Alosetron

Overview

Alosetron is a 5-HT3 antagonist used only for the management of severe diarrhoea-predominant irritable bowel syndrome (IBS) in women. Alosetron has an antagonist action on the 5-HT3 receptors and thus may modulate serotonin-sensitive gastrointestinal (GI) processes. Alosetron was voluntarily withdrawn from the US market in November 2000 by the manufacturer due to numerous reports of severe adverse effects including ischemic colitis, severely obstructed or ruptured bowel, and death. In June 2002, the FDA approved a supplemental new drug application allowing the remarketing of the drug under restricted conditions of use.

Indication

用于治疗女性以腹泻为主要症状的应激性肠综合征，也用于治疗腹痛、便急、大便频繁等症状。

Associated Conditions

Severe Diarrhea predominant irritable bowel syndrome

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Assess the Effect Of Alosetron On Mucosal Blood Flow	2006/08/30	NCT00370032	Phase 4	Completed	GlaxoSmithKline
Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy	2003/08/25	NCT00067561	Phase 3	Completed	GlaxoSmithKline
Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy	2003/08/21	NCT00067457	Phase 3	Completed	GlaxoSmithKline

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
LOTRONEX	Prometheus Laboratories Inc.	65483-894	ORAL	0.5 mg in 1 1	1/19/2016
Alosetron Hydrochloride	Amneal Pharmaceuticals LLC	65162-248	ORAL	0.5 mg in 1 1	5/25/2022
LOTRONEX	Sebela Pharmaceuticals Inc.	54766-895	ORAL	1 mg in 1 1	5/3/2019
Alosetron Hydrochloride	Amneal Pharmaceuticals LLC	65162-249	ORAL	1 mg in 1 1	5/25/2022
Alosetron Hydrochloride	Amneal Pharmaceuticals of New York LLC	53746-248	ORAL	0.5 mg in 1 1	10/26/2023
LOTRONEX	Prometheus Laboratories Inc.	65483-895	ORAL	1.0 mg in 1 1	1/19/2016
Alosetron	Lifestar Pharma LLC	70756-701	ORAL	1 mg in 1 1	3/23/2022
Alosetron Hydrochloride	Actavis Pharma, Inc.	45963-479	ORAL	0.5 mg in 1 1	1/31/2023
Alosetron	Bryant Ranch Prepack	63629-2517	ORAL	0.5 mg in 1 1	3/23/2022
alosetron hydrochloride	Rising Pharmaceuticals, Inc.	64980-454	ORAL	1 mg in 1 1	3/10/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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