TheraRadar
Data updated: May 26, 2026

FORANE (isoflurane)

Trial Activity: Declining 2 active trials
Other Approved 1979-12-18

FORANE is indicated for the treatment of General Anesthesia.

Source: FDA Label • Baxter

Development Insights

Sedana Medical conducting 3 trials (14%)
21 indications explored (Broad Platform)
sedation (4 trials)
mitral valve insufficiency (3 trials)
aortic valve insufficiency (3 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
46
Years on Market

Details

Status
Prescription
First Approved
1979-12-18
Routes
INHALATION
Dosage Forms
LIQUID

Companies

Active Ingredient: ISOFLURANE

FORANE Approval History

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Original
New Indication
New Form
Label Update
36 FDA actions from 1979 to 2024 · 1 indication expansions
Dec 2024 SUPPL
Label · Labeling
Nov 2022 SUPPL
Label · Labeling
Oct 2021 SUPPL
Label · Labeling

What FORANE Treats

1 indications

FORANE is approved for 1 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • General Anesthesia
Source: FDA Label

FORANE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to FORANE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

SEVOFLURANE
SEVOFLURANE
1 shared
SHANGHAI HENGRUI
Shared indications:
General Anesthesia
SOJOURN
SEVOFLURANE
1 shared
PIRAMAL CRITICAL
Shared indications:
General Anesthesia
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Clinical Trial Registry

21 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)
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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

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.

FORANE FDA Label Details

Indications & Usage

FDA Label (PDF)

FORANE is indicated for the treatment of General Anesthesia.

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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