ATP2C1 blockers(ATPase secretory pathway Ca2+ transporting 1 blockers), GABRA1 agonists(gamma-aminobutyric acid type A receptor subunit alpha1 agonists), GLRA1 agonists(glycine receptor alpha 1 agonists)

Therapeutic Areas

Other Diseases

Active Indication

Anesthesia

Inactive Indication-

Originator Organization

Baxter Healthcare Corp.

Active Organization

Hebei Yipin Pharmaceutical Co., Ltd.Baxter Healthcare Corp.

Inactive Organization

Yichang Humanwell Pharmaceuticals Co., Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (18 Dec 1979),

Anesthesia

RegulationFast Track (United States)

Structure/Sequence

Molecular FormulaC3H2ClF5O

InChIKeyPIWKPBJCKXDKJR-UHFFFAOYSA-N

CAS Registry26675-46-7

168

Clinical Trials associated with Isoflurane

NCT07000526

/ RecruitingPhase 4IIT

Inhaled Sedation in Critically Ill Patients: a Multicentre Randomized Clinical Trial

The proposal of this study is to compare inhaled sedation with isoflurane administered via the Sedaconda ACD-S system with intravenous sedation with propofol. Patients will be randomized 1:1 to receive either inhaled sedation with isoflurane administered via the Sedaconda ACD device (Sedana Medical, Uppsala, Sweden) or intravenous propofol. The primary endpoint is the number of ventilator-free days at 28 days after randomization.

Start Date15 Dec 2025

Sponsor / Collaborator

Instituto de Investigación Hospital Universitario La Paz

[+1]

NCT07099014

/ Not yet recruitingPhase 3IIT

Inhaled Isoflurane for Sedation of Invasively Ventilated Patients With Cardiogenic Shock on Extracorporeal Membrane Oxygenation

Midazolam and propofol are the most used intravenous (IV) sedative agents, but their use is associated with well-known adverse effects such as accumulation, myotoxicity, tachyphylaxis, and unpredictable wake-up time.
For benzodiazepines, an increased tolerance, possible accumulation after long-term use, and an increased risk of acute withdrawal syndrome are reported. In patients on extracorporeal membrane oxygenation (ECMO) for cardiogenic shock, the negative hemodynamic effects of these drugs are a particular matter of concern. Besides the extracorporeal circuit itself may affect the pharmacokinetics of these IV sedatives. Indeed, drug sequestration in ECMO circuits is a well-known phenomenon influenced by drug chemo-physical properties. Given the large surface area of tubing and membrane, considerable quantities of drugs used in ECMO patients may be sequestered over a period, resulting in a significant increase in their volume of distribution. Similarly, frequent hemodilution and organ dysfunction would also contribute to an increase in the volume of distribution.
Propofol, which is lipophilic is significantly sequestrated in the circuit. Consequently, it is commonly observed that patients receiving ECMO have substantially higher sedative and analgesic drug requirements than patients without ECMO.
To date, there is no ideal concept for analgesia and sedation of patients on ECMO in the ICU.
A drug that sedates effectively but with minimal residual sedation after the end of the administration and without the aforementioned drawbacks of the current agents would be valuable.
Interestingly, a recent randomized controlled non-inferiority trial that randomized 338 patients showed that, compared with propofol, sedation with inhaled anaesthetics was non-inferior. Sedation with inhaled anaesthetics resulted in a higher rate of spontaneous breathing and a shorter wake-up time after 48h of sedation. Indeed, inhaled sedation, which has been associated with reduced opioid consumption and less delirium in ICU patients, is a promising alternative to IV sedation. Moreover, inhaled anaesthetics might be associated with less myocardial injury and lower doses of inotropic support in patients undergoing cardiac surgery. However, to date, the experience with volatile agents remains limited in patients on ECMO.
We hypothesized that the use of inhaled isoflurane with the Sedaconda anaesthetics conserving device (ACD) in cardiogenic shock patients on ECMO will reduce the mortality and increase the number of ventilation-free days at day 28 following ECMO onset compared to usual IV sedation by propofol and/or midazolam.

Start Date15 Sep 2025

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

NCT07152912

/ RecruitingNot ApplicableIIT

A Comparative Study Between the Impact of Isoflurane and Sevoflurane on Oxidative Stress in Patients Undergoing Laparoscopic Cholecystectomy

The primary aim of this work is to assess the impact of exposure to isoflurane or sevoflurane as an inhalation anesthetic on the oxidative stress and inflammatory conditions in patients undergoing elective moderate invasive surgery (laparoscopic cholecystectomy).

Start Date04 Sep 2025

Sponsor / Collaborator

Ain Shams University

100 Clinical Results associated with Isoflurane

100 Translational Medicine associated with Isoflurane

100 Patents (Medical) associated with Isoflurane

13,484

Literatures (Medical) associated with Isoflurane

01 Apr 2026·NEUROPHARMACOLOGY

Brain-penetrant microtubule-stabilizer epothilone B delays isoflurane-induced unconsciousness in mice

Article

Author: Yu, Xinyue ; Zeng, Xiran ; Huang, Yixiang ; Chang, Abbie ; Lee, Sophia ; Qiu, Zitong ; Wiest, Michael C

Inhalational anesthetics are currently believed to cause unconsciousness by acting on multiple molecular targets including neural ion channels, receptors, mitochondria, synaptic proteins, and cytoskeletal proteins. Inhalational anesthetics including isoflurane bind to cytoskeletal microtubules (MTs), potentially contributing to causing unconsciousness. This possibility is supported by our demonstration of isoflurane resistance in rats treated once with the brain-penetrant MT-stabilizing drug epothilone B (epoB), and by a recent study in mice using a similar drug given daily over two weeks, which found increased sensitivity to isoflurane. To further characterize the contribution of MTs as functionally relevant targets of volatile anesthetics in mice, we measured latencies to loss of righting reflex (LORR) under isoflurane in mice injected once subcutaneously with vehicle or epoB. We found significantly increased LORR latencies (i.e., anesthetic resistance) in 8 mg/kg epoB-treated mice on the day following injection, with reduced effects on subsequent days. The 29-s within-subject increase in LORR latencies is not large compared to the variability among different animals, but it represents a statistically large within-subject effect as represented by a Cohen's d of 0.8. The effect could not be accounted for by tolerance from repeated exposure to isoflurane. Our results support that binding of the inhalational anesthetic isoflurane to MTs contributes to LORR in mice, as it does in rats. Our findings support the Orchestrated Objective Reduction (Orch OR) model that posits consciousness as a property of a quantum physical state of neural MTs. We also discuss possible sex differences in anesthetic mechanisms suggested by our data.

01 Apr 2026·VETERINARY RESEARCH COMMUNICATIONS

Use of epidural anaesthesia as analgesic management in an asiatic lion (Panthera leo persica)

Article

Author: Arenillas, Mario ; Martínez-Nevado, Eva ; Sánchez, Cristina

A 10-year-old lioness (Panthera leo persica), weighing 130 kg, was referred from Madrid Zoo to the Veterinary Teaching Hospital of the Complutense University of Madrid for evaluation of a lumbar soft tissue mass, previously diagnosed by biopsy as a chondrosarcoma, with potential surgical excision planned. A coordinated safety protocol was established between zoo and hospital staff, including predefined emergency routes and continuous supervision by experienced personnel and animal keepers. Anaesthetic premedication included intramuscular medetomidine (0.05 mg kg⁻¹) and ketamine (3 mg kg⁻¹), followed by propofol induction (1.2 mg kg⁻¹ IV) and maintenance with isoflurane in oxygen. Mechanical ventilation and comprehensive monitoring (ECG, non-invasive blood pressure, pulse oximetry, capnography, oesophageal temperature) were used. After computed tomography evaluation, the lion was elected for the chondrosarcoma surgical excision. Perioperative analgesia included intravenous methadone (0.1 mg kg⁻¹) and a sacrococcygeal epidural block with bupivacaine (0.3 mg kg⁻¹) and morphine (0.1 mg kg⁻¹). This epidural technique was integrated into a multimodal analgesic protocol that proved effective, as no intraoperative nociceptive responses were observed and recovery was uneventful, aside from transient and self-limiting neurological deficits. This case illustrates the feasibility of incorporating sacrococcygeal epidural analgesia into a multimodal anaesthetic and analgesic plan for major surgical procedures in large felids.

01 Mar 2026·VETERINARY ANAESTHESIA AND ANALGESIA

Severe bradycardia and asystole in a dog after intravenous metoclopramide injection

Article

Author: Chesnel, Mandoline ; Rolfi, Liliana

A 5-month-old English Bulldog with a history of clinically resolved bronchopneumonia was admitted for a computed tomography scan and corrective surgery for brachycephalic obstructive airway syndrome. The day of imaging and surgery, the dog did not show any signs of cardiovascular abnormalities. The dog was premedicated intravenously (IV) with maropitant (1 mg kg^-1), pantoprazole (1 mg kg^-1) and acepromazine (20 μg kg^-1). Anaesthesia was induced with alfaxalone (2 mg kg^-1) IV after 5 minutes of preoxygenation, and anaesthesia was maintained with isoflurane in oxygen [inspired fraction (FIO₂) =1]. After induction, physiological variables were unremarkable. Metoclopramide (1 mg kg^-1) was injected slowly IV, and the dog immediately developed a severe sinus bradycardia (4 beats minute^-1) followed by asystole. Cardiopulmonary resuscitation was started along with atropine (40 μg kg^-1 IV), and isoflurane discontinued. Within 1 minute, spontaneous circulation with stable haemodynamic variables was restored. Both the diagnostic and the surgical procedures were completed without further complications. The dog recovered and was discharged the same day. Rare but serious cardiac effects have been described following metoclopramide administration in humans, including bradycardia, asystole and arrhythmia. Cardiotoxicity may be linked to its clinical ability to inhibit sodium channels. To our knowledge, no metoclopramide-induced asystole has previously been reported in veterinary patients. The link between cardiac arrest and metoclopramide administration and possible predisposing factors in this case are discussed.

News (Medical) associated with Isoflurane

02 Dec 2025

·www.businesswire.com

Fresenius Kabi Expands Operating Room Portfolio with New Simplist ® Prefilled Syringes

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced two new products in its Simplist® portfolio of ready-to-administer prefilled syringes: Simplist® Ephedrine Sulfate Injection, USP and Simplist® Succinylcholine Chloride Injection, USP. Both medications are used in anesthesia and critical care, and their introduction extends the Simplist line’s use into operating rooms, supporting clinicians with safe, efficient and reliable medication delivery. Fresenius Kabi has expanded its Simplist® ready-to-administer portfolio, introducing new presentations that extend its use into operating rooms and support clinicians in anesthesia and critical care. Simplist Succinylcholine Chloride Injection, USP, is a paralytic used in addition to general anesthesia for intubation and during mechanical ventilation in pediatric and adult patients. Simplist Ephedrine Sulfate Injection, USP is indicated for the treatment of clinically important hypotension (low blood pressure) during anesthesia. “As part of our commitment to simplify medication delivery and improve patient safety, the expansion of our Simplist portfolio into the operating room demonstrates how we’re supporting anesthesiologists and nurse anesthetists in their vital work,” said Arun Verma, president of Fresenius Kabi Region U.S. and member of the Executive Leadership Team at Fresenius Kabi AG. “These ready-to-administer medications are designed to help clinicians throughout the hospital by helping to reduce complexity, help minimize waste, and reduce the number of drug-preparation steps where errors can occur.” About the Products: Simplist Succinylcholine Chloride Injection, USP is available in 100 mg per 5 mL (20 mg per mL) and 200 mg per 10 mL (20 mg per mL) strengths. It offers an 18-month shelf life and is stored in a refrigerator at 36°F (2°C) to 46°F (8°C). The single dose prefilled syringes are stable for up to 14 days at room temperature without loss of potency. Simplist Ephedrine Sulfate Injection, USP is available in 25 mg per 5 mL (5 mg per mL) and 50 mg per 10 mL (5 mg per mL) presentations. It can be stored at room temperature and has a 24-month shelf life. Both prefilled syringes are manufactured and prepared by Fresenius Kabi, eliminating the need for assembly or dilution at the point of care to simplify medication administration, enhance workflow efficiency, and support best practices in medication administration safety. To learn more about Fresenius Kabi’s expanding manufacturing and other operations in the U.S., visit www.MoreInAmerica.com. IMPORTANT SAFETY INFORMATION Succinylcholine Chloride Injection, USP WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS CONTRAINDICATIONS In patients with skeletal muscle myopathies In patients with known hypersensitivity to succinylcholine After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury In patients with a personal or familial history or suspected genetic susceptibility to malignant hyperthermia WARNINGS AND PRECAUTIONS Anaphylaxis: Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. Some cases have been life-threatening and fatal. Take necessary precautions, such as the immediate availability of appropriate emergency treatment. Risk of Death due to Medication Errors: Unintended administration of Succinylcholine Chloride Injection may result in paralysis, respiratory arrest and death. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. Hyperkalemia: Succinylcholine Chloride Injection may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. Malignant Hyperthermia: Malignant hyperthermia may occur, especially in individuals with known or suspected susceptibility based on genetic factors or family history. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapies. Bradycardia: Intravenous bolus administration may result in profound bradycardia or, rarely asystole. The incidence is higher following a second dose of succinylcholine. Pretreatment with anticholinergic agents (e.g. atropine) may reduce the occurrence of bradyarrhythmias. ADVERSE REACTIONS Adverse reactions reported with succinylcholine are cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory depression or apnea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Drugs that May Enhance the Neuromuscular Blocking Action of Succinylcholine: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, terbutaline, and drugs that reduce plasma cholinesterase activity. INDICATIONS AND USAGE Succinylcholine Chloride Injection is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: As an adjunct to general anesthesia To facilitate tracheal intubation To provide skeletal muscle relaxation during surgery or mechanical ventilation This Important Safety Information does not include all the information needed to use Succinylcholine Chloride Injection, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for Succinylcholine Chloride Injection, USP 100 mg per 5 mL and 200 mg per 10 at www.fresenius-kabi.com/us. Ephedrine Sulfate Injection, USP WARNINGS AND PRECAUTIONS Pressor Effects with Concomitant Use with Oxytocic Drugs: Pressor effect of sympathomimetic pressor amines is potentiated. Tachyphylaxis and Tolerance: Repeated administration of ephedrine may cause tachyphylaxis. ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Interactions that Augment Pressor Effect: clonidine, oxytocin and oxytocic drugs, propofol, monoamine oxidase inhibitors (MAOIs), and atropine. Monitor blood pressure. Interactions that Antagonize the Pressor Effect: Antagonistic effects with α-adrenergic antagonists, β-adrenergic antagonists, reserpine, quinidine, mephentermine. Monitor blood pressure. Guanethidine: Ephedrine may inhibit the neuron blockage produced by guanethidine, resulting in loss of antihypertensive effectiveness. Monitor blood pressure and adjust the dosage of pressor accordingly. Rocuronium: Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Be aware of this potential interaction. No treatment or other interventions are needed. Epidural anesthesia: Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. Monitor and treat the patient according to clinical practice. Theophylline: Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia. Monitor patient for worsening symptoms and manage symptoms according to clinical practice. Cardiac glycosides: Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Carefully monitor patients on cardiac glycosides who are also administered ephedrine. INDICATIONS AND USAGE Ephedrine Sulfate Injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. This Important Safety Information does not include all the information needed to use Ephedrine Sulfate Injection, USP safely and effectively. Please see full prescribing information, for Ephedrine Sulfate Injection, USP at www.fresenius-kabi.com/us.” About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving essential medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit www.fresenius-kabi.com/us. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook. This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

29 May 2024

·www.prnewswire.com

Sedana Medical completes patient recruitment for its clinical program in the US

STOCKHOLM, May 29, 2024 /PRNewswire/ -- Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 2 phase III clinical trial in the United States. Earlier this spring, Sedana Medical reported the completion of enrolment to the parallel phase III clinical trial INSPiRE-ICU 1. The company anticipates topline results from both trials in the second half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025. "The completion of INSPiRE-ICU 2 concludes Sedana Medical´s clinical trials in the United States. Running this study together with esteemed clinical investigators from highly ranked academic centers such as Columbia, the Harvard-affiliated medical center Beth Israel Deaconess Medical Center and many others has been very exciting and rewarding. Many investigators from the participating sites have been excited to be part of our pioneering studies. The bedside experience in the studies has generated a lot of interest in using inhaled sedation in US practice, which we hope will be possible soon," said Peter Sackey, Chief Medical Officer of Sedana Medical. Peter Sackey further elaborated: "We now enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months are being collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results for the 30-day outcomes in both studies a few months´ apart before the end of this year, and a swift regulatory submission in Q1, 2025." "The inhaled sedative isoflurane, studied in this trial, is a mainstay of general anesthesia during surgery because of its unique and straightforward pharmacokinetic and pharmacodynamic profile, properties that may potentially also benefit ICU patients. We are very excited to complete enrolment in this trial and eagerly await results evaluating its potential use as a sedative for ventilator-dependent adult ICU patients in the US," said Jeremy Beitler, MD, MPH at Columbia University and Senior Lead Investigator for the INSPiRE-ICU 2 study. Johannes Doll, President and CEO of Sedana Medical, stated: "Completing enrolment of our clinical program marks an important milestone on our journey towards making inhaled sedation accessible to intensive care patients in the United States. I would like to sincerely thank all our clinical trial sites, partners, and the Sedana Medical team for this significant achievement. It makes me very proud that we have been able to convene this exceptional group of intensive care teams from some of the most prominent US hospitals. Their advice and support will be invaluable as we work towards launching our inhaled therapy on the US market." INSPiRE-ICU 1 and 2 are two identical randomized phase III trials, aiming to confirm the efficacy and safety for sedation with isoflurane delivered via Sedana Medical's unique medical device Sedaconda ACD. The primary endpoint is the proportion of time spent at adequate depth of sedation, compared with intravenous sedation using propofol. In addition, several important secondary endpoints are being studied, including opioid use, time to wake-up, cognitive recovery and spontaneous breathing. The first patient was included in April 2022, and 31 highly reputed clinics in the United States are involved in the two trials. The design of the US studies is similar to the Sedaconda study (SED001) successfully performed in Europe in 2017–2019, which resulted in market approval in 2021. For additional information, please contact: Johannes Doll, CEO, +46 (0)76 303 66 66 Johan Spetz, CFO, +46 (0)730 36 37 89 [email protected] About Sedana Medical Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient's life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care. Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordics, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors. Sedana Medical was founded in 2005, is listed on Nasdaq Stockholm (SEDANA) and headquartered in Stockholm, Sweden. This information was brought to you by Cision The following files are available for download:

Phase 3

25 Apr 2024

·www.prnewswire.com

Sedana Medical completes patient recruitment for INSPiRE-ICU 1 clinical trial in the US

STOCKHOLM, April 25, 2024 /PRNewswire/ -- Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 1 phase III clinical trial in the United States. Concurrently, the identical INSPiRE-ICU 2 trial is nearing completion, with 23 of 235 randomized patients remaining. The company anticipates topline results from both trials in the second half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025. "The completion of the INSPiRE-ICU 1 study marks a true milestone for Sedana Medical. Launching the randomized controlled multicenter studies across the large and diverse US healthcare landscape, in mixed surgical and medical ICUs with a different staffing and workflow compared to Europe, has been exciting. There is a lot of enthusiasm and interest in using inhaled sedation in US practice, which we hope will be possible soon", said Peter Sackey, Chief Medical Officer of Sedana Medical. Peter Sackey further elaborated: "Once the 30-day follow-up of all patients is complete, we will enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months will be collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results in the autumn of this year and a swift regulatory submission in Q1, 2025". "Working on these trials from initial design to implementation and completion has been very rewarding and has brought together many experienced clinical researchers in critical care across the US. We, and the clinicians at the bedside, are eager to see inhaled sedation available also in the US", said Christopher Hughes, Professor of Anesthesiology at Vanderbilt University Medical Center and Senior Lead Investigator for the INSPiRE-ICU 1 study. Johannes Doll, President and CEO of Sedana Medical, expressed gratitude, stating: "I would like to sincerely thank all our clinical trial sites, partners, and the Sedana Medical team for this significant achievement. It makes me very proud that we have been able to convene this exceptional group of intensive care teams from some of the most prominent US hospitals. Their advice and support will be invaluable as we work towards making the benefits of inhaled sedation accessible to patients in the United States." INSPiRE-ICU 1 and 2 are two identical randomized phase III trials, aiming to confirm the efficacy and safety for sedation with isoflurane delivered via Sedana Medical's unique medical device Sedaconda ACD. The primary endpoint is the proportion of time spent at adequate depth of sedation, compared with intravenous sedation using propofol. In addition, several important secondary endpoints are being studied, including opioid use, time to wake-up, cognitive recovery and spontaneous breathing. The first patient was included in April 2022, and 31 highly reputed clinics in the United States are involved in the two trials. The design of the US studies is similar to the Sedaconda study (SED001) successfully performed in Europe in 2017–2019, which resulted in market approval in 2021. For additional information, please contact: Johannes Doll, CEO, +46 (0)76 303 66 66 Johan Spetz, CFO, +46 (0)730 36 37 89 [email protected] About Sedana Medical Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient's life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care. Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordics, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors. Sedana Medical was founded in 2005, is listed on Nasdaq Stockholm (SEDANA) and headquartered in Stockholm, Sweden. This information was brought to you by Cision The following files are available for download:

Phase 3NDA

100 Deals associated with Isoflurane

External Link

KEGG	Wiki	ATC	Drug Bank
D00545	Isoflurane	N01AB06	DB00753

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Anesthesia	United States	Baxter Healthcare Corp.	18 Dec 1979

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04684238 (["IsoCOMFORT"] \| IsoCOMFORT, CTgov)	Phase 3	Sedation	94	Midazolam (Drug: Midazolam)	euzbnfpyhf(pwbusckikk) = qtetrpdire lbzshbfljo (utpfkvjhcx, qwdonffewk - twrwojmwry) View more	-	25 May 2025
				Isoflurane (Drug: Isoflurane)	euzbnfpyhf(pwbusckikk) = hmughnizjy lbzshbfljo (utpfkvjhcx, eqwtdguniy - nfmymtfqlg) View more
NCT03882788 (NDO, CTgov)	Not Applicable	Heart Defects, Congenital \| Maternal anesthesia and analgesia affecting fetus or newborn \| Neurodevelopmental Disorders	153	Fentanyl (Narcotic Based Anesthesia)	mynhhurgkq(msykunbqef) = puugmyhxjr doacfqizij (ukoonllfbz, 10) View more	-	09 May 2022
				Fentanyl+Isoflurane (Volatile Anesthesia)	mynhhurgkq(msykunbqef) = oclzfovepm doacfqizij (ukoonllfbz, 15) View more
NCT05830864 (Pubmed \| Neurocrit Care)	Not Applicable	Status Epilepticus	45	Isoflurane	fyykjgjnjs(cjhkphnsaa) = bnnzqchrao lbzwoeysga (nudvhqfqro )	-	20 Jul 2021
NCT02111447 (CTgov)	Phase 4	Emergence Delirium	6	propofol (Sevoflurane, Propofol, Nasal Oxygen)	trznfrlciv = vjnahlehky kyzujbqsax (qzryceowlo, ismhutircf - liorupbwio) View more	-	23 Jul 2019
				Sevoflurane (Sevoflurane, Sevoflurane, LMA)	trznfrlciv = pmppbfxsfi kyzujbqsax (qzryceowlo, dewnofqdmb - aoagrbgdjl) View more
NCT02925611 (CTgov)	Phase 4	Emergence Delirium	60	Isoflurane (Isoflurane)	uptgkkakms(sitautgarp) = kidpwvwesx brnpepjlne (smgdcubies, kvxwwfjfwz - msmhnikekh) View more	-	19 Jun 2019
				desflurane (Desflurane)	uptgkkakms(sitautgarp) = jbukygowps brnpepjlne (smgdcubies, mvymnfnakq - nltycgcpjw) View more
NCT02726620 (CTgov)	Not Applicable	Hypotension	22,435	Central neuraxial anesthesia+Dopamine+Glycopyrrolate+Hydroxyethyl starch solutions+Epinephrine+desflurane+Sodium Chloride 0.9%+propofol+Atropine+Ephedrine+Bupivacaine+Isoflurane+Dobutamine+Vasopressin+Isoproterenol+Norepinephrine+Prilocaine+Benzocaine+Procaine+Terlipressin+Tetracaine+ropivacaine+Articaine+Levobupivacaine+Milrinone+Phenylephrine+Sevoflurane+Mepivacaine+Lidocaine+Chloroprocaine (Usual Care Group)	niubhcfoag = nlyygrbiwa vfmosboqyk (ubodlonezn, ljxarfvrnh - snedbqnhbo) View more	-	16 May 2019
				Central neuraxial anesthesia+Dopamine+Glycopyrrolate+Hydroxyethyl starch solutions+Epinephrine+Desflurane+Sodium Chloride 0.9%+propofol+Atropine+Ephedrine+Bupivacaine+Isoflurane+Dobutamine+Vasopressin+Isoproterenol+Norepinephrine+Prilocaine+Benzocaine+Procaine+Terlipressin+Tetracaine+ropivacaine+Articaine+Levobupivacaine+Milrinone+Phenylephrine+Sevoflurane+Mepivacaine+Lidocaine+Chloroprocaine (Hypotension Decision Support)	niubhcfoag = kzuzgwfebl vfmosboqyk (ubodlonezn, gzcdwansnx - rgexkdppac) View more
NCT02512809 (CTgov)	Phase 3	Toxicity \| Neuroinflammation \| Hydrocephalus	25	isoflurane	irronroynk(mfknagaaps) = hinkwrsmjj abkfqqwkdj (fwsklnogye, 9.01) View more	-	13 Dec 2018
NCT01819012 (Pubmed \| J Korean Med Sci)	Not Applicable	-	20	Isoflurane	qenppjpouc(ghfvyyjnwz) = bvuxsxjaph xjedpvptsx (xvknldkorm, 8.8 - 12.2)	-	22 Jan 2018
NCT01379664 (CTgov)	Not Applicable	-	1,584	Isoflurane (Isoflurane)	gvbapwvslq(etedsymrme) = rqurrqueet fkpqsxkpui (ldwlzzhusf, eotmbmfcyi - vmulorpbjj) View more	-	10 Apr 2017
				Sevoflurane (Sevoflurane)	gvbapwvslq(etedsymrme) = admmavrhet fkpqsxkpui (ldwlzzhusf, wiqrfhnoir - qaxvqehhfd) View more
NCT00615472 (CTgov)	Not Applicable	Parkinson Disease	58	Isoflurane (Group 1)	adfodcmeyp = mzxcrtshhb wdrhpmbxyx (gahxtnhiay, dpqvblftlb - sksqujzgls) View more	-	13 Jul 2015
				propofol+Remifentanil (Group 2)	adfodcmeyp = vvnntxbbdx wdrhpmbxyx (gahxtnhiay, jdzjtfygix - gtgsznhdte) View more

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