Platform)
→ coronary artery disease (2 trials)
→ anesthesia (2 trials)
→ acute respiratory failure (1 trials)
1
Indication
--
Phase 3 Trials
43
Years on Market

Details

Status
Prescription
First Approved
1982-09-07
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Pfizer
Active Ingredient: ETOMIDATE

AMIDATE Approval History

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Original
New Indication
New Form
Label Update
16 FDA actions from 1982 to 2017
Apr 2017 SUPPL
Label · Labeling
FDA Letter Label
Jul 2002 SUPPL
Mfg · Manufacturing (CMC)
Apr 2001 SUPPL
Mfg · Manufacturing (CMC)

What AMIDATE Treats

1 FDA approvals

Originally approved for its first indication in 1982 .

  • Other (1)
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Clinical Trial Registry

15 trials
Trial Sponsor ID Phase Status Title
NCT05277896 RSI results posted 210500 K23HL153584, BPS-2022C3-30021 Ph 4 completed Randomized Trial of Sedative Choice for Intubation
NCT06664138 DKUH 2023-02-005-002 Ph 4 completed Comparison of Remimazolam and Etomidate As Induction Agents for Electroconvulsive Treatment
NCT05223907 ytmz Ph 4 completed Safety and Efficacy of Maintenance of Etomidate in General Anesthesia
NCT06068764 ETOPRO HHC-2023-0114 Ph 4 recruiting Etomidate Versus Propofol in CABG Surgery
NCT02822144 GASS 35RC15_8957 2016-000795-25 Ph 3 completed General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke
NCT02643381 EvK results posted 022015-023 Ph 4 completed Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
NCT03545503 Ket-RSI results posted 1712-4 Ph 4 completed Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
NCT02105415 KEEP PACE results posted 13-000506 Ph 2, Ph 3 completed Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
NCT01823328 results posted HSR 13-3601 Ph 4 completed Ketamine Versus Etomidate for Rapid Sequence Intubation
NCT02500225 Ulku 1 Ph 4 completed Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy
NCT02027311 results posted ETOMI-1 Ph 4 completed Etomidate vs. Midazolam for Sedation During ERCP
NCT02186990 Odu-2 Ph 4 completed Comparison of Etomidate, Propofol and Etomidate-propofol Combination in Terms of Effects on Haemodynamic Response to Intubation
NCT01495949 Si559/2011 Ph 4 completed The Cortisol Levels During Cardiac Surgery. The Comparison Between Etomidate and Thiopentone
NCT01792037 26177 Ph 4 completed Single Dose of Etomidate and Adrenal Cortex
NCT01248234 2010-0097 Ph 3 withdrawn Does Administration of Etomidate and Propofol of the Anesthetic Induction of Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngoscopy When Compared to Propofol or Etomidate Alone?
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

AMIDATE FDA Label Details

Indications & Usage

FDA Label (PDF)

AMIDATE is indicated by intravenous injection for the induction of general anesthesia. When considering use of AMIDATE, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ). Intravenous AMIDATE is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.

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Data Sources

FDA Approval: NDA018227 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment