Dolasetron - PharmaKB

Dolasetron

Anzemet (dolasetron) is a small molecule pharmaceutical. Dolasetron was first approved as Anzemet on 1997-09-11. It is used to treat postoperative nausea and vomiting in the USA.

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

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Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Dolasetron mesylate

Tradename	Company	Number	Date	Products
ANZEMET	Validus Pharmaceuticals	N-020623 DISCN	1997-09-11	2 products, RLD
ANZEMET	Validus Pharmaceuticals	N-020624 DISCN	1997-09-11	3 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
anzemet	New Drug Application	2023-12-12

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
postoperative nausea and vomiting	EFO_0004888	D020250	—

Agency Specific

FDA

EMA

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Patent Expiration

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ATC Codes

A: Alimentary tract and metabolism drugs

— A04: Antiemetics and antinauseants

— A04A: Antiemetics and antinauseants

— A04AA: Serotonin (5ht3) antagonists

— A04AA04: Dolasetron

HCPCS

Code	Description
J1260	Injection, dolasetron mesylate, 10 mg
Q0180	Dolasetron mesylate, 100 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 24 hour dosage regimen
S0174	Dolasetron mesylate, oral 50 mg (for circumstances falling under the medicare statute, use q0180)

Clinical

Clinical Trials

12 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	HP_0002013	R11.1	1	2	2	2	2	9
Nausea	D009325	HP_0002018	R11.0	1	2	2	1	2	8
Cesarean section	D002585	—	—	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	—	1	1	—	—	2
Myofascial pain syndromes	D009209	EFO_1001054	—	—	—	1	—	—	1
Fibromyalgia	D005356	EFO_0005687	M79.1	—	—	1	—	—	1

Indications Phases 2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pancreatic neoplasms	D010190	EFO_0003860	C25	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Postoperative nausea and vomiting	D020250	EFO_0004888	—	—	—	—	—	1	1
Gastrointestinal neoplasms	D005770	—	C26.9	—	—	—	—	1	1
Digestive system neoplasms	D004067	—	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Dolasetron
INN	dolasetron
Description	Dolasetron (trade name Anzemet) is a serotonin 5-HT3 receptor antagonist used to treat nausea and vomiting following chemotherapy. Its main effect is to reduce the activity of the vagus nerve, which is a nerve that activates the vomiting center in the medulla oblongata. It does not have much antiemetic effect when symptoms are due to motion sickness. This drug does not have any effect on dopamine receptors or muscarinic receptors.
Classification	Small molecule
Drug class	serotonin 5-HT3 receptor antagonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	O=C(O[C@@H]1C[C@@H]2C[C@H]3C[C@H](C1)N2CC3=O)c1c[nH]c2ccccc12