CDEK
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remimazolam

Trade name: Byfavo

Small moleculeapproved

Approved

Jul 2, 2020

Remimazolam, sold under the brand name Byfavo, is a medication for the induction and maintenance of procedural sedation in adults for invasive diagnostic or surgical procedures lasting 30 minutes or less. It is a benzodiazepine drug, developed by PAION AG in collaboration with several regional licensees as an alternative to the short-acting imidazobenzodiazepine midazolam, for use in the induction of anesthesia and conscious sedation for minor invasive procedures. — Wikipedia

Clinical trial activity

220 trials · 120 clinical orgs · 1 marketing orgs

Phase 1
17
Phase 2
42
Phase 3
26
Phase 4
67

Earliest trial started Mar 1, 2009 (NCT00869440)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Jul 2, 2020

    Acacia Pharma Ltd — Earliest FDA Approval

  2. Jul 2, 2020

    Acacia Pharma Ltd — Marketing Organization

  3. Jul 2, 2020

    Acacia Pharma Ltd — NDA Secondary Org

  4. Jul 2, 2020

    Acacia Pharma Ltd — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJul 2, 2020

Chemistry & pharmacology

Loading structure…

SMILES

COC(=O)CC[C@@H]1N=C(c2ccccn2)c2cc(Br)ccc2-n2c(C)cnc21.Cc1ccc(S(=O)(=O)O)cc1
Mol. weight
611.52 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • cns 7056
  • cns 7056
  • cns 7056
  • methyl 3-(8-bromo-1-methyl-6-(2-pyridinyl)-4h-imidazo(1,2-a)(1,4)benzodiazepin-4-yl)propanoate
  • ono2745
  • ono 2745
  • ono-2745
  • ono-2745
  • ono-2745
  • remimazolam
  • remimazolam
  • remimazolam
  • remimazolam

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07290205Early Phase 1 (Phase 1)Mar 1, 2026National Institute of General Medical Sciences (NIGMS), University of Pittsburgh
NCT07251101N/AJan 2, 2026Ilsan Hospital
NCT07265050N/AJan 1, 2026Seoul National University
NCT07303985Phase 4Dec 31, 2025Fudan University
NCT07277881Phase 4Dec 31, 2025Medical University of Gdansk
NCT07265128Phase 4Dec 31, 2025Yonsei University
NCT06810843N/ADec 31, 2025Shandong first medical University, Shandong Province Qianfoshan Hospital
NCT07269808Phase 3Dec 1, 2025Harvard University
NCT07213544Phase 4Nov 12, 2025Medical University of South Carolina
NCT07194109Phase 4Oct 1, 2025Anhui Medical University
NCT07155265Phase 3Oct 1, 2025Yancheng First People's Hospital
NCT07113483Phase 3Oct 1, 2025Romanian Society for Enteral and Parenteral Nutrition
NCT07118579Phase 4Sep 23, 2025Huazhong University of Science and Technology
NCT07161297Phase 4Sep 1, 2025Humanitas University
NCT07086911Phase 1/Phase 2 (Phase 2)Aug 31, 2025Kunming Medical University
NCT07094945Phase 4Aug 15, 2025Huazhong University of Science and Technology
NCT06793358Phase 4Jul 31, 2025Indiana University
NCT07036419Phase 2Jul 10, 2025Hengrui Therapeutics, Inc.
NCT07045467Phase 1Jul 1, 2025Shandong Province Qianfoshan Hospital
NCT07012902Early Phase 1 (Phase 1)Jun 12, 2025Shanxi Medical University
Showing 20 of 220 trials
Page 1 / 11

Organizations

Research & Development (120)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Yonsei UniversityAcademic/Hospital222232021
Huazhong University of Science and TechnologyAcademic/Hospital181742021
Paion UK Ltd.For profit151332009
Hengrui Therapeutics, Inc.For profit141442013
Seoul National UniversityAcademic/Hospital121232021
Chinese Academy of Medical SciencesAcademic/Hospital6542020
Peking UniversityAcademic/Hospital6622020
University of UlsanAcademic/Hospital6612022
Wenzhou Medical UniversityAcademic/Hospital6612020
Capital Medical UniversityAcademic/Hospital5322022
Jiao Tong UniversityAcademic/Hospital5522021
Nanchang UniversityAcademic/Hospital5422021
Pharmaceutical Research Associates, Inc. (PRA)For profit5022015
Sichuan UniversityAcademic/Hospital5332022
Tianjin University of Traditional Chinese MedicineAcademic/Hospital5322020
Yichang Humanwell Pharmaceutical Co.,LtdFor profit5032021
Air Force Military Medical University, ChinaAcademic/Hospital4412021
Hana Pharmaceutical Co., LtdFor profit4032021
Pusan National UniversityAcademic/Hospital4412023
Shanxi Medical UniversityAcademic/Hospital4322021
120 organizations
Page 1 / 6

Marketing (3)

OrganizationOrg typeRelationshipDate
Acacia Pharma LtdFor profitMKTGJul 2, 2020
Acacia Pharma LtdFor profitNDA2Jul 2, 2020
Acacia Pharma LtdFor profitNDAJul 2, 2020