Lorcaserin

Generic Name: Lorcaserin

Drug Type: Small Molecule

Chemical Formula: C_₁₁H_₁₄ClN

CAS Number: 616202-92-7

Unique Ingredient Identifier: 637E494O0Z

Background: 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

A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome

Phase 3

Terminated

Conditions: Epilepsies, Myoclonic

Interventions: Drug: Placebo
Drug: Lorcaserin

First Posted Date: 2020-10-01

Last Posted Date: 2025-01-31

Lead Sponsor: Eisai Inc.

Target Recruit Count: 28

Registration Number: NCT04572243

Locations: 🇺🇸
Children's of Alabama / University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
University of California Los Angeles (UCLA), Los Angeles, California, United States
🇺🇸
UCSD Rady's Children's Hosptial, San Diego, California, United States

and more 27 locations

Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies

Conditions: Epilepsies, Myoclonic
Drug Resistant Epilepsy

First Posted Date: 2020-07-07

Last Posted Date: 2025-01-30

Lead Sponsor: Eisai Inc.

Registration Number: NCT04457687

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
David Geffen School of Medicine, UCLA Mattel Children's Hospital, Los Angeles, California, United States
🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States

and more 19 locations

Laboratory Screening of Lorcaserin for Alcohol Use Disorder

Phase 2

Terminated

Conditions: Alcohol Use Disorder
Tobacco Smoking

Interventions: Drug: Placebo oral tablet
Drug: Lorcaserin Oral Tablet

First Posted Date: 2020-05-21

Last Posted Date: 2022-09-07

Lead Sponsor: The Mind Research Network

Target Recruit Count: 5

Registration Number: NCT04396847

Locations: 🇺🇸
The Mind Research Network, Albuquerque, New Mexico, United States

Mechanisms of Lorcaserin for Smoking Cessation

Phase 2

Terminated

Conditions: Smoking Cessation
Tobacco Use Disorder

Interventions: Drug: Lorcaserin Oral Tablet
Drug: Placebo oral tablet

First Posted Date: 2020-05-21

Last Posted Date: 2023-03-20

Lead Sponsor: The Mind Research Network

Target Recruit Count: 3

Registration Number: NCT04396834

Locations: 🇺🇸
The Mind Research Network, Albuquerque, New Mexico, United States

Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer

Phase 1

Withdrawn

Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Chemotherapy-Induced Peripheral Neuropathy
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8

Interventions: Drug: Lorcaserin
Drug: Lorcaserin Hydrochloride
Other: Questionnaire Administration

First Posted Date: 2019-12-19

Last Posted Date: 2021-01-19

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Registration Number: NCT04205071

Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Phase 2

Conditions: Chemotherapy-Induced Peripheral Neuropathy

Interventions: Drug: Duloxetine 60 mg qd
Drug: Lorcaserin

First Posted Date: 2019-01-23

Last Posted Date: 2019-04-04

Lead Sponsor: Southeastern Regional Medical Center

Target Recruit Count: 50

Registration Number: NCT03812523

Locations: 🇺🇸
Cancer Treatment Centers of America - Atlanta, Newnan, Georgia, United States

Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients

Phase 3

Terminated

Conditions: Obesity

Interventions: Drug: Lorcaserin 10 mg BID
Drug: Matching Placebo BID

First Posted Date: 2018-10-25

Last Posted Date: 2022-05-02

Lead Sponsor: Kanion & Huawe Medicine Co.,Ltd

Target Recruit Count: 100

Registration Number: NCT03720574

Locations: 🇨🇳
Second Hospital of Changzhou, Changzhou, Jiangsu, China
🇨🇳
Bengbu Medical College First Affiliated Hospital, Bengbu, Anhui, China
🇨🇳
The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China

and more 6 locations