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

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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, Propofol (discontinued: Diprivan, Propofol)

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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Labels

FDA

EMA

Brand Name	Status	Last Update
diprivan	New Drug Application	2025-09-11
propofol	ANDA	2026-09-18
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

No data

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

2848 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	—	—	16	7	26	79	192	317
General anesthesia	D000768	—	—	7	3	14	28	95	146
Postoperative pain	D010149	—	G89.18	2	8	12	35	92	144
Emergence delirium	D000071257	—	—	6	3	4	30	65	105
Delirium	D003693	—	R41.0	7	2	4	32	60	104
Intravenous anesthesia	D000771	—	—	—	2	2	24	74	102
Pain	D010146	EFO_0003843	R52	6	5	4	21	36	68
Hypotension	D007022	EFO_0005251	I95	1	3	4	13	34	54
Postoperative nausea and vomiting	D020250	EFO_0004888	—	—	1	1	16	25	43
Hypoxia	D000860	—	R09.02	1	—	2	7	32	42

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Anesthesia and analgesia	D000760	—	—	1	1	3	—	15	19
Renal insufficiency	D051437	—	N19	1	1	3	—	4	9
Anxiety disorders	D001008	EFO_0006788	F41.1	1	—	1	—	7	9
Status epilepticus	D013226	EFO_0008526	G41	—	1	6	—	3	9
Injection site reaction	D000075662	—	—	—	2	1	—	6	8
Chronic renal insufficiency	D051436	—	N18	—	—	2	—	4	6
Parasomnias	D020447	—	G47.5	2	—	1	—	3	6
Esophageal neoplasms	D004938	—	C15	—	—	1	—	4	5
Kidney transplantation	D016030	—	—	—	—	1	—	4	5
Blood pressure	D001794	EFO_0004325	—	—	1	1	—	3	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	1	—	—	2	4
Intracranial pressure	D007427	—	—	1	1	—	—	2	3
Airway remodeling	D056151	—	—	—	1	—	—	1	2
Newborn infant diseases	D007232	—	—	—	1	—	—	1	2
Low back pain	D017116	—	M54.5	—	1	—	—	1	2
Spondylolisthesis	D013168	EFO_0007493	M43.1	—	1	—	—	1	2
Obstructive lung diseases	D008173	—	—	—	1	—	—	1	2
Hematologic diseases	D006402	EFO_0005803	D75.9	2	2	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Anxiety	D001007	EFO_0005230	F41.1	1	—	—	—	4	5
Spinal stenosis	D013130	EFO_0007490	M48.0	2	—	—	—	3	5
Sleep deprivation	D012892	—	F51.12	1	—	—	—	3	4
Respiration disorders	D012120	—	J00-J99	1	—	—	—	3	4
Traumatic stress disorders	D040921	—	—	1	—	—	—	2	3
Respiratory tract diseases	D012140	—	—	1	—	—	—	2	3
Dyssomnias	D020920	—	—	1	—	—	—	2	3
Digestive system neoplasms	D004067	—	—	1	—	—	—	2	3
Frailty	D000073496	—	R53.1	1	—	—	—	2	3
Tympanic membrane perforation	D018058	—	H72	1	—	—	—	1	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Brain ischemia	D002545	EFO_0003883	I67.82	—	—	—	—	7	7
Cardiopulmonary bypass	D002315	—	—	—	—	—	—	6	6
Acute cholecystitis	D041881	EFO_1001289	K81.0	—	—	—	—	5	5
Hypersensitivity	D006967	EFO_0003785	T78.40	—	—	—	—	5	5
One-lung ventilation	D061810	—	—	—	—	—	—	5	5
Consciousness monitors	D056805	—	—	—	—	—	—	5	5
Dreams	D004325	—	—	—	—	—	—	5	5
Spinal diseases	D013122	—	M45-M49	—	—	—	—	4	4
Intraoperative complications	D007431	—	—	—	—	—	—	4	4
Invasive hydatidiform mole	D002820	—	D39.2	—	—	—	—	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	GABAA receptor agonist;sedative;general anesthetic
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)c1cccc(C(C)C)c1O