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Data updated: May 26, 2026

ULTANE (sevoflurane)

Other Approved 1995-06-07

ULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available.

Source: FDA Label • AbbVie
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Prescription
First Approved
1995-06-07
Routes
INHALATION
Dosage Forms
LIQUID

Companies

AbbVie
Active Ingredient: SEVOFLURANE

ULTANE Approval History

1996
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Original
New Indication
New Form
Label Update
28 FDA actions from 1995 to 2025 · 1 indication expansions
Feb 2025 SUPPL
Label · Labeling
FDA Letter Label
Nov 2022 SUPPL
Label · Labeling
FDA Letter Label
May 2022 SUPPL
Label · Labeling
FDA Letter Label

What ULTANE Treats

2 FDA approvals

Originally approved for its first indication in 1995 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

136 trials
Trial Sponsor ID Phase Status Title
NCT02166853 SEGA CHU-0195 2013-005389-21 Ph 4 completed Effects of SEvoflurane on Gas Exchange and Inflammation in Patients With ARDS (SEGA Study)
NCT02527083 results posted PRO00000878 Ph 4 completed Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
NCT07289945 FWA 00032748 IORG0011243 Ph 3 completed Effects of Sevoflurane vs Desflurane on Early Recovery and Cognitive Function in Elderly Patients Undergoing Scheduled Non-Cardiac Surgery
NCT06624592 24-002252 Ph 3 recruiting Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium
NCT06779890 TIVolBrain TIVAVolaBrain Ph 4 recruiting Effect of Volatile- Based Versus Total Intravenous Anesthesia on Brain Homeostasis and Neurocognitive Outcome
NCT03089905 TREX TREX TRIAL 2024-512385-34-00 Ph 3 active not recruiting A Study to Compare the Long-term Outcomes After Two Different Anaesthetics
NCT02727296 VAPOR-2 VAPOR-002 Ph 4 completed Volatile Anesthetic Protection Of Renal Transplants 2
NCT05822817 K3501 Ph 4 completed Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery
NCT05990790 RAPID-II RAPIDII_01 Ph 4 recruiting The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium
NCT03643367 SSiS SSiS Ph 2 not yet recruiting Sevoflurane Sedation in Patients With Septic Shock
NCT04316013 18/044 Ph 3 terminated Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: the VAPOR-C Trial
NCT05303805 Sevoflurane in ulcers Ph 4 recruiting Topical Sevoflurane for Treatment of Chronic Leg Ulcers
NCT06024733 525 Ph 4 active not recruiting Intravenous Anesthesia by Targeted Controlled Infusion Versus Inhalational Anesthesia on the Surgical Stress Response
NCT04646967 REB20-1076 Ph 2 completed An Evaluation of Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision
NCT06371638 CODE-POCD 2024-01 Ph 4 completed Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD)
NCT03588429 2018CZTCWM Ph 3 completed The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics
NCT06036095 TIVA GAS STUDY00024667 Ph 4 recruiting Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study
NCT03435003 results posted 1074296-3 Ph 4 completed Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
NCT04567160 PROSEVNOL 2021-2343 Ph 4 completed NOL Index to Compare the Intraoperative Analgesic Effect of Propofol Versus Sevoflurane
NCT03917186 DESEVAR Ph 4 completed Desflurane vs. Sevoflurane in Endovascular Aortic Repair
NCT05223010 1/2022ANET3-A Ph 4 completed Melatonin for Pediatric Emergence Agitation
NCT03569085 PRO17080624 Ph 1 completed Inhaled Anesthetics and Myocardial Strain
NCT05926336 KMUHIRB-F(I)-20230075 Ph 4 recruiting The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action
NCT06017141 STUDY00149314 NCI-2023-05587, IIT-2022-VIVA Ph 2 recruiting Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study
NCT05996588 SIUT-ERC-2021/A-325 Ph 4 completed Comparison Between Sevoflurane and Propofol for Maintenance of Sedation During ERCP
NCT05430750 EC/05/22/2063 Ph 4 completed Global Warming Impact of Nitrous Oxide
NCT05615025 CHUB-ITF sevo-propofol Ph 3 completed Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation
NCT01809041 ZZuo-POCD-1 Ph 4 completed Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction
NCT05331027 RAPID RAPID_01 Ph 4 completed The Effect of Desflurane Versus Sevoflurane on Postoperative Recovery
NCT05742789 6 Ph 1 completed Effect of Anesthetics on Troponin I and С-reactive Protein
NCT05663242 KMUHIRB-F(I)-20210218. Ph 4 recruiting The Effects of Using Different Anesthetics on the Prognosis of Primary Lung Tumors and Its Mechanism of Action
NCT02174575 TMDU-1490 Ph 4 withdrawn Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery
NCT05259631 INVERSE Ph 3 suspended Inhalational (Sevoflurane) Versus Intravenous (Propofol) Sedation in Adults With a Moderate Form of ARDS
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
NCT01975064 CAN CAN/CKF-11115 2013-002380-25 Ph 4 completed Cancer and Anesthesia: Survival After Radical Surgery - a Comparison Between Propofol or Sevoflurane Anesthesia
NCT05636566 0305414 Ph 2, Ph 3 completed Comparing TIVA Using Propofol or Dexmedetomidine Versus Sevoflurane During Anaesthesia of Children Undergoing Bone-Marrow Aspiration
NCT05331911 KMUHIRB-F(I)-20220034 Ph 4 recruiting Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Excision of Primary Liver Tumors
NCT03597997 UW18-176 Ph 4 completed Effects of TIVA With Propofol Versus Inhalational Anaesthesia on Postoperative Pain After Hepatectomy
NCT05025397 TAK-925-1019 Ph 1 completed A Study of Danavorexton in Anesthetized Adults
NCT04125550 PSI Cyanotic children Ph 4 completed Propofol vs Sevoflurane in Cyanotic Congenital Heart Disease
NCT04475705 HKCH-REC-2020-013 Ph 4 recruiting Propofol vs Sevo for Paediatric Tumor Surgery
NCT05019560 R 153 / 2021 Ph 4 completed Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
NCT01219881 results posted 2010H0174 Ph 3 completed Comparing Desflurane to Sevoflurane for the Effect on Recovery Time in Patients Undergoing Urological Cystoscope Surgery
NCT01802255 ECSEVO-LT-011 2011-002555-34 Ph 3 withdrawn Sevoflurane- Safety in Long-term Sedation Procedures
NCT02987985 BIO 16-255 Ph 3 completed Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy
NCT04359862 SEVO-COVID19 SEVO-COVID19 Ph 4 terminated Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
NCT04355962 2020-00719 Ph 3 completed Sevoflurane in COVID-19 ARDS (SevCov)
NCT02918877 APLICS results posted 2016P000306 Ph 1, Ph 2 completed Anesthetics to Prevent Lung Injury in Cardiac Surgery
NCT03336801 ANIMAL-523-2014-2569 Ph 4 completed The Effect of Propofol or Sevoflurane on Renal Function

Showing 50 of 136 trials

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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.

ULTANE FDA Label Details

Indications & Usage

FDA Label (PDF)

ULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.

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Data Sources

FDA Approval: NDA020478 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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