Ondansetron - PharmaKB

Ondansetron

Ondansetron (ondansetron) is a small molecule pharmaceutical. Ondansetron was first approved as Zofran on 1991-01-04. It is used to treat alcoholism in the USA.

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Clinical

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Events Timeline

YTD

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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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Completion date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
chemically-induced disorders	D064419
mental disorders	D001523

Trade Name

FDA

EMA

Ondansetron (discontinued: Ondansetron, Zofran, Zuplenz)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ondansetron hydrochloride

Tradename	Company	Number	Date	Products
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	GSK	N-020403 DISCN	1995-01-31	1 products, RLD
ZOFRAN	Sandoz	N-020007 DISCN	1991-01-04	1 products, RLD
ZOFRAN PRESERVATIVE FREE	Sandoz	N-020007 DISCN	1993-12-10	1 products, RLD
ZOFRAN	Sandoz	N-020103 DISCN	1992-12-31	3 products, RLD
ZOFRAN	Sandoz	N-020605 DISCN	1997-01-24	1 products, RLD

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Ondansetron

Tradename	Company	Number	Date	Products
ZUPLENZ	Aquestive Therapeutics	N-022524 DISCN	2010-07-02	2 products, RLD
ZOFRAN ODT	Sandoz	N-020781 DISCN	1999-01-27	2 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
mko melt dose pack	unapproved drug other	2019-03-04
ondansetron	ANDA	2025-03-25
ondansetron hcl	ANDA	2024-12-31
ondansetron hydrochloride	ANDA	2025-02-13
ondansetron hydrochloride ondansetron hydrochloride	ANDA	2025-01-27
ondansetron ondansetron hydrochloride	ANDA	2024-05-30
sumansetron	unapproved drug other	2023-01-11
zofran	ANDA	2021-10-01

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
alcoholism	EFO_0003829	D000437	F10.1

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag
Ondansetron, Zuplenz, Aquestive
9095577	2030-07-13	DP
8580830	2029-11-23	DP

ATC Codes

A: Alimentary tract and metabolism drugs

— A04: Antiemetics and antinauseants

— A04A: Antiemetics and antinauseants

— A04AA: Serotonin (5ht3) antagonists

— A04AA01: Ondansetron

HCPCS

Code	Description
J2405	Injection, ondansetron hydrochloride, per 1 mg
Q0162	Ondansetron 1 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 48 hour dosage regimen
S0119	Ondansetron, oral, 4 mg (for circumstances falling under the medicare statute, use hcpcs q code)

Clinical

Clinical Trials

587 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Vomiting	D014839	—	R11.1	16	42	60	57	59	230
Nausea	D009325	—	R11.0	14	36	38	44	44	173
Postoperative nausea and vomiting	D020250	EFO_0004888	—	5	16	12	37	37	105
Postoperative pain	D010149	—	G89.18	1	2	1	11	31	45
Neoplasms	D009369	—	C80	5	4	8	3	6	26
Breast neoplasms	D001943	EFO_0003869	C50	—	6	5	3	6	19
Anesthesia	D000758	—	—	—	—	4	3	10	17
Hypotension	D007022	EFO_0005251	I95	1	2	6	4	6	17
Gastroenteritis	D005759	EFO_1001463	K52.9	1	1	7	4	4	16
Alcoholism	D000437	EFO_0003829	F10.1	1	9	4	1	1	15

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223	—	C85.9	4	6	1	—	3	12
Leukemia	D007938	—	C95	2	4	1	—	1	6
Myelodysplastic syndromes	D009190	—	D46	2	4	1	—	1	6
Preleukemia	D011289	—	—	2	4	1	—	1	6
Multiple myeloma	D009101	—	C90.0	2	2	2	—	1	6
Schizophrenia	D012559	EFO_0000692	F20	2	1	2	—	1	6
Laparoscopy	D010535	—	—	—	—	2	—	3	5
Myeloid leukemia acute	D015470	—	C92.0	—	3	1	—	—	4
Myeloproliferative disorders	D009196	—	D47.1	1	2	1	—	1	4
Agnosia	D000377	EFO_0007136	F88	—	1	2	—	2	4

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-hodgkin lymphoma	D008228	—	C85.9	2	4	—	—	1	7
Pancreatic neoplasms	D010190	EFO_0003860	C25	2	2	—	—	1	5
Cocaine-related disorders	D019970	—	F14	—	3	—	—	2	5
Glioma	D005910	EFO_0000520	—	1	4	—	—	—	4
Myeloid leukemia	D007951	—	C92	1	4	—	—	—	4
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	1	3	—	—	—	3
Hodgkin disease	D006689	—	C81	2	2	—	—	—	3
Melanoma	D008545	—	—	—	3	—	—	—	3
Head and neck neoplasms	D006258	—	—	—	2	—	—	—	2
Sarcoma	D012509	—	—	—	2	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	17	—	—	—	2	19
Malnutrition	D044342	EFO_0008572	E40-E46	4	—	—	—	1	5
Traumatic brain injuries	D000070642	—	S06	2	—	—	—	2	4
Brain injuries	D001930	—	S06.9	2	—	—	—	2	4
Brain concussion	D001924	—	S06.0	1	—	—	—	2	3
Disease	D004194	EFO_0000408	R69	3	—	—	—	—	3
Covid-19	D000086382	—	U07.1	1	—	—	—	—	1
Post-concussion syndrome	D038223	EFO_1001827	F07.81	1	—	—	—	—	1
Fasting	D005215	EFO_0002756	—	1	—	—	—	—	1
Dyspnea	D004417	—	R06.0	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Inguinal hernia	D006552	HP_0000023	K40	—	—	—	—	5	5
Male breast neoplasms	D018567	—	—	—	—	—	—	3	3
Conduction anesthesia	D000765	—	—	—	—	—	—	3	3
Coronary artery disease	D003324	—	I25.1	—	—	—	—	2	2
Cardiac surgical procedures	D006348	—	—	—	—	—	—	2	2
Arthritis	D001168	EFO_0005856	M05-M14	—	—	—	—	2	2
Hernia	D006547	—	K40-K46	—	—	—	—	2	2
Substance withdrawal syndrome	D013375	EFO_0005800	—	—	—	—	—	2	2
Acute pain	D059787	—	R52	—	—	—	—	2	2
Pain management	D059408	—	—	—	—	—	—	2	2

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Ondansetron
INN	ondansetron
Description	Ondansetron is a member of carbazoles.
Classification	Small molecule
Drug class	serotonin 5-HT3 receptor antagonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O