Propofol - PharmaKB

Propofol

Diprivan, Propofol (propofol) is a small molecule pharmaceutical. Propofol was first approved as Diprivan on 1989-10-02. It is used to treat delirium, pain, psychomotor agitation, and status epilepticus in the USA. It is known to target potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 1.

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nervous system diseases	D009422
signs and symptoms pathological conditions	D013568
behavior and behavior mechanisms	D001520
psychological phenomena	D011579
mental disorders	D001523
musculoskeletal and neural physiological phenomena	D055687

Trade Name

FDA

EMA

Diprivan (generic drugs available since 1999-01-04)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Propofol

Tradename	Company	Number	Date	Products
DIPRIVAN	Fresenius Kabi	N-019627 RX	1996-06-11	1 products, RLD, RS

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FDA

EMA

Brand Name	Status	Last Update
diprivan	New Drug Application	2024-04-18
propofol	ANDA	2024-08-21
propofol 1%	unapproved drug other	2023-12-27
propofol injectable emulsion	ANDA	2022-09-30
propofol lipuro	unapproved drug other	2021-12-20

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
pain	EFO_0003843	D010146	R52
delirium	—	D003693	R41.0
psychomotor agitation	—	D011595	—
status epilepticus	EFO_0008526	D013226	G41

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Propofol, Diprivan, Fresenius Kabi Usa
8476010	2024-12-01	DS, DP

ATC Codes

N: Nervous system drugs

— N01: Anesthetics

— N01A: Anesthetics, general

— N01AX: Other general anesthetics in atc

— N01AX10: Propofol

HCPCS

Code	Description
J2704	Injection, propofol, 10 mg

Clinical

Clinical Trials

2376 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	—	—	11	7	25	71	169	280
General anesthesia	D000768	—	—	6	3	13	23	75	119
Postoperative pain	D010149	—	G89.18	2	5	8	28	66	107
Delirium	D003693	—	R41.0	5	3	3	31	54	94
Emergence delirium	D000071257	—	—	4	2	3	20	50	77
Intravenous anesthesia	D000771	—	—	—	2	2	20	49	73
Pain	D010146	EFO_0003843	R52	4	4	4	19	31	58
Cognitive dysfunction	D060825	HP_0001268	G31.84	1	1	2	18	22	44
Hypotension	D007022	EFO_0005251	I95	1	3	1	8	28	40
Healthy volunteers/patients	—	—	—	4	—	—	14	13	31

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Renal insufficiency	D051437	HP_0000083	N19	1	1	3	—	3	8
Anesthesia and analgesia	D000760	—	—	—	1	3	—	5	8
Status epilepticus	D013226	EFO_0008526	G41	—	1	5	—	3	8
Injection site reaction	D000075662	—	—	—	2	1	—	6	8
Dyssomnias	D020920	—	—	1	—	1	—	4	6
Esophageal neoplasms	D004938	—	C15	—	—	1	—	4	5
Chronic renal insufficiency	D051436	—	N18	—	—	2	—	2	4
Pruritus	D011537	HP_0000989	L29	2	—	1	—	1	4
Blood pressure	D001794	EFO_0004325	—	—	1	1	—	3	4
Hepatectomy	D006498	—	—	1	—	1	—	2	4

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Subdural hematoma chronic	D020200	—	—	1	3	—	—	2	5
Lung injury	D055370	—	S27.30	1	1	—	—	4	5
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	1	—	—	2	3
Traumatic stress disorders	D040921	—	—	—	1	—	—	2	3
Airway remodeling	D056151	—	—	—	1	—	—	1	2
Newborn infant diseases	D007232	—	—	—	1	—	—	1	2
Intracranial pressure	D007427	—	—	1	1	—	—	1	2
Obstructive lung diseases	D008173	HP_0006536	—	—	1	—	—	1	2
Hematologic diseases	D006402	EFO_0005803	D75.9	2	2	—	—	—	2
Radical mastectomy	D015409	—	—	1	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Respiration disorders	D012120	—	J00-J99	1	—	—	—	3	4
Spinal stenosis	D013130	EFO_0007490	M48.0	2	—	—	—	2	4
Respiratory tract diseases	D012140	—	—	1	—	—	—	2	3
Tympanic membrane perforation	D018058	—	H72	1	—	—	—	1	2
Femur head necrosis	D005271	—	—	1	—	—	—	—	1
Vital signs	D055986	EFO_0004303	—	1	—	—	—	—	1
Cortical spreading depression	D013181	—	—	1	—	—	—	—	1
Insulin resistance	D007333	HP_0000855	—	1	—	—	—	—	1
Snoring	D012913	—	R06.83	1	—	—	—	—	1
Sleep initiation and maintenance disorders	D007319	—	F51.01	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Anxiety disorders	D001008	EFO_0006788	F41.1	—	—	—	—	7	7
Cardiopulmonary bypass	D002315	—	—	—	—	—	—	6	6
Brain ischemia	D002545	EFO_0003883	I67.82	—	—	—	—	6	6
Hypersensitivity	D006967	HP_0012393	T78.40	—	—	—	—	6	6
Colonic polyps	D003111	—	K63.5	—	—	—	—	5	5
One-lung ventilation	D061810	—	—	—	—	—	—	5	5
Consciousness monitors	D056805	—	—	—	—	—	—	5	5
Acute cholecystitis	D041881	EFO_1001289	K81.0	—	—	—	—	4	4
Spinal diseases	D013122	—	M45-M49	—	—	—	—	4	4
Airway management	D058109	—	—	—	—	—	—	4	4

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Propofol
INN	propofol
Description	Propofol is a phenol resulting from the formal substitution of the hydrogen at the 2 position of 1,3-diisopropylbenzene by a hydroxy group. It has a role as an intravenous anaesthetic, a sedative, a radical scavenger, an antiemetic and an anticonvulsant.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)c1cccc(C(C)C)c1O