Remimazolam clinical trials
Remimazolam is named as an intervention in 37 current clinical trials in our China, South Korea, Taiwan, USA, Denmark, Italy, Netherlands and Brazil registers. 19 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Beijing Tsinghua Chang Gung Hospital (3). The most-studied condition is Remimazolam. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Remimazolam is approved
All regulators →Of the three regulators tracked here, the first to approve Remimazolam was the US, on 2 Jul 2020. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Remimazolam patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Remimazolam, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 11 listed patents; the last listed expires 13 Jan 2034 (US 9827251).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Remimazolam
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Remimazolam works
All drug targets →- GABA-A receptor; anion channel positive allosteric modulator Positive allosteric modulatorTarget: GABA-A receptor; anion channelChEMBL only
- Cognitive impairmentPhase 3
- Loss of consciousnessPhase 3
- SedationPhase 3
- Acute respiratory failurePhase 2
- PregnancyPhase 2
- Hypotensive disorderPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297526, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8442, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Remimazolam
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ByfavoEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Remimazolam
37 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Remimazolam in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Remimazolam. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Efficacy and safety of Remimazolam compared to Ketamine and Propofol in Rapid Sequence Induction. A monocentric pilot randomised-controlled study
2025-521602-18-00 · CTIS ↗ · Anesthesia and Analgesia
|
Phase 2 | Authorised | Centre Hospitalier Universitaire De Nantes | France |
|
Rapid sequence emergence of general Anaesthesia
2024-516415-24-03 · CTIS ↗ · Anesthesia and Analgesia
|
Phase 4 | Authorised | Stichting Radboud universitair medisch centrum | Netherlands |
Remimazolam across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Remimazolam on the HPRA medicines list.
- Byfavo 50 mg powder for concentrate for solution for injection/infusionPaion Pharma GmbH · EU/1/20/1505/002
Supply shortages
No entry for Remimazolam in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Remimazolam
74 conditionsAll 74 conditions
| Condition (as registered) | Trials |
|---|---|
| Remimazolam | 7 |
| Propofol | 5 |
| Sedation | 3 |
| Delirium | 2 |
| Postoperative Delirium | 2 |
| Dexmedetomidine | 2 |
| Cholelithiasis | 2 |
| Remimazolam Besylate | 2 |
| Hemodynamic Stability | 2 |
| General Anesthesia | 2 |
| Pediatric ALL | 1 |
| Benzodiazepines | 1 |
| Bladder Cancer | 1 |
| Surgery | 1 |
| Cognitive Functioning | 1 |
| Circadian Rhythm | 1 |
| Induction Anesthesia | 1 |
| Drug Interactions | 1 |
| Spinal Cord Neoplasms | 1 |
| Spinal Neoplasms | 1 |
| Intraoperative Hypotension | 1 |
| Hepatectomy | 1 |
| Mechanical Ventilation | 1 |
| Brain Network Connectivity | 1 |
| Postoperative Nausea and Vomiting | 1 |
| Anesthesia | 1 |
| Surgery-Complications | 1 |
| Esketamine | 1 |
| Pediatric | 1 |
| Neurosurgery | 1 |
| Sevoflurane Anesthesia | 1 |
| Mechanically Ventilated ICU Patients | 1 |
| Peritoneal Neoplasms | 1 |
| Postoperative Recovery | 1 |
| Thoracoscopic Lobectomy | 1 |
| Oxygenation | 1 |
| Postoperative Cognitive Dysfunction | 1 |
| Sedation and Analgesia | 1 |
| Tonsillectomy With or Without Adenoidectomy | 1 |
| Pulmonary Infection | 1 |
| Pulmonary Nodule | 1 |
| Phthisis | 1 |
| Endotracheal Tumour | 1 |
| Coronary Artery Bypass Grafting | 1 |
| Coronary Artery Disease | 1 |
| Postoperative Sleep | 1 |
| Gastric Cancer | 1 |
| Myocardial Injury | 1 |
| IBD (Inflammatory Bowel Disease) | 1 |
| Sedation for Diagnostic Gastroscopy | 1 |
| Intravenous Anesthesia | 1 |
| Acute Kidney Injury | 1 |
| Hysteroscopy | 1 |
| Ambulatory Surgery | 1 |
| Laparoscopic Surgery | 1 |
| Sedation During Lower Extremity Surgery Under Spinal Anesthesia | 1 |
| Emergence Agitation | 1 |
| Nasal Surgical Procedures | 1 |
| Anesthesia, Intravenous | 1 |
| Gynecologic Surgery | 1 |
| Hip Fractures | 1 |
| Knee Osteoarthritis | 1 |
| Femur Fracture | 1 |
| Critical Illness | 1 |
| Aged | 1 |
| Cardiopulmonary Bypass | 1 |
| Postoperative Complications | 1 |
| Respiratory Depression | 1 |
| Postoperative Nausea | 1 |
| Vomiting | 1 |
| Hemodynamic | 1 |
| Cardiac Electrophysiology | 1 |
| OSAS (Obstructive Sleep Apneas Syndrome) | 1 |
| DISE | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Beijing Tsinghua Chang Gung Hospital | 3 |
| Peking University First Hospital | 2 |
| First Affiliated Hospital of Zhejiang University | 2 |
| Acacia Pharma Ltd | 1 |
| The Second Affiliated Hospital of Chongqing Medical University | 1 |
| Second Hospital of Shanxi Medical University | 1 |
| Beijing Tiantan Hospital | 1 |
| Xi'an Aerospace General Hospital | 1 |
| Nanfang Hospital, Southern Medical University | 1 |
| Maternal and Child Health Hospital of Hubei Province | 1 |
| Southeast University, China | 1 |
| Jinqiao Qian | 1 |
| Zhujiang Hospital | 1 |
| Tongji Hospital | 1 |
| Yangzhou University | 1 |
+ 18 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Remimazolam trials
How many clinical trials are testing Remimazolam?
37 current trials in our China, South Korea, Taiwan, USA, Denmark, Italy, Netherlands and Brazil registers name Remimazolam as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Remimazolam trials recruiting patients?
Yes. 19 of the 37 trials are recruiting: 14 with sites in China, 2 with sites in South Korea, 1 with sites in Taiwan, 1 with sites in Netherlands and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Remimazolam clinical trials?
Beijing Tsinghua Chang Gung Hospital (3), Peking University First Hospital (2), First Affiliated Hospital of Zhejiang University (2) and Acacia Pharma Ltd (1), among 33 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Remimazolam licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Remimazolam, for example Byfavo 50 mg powder for concentrate for solution for injection/infusion (Paion Pharma GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Remimazolam shortage?
Not in the lists we track: Remimazolam has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Remimazolam works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Remimazolam works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Remimazolam (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.