Remimazolam - PharmaKB

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

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
anesthesia and analgesia	D000760

Trade Name

FDA

EMA

Byfavo

Drug Products

FDA

EMA

New Drug Application (NDA)

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	2023-10-16

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
conscious sedation	—	D016292	—

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

ATC Codes

N: Nervous system drugs

— N05: Psycholeptics

— N05C: Hypnotics and sedatives

— N05CD: Benzodiazepine derivative hypnotics and sedatives

— N05CD14: Remimazolam

HCPCS

No data

Clinical

Clinical Trials

203 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	—	—	3	1	1	4	7	16
General anesthesia	D000768	—	—	—	2	2	6	6	16
Emergence delirium	D000071257	—	—	—	1	—	4	5	10
Hypotension	D007022	EFO_0005251	I95	—	—	—	3	7	10
Delirium	D003693	—	R41.0	—	1	—	4	4	9
Intravenous anesthesia	D000771	—	—	—	—	1	3	3	7
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	2	4	6
Healthy volunteers/patients	—	—	—	3	—	1	1	—	5
Orthopedic procedures	D019637	—	—	—	—	—	4	1	5
Spinal anesthesia	D000775	—	—	—	—	—	2	3	5

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Atrial fibrillation	D001281	EFO_0000275	I48.0	—	—	1	—	3	4
Critical illness	D016638	—	—	—	2	1	—	—	3
Postoperative pain	D010149	—	G89.18	—	—	1	—	2	3
Colonoscopy	D003113	—	—	—	—	2	—	—	2
Unconsciousness	D014474	HP_0007185	R40.20	—	—	1	—	1	2
Analgesia	D000698	—	—	—	—	1	—	—	1
Tooth extraction	D014081	—	—	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Mechanical ventilators	D012122	—	—	—	2	—	—	—	2
Covid-19	D000086382	—	—	—	1	—	—	—	1
Sepsis	D018805	HP_0100806	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
Conscious sedation	D016292	—	—	—	1	—	—	—	1
Deep sedation	D054810	—	—	—	1	—	—	—	1

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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
Liver diseases	D008107	HP_0002910	K70-K77	1	—	—	—	—	1
Kidney transplantation	D016030	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gastrointestinal endoscopy	D016099	—	—	—	—	—	—	5	5
Stomach neoplasms	D013274	EFO_0003897	C16	—	—	—	—	4	4
Hypoxia	D000860	HP_0012418	R09.02	—	—	—	—	3	3
Leiomyoma	D007889	HP_0000131	D25	—	—	—	—	3	3
Myofibroma	D047708	—	—	—	—	—	—	3	3
Ambulatory surgical procedures	D000556	—	—	—	—	—	—	3	3
Prostatic neoplasms	D011471	—	C61	—	—	—	—	3	3
Thyroid diseases	D013959	HP_0000820	E00-E07	—	—	—	—	2	2
Acute cholecystitis	D041881	EFO_1001289	K81.0	—	—	—	—	2	2
Cholecystitis	D002764	HP_0001082	K81	—	—	—	—	2	2

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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