Drugs / Isoflurane
Isoflurane
also known as
Aerrane · COMPOUND 469 · Forane · Isoflurane Volatile Liquid · Isoflurane, (2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane), Forane · Isoflurano
Other / unclassified targets KCNK10, KCNK18, KCNK2, KCNK3, KCNK9 via activation
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | UK (MHRA) | Sedaconda | inhaled sedation in intensive care | 2021-02-19 | “applications for market approval for the drug candidate Sedaconda (isoflurane) for inhaled sedation in intensive care were submitted in Switzerland and the United Kingdom.” sedanamedical.com ↗ “submitted an application for market approval for the drug candidate Sedaconda (isoflurane) for inhaled sedation in intensive care in the UK.” sedanamedical.com ↗ |
| Filed | Other | Sedaconda | inhaled sedation in intensive care | 2021-01-20 | “submitted an application for marketing approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care in Switzerland.” sedanamedical.com ↗ “applications for market approval for the drug candidate Sedaconda (isoflurane) for inhaled sedation in intensive care were submitted in Switzerland and the United Kingdom.” sedanamedical.com ↗ |
| Label expansion | US (FDA) | FORANE | — | 1982-02-22 | fda.gov ↗ |
| Approved | US (FDA) | FORANE | — | 1979-12-18 | fda.gov ↗ |
Trials 49
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 missed | ||||||
| Phase 1 | NCT05742789 | Nov 2021 → Jan 2023 | aortic valve insufficiency, mitral valve insufficiency | Astana Medical University | Completed | No outcome recorded |
| Phase 1 | NCT05695287 | Jan 2021 → Nov 2022 | aortic valve insufficiency, coronary artery disorder, mitral valve insufficiency | Astana Medical University | Completed | No outcome recorded |
| Phase 1 | NCT03569085 | Jun → Dec 2018 | heart disorder | Kathirvel Subramaniam | Completed | No outcome recorded |
| Phase 1 | NCT01640275 | Mar 2012 → Mar 2015 | — | Duke University | Completed | Missed primary |
| Phase 1 | NCT01302353 | May → Sep 2010 | — | Sichuan University | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05213832 | Jun 2020 → Dec 2022 | acquired aneurysmal subarachnoid hemorrhage | A.O.U. Città della Salute e della Scienza | Completed | No outcome recorded |
| Phase 2 | NCT04171193 | Dec 2019 → Sep 2020 | major depressive disorder | University of Sao Paulo | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01958138 | Apr → Dec 2012 | — | Aga Khan University | Completed | No outcome recorded |
| Phase 311 trials · 2 met primary | ||||||
| Phase 3 | NCT07099014 | Sep 2025 → Oct 2028 expected | cardiogenic shock | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05867472 | Oct 2023 → May 2026 overdue | — | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 3 | NCT05327296 | Jun 2022 → May 2024 | — | Sedana Medical | Completed | Met primary |
| Phase 3 | NCT05312385 | Apr 2022 → Apr 2024 | — | Sedana Medical | Completed | Met primary |
| Phase 3 | NCT06809218 | Apr 2022 → Nov 2024 overdue | — | Sedana Medical | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04684238 | Jan 2021 → Jan 2023 | — | Sedana Medical | Completed | Mixed |
| Phase 3 | NCT04341350 | Aug 2020 → Sep 2025 overdue | — | University Hospital, Brest | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04415060 | Jun 2020 → Mar 2026 overdue | COVID-19, respiratory failure | Sunnybrook Health Sciences Centre | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05696509 | Jan 2020 → Oct 2022 | aortic valve insufficiency, mitral valve insufficiency | Astana Medical University | Completed | No outcome recorded |
| Phase 3 | NCT03588429 | Jan → Aug 2020 | — | Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine | Completed | No outcome recorded |
| Phase 3 | NCT02512809 | Jul 2015 → Oct 2017 | hydrocephalus, poisoning | Nationwide Children's Hospital | Terminated | No outcome recorded |
| Phase 411 trials · 1 met primary · 2 missed | ||||||
| Phase 4 | NCT07000526 | Dec 2025 → Mar 2027 expected | — | Instituto de Investigación Hospital Universitario La Paz | Recruiting | No outcome recorded |
| Phase 4 | NCT04710914 | Dec 2020 | infectious disease with sepsis | University Hospital, Rouen | Terminated | No outcome recorded |
| Phase 4 | NCT03034096 | Jan 2017 → Sep 2024 | — | Stony Brook University | Completed | Missed primary |
| Phase 4 | NCT02678650 | Jan 2016 → Jan 2017 | coronary artery disorder | Liang Zhang | Unknown | No outcome recorded |
| Phase 4 | NCT02105610 | Apr 2014 → Oct 2017 | — | Vita-Salute San Raffaele University | Completed | Missed primary |
| Phase 4 | NCT01477151 | Nov 2011 → Mar 2015 | coronary artery disorder, heart valve disorder | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | Met primary |
| Phase 4 | NCT01212523 | Nov 2009 → Dec 2011 | pulmonary hypertension | University Hospitals Bristol and Weston NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT00830843 | Jan 2009 → Jul 2011 | subarachnoid hemorrhage | Azienda Ospedaliera San Gerardo di Monza | Completed | No outcome recorded |
| Phase 4 | NCT01111227 | Mar 2008 → Dec 2009 | — | UPECLIN HC FM Botucatu Unesp | Completed | No outcome recorded |
| Phase 4 | NCT00854178 | Mar 2008 → Dec 2009 | DNA repair disease | UPECLIN HC FM Botucatu Unesp | Completed | No outcome recorded |
| Phase 4 | NCT00144118 | Jan 2002 → Aug 2005 | kidney failure | Austin Health | Terminated | No outcome recorded |
| Phase not applicable18 trials · 1 met primary · 1 missed | ||||||
| — | NCT07435402 | May 2026 → Dec 2029 expected | critical illness polyneuropathy, myopathy | Charles University, Czech Republic | Not yet recruiting | No outcome recorded |
| — | NCT07152912 | Sep 2025 → Mar 2026 overdue | Halothane hepatitis, disorder of defective peroxisome oxidative status, gallbladder disorder | Ain Shams University | Recruiting | No outcome recorded |
| — | NCT07543523 | Apr 2025 → Jun 2026 overdue | — | Superior University | Active not recruiting | No outcome recorded |
| — | NCT06311604 | Jun 2024 → Jun 2026 overdue | traumatic brain injury | University Hospital, Grenoble | Recruiting | No outcome recorded |
| — | NCT06252207 | Dec 2023 → Mar 2026 | — | The Cleveland Clinic | Withdrawn | No outcome recorded Stop: Business |
| — | NCT05639686 | Jan 2023 → Dec 2024 | cephalocele, chronic rhinosinusitis, paranasal sinus carcinoma, polyp | Our Lady of the Lake Hospital | Unknown | No outcome recorded |
| — | NCT05559970 | Nov 2022 → Sep 2023 | lung disorder | Mahidol University | Completed | No outcome recorded |
| — | NCT05693428 | Jan → Nov 2022 | coronary artery disorder | Astana Medical University | Completed | No outcome recorded |
| — | NCT03860129 | Dec 2014 → May 2017 | — | Ruhr University of Bochum | Completed | Met primary |
| — | NCT02185118 | Jun 2014 → Jun 2018 | infectious disease with sepsis | Air Force Military Medical University, China | Unknown | No outcome recorded |
| — | NCT01911195 | Jul 2013 → Feb 2015 | — | University of Michigan | Completed | No outcome recorded |
| — | NCT01819012 | Mar → Nov 2013 | heart valve disorder, ischemic disease | Konkuk University Medical Center | Completed | No outcome recorded |
| — | NCT01379664 | Jul 2011 → Apr 2013 | — | The Cleveland Clinic | Completed | Missed primary |
| — | NCT01171833 | Jun → Oct 2010 | — | DongGuk University | Completed | No outcome recorded |
| — | NCT01031550 | Jan 2010 → Jan 2012 | liver disorder | Rutgers, The State University of New Jersey | Terminated | No outcome recorded |
| — | NCT00815269 | Dec 2008 → Dec 2009 | — | Nanjing Medical University | Completed | No outcome recorded |
| — | NCT00615472 | Oct 2003 → Apr 2010 | Parkinson disease | Columbia University | Terminated | No outcome recorded Stop: Business |
| — | NCT00434382 | Oct 2002 → Dec 2003 | — | Ludwig-Maximilians - University of Munich | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT07457593 | — | — | Sedana Medical | Available | No outcome recorded |
| Comparator or background therapy57 trials | ||||||
| Phase 0 | NCT05993039 Comparator | Sep 2023 → Dec 2024 | auditory system disorder | Our Lady of the Lake Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05314569 Comparator | Apr → Sep 2022 | — | Cairo University | Completed | No outcome recorded |
| Phase 2 | NCT00000254 Comparator | Jan → Sep 1995 | substance-related disorder | University of Chicago | Completed | No outcome recorded |
| Phase 2 | NCT00000251 Comparator | Apr 1994 → Jan 1996 | substance-related disorder | University of Chicago | Completed | No outcome recorded |
| Phase 2/3 | NCT06014138 Comparator | Nov 2023 → Jul 2027 expected | acute respiratory distress syndrome | Guy's and St Thomas' NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06418893 Comparator | Aug 2023 → Oct 2024 | — | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| Phase 2/3 | NCT01406678 Comparator | Jul 2008 → Mar 2018 | myocardial infarction | University Hospital, Essen | Completed | No outcome recorded |
| Phase 3 | NCT06873906 Comparator | Mar 2025 → Mar 2026 overdue | heart septal defect | Ain Shams University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06624592 Comparator | Dec 2024 → Nov 2026 expected | delirium | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 3 | NCT05444751 Comparator | Mar 2022 → Sep 2026 overdue | lumbar disk disease, radiculopathy | Hospital for Special Surgery, New York | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT04197570 Comparator | Feb → Mar 2020 | substance-related disorder | Benaroya Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT02521831 Comparator | Oct 2015 → Dec 2017 | — | Emmett Whitaker, M.D. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01839084 Comparator | Jul 2013 → Feb 2016 | — | RWTH Aachen University | Completed | Missed primary |
| Phase 4 | NCT07496593 Comparator | Dec 2025 → Dec 2026 expected | diabetes mellitus | Ain Shams University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06330038 Comparator | Aug 2024 → Dec 2028 expected | non-small cell lung carcinoma | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT04039854 Comparator | Nov 2019 → Nov 2021 | coronary artery disorder | King's College Hospital NHS Trust | Unknown | No outcome recorded |
| Phase 4 | NCT04365686 Background | Apr 2019 → Apr 2020 | — | Fayoum University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03729011 Comparator | Jan 2019 → Jan 2024 | delirium | Meshalkin Research Institute of Pathology of Circulation | Completed | No outcome recorded |
| Phase 4 | NCT04074460 Comparator | Aug 2017 → Oct 2019 | breast cancer, colorectal cancer, cutaneous melanoma, lung cancer +1 | Peter MacCallum Cancer Centre, Australia | Completed | No outcome recorded |
| Phase 4 | NCT03146104 Comparator | Aug 2017 → Nov 2018 | — | Jawaharlal Institute of Postgraduate Medical Education & Research | Completed | No outcome recorded |
| Phase 4 | NCT02953210 Background | Nov 2016 | neuropathy, painful, paralytic ileus | Federal University of São Paulo | Unknown | No outcome recorded |
| Phase 4 | NCT03013075 Background | Nov 2016 → Dec 2017 | — | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 4 | NCT02925611 Comparator | Jan 2016 → Mar 2017 | delirium | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 4 | NCT02154074 Background | May → Oct 2014 | post-surgical hypoinsulinemia | Second Affiliated Hospital of Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 4 | NCT02111447 Comparator | Jan → Dec 2014 | delirium | State University of New York at Buffalo | Terminated | No outcome recorded |
| Phase 4 | NCT01993836 Comparator | Nov 2013 → Jan 2019 | Alzheimer disease, delirium, subjective cognitive decline | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT01601795 Comparator | Jul 2012 → Jan 2014 | myocardial disorder | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 4 | NCT01397331 Comparator | Jul 2010 → Jun 2012 | postoperative ventricular dysfunction | Sheba Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00922844 Comparator | May → Nov 2009 | hypotensive disorder | UMC Utrecht | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00575354 Comparator | Mar → Dec 2007 | breast benign neoplasm | Nanjing Medical University | Completed | No outcome recorded |
| Phase 4 | NCT00333632 Background | Jun 2006 → Jun 2011 | — | Duke University | Withdrawn | No outcome recorded |
| Phase 4 | NCT00244517 Comparator | Jun 2004 → Apr 2010 | cardiac ventricle disorder | University Hospital, Basel, Switzerland | Terminated | No outcome recorded |
| — | NCT07460050 Comparator | Mar → Aug 2026 overdue | — | Hayatabad Medical Complex | Not yet recruiting | No outcome recorded |
| — | NCT06625606 Comparator | Sep → Nov 2024 | — | Benha University | Completed | No outcome recorded |
| — | NCT06387836 Comparator | Apr 2024 → May 2025 | subjective cognitive decline | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| — | NCT06613893 Comparator | Jan → Dec 2024 overdue | type 2 diabetes mellitus | Ain Shams University | Active not recruiting | No outcome recorded |
| — | NCT05825430 Background | Apr → Jun 2023 | — | Al-Azhar University | Completed | No outcome recorded |
| — | NCT04727515 Background | Jan → Apr 2021 | — | Ain Shams University | Unknown | No outcome recorded |
| — | NCT04614259 Background | Nov → Dec 2020 | — | Cairo University | Unknown | No outcome recorded |
| — | NCT04095754 Background | Apr → Oct 2020 | — | Ain Shams University | Completed | No outcome recorded |
| — | NCT04188314 Comparator | Feb 2020 → Feb 2022 | — | Sefako Makgatho Health Sciences University | Completed | Missed primary |
| — | NCT03803267 Comparator | May 2019 → Jan 2020 | colorectal cancer | Mansoura University | Completed | No outcome recorded |
| — | NCT03569046 Comparator | Jul → Dec 2018 | — | Abd-Elazeem Abd-Elhameed Elbakry | Completed | No outcome recorded |
| — | NCT02726620 Background | Jan → Dec 2017 | hypotensive disorder | Vanderbilt University Medical Center | Completed | No outcome recorded |
| — | NCT02625181 Background | Jul 2016 → Nov 2017 | — | Vanderbilt University | Completed | No outcome recorded |
| — | NCT02739958 Comparator | Mar → Aug 2016 | larynx cancer | Mansoura University | Completed | No outcome recorded |
| — | NCT02326727 Comparator | Apr 2015 → Apr 2017 | colonic neoplasm | Hillel Yaffe Medical Center | Unknown | No outcome recorded |
| — | NCT02342509 Comparator | Sep → Dec 2014 | — | Ruhr University of Bochum | Completed | No outcome recorded |
| — | NCT01903421 Comparator | Mar 2014 → Nov 2019 | Alzheimer disease | University Health Network, Toronto | Unknown | No outcome recorded |
| — | NCT01983800 Comparator | Jul 2013 → Feb 2018 | — | University Health Network, Toronto | Completed | No outcome recorded |
| — | NCT03882788 Comparator | Apr 2013 → Nov 2020 | congenital heart disease, neurodevelopmental disorder | Stanford University | Completed | No outcome recorded |
| — | NCT01772537 Comparator | May 2012 → Feb 2014 | abdominal aortic aneurysm, thoracic aortic aneurysm | Johns Hopkins University | Terminated | No outcome recorded |
| — | NCT02794584 Comparator | Jan 2011 → Dec 2016 | ventricular septal defect | Nanjing Medical University | Completed | No outcome recorded |
| — | NCT01151254 Comparator | Sep 2009 → Jan 2012 | cardiac valvular defect | University Health Network, Toronto | Completed | No outcome recorded |
| — | NCT00983918 Comparator | Sep 2009 → Jun 2010 | — | Baylor College of Medicine | Completed | No outcome recorded |
| — | NCT00788008 Comparator | Nov 2008 → Dec 2013 | osteoarthritis, hip, osteoarthritis, knee, spondylosis, spondylosis, cervical | Duke University | Completed | No outcome recorded |
| — | NCT00521612 Comparator | Sep → Nov 2007 | — | General Hospital Dubrovnik | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 41
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | Sedana Medical | Regulatory Sedana Medical announces PDUFA target action date for its New Drug Application in the U.S. sedanamedical.com ↗
Sedana Medical AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has set April 16, 2027 as the target action date under the Prescription Drug User Fee Act (PDUFA) for its review of the company’s New Drug Application (NDA) for isoflurane delivered via the Sedana Medical ACD Delivery System, for sedation of mechanically ventilated adult patients in intensive care units (ICUs). |
| 2026-08-19 | Sedana Medical | Regulatory Sedana Medical announces FDA acceptance for review of its New Drug Application in the U.S. sedanamedical.com ↗
The NDA acceptance confirms that the FDA has determined the application is sufficiently complete to permit a substantive review. |
| 2026-06-17 | Sedana Medical | Regulatory Sedana Medical submits New Drug Application to the U.S. FDA for inhaled sedation in the ICU sedanamedical.com ↗
Sedana Medical AB (publ) today announces that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the drug-device combination product isoflurane delivered via the Sedana Medical ACD Delivery System for the sedation of mechanically ventilated adult patients in intensive care units (ICUs). |
| 2025-07-16 | Sedana Medical | Results Sedana Medical’s paediatric study published in The Lancet sedanamedical.com ↗
Besides non-inferior sedation efficacy versus midazolam, the study demonstrated lower opioid requirements and shorter and more predictable wake-up time compared with the control group – key features of inhaled isoflurane sedation |
| 2025-06-10 | Sedana Medical | Results Both of Sedana Medical´s pivotal US studies meet first key secondary endpoint sedanamedical.com ↗
For the most important key secondary endpoint – opioid dosing – a significant and clinically relevant opioid dose reduction compared to baseline opioid dose was found in the isoflurane group. |
| 2025-04-23 | Sedana Medical | Regulatory Sedana Medical Receives FDA Approval for Early Access Program in the U.S. sedanamedical.com ↗
the U.S. Food and Drug Administration (FDA) has approved the company’s application to initiate an Early Access Program for its investigational inhaled sedation therapy, providing eligible patients access to the treatment prior to market authorization. |
| 2025-02-12 | Sedana Medical | Results Sedana Medical announces positive high-level results also for its second pivotal trial in the United States sedanamedical.com ↗
Sedana Medical AB (publ) announces that its second pivotal US trial INSPiRE-ICU 2 has met its primary endpoint, and hence established non-inferiority of inhaled sedation with isoflurane compared with intravenous sedation using propofol. |
| 2025-02-03 | Sedana Medical | Regulatory Sedana Medical receives an additional year of market protection for Sedaconda® (isoflurane) sedanamedical.com ↗
The CMDh (Co-ordination Group for Mutual Recognition and Decentralized Procedures – Human) have now agreed by consensus to an additional year of market protection (to 2032). |
| 2024-12-19 | Sedana Medical | Results Sedana Medical announces positive high-level results of its first pivotal trial in the United States (INSPiRE-ICU 1) sedanamedical.com ↗
Sedana Medical AB (publ) announces that its first pivotal US trial INSPiRE-ICU 1 has met its primary endpoint: to prove that inhaled sedation with isoflurane is an effective sedation method by establishing non-inferiority compared with intravenous sedation using propofol. |
| 2024-12-13 | Sedana Medical | Regulatory Sedana Medical receives a positive decision to include children (3-17 years) into the Sedaconda® (isoflurane) indication sedanamedical.com ↗
Sedana Medical AB (publ) announces that the company has received a positive decision from the authorities in all involved countries that the pediatric indication of Sedaconda (isoflurane) is approvable in Europe. |
| 2023-12-20 | Sedana Medical | Regulatory Sedana Medical files submission for paediatric indication sedanamedical.com ↗
Now, the Type II variation to extend the indication to include paediatric patients of 3-17 years has been submitted to the Reference Member State (RMS) Germany and 15 Concerned Member States (CMS) in Europe. |
| 2023-11-22 | Sedana Medical | Regulatory Sedana Medical secures data exclusivity and market protection for Sedaconda[®] (isoflurane) until 2031 sedanamedical.com ↗
Sedana Medical AB (publ) announces that the European Medicines Agency’s Paediatric Committee has issued a positive opinion regarding the compliance with the company’s Paediatric Investigation Plan. |
| 2023-11-16 | Sedana Medical | Results Key results of Sedana Medical’s paediatric study IsoCOMFORT published sedanamedical.com ↗
Opioid requirements were significantly lower during sedation with isoflurane than with midazolam, with LSM [95% CI] of 2.1 [1.3 to 2.9] fentanyl equivalents/hour for isoflurane vs. 4.6 [3.5 to 5.6] for midazolam. |
| 2023-10-10 | Sedana Medical | Regulatory Sedana Medical receives market approval in the UK sedanamedical.com ↗
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Sedana Medical AB (publ) marketing authorization for the company’s pharmaceutical product Sedaconda[®] (isoflurane) in the United Kingdom. |
| 2023-07-12 | Sedana Medical | Regulatory Sedana Medical informs about adjusted US submission plan following FDA interaction sedanamedical.com ↗
Sedana Medical AB (publ) today informs that the US Food and Drug Administration (FDA) has requested the company to include long-term outcomes data in the Clinical Study Report (CSR) of the INSPIRE-ICU trials before the New Drug Application (NDA) can be submitted. |
| 2023-06-20 | Sedana Medical | Results Sedana Medical’s Sedaconda study post-hoc analysis published in the Journal of Critical Care sedanamedical.com ↗
Isoflurane-treated patients had less need for additional sedatives in comparison to those receiving propofol. |
| 2023-05-17 | Sedana Medical | Results Sedana Medical reports topline results from phase 3 paediatric IsoCOMFORT study sedanamedical.com ↗
Sedana Medical AB (publ) today announces that the primary endpoint of its Phase 3 IsoCOMFORT study was met in the full analysis set, but was not met in the per-protocol analysis. |
| 2023-02-07 | Sedana Medical | Regulatory Sedana Medical receives market approval in Italy sedanamedical.com ↗
Sedana Medical AB (publ) has received market approval for Sedaconda[®] (isoflurane) for inhaled sedation in intensive care in Italy, bringing the number of European countries where the company’s therapy is approved to 17. |
| 2023-01-04 | Sedana Medical | Regulatory Sedana Medical receives FDA Fast Track Designation in the United States sedanamedical.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the evaluation of isoflurane via the Sedaconda ACD-S device for sedation of mechanically ventilated patients in the intensive care (ICU) setting. |
| 2022-12-23 | Sedana Medical | Regulatory Correction: Sedana Medical receives positive opinion from EMA’s Pediatric Committee on reduced pediatric study design sedanamedical.com ↗
We are glad that the PDCO has viewed our proposal favorably. |
| 2022-12-08 | Sedana Medical | Regulatory Sedana Medical’s Sedaconda (isoflurane) now approved in all 15 European countries included in the first submission sedanamedical.com ↗
The applications have been approved by the national competent authorities in Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Ireland, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and Sweden. |
| 2022-10-20 | Sedana Medical | Results Sedana Medical presents at ESICM sedanamedical.com ↗
The results show that the smaller Sedaconda ACD-S enabled isoflurane administration with lower minute ventilation without affecting ventilatory measures, compared to intravenous propofol sedation. |
| 2022-03-22 | Sedana Medical | Results Sedana Medical presents post hoc analysis at ISICEM sedanamedical.com ↗
The poster “ICU-free and ventilator-free days with Isoflurane or Propofol as a primary sedative – a post hoc analysis of the Sedaconda study” concludes that isoflurane sedation as the primary sedative during mechanical ventilation in the first 30 days after randomisation, was associated with significantly more ICU-free days than propofol sedation, with a difference of four days. |
| 2022-01-27 | Sedana Medical | Regulatory Sedana Medical’s Sedaconda ACD recommended by NICE sedanamedical.com ↗
Sedaconda ACD is recommended as an option for delivering inhaled sedation in intensive care in England and Wales when volatile anaesthetics are being considered. |
| 2021-12-23 | Sedana Medical | Regulatory Sedana Medical receives IND approval for US trials sedanamedical.com ↗
With the IND approval, we can keep our ambitious timelines for initiating our pivotal clinical trials. |
| 2021-12-22 | Sedana Medical | Regulatory Sedana Medical applies for market approval in Italy sedanamedical.com ↗
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has submitted an application for market approval for Sedaconda (isoflurane) for inhaled sedation in intensive care in Italy. |
| 2021-11-24 | Sedana Medical | Regulatory Sedana Medical submits IND for US clinical trials sedanamedical.com ↗
We are happy to announce that we have now submitted the IND to the FDA and the preparations for our clinical program in the United States are progressing according to plan. |
| 2021-09-30 | Sedana Medical | Results Sedana Medical presents at ESICM sedanamedical.com ↗
Despite a limited patient population, the results indicate that the use of inhaled sedation is a safe method, comparable to intravenous sedation, with the potential to be cost saving. |
| 2021-09-28 | Sedana Medical | Regulatory Sedana Medical receives approval in Germany sedanamedical.com ↗
The application has been approved by the German pharmaceutical authority BfArM and is based on the DCP approval Sedana Medical received in July. |
| 2021-08-30 | Sedana Medical | Results Sedana Medical presenting at ISICEM sedanamedical.com ↗
The investigators conclude that inhaled sedation provided adequate depth of sedation in all the study’s 30 COVID-19 patients. |
| 2021-08-27 | Sedana Medical | Results Sedana Medical’s Sedaconda study published in the Lancet sedanamedical.com ↗
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the results of the company’s pivotal study Sedaconda (SED001) have been published in the highly ranked scientific journal, the Lancet Respiratory Medicine. |
| 2021-08-13 | Sedana Medical | Regulatory Sedana Medical receives approval in France sedanamedical.com ↗
The application has been approved by the French Medicines Agency, L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) and is based on the DCP approval Sedana Medical received in July. |
| 2021-05-06 | Sedana Medical | Regulatory Sedana Medical AB (publ), First Quarter Report 2021 sedanamedical.com ↗
An application for market approval for the drug candidate Sedaconda (isoflurane), previously known as IsoConDa, for inhaled sedation in intensive care was submitted in Switzerland and the United Kingdom. |
| 2021-02-19 | Sedana Medical | Regulatory Sedana Medical submits application for market approval in UK sedanamedical.com ↗
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane) for inhaled sedation in intensive care in the UK. |
| 2021-01-20 | Sedana Medical | Regulatory Sedana Medical submits application for marketing approval in Switzerland sedanamedical.com ↗
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for marketing approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care in Switzerland. |
| 2020-12-08 | Sedana Medical | Results Sedana Medical’s Sedaconda study presented at ESICM sedanamedical.com ↗
Secondary endpoints of the study demonstrate that Sedaconda (isoflurane), delivered via AnaConDa, compared to propofol , enables Shorter and predictable wake-up Reduced need of opiates Higher proportion of spontaneous breathing |
| 2020-11-27 | Sedana Medical | Regulatory Sedana Medical submits market approval application for the drug Sedaconda sedanamedical.com ↗
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care. |
| 2020-07-10 | Sedana Medical | Results Sedana Medical announces positive top line result in pivotal IsoConDa study sedanamedical.com ↗
The study reached its primary endpoint; to show that IsoConDa (isoflurane), administered with AnaConDa, is an effective sedation method, for ventilator-intensive care patients, which is non-inferior to propofol. |
| 2019-03-08 | Sedana Medical | Results Positive interim analysis in pivotal IsoConDa phase III study sedanamedical.com ↗
The interim analysis shows smaller variations in efficacy than anticipated and the study will therefore only need to cover a total of 300 patients instead of initially estimated 550 patients. |
| 2019-02-12 | Sedana Medical | Regulatory Sedana Medical receives go-ahead for pediatric study – Milestone on the road to market exclusivity sedanamedical.com ↗
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces the company has been approved for its planned pediatric study from the Pediatric Committee of EMA, European Medicines Agency, (PDCO). |
| 2018-11-14 | Sedana Medical | Results Sedana Medical shows significant health-economic benefits with AnaConDa sedanamedical.com ↗
Sedation with isoflurane via AnaConDa significantly reduces mortality compared to propofol / midazolam. |
All press releases naming this drug 43 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 107 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Isoflurane | “Maintenance of anesthesia will be achieved by isoflurane at an end tidal concentration of 1-1.5% in FiO2 of 0.5, intravenous fentanyl at a dose of 1 µg/kg in incremental...” NCT06873906 ↗105“Maintenance of general anesthesia: propofol infusion (50-150 μg.kg.min-1); ketamine infusion (up to 50 mg total); and inhaled anesthetic agent (isoflurane or sevoflurane) up to 0.5 MAC.” NCT05444751 ↗ “general anesthetic by midazolam 0.02 mg kg-1 , propofol 2-3 mg kg-1 and lidocaine 0.5 mg kg-1 , fentanyl 2 μg kg-1 , atracurium 0.5 mg kg-1 , isoflurane in 50% oxygen/air.” NCT03569046 ↗ “The intervention was maintenance of anesthesia with sevoflurane (n = 231) or isoflurane (n = 233) administered at a dose of 0.5-2.0 MAC throughout the entire operation.” PMID 27465213 ↗ Jul 2016 “The GAS group will receive one or more volatile anesthetics (sevoflurane, desflurane, or isoflurane) for induction and maintenance of anesthesia during the surgery.” NCT06330038 ↗ “general anesthesia maintained by isoflurane 1.5 volume % in 2 L\\min oxygen-air mixture 50:50 and atracurium 0.1 mg\\kg every 30 minutes, if needed.” NCT04365686 ↗ “Subsequently anesthesia will be maintained in both the groups, with isoflurane inhalation to maintain BIS values between 40 to 60.” NCT03013075 ↗ “Anaesthesia will be maintained using isoflurane 1 % in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 20 mim.” NCT04095754 ↗ “Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)” NCT03034096 ↗ “Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal” NCT02794584 ↗ “Anesthesia will be maintained with inhaled isoflurane, Iso-MAC from (0.7 to 1.4%)” NCT06613893 ↗ |
| Known as | Aerrane | ChEMBL registry synonym — accepted as the source's own label CHEMBL1256 ↗ |
| Known as | COMPOUND 469 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1256 ↗ |
| Known as | Forane | ChEMBL registry synonym — accepted as the source's own label CHEMBL1256 ↗ |
| Known as | Isoflurane Volatile Liquid | “Drug: Isoflurane Volatile Liquid” NCT02953210 ↗ |
| Known as | Isoflurane, (2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane), Forane | “Isoflurane, (2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane), Forane” NCT01406678 ↗ |
| Known as | Isoflurano | ChEMBL registry synonym — accepted as the source's own label CHEMBL1256 ↗ |
| Action | Activate | “Potassium channel subfamily K member 18 opener” CHEMBL1256 ↗4“Potassium channel subfamily K member 10 opener” CHEMBL1256 ↗ “Potassium channel subfamily K member 9 opener” CHEMBL1256 ↗ “Potassium channel subfamily K member 2 opener” CHEMBL1256 ↗ “Potassium channel subfamily K member 3 opener” CHEMBL1256 ↗ |
| Action | Inhibit | “100% oxygen or 0.5 MAC isoflurane/sevoflurane in 60% oxygen would inhibit increases of tumor necrosis factor (TNF)-alpha, interleukin-1beta, interleukin-6 in the cell culture...” NCT02185118 ↗ |
| Modality | Other / unclassified | “Volatile anaesthetic isoflurane” NCT00521612 ↗ |
| Route | Other | “Subjects inhale 0.2% isoflurane” NCT00000251 ↗ |
| Target | KCNK10 | “Potassium channel subfamily K member 10 opener” CHEMBL1256 ↗ |
| Target | KCNK18 | “Potassium channel subfamily K member 18 opener” CHEMBL1256 ↗ |
| Target | KCNK2 | “Potassium channel subfamily K member 2 opener” CHEMBL1256 ↗ |
| Target | KCNK3 | “Potassium channel subfamily K member 3 opener” CHEMBL1256 ↗ |
| Target | KCNK9 | “Potassium channel subfamily K member 9 opener” CHEMBL1256 ↗ |