Byfavo(remimazolam)
Byfavo (remimazolam) is a small molecule pharmaceutical. Remimazolam was first approved as Byfavo on 2020-10-06. It has been approved in Europe to treat conscious sedation.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| anesthesia and analgesia | D000760 |
Trade Name
FDA
EMA
Byfavo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Remimazolam besylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BYFAVO | Acacia Pharma | N-212295 RX | 2020-10-06 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| byfavo | New Drug Application | 2020-11-23 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
REMIMAZOLAM BESYLATE, BYFAVO, ACACIA | |||
| 2025-10-06 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Remimazolam Besylate, Byfavo, Acacia | |||
| 9561236 | 2033-04-30 | U-2968 | |
| 9737547 | 2031-11-07 | U-2968 | |
| 9827251 | 2031-11-07 | U-2968 | |
| 10052334 | 2031-11-07 | U-2968 | |
| 10195210 | 2031-11-07 | U-2968 | |
| 10342800 | 2031-11-07 | U-2968 | |
| 10722522 | 2031-11-07 | U-2968 | |
| 9777007 | 2027-07-10 | DP | |
| 9914738 | 2027-07-10 | DP | |
| 10472365 | 2027-07-10 | U-2968 | |
| 10961250 | 2027-07-10 | DP | U-2968 |
HCPCS
No data
Clinical
Clinical Trials
133 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anesthesia | D000758 | 2 | 1 | 1 | 3 | 3 | 10 | ||
| General anesthesia | D000768 | — | 2 | 1 | 2 | 3 | 8 | ||
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | 2 | 4 | 6 |
| Orthopedic procedures | D019637 | — | — | — | 4 | 1 | 5 | ||
| Healthy volunteers/patients | — | 3 | — | — | 1 | — | 4 | ||
| Intravenous anesthesia | D000771 | — | — | 1 | 1 | 1 | 3 | ||
| Spinal anesthesia | D000775 | — | — | — | 2 | 1 | 3 | ||
| Emergence delirium | D000071257 | — | — | — | 1 | 1 | 2 | ||
| Bronchoscopy | D001999 | — | — | 1 | 1 | — | 2 | ||
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | 1 | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | — | 1 | — | — | — | 1 | |
| Sepsis | D018805 | A41.9 | — | 1 | — | — | — | 1 | |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | — | 1 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 1 | — | — | — | 1 |
| Shock | D012769 | R57.1 | — | 1 | — | — | — | 1 | |
| Wounds and injuries | D014947 | T14.8 | — | 1 | — | — | — | 1 | |
| Endoscopy | D004724 | — | 1 | — | — | — | 1 | ||
| Critical illness | D016638 | — | 1 | — | — | — | 1 | ||
| Deep sedation | D054810 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biological availability | D001682 | 1 | — | — | — | — | 1 | ||
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal endoscopy | D016099 | — | — | — | — | 3 | 3 | ||
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 2 | 2 |
| Laparoscopic cholecystectomy | D017081 | — | — | — | — | 2 | 2 | ||
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | — | — | 1 | 1 | |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 1 | 1 |
| Hypoxia | D000860 | R09.02 | — | — | — | — | 1 | 1 | |
| Ossification of posterior longitudinal ligament | D017887 | M48.8 | — | — | — | — | 1 | 1 | |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | — | — | 1 | 1 |
| Neoplasms | D009369 | C80 | — | — | — | — | 1 | 1 | |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | REMIMAZOLAM |
| INN | remimazolam |
| Description | 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. Remimazolam was found to have both a more rapid onset and a shorter duration than midazolam, and human clinical trials showed a faster recovery time and predictable, consistent pharmacokinetics, suggesting some advantages over existing drugs for these applications.
|
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)CC[C@@H]1N=C(c2ccccn2)c2cc(Br)ccc2-n2c(C)cnc21 |
Identifiers
| PDB | — |
| CAS-ID | 308242-62-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297526 |
| ChEBI ID | — |
| PubChem CID | 9867812 |
| DrugBank | DB12404 |
| UNII ID | 7V4A8U16MB (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 312 documents
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Safety
Black-box Warning
Black-box warning for: Byfavo
Adverse Events
Top Adverse Reactions
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6,444 adverse events reported
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