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Lorcaserin

Generic Name
Lorcaserin
Drug Type
Small Molecule
Chemical Formula
C11H14ClN
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

Eisai Halts Lorcaserin Program for Dravet Syndrome Due to Recruitment Issues

• Eisai discontinued its lorcaserin clinical trials (MOMENTUM 1 and 2) for Dravet syndrome, citing challenges in patient recruitment for this rare epilepsy. • The decision impacts families who found lorcaserin effective after other antiseizure medications failed, prompting engagement between the Dravet Syndrome Foundation and Eisai. • The introduction of fenfluramine (Fintepla) during the lorcaserin studies may have contributed to enrollment difficulties, as many patients began using the newly available treatment. • Lorcaserin, a selective serotonin 5-HT2c receptor agonist, was previously withdrawn from the market due to cancer risk but was being explored for Dravet syndrome treatment.

Harmony Biosciences Reports Strong Q3 2024 Results and Pipeline Advancements

• Harmony Biosciences reported $186.0 million in net revenue for Q3 2024, surpassing $2 billion in cumulative net revenue for WAKIX since its launch. • The company is on track to submit a supplemental New Drug Application (sNDA) for pitolisant in idiopathic hypersomnia (IH) in Q4 2024. • Harmony's pipeline includes next-generation pitolisant formulations and EPX-100 for rare epilepsies, with Phase 3 trials ongoing for Dravet syndrome and planned for Lennox-Gastaut syndrome. • Topline data from the ZYN-002 Phase 3 RECONNECT trial in Fragile X syndrome is expected in mid-2025.
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