Drugs / Sugammadex
Sugammadex
also known as
bridion · sugammadex sodium · HengShu, Sugammadex sodium · MK-8616 · Org 25969 · Org 25969, Bridion · SUG · Sugammadex adroiq · +6 more
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | BRIDION | — | 2020-06-09 – 2024-12-12 | fda.gov ↗ |
| Approved | US (FDA) | BRIDION | — | 2015-12-15 | fda.gov ↗ |
| Filed | US (FDA) | — | neuromuscular blockade reversal | 2015-07-28 | “The FDA has accepted the resubmission of the NDA for sugammadex injection, an investigational medicine for the reversal of” merck.com ↗ |
| Rejected (CRL) | US (FDA) | — | neuromuscular blockade reversal | 2015-04-28 | “The company received a Complete Response Letter (CRL) from the FDA for sugammadex injection, an investigational medicine for the reversal of neuromuscular blockade” merck.com ↗ |
| Filed | US (FDA) | — | neuromuscular blockade reversal | 2014-11-24 | “today announced that the resubmitted New Drug Application (NDA) for sugammadex sodium injection was recently accepted for review by the U.S. Food and Drug Administration (FDA).” merck.com ↗ |
| Rejected (CRL) | US (FDA) | — | neuromuscular blockade reversal | 2013-10-28 | “Announced the receipt of a Complete Response Letter from the FDA for the resubmission of the New Drug Application for sugammadex sodium injection” merck.com ↗ “In 2008, the FDA did not approve the original NDA for sugammadex sodium injection, requesting additional data related to hypersensitivity” merck.com ↗ |
| Filed | US (FDA) | — | neuromuscular blockade reversal | 2013-01-07 | “today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA).” merck.com ↗ |
| Approved | EU (EMA) | Bridion | — | 2008-07-25 | europa.eu ↗ |
Trials 158 · started per year
today
EU approved 2008
US approved 2015
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04556721 | Sep 2021 | kidney disorder | Tetsuro Sakai | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02028065 | Jan → Jul 2014 | anaphylaxis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02011490 | Dec 2013 → Jun 2014 | impaired renal function disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00988065 | Sep 2009 → Apr 2010 | hypersensitivity reaction disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06794450 | Nov 2024 → Feb 2025 overdue | curariform drugs toxicity | Padjadjaran University | Recruiting | No outcome recorded |
| Phase 216 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT06575036 | Sep 2024 → Apr 2025 overdue | — | Sang-Hwan Ji | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05723406 | Mar → Nov 2023 | osteoarthritis, hip | Radboud University Medical Center | Completed | Missed primary |
| Phase 2 | NCT04347486 | Apr 2020 → Dec 2021 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03943888 | Aug 2019 → Feb 2020 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03532178 | Jan 2019 → Mar 2022 | — | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2 | NCT03519724 | Jul → Sep 2018 | curariform drugs toxicity | Campus-Bio-Medico University | Unknown | No outcome recorded |
| Phase 2 | NCT03519633 | Apr 2018 → Dec 2024 | curariform drugs toxicity | Campus-Bio-Medico University | Completed | No outcome recorded |
| Phase 2 | NCT02545595 | May 2012 → Dec 2013 | morbid obesity | Poitiers University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01911520 | Jan 2011 → Jun 2012 | morbid obesity | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 2 | NCT00591409 | Jan → Sep 2006 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00591786 | Dec 2005 → Aug 2006 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00552929 | Oct 2005 → Sep 2006 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00552617 | Sep 2005 → Aug 2006 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT00535743 | Mar → Jul 2004 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT00379613 | Nov 2003 → Jul 2004 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT03519854 | Dec 2002 → Jun 2003 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03728543 | Nov 2018 → Nov 2019 | beta thalassemia, childhood malignant neoplasm, hepatoblastoma | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Unknown | No outcome recorded |
| Phase 332 trials · 10 met primary · 2 missed | ||||||
| Phase 3 | NCT07271875 | Jan 2026 → Nov 2027 expected | ileus, intestinal dysmotility syndrome | Xijing Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06136585 | Jun 2024 → Oct 2026 expected | — | The Cleveland Clinic | Recruiting | No outcome recorded |
| Phase 3 | NCT05801679 | Jul 2023 → Jul 2025 | — | Endeavor Health | Completed | No outcome recorded |
| Phase 3 | NCT05276804 | Apr 2022 → Sep 2024 | urinary bladder disorder | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 3 | NCT04854993 | Jul 2021 → Sep 2022 | prostate cancer | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Completed | No outcome recorded |
| Phase 3 | NCT04096144 | Oct 2019 → Mar 2020 overdue | — | University of South Florida | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03196791 | Oct 2017 → Aug 2020 | gastric cancer, obesity disorder | Korea University Anam Hospital | Completed | Missed primary |
| Phase 3 | NCT01570179 | May → Jul 2012 | — | Central Hospital, Nancy, France | Completed | No outcome recorded |
| Phase 3 | NCT01509651 | Jan → Mar 2012 | — | Onze Lieve Vrouw Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01479764 | Dec 2011 → Oct 2012 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01422304 | Oct 2011 → Sep 2012 | blood coagulation disease, osteoarthritis, hip, osteoarthritis, knee | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01809886 | Oct 2011 → Oct 2013 | — | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Completed | No outcome recorded |
| Phase 3 | NCT01050543 | Feb → Aug 2010 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00825812 | Jan → Sep 2010 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00826176 | Jan → Aug 2010 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00758485 | Oct 2008 → May 2009 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00702715 | Sep 2008 → Mar 2010 | — | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT00724932 | Jul 2008 → Apr 2009 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00675792 | May → Sep 2008 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00656799 | Apr 2008 → Jul 2009 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00535496 | Sep 2007 → Jan 2008 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00559468 | Dec 2006 → Mar 2007 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00474253 | Feb → Aug 2006 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00474617 | Dec 2005 → Oct 2006 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00473694 | Nov 2005 → Nov 2006 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00451217 | Nov 2005 → Mar 2006 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00451100 | Nov 2005 → May 2006 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00420680 | Nov 2005 → Aug 2006 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00475215 | Oct 2005 → Aug 2006 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00298831 | Oct 2005 → May 2006 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00482599 | Jun 2005 → Apr 2006 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00421148 | May 2005 → May 2006 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 470 trials · 7 met primary · 8 missed | ||||||
| Phase 4 | NCT07477132 | Mar 2026 → Aug 2027 expected | curariform drugs toxicity | University Hospital, Caen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05985343 | Jan 2024 → May 2025 | abdominal wall malformation, ileus | Clayton Petro | Completed | No outcome recorded |
| Phase 4 | NCT05887375 | Aug 2023 → Jan 2026 | urinary tract obstruction | University of Missouri-Columbia | Completed | No outcome recorded |
| Phase 4 | NCT05661409 | Jul 2023 → Aug 2024 | — | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT05256901 | Jul 2023 → Jul 2024 | appendicitis | Emory University | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT05817019 | Apr 2023 → Dec 2024 | COVID-19 | Korea University Ansan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05718934 | Nov 2022 → Dec 2023 | — | Ciusss de L'Est de l'Île de Montréal | Completed | Met primary |
| Phase 4 | NCT05354466 | Jun 2022 → Sep 2024 | respiratory system disorder | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05328778 | Apr 2022 → Jan 2025 | — | Guangzhou General Hospital of Guangzhou Military Command | Completed | No outcome recorded |
| Phase 4 | NCT04263363 | Feb 2022 → May 2024 | obstructive sleep apnea syndrome | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 4 | NCT05246397 | Feb → Nov 2022 | aortic disorder, coronary artery disorder, heart failure, heart valve disorder | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT05187455 | Jan → Nov 2022 | — | Guangzhou General Hospital of Guangzhou Military Command | Unknown | No outcome recorded |
| Phase 4 | NCT05028088 | Jul 2021 → Dec 2022 | liver disorder | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 4 | NCT04546672 | Mar 2021 → Jun 2023 | bowel dysfunction | Oregon Health and Science University | Completed | Missed primary |
| Phase 4 | NCT03923556 | Feb 2021 → Sep 2023 | curariform drugs toxicity | University of Colorado, Denver | Completed | Met primary |
| Phase 4 | NCT05202899 | Sep 2020 → Feb 2022 | brain neoplasm | Guangzhou General Hospital of Guangzhou Military Command | Unknown | No outcome recorded |
| Phase 4 | NCT03909165 | Jul 2019 → Sep 2023 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 4 | NCT04131218 | Jul 2019 → Jul 2020 | — | Guangzhou General Hospital of Guangzhou Military Command | Unknown | No outcome recorded |
| Phase 4 | NCT03944473 | Jun 2019 → Jul 2020 | gait apraxia | Montefiore Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT03996655 | Jun → Sep 2019 | curariform drugs toxicity | National Cancer Institute, Egypt | Unknown | No outcome recorded |
| Phase 4 | NCT03958201 | May 2019 → Jan 2020 | respiratory paralysis | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT03679611 | Jan 2019 → Oct 2021 | obstructive sleep apnea syndrome | University Health Network, Toronto | Completed | Missed primary |
| Phase 4 | NCT03643913 | Dec 2018 → Nov 2024 | arthropathy | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT03543826 | May → Nov 2018 | myopathy | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT03515694 | Apr → Sep 2018 | — | Erasme University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03351608 | Feb 2018 → Jan 2020 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 4 | NCT03346070 | Jan 2018 → Jan 2019 | — | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 4 | NCT03346057 | Dec 2017 → Sep 2019 | — | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 4 | NCT03210376 | Nov 2017 → Sep 2018 | digestive system cancer, female reproductive organ cancer, male reproductive organ cancer, malignant urinary system neoplasm | M.D. Anderson Cancer Center | Completed | Missed primary |
| Phase 4 | NCT03322657 | Nov 2017 → Dec 2020 | — | The Cleveland Clinic | Completed | Mixed |
| Phase 4 | NCT03138967 | Sep 2017 → Sep 2018 | urinary bladder cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 4 | NCT03039543 | Jun → Nov 2017 | — | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03112993 | May 2017 → Aug 2018 | — | University of Missouri-Columbia | Completed | Met primary |
| Phase 4 | NCT03196167 | May 2017 → Oct 2020 | — | Yale University | Completed | No outcome recorded |
| Phase 4 | NCT03144453 | May 2017 → Dec 2019 | — | Regina Elena Cancer Institute | Unknown | No outcome recorded |
| Phase 4 | NCT03229486 | Mar 2017 → Jul 2019 | delirium | Pusan National University Yangsan Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02861131 | Jan 2017 → Apr 2018 | — | Oregon Health and Science University | Completed | Missed primary |
| Phase 4 | NCT02845375 | Sep 2016 → Sep 2018 | respiratory failure | Leiden University Medical Center | Completed | Missed primary |
| Phase 4 | NCT02484651 | Sep 2016 → Jun 2017 | neuromuscular disease | Centro Hospitalar do Porto | Completed | Mixed |
| Phase 4 | NCT02860507 | Aug 2016 → Feb 2018 | — | University of South Florida | Completed | No outcome recorded |
| Phase 4 | NCT02728726 | Jun 2016 → Dec 2019 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03420937 | Jun 2016 → Jun 2017 | — | University Hospital Olomouc | Completed | Met primary |
| Phase 4 | NCT02451202 | Jun 2016 → Mar 2018 | — | Chulalongkorn University | Completed | No outcome recorded |
| Phase 4 | NCT02648503 | Mar → Sep 2016 | neuromuscular disease | University of Medicine and Pharmacy at Ho Chi Minh City | Unknown | No outcome recorded |
| Phase 4 | NCT02403063 | Sep → Oct 2015 | — | Onze Lieve Vrouw Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02513693 | Jul 2015 → Mar 2016 | — | Palacky University | Unknown | No outcome recorded |
| Phase 4 | NCT02410590 | Jul 2015 → Oct 2016 | — | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 4 | NCT02580188 | Mar 2015 → Jun 2016 | — | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02329964 | Feb → Aug 2015 | — | Korea University Anam Hospital | Unknown | Met primary |
| Phase 4 | NCT02361060 | Feb 2015 → Jul 2016 | — | Enrique Alday Muñoz | Completed | No outcome recorded |
| Phase 4 | NCT02256280 | Jan 2015 → Mar 2020 | — | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02708056 | Jan 2015 → Feb 2016 | brain cancer | Baskent University | Completed | No outcome recorded |
| Phase 4 | NCT02284412 | Dec 2014 | — | Onze Lieve Vrouw Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02698969 | Nov 2014 → Feb 2017 | curariform drugs toxicity | University of Florence | Unknown | Missed primary |
| Phase 4 | NCT02243943 | Sep 2014 → Apr 2016 | lung disorder | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02100280 | Jun 2014 → Jun 2017 | — | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01965067 | Oct 2013 → Feb 2014 | — | MSD Korea Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01761552 | Aug 2013 → Dec 2015 | — | Hadassah Medical Organization | Unknown | No outcome recorded |
| Phase 4 | NCT01748643 | Apr 2013 → Jan 2015 | obesity disorder | Ziekenhuis Oost-Limburg | Completed | Missed primary |
| Phase 4 | NCT02568345 | Jan → Oct 2013 | — | Faculdade de Ciências Médicas da Santa Casa de São Paulo | Completed | No outcome recorded |
| Phase 4 | NCT01718236 | Sep 2012 → Jan 2015 | pregnancy disorder | Brno University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01539044 | Feb 2012 → Jun 2013 | curariform drugs toxicity | Hospital Sultanah Aminah Johor Bahru | Completed | No outcome recorded |
| Phase 4 | NCT02160223 | Jan 2012 → Jun 2014 | obstructive sleep apnea syndrome | Diskapi Teaching and Research Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01785758 | Oct 2011 → Jan 2012 | chronic renal failure syndrome | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 4 | NCT01424488 | Sep 2011 → Feb 2012 | — | Central Clinical Hospital #1 of LLC Russian Railways | Unknown | No outcome recorded |
| Phase 4 | NCT01161004 | Sep 2010 → Aug 2011 | — | Hopital Foch | Completed | No outcome recorded |
| Phase 4 | NCT01101139 | Apr 2010 → May 2011 | — | Technical University of Munich | Completed | Missed primary |
| Phase 4 | NCT00953550 | Sep 2009 → Jan 2011 | — | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 4 | NCT01142648 | Apr 2009 → Mar 2010 | — | Tampere University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00895609 | Mar → Aug 2009 | neuromuscular disease | Technical University of Munich | Completed | No outcome recorded |
| Phase not applicable34 trials · 3 met primary | ||||||
| — | NCT07534475 | Apr → May 2026 overdue | bipolar disorder, major depressive disorder, schizophrenia | Medipol University | Not yet recruiting | No outcome recorded |
| — | NCT07309393 | Dec 2025 → Sep 2026 overdue | — | Shanghai Pulmonary Hospital, Shanghai, China | Recruiting | No outcome recorded |
| — | NCT06962007 | Jul 2025 → Sep 2026 overdue | facial spasm | Wonkwang University Hospital | Recruiting | No outcome recorded |
| — | NCT06634355 | Mar 2025 → Sep 2026 overdue | pregnancy disorder | Universitaire Ziekenhuizen KU Leuven | Enrolling by invitation | No outcome recorded |
| — | NCT06678451 | Dec 2024 → May 2025 overdue | — | Shanxi Bethune Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05751603 | Oct 2024 → Oct 2025 overdue | — | Ajou University School of Medicine | Not yet recruiting | No outcome recorded |
| — | NCT06334562 | Jun 2024 → Dec 2025 overdue | — | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | No outcome recorded |
| — | NCT06436768 | Jun 2024 → Mar 2025 | — | Beijing Tongren Hospital | Completed | No outcome recorded |
| — | NCT06398899 | May 2024 → Jun 2025 | chronic otitis media, chronic rhinosinusitis, laryngeal disorder | National Taiwan University Hospital | Completed | No outcome recorded |
| — | NCT05993390 | Jan 2024 → Aug 2027 expected | — | Seoul National University Hospital | Recruiting | No outcome recorded |
| — | NCT05724550 | Feb 2023 → Jun 2024 | curariform drugs toxicity | Seoul National University Hospital | Completed | Met primary |
| — | NCT06210165 | Dec 2022 → Jun 2024 | pulmonary immaturity | Rhendra Hardy Mohamad Zaini | Unknown | No outcome recorded |
| — | NCT04997759 | Sep 2021 → Aug 2022 | — | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| — | NCT05040490 | Aug 2021 → Jul 2022 | — | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| — | NCT04608682 | Aug 2021 → Aug 2022 | — | Beijing Tiantan Hospital | Completed | Met primary |
| — | NCT04545099 | Sep 2020 → Sep 2022 | — | Yonsei University | Unknown | No outcome recorded |
| — | NCT04566796 | Aug 2020 → Feb 2021 | — | Alexandria University | Unknown | No outcome recorded |
| — | NCT04161508 | Dec 2019 → Dec 2021 | — | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
| — | NCT04407078 | Dec 2019 → Jan 2021 | gallbladder disorder | Ajou University School of Medicine | Completed | No outcome recorded |
| — | NCT03803982 | Jan → Dec 2019 | — | McMaster University | Unknown | No outcome recorded |
| — | NCT03689413 | Oct 2018 → Aug 2019 | — | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT03634956 | Aug 2018 → Feb 2019 | cranial nerves, recurrent paresis of, voice disorders | Lütfiye Nuri Burat Government Hospital | Unknown | No outcome recorded |
| — | NCT03583021 | Jun → Oct 2018 | gallbladder disorder | Ajou University School of Medicine | Completed | No outcome recorded |
| — | NCT03381209 | Jun → Nov 2017 | — | Ain Shams University | Completed | No outcome recorded |
| — | NCT03108989 | Feb → Jul 2017 | — | Yonsei University | Completed | Met primary |
| — | NCT02939430 | Nov 2016 → Oct 2017 | — | Mansoura University | Unknown | No outcome recorded |
| — | NCT02762890 | Oct 2016 → Feb 2017 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT02944175 | Jul 2016 → Sep 2019 | supratentorial cancer | Mansoura University | Unknown | No outcome recorded |
| — | NCT02546843 | Dec 2015 → Sep 2018 | — | Brno University Hospital | Completed | No outcome recorded |
| — | NCT03911232 | Mar 2015 → Mar 2016 | thyroid gland disorder | Kaohsiung Medical University Chung-Ho Memorial Hospital | Completed | No outcome recorded |
| — | NCT03137290 | Dec 2014 → Jun 2016 | — | Universiti Sains Malaysia | Completed | No outcome recorded |
| — | NCT02109133 | May → Dec 2014 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT01890057 | Jun 2013 → Jan 2014 | — | Severance Hospital | Completed | No outcome recorded |
| — | NCT01564576 | Apr → Aug 2012 | morbid obesity | Sheba Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy84 trials | ||||||
| Phase 0 | NCT03328312 Comparator | Dec 2017 → Mar 2018 | curariform drugs toxicity | Iuliu Hatieganu University of Medicine and Pharmacy | Unknown | No outcome recorded |
| Phase 1 | NCT06982092 Comparator | Aug 2024 → Jan 2025 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 1 | NCT03579589 Comparator | Aug 2018 → Dec 2019 | — | Ohio State University | Completed | No outcome recorded |
| Phase 1 | NCT02888067 Comparator | Jul 2017 → Jul 2022 | — | Thomas Schricker | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05664633 Comparator | Aug 2023 → Jun 2024 | urinary bladder disorder | West Virginia University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03904550 Comparator | Dec 2019 → Aug 2022 | impaired renal function disease | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03448068 Background | Apr 2018 → Jan 2020 | — | Mayo Clinic | Completed | Met primary |
| Phase 2/3 | NCT01937247 Comparator | May 2018 → Oct 2020 | — | American University of Beirut Medical Center | Completed | No outcome recorded |
| Phase 2/3 | NCT02147054 Comparator | May 2014 → Jul 2016 | organophosphate poisoning | University of Edinburgh | Completed | No outcome recorded |
| Phase 2/3 | NCT01629394 Comparator | Jan → Oct 2012 | morbid obesity | University of Patras | Unknown | No outcome recorded |
| Phase 3 | NCT03513406 Comparator | Mar 2018 → Mar 2023 | — | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT03116997 Comparator | Apr 2017 → Mar 2022 | — | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT02666014 Comparator | Jun 2015 → Dec 2017 | — | KK Women's and Children's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02713113 Comparator | Mar 2015 → Feb 2016 | — | Assiut University | Completed | No outcome recorded |
| Phase 3 | NCT01962298 Comparator | Oct 2013 → Dec 2014 | diaphragm disorder, myopathy | University Hospital, Antwerp | Completed | No outcome recorded |
| Phase 3 | NCT01855217 Comparator | Apr 2013 → Apr 2014 | — | St. Antonius Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT00751179 Comparator | Nov 2008 → Dec 2009 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT07835295 Comparator | Sep 2026 → Sep 2028 expected | — | Mayo Clinic | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07666984 Comparator | Jun → Sep 2026 | — | Cukurova University | 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 | NCT06112353 Comparator | Apr 2024 → Jul 2026 overdue | intestinal disorder | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 4 | NCT06225466 Comparator | Apr → Sep 2024 | — | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT06228092 Comparator | Dec 2023 → May 2025 | curariform drugs toxicity | Matias Vested | Completed | No outcome recorded |
| Phase 4 | NCT06035757 Comparator | Dec 2023 → Mar 2026 | childhood acute lymphoblastic leukemia, delirium, strabismus | Konkuk University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT05545280 Comparator | Dec 2023 → Aug 2024 | — | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT05794503 Comparator | Sep 2023 → Jun 2024 | urinary tract obstruction | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT06081738 Comparator | Mar → Sep 2023 | — | Menoufia University | Unknown | No outcome recorded |
| Phase 4 | NCT04606901 Comparator | Apr 2021 → Jul 2023 | chronic obstructive pulmonary disease | Temple University | Completed | No outcome recorded |
| Phase 4 | NCT04570150 Comparator | Jan 2021 → Jan 2023 | — | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT05468671 Background | Jan → Aug 2021 | bronchial neoplasm | Zhejiang Cancer Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04332627 Comparator | Feb → May 2020 | gallbladder disorder | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03939923 Comparator | May 2019 → Jul 2021 | coronary artery disorder | West Virginia University | Completed | No outcome recorded |
| Phase 4 | NCT02825576 Comparator | Dec 2018 → Apr 2020 | — | Northern Sydney Anaesthesia Research Institute | Terminated | No outcome recorded |
| Phase 4 | NCT03574337 Comparator | Aug 2018 | curariform drugs toxicity | Henry Ford Health System | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03460509 Comparator | Aug 2018 → Dec 2019 | curariform drugs toxicity, neuromuscular disease | The Hospital of Vestfold | Unknown | No outcome recorded |
| Phase 4 | NCT03276026 Comparator | Feb → Nov 2018 | respiratory system disorder | Virtua Health, Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT03087513 Comparator | Feb 2018 → Dec 2019 | — | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 4 | NCT03591289 Comparator | Feb 2018 | female reproductive system disorder, urinary system disorder | Rainer Lenhardt | Withdrawn | No outcome recorded |
| Phase 4 | NCT03369782 Comparator | Dec 2017 → Apr 2018 | — | Algemeen Ziekenhuis Maria Middelares | Withdrawn | No outcome recorded |
| Phase 4 | NCT03168308 Comparator | Sep 2017 → Sep 2019 | — | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03435003 Background | Aug 2017 → Mar 2019 | — | Stony Brook University | Completed | No outcome recorded |
| Phase 4 | NCT03226080 Comparator | Jul 2017 → Aug 2019 | bone disorder | Loyola University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03034577 Comparator | Jun 2017 → Feb 2019 | — | University of Melbourne | Completed | No outcome recorded |
| Phase 4 | NCT03111121 Comparator | May 2017 → Jun 2018 | — | West Virginia University | Completed | No outcome recorded |
| Phase 4 | NCT02909439 Comparator | Nov 2016 → Nov 2017 | — | Stony Brook University | Completed | No outcome recorded |
| Phase 4 | NCT02794714 Comparator | Jun 2016 → Dec 2017 | — | Kuala Lumpur General Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT02724111 Comparator | May 2016 → Feb 2017 | vertebral column disorder | Korea University Guro Hospital | Completed | Met primary |
| Phase 4 | NCT02769325 Background | May 2016 → May 2017 | — | Clinica Santa Maria | Unknown | No outcome recorded |
| Phase 4 | NCT02455921 Comparator | Jun 2015 → Mar 2018 | — | Attikon Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02390817 Comparator | Mar 2015 → Aug 2017 | scoliosis | Cukurova University | Completed | No outcome recorded |
| Phase 4 | NCT02247466 Comparator | Feb 2015 → Feb 2017 | — | Herlev Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02414880 Comparator | Dec 2014 → Aug 2015 | cirrhosis of liver | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT02375217 Comparator | Oct 2014 → Oct 2015 | — | American University of Beirut Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02215382 Comparator | Aug → Oct 2014 | ocular hypotension | Ordu University | Completed | No outcome recorded |
| Phase 4 | NCT02286752 Comparator | Jun 2014 → Jan 2015 | — | Ordu University | Completed | No outcome recorded |
| Phase 4 | NCT02079337 Comparator | Nov 2013 → Apr 2014 | — | Herlev Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01933425 Comparator | Aug 2013 → Apr 2014 | — | Herlev Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05066035 Comparator | May 2013 → Oct 2016 | curariform drugs toxicity | Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01728584 Background | Nov 2012 → Apr 2014 | gallbladder disorder | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 4 | NCT01972659 Background | Oct 2012 → Dec 2013 | preeclampsia | Kocaeli University | Completed | No outcome recorded |
| Phase 4 | NCT05313100 Comparator | Apr 2012 → Jan 2013 | — | Duzce University | Completed | No outcome recorded |
| Phase 4 | NCT01579851 Comparator | Jan 2012 → Jan 2015 | — | Hopital Foch | Completed | No outcome recorded |
| Phase 4 | NCT01453530 Comparator | Oct 2011 → Sep 2012 | — | Radboud University Medical Center | Unknown | No outcome recorded |
| — | NCT07092046 Comparator | Aug 2025 | — | Ankara City Hospital Bilkent | Completed | No outcome recorded |
| — | NCT06553066 Background | Aug 2024 → Aug 2026 overdue | — | University Hospital of Patras | Not yet recruiting | No outcome recorded |
| — | NCT05344417 Background | Mar 2024 → Dec 2026 expected | ileus | Ohio State University | Recruiting | No outcome recorded |
| — | NCT04944303 Comparator | Dec 2020 → Apr 2021 | — | Second Affiliated Hospital of Guangzhou Medical University | Completed | No outcome recorded |
| — | NCT04471376 Comparator | Jul → Dec 2020 | — | Beijing Tiantan Hospital | Completed | No outcome recorded |
| — | NCT04258007 Comparator | Jan → Nov 2020 | — | Mansoura University | Completed | No outcome recorded |
| — | NCT04205097 Background | Dec 2019 → Dec 2020 | gastric cancer | Ajou University School of Medicine | Completed | No outcome recorded |
| — | NCT04022733 Background | Oct 2019 → Aug 2021 | abdominal wall malformation | Ajou University School of Medicine | Completed | No outcome recorded |
| — | NCT03791801 Comparator | Sep 2019 → Dec 2020 | — | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| — | NCT04720573 Comparator | Jun → Oct 2019 | — | Başakşehir Çam & Sakura City Hospital | Completed | No outcome recorded |
| — | NCT03871387 Background | Mar 2019 → Feb 2020 | thyroid tumor | Yonsei University | Completed | No outcome recorded |
| — | NCT03795259 Comparator | Dec 2018 → May 2019 | — | Istanbul University | Completed | No outcome recorded |
| — | NCT03292965 Comparator | Sep → Nov 2017 | curariform drugs toxicity | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| — | NCT02510157 Comparator | May 2015 → Sep 2016 | — | Attikon Hospital | Completed | No outcome recorded |
| — | NCT02454504 Comparator | Mar 2015 → Aug 2016 | — | Regina Elena Cancer Institute | Completed | No outcome recorded |
| — | NCT02697929 Comparator | Jan 2014 → Jan 2019 | curariform drugs toxicity | Azienda Ospedaliera S. Maria della Misericordia | Completed | No outcome recorded |
| — | NCT01980069 Comparator | Nov 2013 → Oct 2014 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT01503840 Comparator | Dec 2011 → Jun 2012 | respiratory paralysis | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Completed | No outcome recorded |
| — | NCT01902641 Comparator | Oct 2011 → Mar 2012 | pharyngitis | Dr. Horst Schmidt Klinik GmbH | Completed | No outcome recorded |
| — | NCT01301261 Comparator | Dec 2010 → Feb 2013 | — | University of Athens | Unknown | No outcome recorded |
| — | NCT02419352 Comparator | Sep 2010 → Dec 2015 | — | Attikon Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | Lupin Limited | Regulatory Lupin Announces U.S. FDA Approval and Launch of Sugammadex Injection lupin.com ↗ |
| 2026-03-31 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Sugammadex Injection lupin.com ↗ |
| 2022-09-16 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Sugammadex Injection zyduslife.com ↗
Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Sugammadex Injection USP 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vial (US RLD: Bridion®). |
| 2015-12-17 | Merck Sharp & Dohme LLC | Regulatory Merck’s BRIDION® (sugammadex) Receives FDA Approval for the Reversal of Neuromuscular Blockade Induced by Rocuronium and Vecuronium in Adults Undergoing Surgery merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved BRIDION ® (sugammadex) Injection 100 mg/mL (equivalent to 108.8 mg/mL sugammadex sodium) for the reversal of neuromuscular blockade (NMB) induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. |
| 2015-03-13 | Merck Sharp & Dohme LLC | Regulatory Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, said it was informed today that the U.S. Food and Drug Administration (FDA) has cancelled the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 18, 2015. |
| 2014-11-24 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmitted New Drug Application (NDA) for sugammadex sodium injection was recently accepted for review by the U.S. Food and Drug Administration (FDA). |
| 2013-09-23 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application for sugammadex sodium injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. |
| 2013-07-16 | Merck Sharp & Dohme LLC | Regulatory Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, confirmed today that the U.S. Food and Drug Administration (FDA) has cancelled Thursday’s discussion of sugammadex at the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). |
| 2013-03-14 | Merck Sharp & Dohme LLC | Regulatory Merck Provides U.S. Regulatory Update on Sugammadex Sodium Injection merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has notified Merck that the agency will take an additional three months to review the New Drug Application (NDA) resubmission for sugammadex sodium injection. |
| 2013-01-07 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA). |
All press releases naming this drug 14 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 245 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sugammadex | “Sugammadex is a modified cyclodextrin that forms complexes with rocuronium, reducing free plasma concentrations of rocuronium and reversing its neuromuscular blocking action...” NCT02794714 ↗239“At the end of surgery, deep Block patients' will receive 4 mg/kg sugammadex and the patient's trachea will be extubated according to routine extubation criteria.” NCT03591289 ↗ “Depending on depth of block (subjectively assessed by TOF response), Neostigmine, Sugammadex, or no reversal drug is used to reverse block prior to extubation.” NCT03543826 ↗ “Sugammadex is a modified γ-cyclodextrin that reverses the effect of the steroidal nondepolarizing neuromuscular blocking agents rocuronium and vecuronium (2).” NCT03791801 ↗ “Sugammadex is administered at the end of surgery after assessment of the level of neuromuscular blockade is done.” NCT06035757 ↗ “Used for Neuromuscular reversal; Sugammadex is devoid of the parasympathetic effects caused by Neostigmine.” NCT04096144 ↗ “After the end of surgery, sugammadex of 4 mg/kg will be administered to reverse neuromuscular blockade.” NCT02762890 ↗ “Reversal of the TOF=2 will be done by Sugammadex 2 mg/kg at end of procedure (Time of last suture)” NCT03643913 ↗ “Specific Neuromuscular Blockade reversal will be performed with Sugammadex intravenously.” NCT02546843 ↗ “sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block” NCT02100280 ↗ “At the end of surgery, IV Sugammadex (Bridion®, Merck Sharp and Dohme” NCT03871387 ↗ |
| Known as | bridion | “In sugammadex group, sugammadex (Bridion, Merck Shart and Dohme (MSD), Oss, the Netherlands) will be administered intravenously in different doses according to the degree of...” NCT01980069 ↗11“At present, the introduction of sugammadex (Bridion®), an antagonist of nondepolarizing the neuromuscular relaxant rocuronium, may lead to an extraordinary breakthrough.” NCT01809886 ↗ “Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®).” NCT01911520 ↗ “Rocuronium: Zemuron. Sugammadex: Bridion. Succinylcholine: Suxamethonium” NCT03532178 ↗ “At the end of surgery, IV Sugammadex (Bridion®, Merck Sharp and Dohme” NCT03871387 ↗ “Group A - Sugammadex (Bridion®) 2 mg/kg,” NCT03328312 ↗ “Sugammadex Injection [Bridion]” NCT03996655 ↗ “Sugammadex Injection [Bridion]” NCT03087513 ↗ “Sugammadex Injection [Bridion]” NCT03515694 ↗ “Sugammadex Injection [Bridion]” NCT03229486 ↗ “Sugammadex (tradename Bridion)” NCT01761552 ↗ |
| Known as | HengShu, Sugammadex sodium | “HengShu, Sugammadex sodium” NCT07309393 ↗ |
| Known as | MK-8616 | “sugammadex (Org 25969; MK-8616)” NCT03519854 ↗ |
| Known as | Org 25969 | “sugammadex (Org 25969; MK-8616)” NCT03519854 ↗ |
| Known as | Org 25969, Bridion | “Org 25969, Bridion®” NCT00826176 ↗ |
| Known as | SUG | “Sugammadex (SUG) is a novel-specific antagonist of aminosteroidal muscle relaxants, which can effectively antagonise muscle relaxants at different depths.” PMID 35105573 ↗ Feb 2022 |
| Known as | Sugammadex adroiq | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111107 ↗ |
| Known as | Sugammadex amomed | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111107 ↗ |
| Known as | Sugammadex fresenius kabi | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111107 ↗ |
| Known as | Sugammadex mylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111107 ↗ |
| Known as | Sugammadex octasodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111107 ↗ |
| Known as | Sugammadex piramal | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111107 ↗ |
| Known as | sugammadex sodium | “This study administers sugammadex sodium to pediatric patients under general anesthesia with rocuronium.” NCT04347486 ↗ |
| Known as | sugammadex: Bridion | “sugammadex: Bridion” NCT01748643 ↗ |
| Action | Inhibit | “Sugammadex, a cyclodextrin molecule that encapsulates and inactivates rocuronium and vecuronium” NCT01748643 ↗ |
| Modality | Other / unclassified | “sugammadex, a modified gamma-cyclodextrin derivative” PMID 17667567 ↗ Aug 2007 |
| Route | Intravenous | “sugammadex 2.0 to 16.0 mg/kg IV was administered” NCT00379613 ↗ |