Drugs / Cisatracurium
Cisatracurium
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | NIMBEX PRESERVATIVE FREE | — | 1998-10-15 – 2003-07-18 | fda.gov ↗ |
| Approved | US (FDA) | NIMBEX PRESERVATIVE FREE | — | 1995-12-15 | fda.gov ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01273831 | Jul → Dec 2009 | — | Isfahan University of Medical Sciences | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02502032 | Jul → Oct 2015 | — | Zhuan Zhang | Completed | No outcome recorded |
| Phase 3 | NCT02481193 | Mar 2013 → Jan 2014 | — | Yangzhou No.1 People's Hospital | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT07185074 | Jan 2025 → May 2026 | — | Jiangang Song | Completed | No outcome recorded |
| Phase 4 | NCT05153525 | Jan → Jul 2022 | pediatric acute respiratory distress syndrome | Tanta University | Unknown | No outcome recorded |
| Phase 4 | NCT03337373 | Dec 2017 → Aug 2018 | adult acute respiratory distress syndrome, palsy | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT02816567 | Jan 2016 → Jan 2018 | — | Reims University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02404779 | Mar 2015 → Mar 2022 | intracranial hypertension, traumatic brain injury | University Hospital, Clermont-Ferrand | Unknown | No outcome recorded |
| Phase 4 | NCT02194855 | Jan 2015 → Jan 2016 | — | Fudan University | Completed | No outcome recorded |
| Phase 4 | NCT01651572 | Jul 2012 → Jul 2013 | curariform drugs toxicity | Azienda Ospedaliera di Padova | Completed | No outcome recorded |
| Phase 4 | NCT01573715 | Apr 2012 → Sep 2014 | acute respiratory distress syndrome | Assistance Publique Hopitaux De Marseille | Unknown | No outcome recorded |
| Phase not applicable9 trials | ||||||
| — | NCT06212492 | Aug 2024 → Aug 2026 overdue | adult acute respiratory distress syndrome | Assistance Publique Hopitaux De Marseille | Recruiting | No outcome recorded |
| — | NCT06514209 | Jun 2024 → May 2025 overdue | acute respiratory distress syndrome | Southeast University, China | Recruiting | No outcome recorded |
| — | NCT06203405 | Dec 2023 → Mar 2026 overdue | acute lung injury, adult acute respiratory distress syndrome | Siriraj Hospital | Recruiting | No outcome recorded |
| — | NCT06214169 | Jun → Dec 2023 | — | Watim Medical & Dental College | Completed | No outcome recorded |
| — | NCT05760976 | Feb → Aug 2023 | — | Yangzhou University | Unknown | No outcome recorded |
| — | NCT05310110 | Apr 2022 → Aug 2023 | — | Chang Gung Memorial Hospital | Completed | No outcome recorded |
| — | NCT04922814 | Aug 2021 → Mar 2022 | acute respiratory distress syndrome | Assiut University | Completed | No outcome recorded |
| — | NCT04524585 | Oct 2020 → Dec 2026 expected | acute respiratory failure | University Health Network, Toronto | Recruiting | No outcome recorded |
| — | NCT02495038 | Mar 2014 → Feb 2015 | chronic otitis media | Yonsei University | Completed | No outcome recorded |
| Comparator or background therapy44 trials | ||||||
| Phase 0 | NCT06561672 Background | Sep 2024 → Mar 2025 overdue | — | Zagazig University | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07446309 Comparator | Apr → Jul 2026 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04545424 Background | Jun 2021 → Jun 2026 overdue | adult acute respiratory distress syndrome | University of Maryland, Baltimore | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03904550 Comparator | Dec 2019 → Aug 2022 | impaired renal function disease | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03376854 Background | May 2018 → Apr 2021 | COVID-19, adult acute respiratory distress syndrome | University of Maryland, Baltimore | Withdrawn | No outcome recorded |
| Phase 2 | NCT02884440 Background | Nov 2016 → May 2019 | spondylolisthesis | Rennes University Hospital | Completed | Missed primary |
| Phase 2 | NCT02030808 Comparator | Jan → Feb 2014 | — | Imam Abdulrahman Bin Faisal University | Completed | No outcome recorded |
| Phase 2/3 | NCT05736744 Comparator | Jun 2023 → Feb 2025 overdue | — | Assiut University | Recruiting | No outcome recorded |
| Phase 3 | NCT02509078 Comparator | Jan 2016 → Jul 2018 | acute respiratory distress syndrome | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT07203287 Comparator | Aug 2025 → Dec 2026 expected | — | The University of Texas Medical Branch, Galveston | Recruiting | No outcome recorded |
| Phase 4 | NCT05962671 Comparator | Aug 2023 → Mar 2024 | respiratory underresponsiveness to hypoxia and hypercapnia, substance-related disorder | Tanta University | Unknown | No outcome recorded |
| Phase 4 | NCT05624424 Background | Nov 2022 → Oct 2023 | — | Second Affiliated Hospital of Nanchang University | Unknown | No outcome recorded |
| Phase 4 | NCT05172739 Comparator | Oct 2021 → Nov 2025 overdue | chronic pain syndrome, non-small cell lung carcinoma, substance-related disorder | University of Crete | Recruiting | No outcome recorded |
| Phase 4 | NCT04894864 Comparator | Oct 2020 → Sep 2026 overdue | abdominal aortic aneurysm | University of Crete | Recruiting | No outcome recorded |
| Phase 4 | NCT02635542 Comparator | Mar 2016 → Sep 2017 | — | University of Chicago | Completed | Missed primary |
| Phase 4 | NCT02518789 Background | Sep 2015 → Aug 2016 | — | Tang-Du Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02410590 Comparator | Jul 2015 → Oct 2016 | — | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 4 | NCT02483611 Background | Jul → Aug 2015 | neuromuscular disease | University of Sao Paulo | Completed | Mixed |
| Phase 4 | NCT02503826 Background | Jan → Dec 2015 | — | Second Affiliated Hospital of Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 4 | NCT02289391 Background | Dec 2014 → Dec 2015 | asthma | Second Affiliated Hospital of Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 4 | NCT02147678 Background | Dec 2014 → Feb 2015 | — | Shaanxi Provincial People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02202239 Background | Sep 2014 → Aug 2015 | — | Zhujiang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02224443 Background | Sep 2014 → Aug 2015 | — | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 4 | NCT02143362 Background | Jun 2014 → Dec 2015 | — | Second Affiliated Hospital of Xi'an Jiaotong University | Unknown | 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 | NCT02111265 Background | Apr → Jul 2014 | adrenocortical insufficiency | Second Affiliated Hospital of Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 4 | NCT01690338 Comparator | Oct 2012 → Oct 2014 | curariform drugs toxicity | Peking University First Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00299650 Comparator | Mar 2006 → Oct 2008 | acute respiratory distress syndrome | Assistance Publique Hopitaux De Marseille | Completed | No outcome recorded |
| — | NCT07519694 Comparator | May → Jun 2026 overdue | — | Sohag University | Not yet recruiting | No outcome recorded |
| — | NCT07143799 Comparator | Aug 2025 → Mar 2026 overdue | — | Sohag University | Recruiting | No outcome recorded |
| — | NCT05550714 Background | Oct 2022 → Mar 2024 overdue | Parkinson disease | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT05527314 Background | Aug 2022 → Feb 2023 | — | Second Affiliated Hospital of Nanchang University | Completed | No outcome recorded |
| — | NCT04553536 Background | Nov 2020 → Jun 2023 | poisoning | Second Hospital of Shanxi Medical University | Unknown | No outcome recorded |
| — | NCT04507165 Comparator | Aug 2020 → Jul 2021 | — | Peking University People's Hospital | Unknown | Met primary |
| — | NCT03806374 Comparator | Jan → Dec 2018 | — | Ain Shams University | Completed | No outcome recorded |
| — | NCT02910206 Background | Aug 2017 → Nov 2019 | — | Zhihong LU | Completed | Met primary |
| — | NCT03129009 Comparator | Apr 2017 → Jun 2018 | intracerebral hemorrhage | Xuzhou Medical University | Unknown | No outcome recorded |
| — | NCT02534012 Background | May 2016 → Apr 2022 | — | Makassed General Hospital | Unknown | No outcome recorded |
| — | NCT02546843 Comparator | Dec 2015 → Sep 2018 | — | Brno University Hospital | Completed | No outcome recorded |
| — | NCT02601508 Comparator | Nov 2015 → Aug 2016 | — | Chonnam National University Hospital | Unknown | No outcome recorded |
| — | NCT02462915 Background | Jun 2015 → Dec 2016 | — | National Taiwan University Hospital | Unknown | No outcome recorded |
| — | NCT02840526 Background | May 2013 → Dec 2014 | — | Silesian University of Medicine | Completed | No outcome recorded |
| — | NCT01785446 Comparator | Nov 2012 → Feb 2013 | — | Tianjin Medical University General Hospital | Unknown | No outcome recorded |
| — | NCT00912990 Comparator | Jan 2007 → Feb 2008 | — | Rady Children's Hospital, San Diego | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-09-02 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives final approval from the USFDA for Cisatracurium Besylate Injection zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Cisatracurium Besylate Injection USP (US RLD: Nimbex ®) in the strength of 20 mg (base)/10 mL (2 mg/mL) Multiple-Dose Vial. |
| 2019-11-05 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Cisatracurium Besylate Injection USP zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Cisatracurium Besylate Injection USP 10 mg (base)/5 mL (2 mg/mL) and 200 mg (base)/20 mL (10 mg/mL) Single-Dose Vials (Preservative -free) (US RLD - Nimbex). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-09-02 | Zydus Lifesciences Limited | Zydus Cadila receives final approval from the USFDA for Cisatracurium Besylate Injection zyduslife.com ↗ |
| 2019-11-05 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Cisatracurium Besylate Injection USP zyduslife.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 66 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cisatracurium | “Rocuronium and cisatracurium are representative neuromuscular blocking agents used widely because the former have features of fast onset of peak effect and short duration of...” NCT02495038 ↗56“Subjects in the TH + NMB arm will be deeply sedated using agents at the discretion of the primary ICU team, then start continuous iv infusion of either cisatracurium,...” NCT04545424 ↗ “Subjects in the TH + NMB arm will be deeply sedated using agents at the discretion of the primary ICU team, then start continuous iv infusion of either cisatracurium,...” NCT03376854 ↗ “The objective of this study is therefore to evaluate, using a recent and reliable biomarker, the synergistic effect of a short-term NMBAs infusion using cisatracurium and PP on...” NCT06212492 ↗ “Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion” NCT03129009 ↗ “patients received 0.2 mL/kg cisatracurium® (Nimbex) 0.2%, and a left-sided endobronchial double-lumen tube was placed when the TOF revealed one or two twitches” NCT02030808 ↗ “general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg” NCT02154074 ↗ “were given sufentanil citrate 0.1-0.2 µg/kg, cisatracurium 0.2 mg/kg and propofol 1.5-2.0 mg/kg during anesthesia induction.” NCT05550714 ↗ “Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.” NCT02289391 ↗ “For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.” NCT02147678 ↗ “Fentanyl 1-2mcg/kg and Cisatracurium 0.2mg/kg or alternatively Rocuronium 0.6-1.2mg/kg” NCT04894864 ↗ |
| Known as | 51 W89 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201248 ↗ |
| Known as | Besilate de cisatracurium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201248 ↗ |
| Known as | Besilato de cisatracurio | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201248 ↗ |
| Known as | Cisatracurium (as besilate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201248 ↗ |
| Known as | Cisatracurium Besilate | “Anesthesia was induced with cisatracurium besilate 0.1 mg/kg by intravenous injection after the LoC. And the cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate...” NCT05527314 ↗2“Cisatracurium Besilate 0.14 mg/kg will be used after fentanyl is injected for induction.” NCT02202239 ↗ “Cisatracurium besilate infusion (900mg/day)” NCT00299650 ↗ |
| Known as | cisatracurium besylate | “cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation)” NCT04507165 ↗6“Propofol, Atracurium Besilate or Cisatracurium besylate or Rocuronium Bromide” NCT04553536 ↗ “either cisatracurium besylate (178 patients) or placebo (162 patients)” PMID 20843245 ↗ Sep 2010 |
| Known as | Cisatracurium besylate preservative free | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201248 ↗ |
| Known as | Cisatracurium cation | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201248 ↗ |
| Known as | Cisatracurium ion | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201248 ↗ |
| Known as | Nimbex | “patients received 0.2 mL/kg cisatracurium® (Nimbex) 0.2%, and a left-sided endobronchial double-lumen tube was placed when the TOF revealed one or two twitches” NCT02030808 ↗3“Then, endotracheal intubation is facilitated by 0.15 mg nimbex (cisatracurium).” NCT02534012 ↗ “Cisatracurium (Nimbex):” NCT01651572 ↗ |
| Known as | Nimbex preservative free | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201248 ↗ |
| Modality | Small molecule | — CHEMBL1201248 ↗ |
| Route | Intravenous | “One intravenous dose: 0.2mg/kg/dose” NCT00912990 ↗ |