ISOFLURANE
Isoflurane USP may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. Isoflurane USP, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1993-01-25
- Routes
- INHALATION
- Dosage Forms
- LIQUID
ISOFLURANE Approval History
What ISOFLURANE Treats
6 FDA approvalsOriginally approved for its first indication in 1993 . Covers 6 distinct patient populations.
- Other (6)
Other
(6 approvals)- • Approved indication (Jan 1993)
- • Approved indication (Sep 1994)
- • Approved indication (May 1995)
- • Approved indication (Jun 1995)
- • Approved indication (Oct 1999)Letter
- • Approved indication (Nov 2025) New
Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05312385 INSPiRE-ICU1 results posted | SED003 | Ph 3 | completed | 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) |
| NCT05327296 INSPiRE-ICU2 results posted | SED004 | Ph 3 | completed | 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) |
| NCT07000526 IS-CRITIC | HULP6844 2024-518521-14-00 | Ph 4 | recruiting | Inhaled Sedation in Critically Ill Patients |
| NCT06624592 | 24-002252 | Ph 3 | recruiting | Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium |
| NCT04684238 IsoCOMFORT results posted | SED002 | Ph 3 | completed | Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old |
| NCT03588429 | 2018CZTCWM | Ph 3 | completed | The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics |
| NCT05314569 | N-11-2022 | Ph 1 | completed | Cardioprotective Effect of Ketamine-dexmeditomidine Versus Fentanyl-midazolam in Open Heart Surgery in Pediatrics |
| NCT03569085 | PRO17080624 | Ph 1 | completed | Inhaled Anesthetics and Myocardial Strain |
| NCT05742789 | 6 | Ph 1 | completed | Effect of Anesthetics on Troponin I and С-reactive Protein |
| NCT05696509 | AMU3 | Ph 3 | completed | Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults |
| NCT05695287 | 10 | Ph 1 | completed | The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery |
| NCT02111447 results posted | 412889-6 | Ph 4 | terminated | Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI |
| NCT02925611 results posted | 10313/PG-2Trg/2015/5408-9 | Ph 4 | completed | Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery |
| NCT03146104 | PGRMC-27.10.2016/29 | Ph 4 | completed | Comparison of Total Intravenous Anesthesia vs. Inhalational Anesthesia in Acute Subdural Hematoma Patients |
| NCT02512809 results posted | IRB14-00625 | Ph 3 | terminated | Isoflurane-induced Neuroinflammation in Children With Hydrocephalus |
| NCT01397331 | SHEBA-09-7199-SP-CTIL | Ph 4 | terminated | Influence of Anesthesia on Mechanical Efficiency of Left Ventricle in Patients Undergoing Open Heart Surgery |
| NCT03373266 | IRB0000871242 | Ph 2 | completed | Serun Fluoride and Kidney Transplant |
| NCT00830843 GAS-SAH | 1-citerio | Ph 4 | completed | Inhalatorial Sedation in Patient With Subarachnoid Hemorrhage (SAH) Versus Conventional Intravenous Sedation |
| NCT01839084 PaNeX | 12-051 2012-005698-30 | Ph 3 | completed | PaNeX: Partial Nephrectomy Under Xenon |
| NCT01640275 MAD-PIA | Pro00030861 | Ph 1 | completed | Markers of Alzheimers Disease After Propofol or Isoflurane Anesthesia |
| NCT01601795 | BS-57/12 Fassl_57/12 | Ph 4 | completed | Sevoflurane and Isoflurane - During Cardiopulmonary Bypass With the MECC System (Minimized Extracorporeal Circuit) |
| NCT06014138 ISO-DRIVE | SMRG_318537 | Ph 2, Ph 3 | recruiting | Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ISOFLURANE FDA Label Details
Indications & Usage
Isoflurane USP may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. Isoflurane USP, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia.
Looking for the branded version?
FORANE
Full clinical data, patents, trials, and competitive landscape for isoflurane.
Data Sources
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