Drugs / Remimazolam
Remimazolam
also known as
Remimazolam besylate · Byfavo · Remimazolam Tosilate · Remimazolam tosylate · CNS 7056 · HR7056 · Anerem · Aptimyda · +15 more
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | sedation during mechanical ventilation in the ICU | 2025-12-03 | “注射用甲苯磺酸瑞马唑仑的药品上市许可申请获受理，适应症为： 重症监护期间机械通气时的镇静” hengrui.com ↗ |
| Filed | Other | — | general anesthesia, procedural sedation | 2023-01-19 | “submission of a New Drug Application (NDA) to the Brazilian Health Regulatory Agency (ANVISA) for remimazolam in both indications general anesthesia and procedural sedation.” paion.com ↗ “Taiwanese licensee TTY Biopharm has submitted the marketing authorization application for remimazolam in general anesthesia in March 2023.” paion.com ↗ “in South Korea, licensee Hana Pharm filed for market approval for remimazolam in general anesthesia in December 2019.” paion.com ↗ “In South Korea, licensee Hana Pharm submitted a market approval dossier in general anesthesia in December 2019.” paion.com ↗ “In South Korea, a market application for remimazolam in general anesthesia was filed in December 2019.” paion.com ↗ |
| Filed | EU (EMA) | Byfavo(R) | general anesthesia | 2021-12-31 | “In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019.” paion.com ↗ “PAION SUBMITS EXTENSION APPLICATION OF MARKETING AUTHORIZATION FOR REMIMAZOLAM IN THE INDICATION GENERAL ANESTHESIA TO THE EUROPEAN MEDICINES AGENCY” paion.com ↗ “PAION submitted a Marketing Authorization Application (MAA) for procedural sedation to the European Medicines Agency (EMA) in November 2019.” paion.com ↗ “PAION submitted a market approval application (MAA) for procedural sedation to the European Medicines Agency (EMA) in November 2019.” paion.com ↗ |
| Filed | China (NMPA) | — | general anesthesia | 2021-07-09 | “In China, licensee Yichang Humanwell submitted a market approval dossier for remimazolam for procedural sedation to the Chinese National Medical Products Administration (NMPA)...” paion.com ↗ “the National Medical Products Administration (NMPA) has accepted their New Drug Application (NDA) for remimazolam besylate in general anesthesia for review.” paion.com ↗ “In China, licensee Yichang Humanwell filed for market approval for remimazolam in procedural sedation in November 2018.” paion.com ↗ |
| Approved | EU (EMA) | Byfavo | — | 2021-03-26 | europa.eu ↗ |
| Approved | US (FDA) | BYFAVO | — | 2020-07-02 | fda.gov ↗ |
| Filed | Japan (PMDA) | — | general anesthesia | — | “In Japan, licensee Mundipharma filed for market approval for remimazolam in general anesthesia in December 2018.” paion.com ↗ |
Trials 215 · started per year
today
US approved 2020
EU approved 2021
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT07290205 | Mar 2026 → Dec 2027 expected | — | Keith M Vogt | Recruiting | No outcome recorded |
| Phase 0 | NCT07012902 | Jun 2025 overdue | — | Second Hospital of Shanxi Medical University | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06756178 | Jan 2025 → Nov 2026 expected | delirium | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06717945 | Jan → May 2025 overdue | — | Chinese Academy of Medical Sciences, Fuwai Hospital | Not yet recruiting | No outcome recorded |
| Phase 111 trials | ||||||
| Phase 1 | NCT07045467 | Jul 2025 → Jul 2026 overdue | chronic kidney disease | Qianfoshan Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06129188 | Feb → Nov 2025 | — | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 1 | NCT07704437 | Apr 2024 → Jul 2025 | delirium | University Hospital of Split | Completed | No outcome recorded |
| Phase 1 | NCT04670471 | Apr 2021 → Jan 2022 | — | Paion UK Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04113343 | May → Aug 2017 | — | Paion UK Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03329014 | May → Jun 2017 | — | Paion UK Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04113564 | Nov 2015 | — | Paion UK Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04110535 | Jun → Oct 2015 | substance abuse | Paion UK Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03444480 | Jul → Aug 2014 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01970072 | Oct 2013 → Jun 2014 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01790607 | Feb → Nov 2013 | — | Ono Pharma USA Inc | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07086911 | Aug 2025 → Aug 2026 overdue | — | Jinqiao Qian | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05913336 | Jun 2023 → Mar 2025 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 216 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06398275 | Mar → Sep 2024 | delirium | University Hospital of Split | Unknown | Met primary |
| Phase 2 | NCT06275594 | Mar 2024 → Feb 2025 | — | Yeungnam University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05975255 | Nov 2023 → Oct 2024 | — | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06153498 | Nov 2023 → Dec 2024 | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 2 | NCT05152303 | Oct 2022 → Apr 2023 | — | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05539521 | Sep 2022 → Feb 2023 | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 2 | NCT05635955 | Aug → Sep 2022 | — | Maternal and Child Health Hospital of Hubei Province | Completed | No outcome recorded |
| Phase 2 | NCT06124404 | Apr 2022 → Feb 2023 | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Completed | Missed primary |
| Phase 2 | NCT04790734 | May 2021 → Apr 2022 | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Completed | No outcome recorded |
| Phase 2 | NCT05015361 | May → Jun 2021 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04611425 | Nov → Dec 2020 | COVID-19, acute respiratory failure, infectious disease with sepsis, stroke disorder | Nantes University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03003884 | Nov 2016 → Mar 2017 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02406872 | Dec 2014 → Aug 2015 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01937767 | Aug 2013 → Feb 2014 | — | Paion UK Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01145222 | May → Sep 2010 | — | Paion UK Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00869440 | Mar → Sep 2009 | — | Paion UK Ltd. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07036419 | Jul 2025 → May 2026 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2/3 | NCT04851717 | Nov 2021 → Oct 2027 expected | childhood acute lymphoblastic leukemia | Acacia Pharma Ltd | Active not recruiting | No outcome recorded |
| Phase 323 trials · 6 met primary | ||||||
| Phase 3 | NCT07269808 | Mar → Jun 2026 | — | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT07303985 | Dec 2025 → Feb 2026 | — | Jun Zhang | Completed | No outcome recorded |
| Phase 3 | NCT07155265 | Oct 2025 → Jun 2027 expected | respiratory failure | Yancheng First People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07596589 | Apr 2025 → Jan 2027 expected | — | Southeast University, China | Recruiting | No outcome recorded |
| Phase 3 | NCT06714669 | Jun → Oct 2024 | — | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 3 | NCT06222294 | Mar → Aug 2024 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT06013345 | Oct 2023 → Sep 2024 | atrial fibrillation | Charles University, Czech Republic | Completed | Met primary |
| Phase 3 | NCT05555667 | May 2023 → Nov 2025 | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 3 | NCT05836545 | Apr 2023 → Jan 2024 | — | Samsung Medical Center | Completed | Met primary |
| Phase 3 | NCT05782894 | Feb → Nov 2023 | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Completed | Met primary |
| Phase 3 | NCT05635201 | Dec 2022 → Sep 2023 | — | Daegu Catholic University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT05220462 | Mar 2022 → May 2024 | — | Guy's and St Thomas' NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 3 | NCT04947345 | Sep 2021 → Mar 2022 | — | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04400201 | Jun → Oct 2020 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03921775 | May → Dec 2019 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03661489 | Jul 2018 → Apr 2020 | — | Paion UK Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03779061 | Jun → Sep 2018 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03425474 | Sep → Nov 2017 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03669484 | Aug 2017 → May 2018 | — | R-Pharm | Completed | No outcome recorded |
| Phase 3 | NCT02532647 | Nov 2015 → Dec 2016 | — | Paion UK Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02523859 | Jul 2015 → Mar 2016 | — | Paion UK Ltd. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02296892 | Apr 2015 → Mar 2017 | — | Paion UK Ltd. | Completed | Met primary |
| Phase 3 | NCT02290873 | Mar 2015 → Apr 2016 | — | Paion UK Ltd. | Completed | Met primary |
| Phase 466 trials · 3 met primary | ||||||
| Phase 4 | NCT07651956 | Nov 2026 → May 2028 expected | anxiety | Icahn School of Medicine at Mount Sinai | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07863063 | Oct 2026 → Oct 2027 expected | — | Seoul National University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07816068 | Oct 2026 → Oct 2027 expected | delirium, thoracic aortic aneurysm | Seoul National University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07325227 | Sep 2026 → Jan 2028 expected | cataract | Fred E, Shapiro | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07806006 | Sep 2026 → Sep 2027 expected | abdominal aortic aneurysm | Seoul National University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07836205 | Sep 2026 → Sep 2028 expected | — | Beijing Chao Yang Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07829458 | Sep 2026 → Sep 2027 expected | heart disorder | Icahn School of Medicine at Mount Sinai | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07663877 | Jun 2026 → Jun 2028 expected | — | Chung-Ang University Gwangmyeong Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07611344 | May → Aug 2026 | — | Xuyu Zhang | Completed | No outcome recorded |
| Phase 4 | NCT07395596 | Feb → Dec 2026 expected | infectious disease, lung disorder, lymphangiectasis, trachea neoplasm | First Affiliated Hospital of Zhejiang University | Recruiting | No outcome recorded |
| Phase 4 | NCT07265128 | Dec 2025 → Sep 2027 expected | delirium | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07194109 | Oct 2025 → Oct 2030 expected | disorder of pharynx | The First Affiliated Hospital of Anhui Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07118579 | Sep 2025 → Aug 2026 overdue | — | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07094945 | Aug 2025 → Aug 2026 overdue | — | Tongji Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06793358 | Jul 2025 → Feb 2026 | — | Indiana University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT06690424 | Jun → Dec 2025 | — | Affiliated Hospital of Nantong University | Completed | No outcome recorded |
| Phase 4 | NCT06998732 | Jun → Sep 2025 overdue | uremia | Gang Chen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07838948 | Apr → Oct 2025 | — | Wuhan Fourth Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05980117 | Mar → Dec 2025 overdue | cataract, cognitive disorder | University of California, Los Angeles | Recruiting | No outcome recorded |
| Phase 4 | NCT06784479 | Mar 2025 → Mar 2026 overdue | obstructive sleep apnea syndrome | Dan Liu | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06777758 | Feb 2025 → Dec 2026 expected | constipation disorder, respiratory underresponsiveness to hypoxia and hypercapnia | Kaohsiung Veterans General Hospital. | Recruiting | No outcome recorded |
| Phase 4 | NCT06816173 | Feb 2025 → Jan 2026 overdue | respiratory underresponsiveness to hypoxia and hypercapnia | Second Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06575530 | Jan 2025 → May 2026 overdue | — | Beijing Shijitan Hospital, Capital Medical University | Recruiting | No outcome recorded |
| Phase 4 | NCT07046364 | Jan 2025 → Jan 2027 expected | delirium | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07456111 | Jan 2025 → Nov 2027 expected | polyp of colon | Clinical Hospital Centre Zagreb | Recruiting | No outcome recorded |
| Phase 4 | NCT06614036 | Oct 2024 → Dec 2025 overdue | — | Koen Munters | Recruiting | No outcome recorded |
| Phase 4 | NCT06565715 | Aug → Oct 2024 | — | Jun Zhang | Completed | No outcome recorded |
| Phase 4 | NCT06382467 | May 2024 → May 2025 | nervous system disorder | Chung-Ang University Gwangmyeong Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT06303037 | Apr → Aug 2024 | — | Second Affiliated Hospital of Wenzhou Medical University | Completed | No outcome recorded |
| Phase 4 | NCT06333145 | Feb 2024 → Jun 2026 | — | Tongji Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06214117 | Feb 2024 → Feb 2025 | delirium | Second Affiliated Hospital of Wenzhou Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT06507202 | Jan 2024 → Jan 2025 overdue | disorder of pharynx, laryngeal disorder, mouth disorder, nasal disorder | Chung-Ang University Gwangmyeong Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05758597 | Jan 2024 → May 2025 | acute respiratory distress syndrome | Zhiming Jiang | Unknown | No outcome recorded |
| Phase 4 | NCT06216444 | Jan → Mar 2024 | — | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT06169995 | Dec 2023 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT06061159 | Oct 2023 → Feb 2024 | — | Second Affiliated Hospital of Wenzhou Medical University | Completed | No outcome recorded |
| Phase 4 | NCT06664138 | Apr 2023 → Jan 2024 | bipolar disorder, major depressive disorder, schizoaffective disorder, schizophrenia | Yeongseok Yun | Completed | No outcome recorded |
| Phase 4 | NCT05728775 | Apr 2023 → Dec 2027 expected | — | Nanfang Hospital, Southern Medical University | Recruiting | No outcome recorded |
| Phase 4 | NCT05760534 | Mar 2023 → Nov 2025 | arthropathy | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06513923 | Feb → Sep 2023 | — | Central South University | Completed | No outcome recorded |
| Phase 4 | NCT05412914 | Jan 2023 → Jan 2024 | — | Konkuk University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT05624424 | Nov 2022 → Oct 2023 | — | Second Affiliated Hospital of Nanchang University | Unknown | No outcome recorded |
| Phase 4 | NCT05856617 | Oct 2022 → Aug 2023 | morbid obesity | Seoul National University Bundang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05436522 | Aug 2022 → May 2024 | — | Nanfang Hospital, Southern Medical University | Completed | No outcome recorded |
| Phase 4 | NCT05423080 | Aug → Nov 2022 | — | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05486377 | Aug 2022 → May 2023 | cardiac rhythm disease | Seoul National University Bundang Hospital | Completed | Met primary |
| Phase 4 | NCT05406102 | Jul 2022 → May 2023 | — | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 4 | NCT05429086 | Jun → Aug 2022 | — | Sichuan Provincial People's Hospital | Unknown | Met primary |
| Phase 4 | NCT05379777 | May → Aug 2022 | — | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT05340335 | Apr → May 2022 | — | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT05644483 | Mar 2022 → Jan 2023 | — | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT05606315 | Mar 2022 → Jan 2025 | — | Nanfang Hospital, Southern Medical University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05554965 | Feb → Oct 2022 | — | Renmin Hospital of Wuhan University | Unknown | No outcome recorded |
| Phase 4 | NCT05480787 | Feb → Aug 2022 | liver failure | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05255211 | Dec 2021 → Dec 2024 | — | RenJi Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05041725 | Nov 2021 → Nov 2022 | coronary artery disorder | Konkuk University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT04969068 | Jul → Dec 2021 | — | Tianjin Nankai Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04908553 | Jul 2021 → Mar 2025 | — | Tongji Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04861337 | May 2021 → Dec 2022 | — | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04919174 | Apr 2021 → Apr 2022 | — | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT04602845 | Apr → Jun 2021 | — | Peking University | Completed | No outcome recorded |
| Phase 4 | NCT04815265 | Apr 2021 → Dec 2023 | — | Tianjin Nankai Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04720963 | Feb 2021 → Feb 2022 | mixed anxiety and depressive disorder | Second Affiliated Hospital of Wenzhou Medical University | Completed | Met primary |
| Phase 4 | NCT04532606 | Feb 2021 → Oct 2025 overdue | delirium, urinary bladder cancer | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05468671 | Jan → Aug 2021 | bronchial neoplasm | Zhejiang Cancer Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04621305 | Nov 2020 → Nov 2021 | delirium | Second Affiliated Hospital of Wenzhou Medical University | Unknown | No outcome recorded |
| Phase not applicable91 trials · 8 met primary · 2 missed | ||||||
| — | NCT07854197 | Oct 2026 → Jun 2027 expected | — | RenJi Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07740343 | Aug 2026 → Jan 2027 expected | — | General Hospital of Ningxia Medical University | Recruiting | No outcome recorded |
| — | NCT07674719 | Jun 2026 → Jun 2027 expected | acute kidney injury | Seoul National University Bundang Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07620782 | May 2026 → Apr 2027 expected | — | Pusan National University Yangsan Hospital | Recruiting | No outcome recorded |
| — | NCT07251101 | May 2026 → Oct 2027 expected | — | Ilsan Cha hospital | Not yet recruiting | No outcome recorded |
| — | NCT07459322 | Apr 2026 → Apr 2027 expected | obstructive sleep apnea syndrome | Fu Jen Catholic University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07351474 | Jan → Jul 2026 | delirium, gastric cancer | The First Affiliated Hospital with Nanjing Medical University | Completed | No outcome recorded |
| — | NCT07265050 | Jan 2026 → Dec 2027 expected | — | Seoul National University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07335536 | Oct 2025 → Dec 2026 expected | infertility disorder | Diansan Su | Recruiting | No outcome recorded |
| — | NCT07109362 | Aug 2025 → Jun 2026 overdue | glioma | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06990763 | Jun → Dec 2025 overdue | female reproductive system disorder | Second Hospital of Shanxi Medical University | Not yet recruiting | No outcome recorded |
| — | NCT07569614 | Apr 2025 → Feb 2026 | delirium | First Affiliated Hospital of Kunming Medical University | Completed | No outcome recorded |
| — | NCT07050212 | Apr 2025 → Mar 2026 overdue | — | Maternal and Child Health Hospital of Hubei Province | Recruiting | No outcome recorded |
| — | NCT06775366 | Feb 2025 → Apr 2026 overdue | circadian rhythm sleep disorder, cognitive disorder | The Second Affiliated Hospital of Chongqing Medical University | Not yet recruiting | No outcome recorded |
| — | NCT06716840 | Feb → Apr 2025 overdue | — | First Affiliated Hospital of Zhejiang University | Recruiting | No outcome recorded |
| — | NCT07467603 | Feb → Apr 2025 | — | The First Hospital of Hebei Medical University | Completed | No outcome recorded |
| — | NCT06700681 | Sep 2024 → Dec 2026 expected | vascular hemostatic disease | Taipei Veterans General Hospital, Taiwan | Enrolling by invitation | No outcome recorded |
| — | NCT06332157 | Sep 2024 → Dec 2025 | — | Beijing Chao Yang Hospital | Unknown | No outcome recorded |
| — | NCT06496165 | Jul 2024 → Dec 2026 expected | coronary artery disorder | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06583811 | Jul 2024 → Jan 2025 overdue | — | Egymedicalpedia | Recruiting | No outcome recorded |
| — | NCT06581731 | Jun 2024 → Mar 2026 | — | Nanjing First Hospital, Nanjing Medical University | Completed | No outcome recorded |
| — | NCT06419543 | May → Oct 2024 | — | Tongji Hospital | Completed | No outcome recorded |
| — | NCT06359834 | Apr → Aug 2024 | hepatobiliary disorder | Yonsei University | Completed | Met primary |
| — | NCT06258356 | Feb 2024 → Dec 2028 expected | — | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06121609 | Jan → Apr 2024 | — | Tongji Hospital | Completed | No outcome recorded |
| — | NCT06187896 | Jan 2024 → Feb 2026 overdue | obesity disorder | RenJi Hospital | Recruiting | No outcome recorded |
| — | NCT06217055 | Jan → Oct 2024 | urinary bladder cancer | Yonsei University | Unknown | No outcome recorded |
| — | NCT06170918 | Dec 2023 → May 2024 | — | Zhihong LU | Unknown | No outcome recorded |
| — | NCT06093971 | Nov 2023 → Oct 2024 | prostate neoplasm | Yonsei University | Completed | Missed primary |
| — | NCT06115031 | Nov 2023 → Nov 2025 | delirium | Samsung Medical Center | Completed | No outcome recorded |
| — | NCT06009055 | Sep 2023 → Nov 2024 | type 2 diabetes mellitus | Zheng Guo | Unknown | No outcome recorded |
| — | NCT05748665 | Aug 2023 → Jan 2024 | — | Xijing Hospital | Completed | No outcome recorded |
| — | NCT05990673 | Aug → Sep 2023 | — | Zhihong LU | Unknown | No outcome recorded |
| — | NCT05935657 | Aug 2023 → Jun 2024 | — | Pusan National University Yangsan Hospital | Unknown | No outcome recorded |
| — | NCT06004843 | Aug 2023 → Feb 2026 | obesity disorder | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT06009991 | Jul 2023 → Sep 2025 | — | Tongji Hospital | Unknown | No outcome recorded |
| — | NCT05538741 | Jul 2023 → Jun 2024 | hypotensive disorder | Kangbuk Samsung Hospital | Completed | No outcome recorded |
| — | NCT05536323 | Jul → Nov 2023 | — | Kangbuk Samsung Hospital | Unknown | No outcome recorded |
| — | NCT05907525 | Jun 2023 → Apr 2024 | — | Pusan National University Yangsan Hospital | Completed | No outcome recorded |
| — | NCT05864625 | Jun 2023 → Jun 2025 | aortic valve stenosis | Pusan National University Yangsan Hospital | Completed | No outcome recorded |
| — | NCT06178848 | Jun → Oct 2023 | acalculous cholecystitis, acute cholecystitis, gallbladder neoplasm | Yonsei University | Completed | No outcome recorded |
| — | NCT06275425 | Jun → Nov 2023 | thyroid tumor | Yonsei University | Completed | No outcome recorded |
| — | NCT05876793 | Jun 2023 | — | Sichuan Provincial People's Hospital | Completed | No outcome recorded |
| — | NCT07083440 | Jun 2023 → May 2024 | digestive system disorder | Children's Hospital of Hebei Province | Completed | Met primary |
| — | NCT05864404 | May 2023 → Oct 2024 | — | Yonsei University | Unknown | No outcome recorded |
| — | NCT05866315 | May → Sep 2023 | — | Wonkwang University Hospital | Completed | No outcome recorded |
| — | NCT05736341 | May 2023 | pregnancy disorder | Yonsei University | Completed | No outcome recorded |
| — | NCT05801757 | May 2023 → Apr 2024 | colonic disorder | Tongji Hospital | Completed | No outcome recorded |
| — | NCT05723627 | Apr → Sep 2023 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT05835713 | Apr 2023 → Apr 2024 | bronchial disorder, tracheal stenosis | Samsung Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT05774366 | Mar → Dec 2023 | — | Daegu Catholic University Medical Center | Unknown | No outcome recorded |
| — | NCT05891145 | Feb 2023 → Dec 2026 expected | — | Yangzhou University | Recruiting | No outcome recorded |
| — | NCT05686863 | Jan → Jul 2023 | — | Tongji Hospital | Completed | Met primary |
| — | NCT05356091 | Dec 2022 → Feb 2023 | — | Kangbuk Samsung Hospital | Completed | No outcome recorded |
| — | NCT05631028 | Dec 2022 | lung cancer | Shiyou Wei | Completed | No outcome recorded |
| — | NCT05557253 | Oct 2022 → Oct 2023 | — | Seoul National University Hospital | Unknown | No outcome recorded |
| — | NCT05533567 | Oct 2022 → Jan 2023 | gallbladder disorder | Second Affiliated Hospital of Nanchang University | Unknown | No outcome recorded |
| — | NCT05519371 | Oct 2022 | — | Beijing Chao Yang Hospital | Unknown | No outcome recorded |
| — | NCT05533580 | Oct 2022 → Jan 2023 | gallbladder disorder | Second Affiliated Hospital of Nanchang University | Unknown | No outcome recorded |
| — | NCT05527314 | Aug 2022 → Feb 2023 | — | Second Affiliated Hospital of Nanchang University | Completed | No outcome recorded |
| — | NCT05397886 | Aug 2022 → Apr 2023 | — | Seoul National University Hospital | Completed | Met primary |
| — | NCT05435911 | Aug → Dec 2022 | — | Seoul National University Hospital | Completed | Met primary |
| — | NCT05485064 | Aug → Nov 2022 | — | The Affiliated Hospital of Qingdao University | Completed | No outcome recorded |
| — | NCT05514405 | Aug 2022 → Aug 2026 overdue | osteoarthritis, knee | Inje University | Recruiting | No outcome recorded |
| — | NCT05453955 | Aug 2022 → Feb 2023 | vertebral column disorder | Korea University Guro Hospital | Completed | No outcome recorded |
| — | NCT05423951 | Jul 2022 → Nov 2023 | — | Seoul National University Hospital | Completed | Met primary |
| — | NCT06180876 | Jul 2022 → Jan 2024 | — | Zhihong LU | Completed | No outcome recorded |
| — | NCT05396690 | Jun 2022 → May 2023 | — | Ajou University School of Medicine | Unknown | No outcome recorded |
| — | NCT05375747 | Jun 2022 → Jan 2023 | hypotensive disorder | Seoul National University Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT05322902 | Jun 2022 → Jul 2023 | osteoarthritis, knee | Gangnam Severance Hospital | Completed | No outcome recorded |
| — | NCT05305248 | Apr → Sep 2022 | — | Gangnam Severance Hospital | Completed | No outcome recorded |
| — | NCT05350085 | Apr 2022 → Apr 2023 | anterograde amnesia | Peking Union Medical College Hospital | Unknown | Met primary |
| — | NCT05439057 | Apr 2022 → Oct 2024 | — | Inje University | Completed | No outcome recorded |
| — | NCT05160987 | Mar 2022 → Nov 2027 expected | — | Zhujiang Hospital | Recruiting | No outcome recorded |
| — | NCT05280236 | Mar 2022 → Apr 2024 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT05357430 | Mar 2022 → Apr 2023 | — | Yangzhou University | Completed | No outcome recorded |
| — | NCT05298228 | Mar 2022 → Jul 2023 | — | Yonsei University | Unknown | No outcome recorded |
| — | NCT05164146 | Feb → Aug 2022 | — | Yonsei University | Completed | Missed primary |
| — | NCT05164159 | Feb → Aug 2022 | acute cholecystitis | Yonsei University | Completed | No outcome recorded |
| — | NCT05201300 | Feb → Nov 2022 | — | Ajou University School of Medicine | Completed | No outcome recorded |
| — | NCT05574257 | Feb → May 2022 | female reproductive system disorder, urinary system disorder | Wonkwang University Hospital | Completed | No outcome recorded |
| — | NCT05047939 | Dec 2021 → Aug 2022 | — | Seoul National University Hospital | Completed | Met primary |
| — | NCT05103696 | Oct 2021 → Dec 2022 | — | Peking University People's Hospital | Completed | No outcome recorded |
| — | NCT05053763 | Sep 2021 → Dec 2022 | — | Jianbo Yu | Unknown | No outcome recorded |
| — | NCT05437497 | Aug 2021 → Dec 2022 | — | The Third Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| — | NCT04968054 | Jul 2021 → May 2023 | ossification of the posterior longitudinal ligament of the spine, spondylosis, cervical | Gangnam Severance Hospital | Completed | No outcome recorded |
| — | NCT04950621 | Jul 2021 → Jun 2022 | cerebrovascular disorder | Air Force Military Medical University, China | Completed | No outcome recorded |
| — | NCT04656964 | Apr 2021 → Dec 2022 | — | Peking University People's Hospital | Completed | No outcome recorded |
| — | NCT04727034 | Mar 2021 → Jul 2023 | gastric cancer | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT04658173 | Dec 2020 → Oct 2022 | — | Tianjin Nankai Hospital | Unknown | No outcome recorded |
| — | NCT04601350 | Nov 2020 → May 2022 | — | Yangzhou University | Completed | No outcome recorded |
| Comparator or background therapy31 trials | ||||||
| Phase 2 | NCT06231563 Comparator | Mar 2026 → Sep 2029 expected | Parkinson disease | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 3 | NCT07113483 Comparator | Oct 2025 → Jan 2026 overdue | — | Romanian Society for Enteral and Parenteral Nutrition | Recruiting | No outcome recorded |
| Phase 3 | NCT04901871 Comparator | May → Jul 2021 | — | Gangnam Severance Hospital | Completed | No outcome recorded |
| Phase 4 | NCT07675850 Comparator | Jul 2026 → Apr 2027 expected | — | Seoul National University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07347496 Comparator | Mar 2026 → May 2028 expected | — | The First Affiliated Hospital of Xinxiang Medical College | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07277881 Background | Jan 2026 → Oct 2027 expected | delirium | Medical University of Gdansk | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07213544 Comparator | Nov 2025 → Jan 2027 expected | — | Medical University of South Carolina | Recruiting | No outcome recorded |
| Phase 4 | NCT07161297 Comparator | Sep 2025 overdue | inflammatory bowel disease | Humanitas Clinical and Research Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07362173 Comparator | Mar 2025 → May 2026 overdue | chronic obstructive pulmonary disease, multiple organ dysfunction syndrome | Iuliu Hatieganu University of Medicine and Pharmacy | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07076628 Comparator | Aug 2023 → May 2025 | respiratory failure | DongGuk University | Completed | No outcome recorded |
| Phase 4 | NCT05688345 Comparator | Feb → Aug 2023 | — | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT05651399 Comparator | Dec 2022 → Jun 2023 | — | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT06095570 Comparator | Jul 2022 → Dec 2023 | — | The Second Affiliated Hospital of Hainan Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05447507 Comparator | Jul → Oct 2022 | musculoskeletal system disorder | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05468996 Comparator | May → Oct 2022 | — | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT05994547 Comparator | Apr 2022 → Jun 2023 | — | Chungbuk National University Hospital | Completed | Met primary |
| — | NCT07707258 Background | Jul → Sep 2026 overdue | — | Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | No outcome recorded |
| — | NCT07192549 Background | Sep 2025 → Sep 2030 expected | delirium | General Hospital of Ningxia Medical University | Not yet recruiting | No outcome recorded |
| — | NCT07035301 Background | Mar → Jul 2025 | respiratory system disorder | Harbin Medical University | Completed | No outcome recorded |
| — | NCT07002801 Background | Mar 2025 → Jun 2026 overdue | digestive system disorder | Harbin Medical University | Recruiting | No outcome recorded |
| — | NCT06755996 Background | Jan → Aug 2025 | — | Tongji Hospital | Completed | No outcome recorded |
| — | NCT06531915 Comparator | Dec 2024 | — | Anhui Provincial Hospital | Unknown | No outcome recorded |
| — | NCT06284668 Comparator | Mar 2024 → May 2025 | sleep disorder | Tianjin Medical University General Hospital | Completed | No outcome recorded |
| — | NCT06108830 Comparator | Dec 2023 → Nov 2024 overdue | sleep disorder | Tianjin Medical University General Hospital | Recruiting | No outcome recorded |
| — | NCT06385002 Comparator | Jul 2023 → Aug 2024 | — | Pusan National University Yangsan Hospital | Completed | No outcome recorded |
| — | NCT05785234 Background | Apr 2023 → Mar 2025 | gastric neoplasm | Yonsei University | Unknown | No outcome recorded |
| — | NCT05434494 Comparator | Jul 2022 → Jul 2023 | — | Ajou University School of Medicine | Unknown | No outcome recorded |
| — | NCT04994704 Comparator | Dec 2021 → Jul 2023 | — | Gangnam Severance Hospital | Completed | No outcome recorded |
| — | NCT05019222 Comparator | Sep 2021 → Aug 2022 | atlanto-axial fusion | Gangnam Severance Hospital | Completed | No outcome recorded |
| — | NCT05016518 Comparator | Sep 2021 → May 2022 | thyroid tumor | Gangnam Severance Hospital | Completed | No outcome recorded |
| — | NCT04983966 Comparator | Aug 2021 → Feb 2024 | — | Gangnam Severance Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2025-12-03 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory 恒瑞创新药甲苯磺酸瑞马唑仑新适应症上市申报获受理 hengrui.com ↗ |
| 2025-10-31 | Jiangsu HengRui Medicine Co., Ltd. | Results 恒瑞医药三项研究成果亮相2025美国麻醉医师协会（ASA）年会 hengrui.com ↗
甲苯磺酸瑞马唑仑组术后谵妄（POD）发生率显著低于丙泊酚组（4.4%[3/68]vs.17.6%[12/68]；风险差[RD]-13.2%，相对风险[RR]0.25，P=0.0143）。 |
| 2023-09-28 | Paion UK Ltd. | Regulatory PAION ANNOUNCES SUBMISSION OF NEW DRUG APPLICATION FOR REMIMAZOLAM BY ITS LICENSEE MUNDIPHARMA IN JAPAN paion.com ↗
In addition, a new application was submitted for an additional dosage form of remimazolam (Anerem® 20 mg) for Intravenous Injection for the indications of “induction and maintenance of general anaesthesia” and “sedation during examination and procedures in gastrointestinal endoscopy”. |
| 2023-08-31 | Paion UK Ltd. | Regulatory PAION receives UK MHRA approval of Byfavo® (remimazolam) for the induction and maintenance of general anesthesia in adults paion.com ↗
We are excited that the MHRA has approved Byfavo® for the induction and maintenance of general anesthesia in adults. |
| 2023-07-17 | Paion UK Ltd. | Regulatory PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR BYFAVO IN GENERAL ANESTHESIA IN THE PHILIPPINES paion.com ↗
Hana Pharm, licensee of Byfavo® for South Korea and Southeast Asia, has informed PAION that "ByfavoTM 50mg (Remimazolam besylate)" has been approved by the Philippine FDA for the induction and maintenance of general anesthesia. |
| 2023-01-19 | Paion UK Ltd. | Regulatory PAION ANNOUNCES SUBMISSION OF NEW DRUG APPLICATION FOR REMIMAZOLAM BY ITS LICENSEE CRISTÁLIA IN BRASIL paion.com ↗
We congratulate our partner Cristália on the submission of a marketing authorization application for remimazolam in Brazil. |
| 2022-11-14 | Paion UK Ltd. | Regulatory PAION AG’S PARTNER TTY BIOPHARM RECEIVES MARKET APPROVAL FOR REMIMAZOLAM IN PROCEDURAL SEDATION IN TAIWAN paion.com ↗
Aachen (Germany), 14 November 2022 – The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today informs that the Taiwan Food and Drug Administration (TFDA) has approved remimazolam for injection for the induction and maintenance of procedural sedation in adults. |
| 2021-12-31 | Paion UK Ltd. | Regulatory PAION SUBMITS EXTENSION APPLICATION OF MARKETING AUTHORIZATION FOR REMIMAZOLAM IN THE INDICATION GENERAL ANESTHESIA TO THE EUROPEAN MEDICINES AGENCY paion.com ↗
Based on the positive results in the EU Phase III trial in general anesthesia, PAION has now submitted an extension application to the marketing authorization for remimazolam in the indication of general anesthesia. |
| 2021-08-31 | Paion UK Ltd. | Regulatory PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR BYFAVO (REMIMAZOLAM) IN PROCEDURAL SEDATION IN SOUTH KOREA paion.com ↗
This additional approval of 'Byfavo 20mg' is expected to be widely used in endoscopy-related sedation procedures and surgeries. |
| 2021-07-09 | Paion UK Ltd. | Regulatory PAION ANNOUNCES THAT NMPA ACCEPTS SUBMISSION OF NEW DRUG APPLICATION FOR REMIMAZOLAM BESYLATE IN GENERAL ANESTHESIA BY CHINESE LICENSEE YICHANG HUMANWELL paion.com ↗
We are therefore very pleased that the second indication for use in general anesthesia has been submitted under an NDA, and look forward to the outcome of the NMPA review, and possibly further market expansion for use. |
| 2021-06-29 | Paion UK Ltd. | Regulatory PAION RECEIVES UK MHRA APPROVAL OF BYFAVO (REMIMAZOLAM) FOR PROCEDURAL SEDATION paion.com ↗
Aachen (Germany), 29 June 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo(R) (remimazolam besylate) in adults for procedural sedation. |
| 2020-11-19 | Paion UK Ltd. | Results PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA paion.com ↗
In the trial with 424 patients, remimazolam met both the primary and key secondary endpoints. |
| 2020-10-06 | Paion UK Ltd. | Regulatory PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S. paion.com ↗
PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) reports that Acacia Pharma (Acacia), remimazolam licensee for the U.S., today announced that the U.S. Drug Enforcement Administration (DEA) has designated the procedural sedative BYFAVO(TM) (remimazolam) as a Schedule IV medicine. |
| 2020-08-03 | Paion UK Ltd. | Regulatory PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE PROGRAM FOR REMIMAZOLAM IN BELGIUM paion.com ↗
PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the Federal Agency for Medicines and Health Products in Belgium (FAMHP) has granted approval for the compassionate use of remimazolam, an ultra-short-acting benzodiazepine sedative/anesthetic. |
| 2020-07-03 | Hana Pharm Co., Ltd. | Regulatory 하나제약, “레미마졸람, 미국 FDA 판매 허가 승인” hanaph.co.kr ↗
하나제약(293480, 대표 이윤하)은 독일 파이온(PAION)사의 미국 판권보유사가 미국 식품의약국(FDA, Food and Drug Administration)으로부터 마취제 신약 레미마졸람의 신약 허가를 승인받았다고 밝혔다. |
| 2020-07-02 | Paion UK Ltd. | Regulatory PAION ANNOUNCES U.S. FDA APPROVAL OF REMIMAZOLAM (BYFAVOTM) FOR THE INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION paion.com ↗
The specialty pharma company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the U.S. Food and Drug Administration (FDA) has approved BYFAVOTM (remimazolam) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. |
| 2020-06-02 | Paion UK Ltd. | Regulatory PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE FOR REMIMAZOLAM IN ITALIAN HOSPITAL paion.com ↗
PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the local Ethics Commitee of the Hospital San Raffaele in Milan/Italy has granted approval for the compassionate use of remimazolam for the use of sedation of five intensive care unit (ICU) patients with COVID-19. |
| 2020-03-12 | Paion UK Ltd. | Regulatory PAION AG: COSMO ANNOUNCES BRIEF EXTENSION OF FDA REVIEW PERIOD FOR NDA FOR REMIMAZOLAM paion.com ↗
In order for this data to be reviewed FDA has extended the PDUFA date to 5 July 2020. |
| 2019-06-12 | Hana Pharm Co., Ltd. | Results 하나제약, 세계심폐혈관마취학회에서 ‘레미마졸람’ 임상결과 발표 hanaph.co.kr ↗
한국과 유럽 대규모 임상 결과를 봤을 때, 레미마졸람은 프로포폴과 동일 효과가 있었으며, 혈역학적으로 부작용 발생 시 투여하는 노르에피네프린의 사용량이 프로포폴에 비해 감소한다는 점에서 레미마졸람의 우수성이 입증됐다. |
All press releases naming this drug 31 releases
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 259 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Remimazolam | “an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general...” NCT07675850 ↗230“This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients.” NCT04790734 ↗ “As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia.” NCT05624424 ↗ “Remimazolam is a new type of benzodiazepine drug that can be safely used for the induction and maintenance of general anesthesia” NCT05631028 ↗ “Anesthesia was induced by sequential intravenous injection of remimazolam, sufentanil, and rocuronium.” NCT07192549 ↗ “Remimazolam is a new rapid offset benzodiazepine used for procedural sedation and general anaesthesia.” PMID 35562226 ↗ May 2022 “all subjects were administered remimazolam via a TCI pump until they reached a state of mild sedation” NCT07109362 ↗ “Remimazolam is a new benzodiazepine for procedural sedation and general anaesthesia.” PMID 34246461 ↗ Jul 2021 “Remimazolam besylate is a newly marketed ultra-short-acting GABAa receptor agonist” NCT05758597 ↗ “Group B: Remimazolam Group” NCT06583811 ↗ “A. Remimazolam (CNS 7056)” NCT01145222 ↗ |
| Known as | Anerem | “Remimazolam (Anerem® in Japan; ByFavo™ in the USA; Aptimyda™ in the EU) is an ultra-short-acting intravenous (IV) benzodiazepine sedative/anesthetic being developed by PAION AG...” PMID 32274703 ↗ Apr 2020 |
| Known as | Aptimyda | “Remimazolam (Anerem® in Japan; ByFavo™ in the USA; Aptimyda™ in the EU) is an ultra-short-acting intravenous (IV) benzodiazepine sedative/anesthetic being developed by PAION AG...” PMID 32274703 ↗ Apr 2020 |
| Known as | BIPRAZINE PF | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297526 ↗ |
| Known as | Byfavo | “Remimazolam (Anerem® in Japan; ByFavo™ in the USA; Aptimyda™ in the EU) is an ultra-short-acting intravenous (IV) benzodiazepine sedative/anesthetic being developed by PAION AG...” PMID 32274703 ↗ Apr 202014“Remimazolam (Byfavo) is a novel benzodiazepine approved by the U.S. Food and Drug Administration in July 2020 for sedation in patients undergoing procedures less than 30...” NCT07325227 ↗ “Exploring the Use of Remimazolam (BYFAVO®) in Patients at High Risk for ERCP to Reduce Intraoperative Hypotension and Assess Safety and Efficacy: A Randomized Controlled Trial” NCT06258356 ↗ “REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]” NCT05423951 ↗ “Byfavo 20 mg powder for solution for injection, remimazolam.” NCT06614036 ↗ “Remimazolam 20 MG Injection [Byfavo]” NCT06398275 ↗ “Remimazolam 20 MG Injection [Byfavo]” NCT07704437 ↗ “Remimazolam Injection [Byfavo]” NCT05396690 ↗ “Remimazolam Injection [Byfavo]” NCT05041725 ↗ “Drug: Remimazolam (Byfavo)” NCT05514405 ↗ “Remimazolam (Byfavo)” NCT07620782 ↗ |
| Known as | CNS 7056 | “A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety,...” PMID 22190555 ↗ Dec 20113“A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy.” PMID 29723512 ↗ Apr 2018 “A. Remimazolam (CNS 7056)” NCT01145222 ↗ |
| Known as | CNS 7056 besylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297526 ↗ |
| Known as | CNS 7056B | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297526 ↗ |
| Known as | CNS 70754 | “The goal of this clinical trial is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of remimazolam (CNS 70754) in healthy adult participants.” NCT07045467 ↗ |
| Known as | GW-502056X | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297526 ↗ |
| Known as | HR7056 | “HR7056 is a new benzodiazepine, showing more faster acting onset and recovery than currently available short-acting sedatives.” PMID 30510509 ↗ Nov 20181“PURPOSE: Remimazolam tosylate (HR-7056) is a novel ester-type benzodiazepine with ultrafast onset of effect.” PMID 32178858 ↗ Mar 2020 |
| Known as | ONO-2745 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297526 ↗ |
| Known as | ONO-2745BS | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297526 ↗ |
| Known as | ONO-IN-251 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297526 ↗ |
| Known as | Remimazolam (CNS 7056) | “Remimazolam (CNS 7056)” NCT04611425 ↗ |
| Known as | Remimazolam besilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297526 ↗ |
| Known as | Remimazolam besylate | “Remimazolam besylate (RB), as a new benzodiazepine sedative agent, has been approved in clinical anesthesia with prominent characteristics of short onset/offset, less...” NCT06717945 ↗24“Remimazolam Besylate is a 1.1 class new drug that acts on GABA receptors and is metabolized by plasma esterase with fast metabolism time, only 1/7 of midazolam, which may be...” NCT05103696 ↗ “Remimazolam besylate is a new type of water-soluble ultra short acting benzodiazepine drug that is hydrolyzed and metabolized by plasma esterase in the body, independent of...” NCT06061159 ↗ “Remimazolam besylate is a novel, ultra-short-acting benzodiazepine that undergoes organ-independent metabolism by tissue esterases into an inactive metabolite.” NCT06496165 ↗ “Remimazolam besylate is a novel ultra-short-acting benzodiazepine that can potentially be a safe and effective sedative in intensive care units.” PMID 37576823 ↗ Jul 2023 “Remimazolam besylate, as a novel anesthetic drug, has not yet had its advantages in thoracoscopic surgery in elderly patients fully clarified.” NCT07086911 ↗ “Remimazolam Besylate (Trade name: Rymazol®), supplied as a lyophilized powder (25 mg/vial) reconstituted with sterile water.” NCT07045467 ↗ “Participants in the remimazolam group will be intravenously injected with 0.1 mg/kg of remimazolam besylate” NCT06531915 ↗ “After regional anesthesia, remimazolam besylate was administered at the assigned dose.” PMID 38378937 ↗ Feb 2024 “Remimazolam besylate is a newly marketed ultra-short-acting GABAa receptor agonist” NCT05758597 ↗ “Remimazolam besylate and low-dose Esketamine” NCT06303037 ↗ |
| Known as | Remimazolam Tosilate | “A Multi-center, Randomized, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Remimazolam Tosilate (Ruibeining®) for Injection for Sedation in Non-intubated...” NCT06216444 ↗13“The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in Upper Gastrointestinal Endoscopy” NCT06169995 ↗ “To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation” NCT05015361 ↗ “Remimazolam tosilate, an ultra-short-acting benzodiazepine, offers a promising safety profile” NCT07467603 ↗ “Remimazolam tosilate (RT) is a new short-acting GABA(A) receptor agonist” PMID 32677707 ↗ Jul 2020 “Remimazolam Tosilate for Injection 0.1mg/kg at induction” NCT04908553 ↗ “IV Remimazolam tosilate 0.3mg/kg” NCT05255211 ↗ “Drug: Remimazolam Tosilate” NCT06222294 ↗ “Drug: Remimazolam Tosilate” NCT03921775 ↗ “Drug: Remimazolam Tosilate” NCT07035301 ↗ |
| Known as | Remimazolam tosylate | “Remimazolam tosylate, a novel benzodiazepine with rapid onset and short duration, metabolized by tissue esterases, represents a promising agent for ICU sedation.” PMID 42164575 ↗ Mar 20264“IV bolus of Remimazolam Tosylate with a loading dose of 0.4mg/kg body weight over 1 minute followed by a maintenance dose of 1.5mg/kg/h over 2 hours.” NCT03444480 ↗ “Single IV bolus of Remimazolam Tosylate over 1 minute at 0.01 mg/kg body weight” NCT01970072 ↗ “Remimazolam tosylate, a novel short-acting benzodiazepine” PMID 41855428 ↗ Mar 2026 “Remimazolam tosylate is a novel benzodiazepine drug” NCT05876793 ↗ |
| Known as | RF-10007 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297526 ↗ |
| Known as | Ruibeining | “A Multi-center, Randomized, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Remimazolam Tosilate (Ruibeining®) for Injection for Sedation in Non-intubated...” NCT06216444 ↗ |
| Known as | Ruima | “this clinical study was initiated by Yichang Humanwell Pharmaceutical Co., Ltd. to obtain approval from the Center for Drug Evaluation (CDE) of the National Medical Products...” PMID 41915173 ↗ Mar 2026 |
| Known as | Rymazol | “Remimazolam Besylate (Trade name: Rymazol®), supplied as a lyophilized powder (25 mg/vial) reconstituted with sterile water.” NCT07045467 ↗ |
| Known as | SP148.5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297526 ↗ |
| Action | Activate | “Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor.” NCT05201300 ↗ |
| Modality | Small molecule | “Remimazolam is an ultra-short-acting benzodiazepine” PMID 26363333 ↗ Sep 2015 |
| Route | Intravenous | “Patients received their assigned treatment administered as a single intravenous injection by a syringe driver over 1 minute” NCT00869440 ↗ |