Lorcaserin

Overview

Lorcaserin (previously APD-356), a highly selective 5HT2C receptor agonist, is used for the treatment of obesity. It has been shown to reduce body weight and food intake in animal models of obesity, and it is thought that targeting the 5HT2C receptor may alter body weight by regulating satiety. Lorcaserin is marketed as a salt form called Belviq, which is lorcaserin hydrochloride. In February 2020, the FDA issued a Drug Safety Communication requesting the manufacturer of Belviq (lorcaserin hydrochloride tablets, 10 mg) and Belviq XR (lorcaserin hydrochloride extended-release tablets, 20 mg) to voluntarily withdraw these products from the U.S. market, and the company has submitted a request to voluntarily withdraw the drug. This decision was based on the results of a clinical trial assessing the risk of heart-related problems that found that patients treated with lorcaserin may have a higher risk of cancer.

Indication

For the treatment of obesity, as an adjunct to a reduced-calorie diet and increased physical activity.

Associated Conditions

Obesity

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome	2020/10/01	NCT04572243	Phase 3	Terminated	Eisai Inc.
Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies	2020/07/07	NCT04457687	N/A	AVAILABLE	Eisai Inc.
Laboratory Screening of Lorcaserin for Alcohol Use Disorder	2020/05/21	NCT04396847	Phase 2	Terminated	The Mind Research Network
Mechanisms of Lorcaserin for Smoking Cessation	2020/05/21	NCT04396834	Phase 2	Terminated	The Mind Research Network
Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer	2019/12/19	NCT04205071	Phase 1	Withdrawn	Ohio State University Comprehensive Cancer Center
Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy	2019/01/23	NCT03812523	Phase 2	UNKNOWN	Southeastern Regional Medical Center
Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients	2018/10/25	NCT03720574	Phase 3	Terminated	Kanion & Huawe Medicine Co.,Ltd
Lorcaserin for Cannabis Use Disorder	2018/08/20	NCT03637842	Early Phase 1	Terminated	New York State Psychiatric Institute
A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants	2018/08/14	NCT03627936	Phase 1	Completed	Eisai Inc.
Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic	2018/06/11	NCT03552107	N/A	Completed	Scripps Whittier Diabetes Institute

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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.

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