Drugs / Lorcaserin
Lorcaserin
also known as
APD356 · lorcaserin hydrochloride · Belviq · ADP-356 · Belviq XR · lorcaserin extended-release · Lorcaserin HCl · lorcaserin hydrochloride XR · +3 more
Small molecule targets HTR2C via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | obesity disorder | 2016-07-04 | “submitted the antiepileptic agent Fycompa® as well as the antiobesity agent lorcaserin for regulatory review.” eisai.com ↗ |
| Filed | US (FDA) | BELVIQ | obesity disorder | 2015-12-01 | “A New Drug Application (NDA) for lorcaserin was submitted to the U.S. Food and Drug Administration (FDA) by Arena in December 2009.” eisai.com ↗ “FDA has accepted for review a New Drug Application (NDA) for a once-daily formulation of its antiobesity agent BELVIQ” eisai.com ↗ |
Trials 39
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials | ||||||
| Phase 1 | NCT04205071 | Nov 2020 → Dec 2021 | chemotherapy-induced neuropathy, digestive system carcinoma, female breast carcinoma | Ohio State University Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT03143855 | Jan 2017 → Apr 2019 | opiate dependence, opioid abuse | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1 | NCT02932215 | Oct 2016 → Jan 2019 | cannabis dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 1 | NCT02537873 | Jul 2015 → Jul 2018 | substance-related disorder | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1 | NCT03143543 | Jul 2015 → Dec 2019 | cocaine dependence, opiate dependence | Virginia Commonwealth University | Terminated | No outcome recorded |
| Phase 1 | NCT02393599 | May → Aug 2015 | cocaine abuse | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT02398669 | Mar → Apr 2015 | obesity disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02192515 | Jul 2014 → Nov 2015 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02022956 | Dec 2013 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00828659 | Dec 2008 → Apr 2009 | substance abuse | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00828724 | Nov → Dec 2008 | obesity disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00829140 | Nov 2008 → Sep 2009 | obesity disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00828438 | Oct 2008 → Feb 2009 | impaired renal function disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00828581 | Oct → Dec 2008 | obesity disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00828932 | Aug → Dec 2008 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT03253926 | Sep 2017 → May 2021 | cannabis dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02523690 | Dec 2015 → Dec 2017 | infectious disease with sepsis, myopathy | Johns Hopkins University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02680288 | Nov 2015 → Sep 2018 | substance-related disorder | Midwest Biomedical Research Foundation | Unknown | No outcome recorded |
| Phase 1/2 | NCT02393547 | Sep 2013 → Dec 2015 | nicotine dependence | Mayo Clinic | Completed | No outcome recorded |
| Phase 27 trials · 2 met primary | ||||||
| Phase 2 | NCT04396834 | Dec 2019 → Feb 2020 | nicotine dependence | The Mind Research Network | Terminated | No outcome recorded |
| Phase 2 | NCT04396847 | Oct 2019 → Feb 2020 | alcohol-related disorders, nicotine dependence | The Mind Research Network | Terminated | No outcome recorded |
| Phase 2 | NCT03812523 | Jun 2019 → Feb 2021 | chemotherapy-induced neuropathy | Southeastern Regional Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02906644 | Nov 2016 → Mar 2018 | nicotine dependence | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT02044874 | Mar → Nov 2014 | — | Arena Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT00116740 | Jun → Nov 2005 | obesity disorder | Eisai Inc. | Completed | Met primary |
| Phase 2 | NCT00104507 | Dec 2004 → May 2005 | obesity disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT03169816 | May 2017 → Aug 2019 | substance-related disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2/3 | NCT02412631 | Jun 2016 → Apr 2020 | obesity disorder | Mayo Clinic | Terminated | Missed primary |
| Phase 35 trials · 4 met primary | ||||||
| Phase 3 | NCT04572243 | Sep 2020 → Aug 2024 | myoclonic epilepsy | Eisai Inc. | Terminated | Met primary |
| Phase 3 | NCT03720574 | Sep 2019 → Dec 2020 | obesity disorder | Kanion & Huawe Medicine Co.,Ltd | Terminated | No outcome recorded |
| Phase 3 | NCT00603902 | Jan 2008 → Jul 2009 | obesity disorder | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT00603291 | Dec 2007 → Jun 2010 | obesity disorder | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT00395135 | Nov 2006 → Feb 2009 | obesity disorder | Eisai Inc. | Completed | Met primary |
| Phase 45 trials · 1 met primary | ||||||
| Phase 4 | NCT03799198 | Jan 2019 → May 2020 | obesity disorder | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT03338296 | Sep 2017 → Apr 2020 | obesity disorder | Eisai Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT02019264 | Jan 2014 → May 2018 | cardiovascular disorder, obesity disorder, type 2 diabetes mellitus | Eisai Inc. | Completed | Mixed |
| Phase 4 | NCT01962402 | Jan 2014 → Jul 2015 | — | Southern California Institute for Research and Education | Unknown | No outcome recorded |
| Phase 4 | NCT01987427 | Oct 2013 → Aug 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04457687 | — | myoclonic epilepsy | Eisai Inc. | Available | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 0 | NCT03637842 Comparator | Aug 2019 → Feb 2020 | cannabis dependence | New York State Psychiatric Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03266939 Comparator | Oct 2018 | cocaine dependence | Mclean Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03011645 Comparator | May 2018 → Jan 2020 | cardiovascular disorder | Duke University | Terminated | No outcome recorded |
| Phase 2 | NCT03192995 Comparator | Jan 2018 → Feb 2020 | substance-related disorder | Glenn-Milo Santos | Terminated | No outcome recorded |
| Phase 2 | NCT03007394 Comparator | Dec 2017 → Dec 2019 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 3 | NCT02129608 Comparator | Jun 2014 → Dec 2015 | obesity disorder | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT02796144 Comparator | Sep 2016 → Feb 2020 | obesity disorder, schizoaffective disorder, schizophrenia | University of North Carolina, Chapel Hill | Terminated | No outcome recorded |
| Phase 4 | NCT02400359 Comparator | Oct 2014 → Jun 2027 expected | obesity disorder | Beth Israel Deaconess Medical Center | Active not recruiting | No outcome recorded |
| — | NCT02388568 Comparator | Jan 2015 → Jun 2017 | obesity disorder | University of Pennsylvania | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2020-02-14 | Eurofarma Laboratorios S.A. | Regulatory Atualização sobre alerta emitido pelo FDA para lorcasserina eurofarma.com.br ↗
O órgão americano divulgou nesta quinta, 13 de fevereiro, que após avaliação de dados complementares do estudo Camellia - TIMI 61, os benefícios do medicamento não superam os potenciais riscos. |
| 2019-12-03 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Lorcaserin Hydrochloride Tablets zyduslife.com ↗
Zydus Cadila has received the tentative approval from the USFDA to market Lorcaserin Hydrochloride Tablets ( US RLD – Belviq Tablets ), 10 mg. |
| 2018-10-05 | Eisai Inc. | Results NEW DATA ON EFFECT OF ANTI-OBESITY AGENT BELVIQ® ON PREVENTION AND REMISSION OF TYPE 2 DIABETES PRESENTED AT THE EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES AND PUBLISHED IN THE LANCET eisai.com ↗
From the results of this analysis, treatment with BELVIQ compared to placebo in patients with pre-diabetes reduced the risk of incident T2DM by 19% (BELVIQ 8.5% vs. placebo 10.3%; hazard ratio [HR] 0.81; 95% confidence interval [CI]: 0.66-0.99; nominal p-value=0.038) |
| 2018-08-28 | Eisai Inc. | Results LONG-TERM CARDIOVASCULAR OUTCOMES DATA FOR ANTI-OBESITY AGENT BELVIQ® PRESENTED AT THE EUROPEAN SOCIETY OF CARDIOLOGY AND PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE eisai.com ↗
BELVIQ is the first ever weight loss medication approved for chronic weight management which has been proven to not increase the incidence of major cardiovascular (CV) events in a dedicated long-term cardiovascular outcome trial. |
| 2018-07-18 | Eisai Inc. | Results POSITIVE TOPLINE RESULTS OBTAINED FROM LARGE-SCALE CARDIOVASCULAR OUTCOMES TRIAL OF ANTI-OBESITY AGENT BELVIQ® eisai.com ↗
From the results, CAMELLIA-TIMI 61 met its primary safety objective, finding that long-term treatment with BELVIQ does not increase incidence of MACE. |
| 2016-12-20 | Eisai Inc. | Regulatory ANTI-OBESITY AGENT BELVIQ® APPROVED IN BRAZIL eisai.com ↗
Brazil marks the second country in Latin America to approve lorcaserin after Mexico. |
| 2016-07-19 | Eisai Inc. | Regulatory U.S. FDA APPROVES BELVIQ XR®, A ONCE-DAILY FORMULATION OF LORCASERIN FOR CHRONIC WEIGHT MANAGEMENT eisai.com ↗ |
| 2016-07-14 | Eisai Inc. | Regulatory ANTIOBESITY AGENT VENESPRI® (LORCASERIN) APPROVED IN MEXICO FIRST COUNTRY IN LATIN AMERICA TO APPROVE LORCASERIN eisai.com ↗
Mexico marks the first country in Latin America where lorcaserin is approved. |
| 2015-12-01 | Eisai Inc. | Regulatory U.S. FDA ACCEPTS NDA FOR ONCE-DAILY FORMULATION OF ANTIOBESITY AGENT BELVIQ® eisai.com ↗ |
| 2015-04-24 | Eisai Inc. | Regulatory EISAI COMMENCES BUSINESS IN MEXICO, AIMS TO EXPAND CONTRIBUTION TO PATIENTS IN LATIN AMERICA ANTICANCER AGENTS HALAVEN® AND GLIADEL® NEWLY LAUNCHED eisai.com ↗
In addition to these newly launched anticancer products, Eisai Mexico has submitted the antiepileptic agents Inovelon® and Fycompa®, the anticancer agent Targretin® as well as the antiobesity agent BELVIQ® for regulatory review. |
| 2014-11-04 | Eisai Inc. | Results LORCASERIN MEETS PRIMARY ENDPOINT AND CONFIRMS PROOF-OF-CONCEPT AS POTENTIAL AID FOR SMOKING CESSATION IN INVESTIGATIONAL PHASE Ⅱ CLINICAL STUDY eisai.com ↗
The results of this study are the first clinical evidence that a selective serotonin 2C agonist has a potential as a treatment for smoking cessation. |
| 2014-10-29 | Eisai Inc. | Results EISAI ANNOUNCES TOP-LINE RESULTS OF INVESTIGATIONAL STUDY ON COADMINISTRATION OF LORCASERIN AND PHENTERMINE Trial Supports Safety and Tolerability After 12 Weeks of Treatment eisai.com ↗
The results of the study demonstrate that the short-term combination of lorcaserin plus phentermine does not appear to be associated with an exacerbation in the proportion of pre-specified adverse events compared to therapy with lorcaserin alone. |
| 2013-05-08 | Eisai Inc. | Regulatory PUBLICATION IN FEDERAL REGISTER TOMORROW MOVES BELVIQ® CLOSER TO LAUNCH eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that U.S. Drug Enforcement Administration (DEA) has placed antiobesty agent BELVIQ® (lorcaserin hydrochloride) into Schedule IV of the Controlled Substance Act. |
| 2012-06-28 | Eisai Inc. | Regulatory U.S. FDA APPROVES ANTIOBESITY AGENT BELVIQ®(lorcaserin HCl) for Adults First Prescription Weight-Loss Treatment Approved in U.S. in 13 Years eisai.com ↗
BELVIQ is the first prescription weight-loss treatment approved in the United States in 13 years. |
| 2012-05-11 | Eisai Inc. | Regulatory ANTI-OBESITY AGENT LORCASERIN RECEIVES POSITIVE VOTE FROM FDA ADVISORY COMMITTEE eisai.com ↗
The results of the vote mean that the advisory committee supports lorcaserin as a potential new treatment option for the medical management of overweight and obese patients. |
| 2012-01-05 | Eisai Inc. | Regulatory ARENA SUBMITS RESPONSE TO FDA COMPLETE RESPONSE LETTER FOR LORCASERIN eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that Arena Pharmaceuticals, Inc. (Headquarters: California, United States, President & CEO: Jack Lief, “Arena”) has submitted its response to the Complete Response Letter (CRL) issued by the U.S. Food and Drug Administration (FDA) following review of the lorcaserin (generic name) New Drug Application (NDA). |
| 2010-11-10 | Eisai Inc. | Results LORCASERIN PHASE 3 CLINICAL TRIAL IN PATIENTS WITH TYPE 2 DIABETES SHOWS STATISTICALLY SIGNIFICANT WEIGHT LOSS eisai.com ↗
Using Modified Intent-to-Treat Last Observation Carried Forward (MITT-LOCF) analysis, lorcaserin 10 mg BID met the three primary efficacy endpoints by producing statistically significant weight loss compared to placebo (p < 0.0001). |
| 2010-10-23 | Eisai Inc. | Regulatory FDA ISSUES COMPLETE RESPONSE LETTER FOR LORCASERIN NEW DRUG APPLICATION eisai.com ↗
In the complete response letter, the FDA outlined the non-clinical and clinical reasons for their decision. |
| 2010-09-17 | Eisai Inc. | Regulatory EISAI PROVIDES UPDATE ON LORCASERIN FDA ADVISORY COMMITTEE MEETING eisai.com ↗
the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 9 to 5 that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks |
| 2010-07-15 | Eisai Inc. | Results NEW ENGLAND JOURNAL OF MEDICINE PUBLISHES RESULTS OF TWO-YEAR BLOOM TRIAL SHOWING LORCASERIN CAUSED SIGNIFICANT WEIGHT LOSS AND IMPROVED MAINTENANCE OF WEIGHT LOSS eisai.com ↗
The data presented in the article show that lorcaserin caused statistically significantly greater weight loss and improved maintenance of weight loss compared to placebo. |
All press releases naming this drug 31 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lorcaserin | “Lorcaserin (APD356), a selective 5-HT(2C) agonist, reduces body weight in obese men and women.” PMID 19057523 ↗ Dec 200846“Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.)” NCT03799198 ↗ “A Study of APD356 (Lorcaserin) in Healthy Japanese Adult Subjects” NCT02192515 ↗ |
| Known as | ADP-356 | ChEMBL registry synonym — accepted as the source's own label CHEMBL360328 ↗ |
| Known as | APD356 | “APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks” NCT02044874 ↗ |
| Known as | Belviq | “Lorcaserin is a serotonin (5-HT) 2C receptor agonist (Trade Name Belviq) approved for treatment of obesity.” NCT03143855 ↗1“Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.)” NCT03799198 ↗ |
| Known as | Belviq XR | “Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.)” NCT03799198 ↗ |
| Known as | lorcaserin extended-release | “Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.)” NCT03799198 ↗ |
| Known as | Lorcaserin HCl | “A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes...” NCT02019264 ↗ |
| Known as | lorcaserin hydrochloride | “Participants will receive lorcaserin hydrochloride extended release (XR) 20 milligrams (mg) once daily (QD) for up to 52 weeks.” NCT03338296 ↗2“APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks” NCT02044874 ↗ “Drug: Lorcaserin Hydrochloride” NCT04205071 ↗ |
| Known as | lorcaserin hydrochloride XR | “Drug: lorcaserin hydrochloride XR” NCT03338296 ↗ |
| Known as | Lorcaserina | ChEMBL registry synonym — accepted as the source's own label CHEMBL360328 ↗ |
| Known as | Lorcaserine | ChEMBL registry synonym — accepted as the source's own label CHEMBL360328 ↗ |
| Known as | Lorqess | ChEMBL registry synonym — accepted as the source's own label CHEMBL360328 ↗ |
| Action | Activate | “a novel, selective 5-HT2c receptor agonist” NCT00104507 ↗ |
| Modality | Small molecule | — CHEMBL360328 ↗ |
| Route | Oral | “single oral doses of lorcaserin (20, 40, and 60 mg), zolpidem (15 and 30 mg), ketamine (100 mg), and placebo was conducted” PMID 21412231 ↗ Mar 2011 |
| Target | HTR2C | “5HTR2C agonist (lorcaserin) to increase and antagonist (ziprasidone) to reduce cortisol response to mental and metabolic stress in men carrying the rs6318 C allele and women in...” NCT03011645 ↗ |