NCT02412631
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
pharma · Cocaine-Related Disorders · Cocaine Dependence · DRUG
BRIGHT MINDS BIOSCIENCES
BRIGHT MINDS BIOSCIENCES INC.
Bright Minds Biosciences is a pharma organization headquartered in New York, USA. It trades on NYSE under ticker DRUG. Primary therapeutic focus areas include Cocaine-Related Disorders, Cocaine Dependence, Nicotine Depen
19 Vestry St, New York, NY 10013, US HQ
12 Employees
Public company Type
DRUG · NYSE Ticker
Company details
- Status
- Public
- HQ
- 19 Vestry St, New York, NY 10013, US
- Employees
- 12
- Programs
- 1063
- Drugs
- 444
- Patents
- 57
lorcaserin
Phase 3 · small molecule · Obesity
Lorcaserin hydrochloride is an oral small-molecule therapeutic developed by Bright Minds Biosciences Inc. for the treatment of obesity. The program, identified by internal code 15-005230, reached Phase 3 clinical development but was terminated as of June 2021. Lorcaserin hydrochloride has been approved in the United St
Internal code 15-005230
At a glance
- Sponsor
- BRIGHT MINDS BIOSCIENCES INC.
- Phase
- Phase 3
- Modality
- small_molecule
- Indication
- Obesity
- Status
- terminated
- Trials
- 1
Executive summary
Lorcaserin hydrochloride is an oral small-molecule therapeutic developed by Bright Minds Biosciences Inc. for the treatment of obesity. The program, identified by internal code 15-005230, reached Phase 3 clinical development but was terminated as of June 2021. Lorcaserin hydrochloride has been approved in the United States under ANDA209464 by Zydus Pharms USA Inc., indicating it is marketed as a generic formulation. The drug is administered orally and represents a small-molecule approach to weight management. The termination of the Phase 3 program by Bright Minds Biosciences in mid-2021 suggests a strategic decision to discontinue further development efforts by the sponsor, despite the existence of an approved formulation in the U.S. market. The program's latest disclosed milestone occurred on June 10, 2021, marking the end of active development tracking for this indication under the sponsor's portfolio. No mechanism of action, specific target, or lead investigator information has been disclosed in available records.
Why this program matters
Obesity represents a significant unmet medical need globally, with limited pharmacological treatment options that demonstrate sustained efficacy and favorable safety profiles. The obesity therapeutic market encompasses multiple approved agents addressing different mechanistic pathways, reflecting the complexity of weight management and the clinical demand for diverse treatment approaches. Lorcaserin's development within this competitive landscape underscores the pharmaceutical industry's ongoing efforts to expand the obesity treatment armamentarium. The termination of Bright Minds Biosciences' Phase 3 program, despite the existence of an approved generic formulation through Zydus Pharms USA Inc., suggests market dynamics or strategic portfolio prioritization influenced the sponsor's decision to discontinue development. The competitive environment includes established therapies such as Mysimba (naltrexone/bupropion combination), semaglutide-based products (Wegovy), and emerging dual and triple agonist therapies like cagrilintide combinations and tirzepatide (Mounjaro). The patient population for obesity treatment spans millions globally, with significant commercial opportunity for efficacious, well-tolerated agents. Lorcaserin's positioning within this market reflects the ongoing evolution of obesity pharmacotherapy and the competitive pressures facing individual sponsors in this therapeutic area.
Drug intelligence
Lorcaserin hydrochloride is a small-molecule oral therapeutic for obesity. The drug is administered via the oral route of administration. Mechanism of action, specific molecular target, and therapeutic class information have not been disclosed in available records. The compound is marketed as a generic formulation in the United States under ANDA209464 by Zydus Pharms USA Inc., indicating bioequivalence to a reference-listed drug and approval through the abbreviated new drug application pathway.
- Modality: Small molecule
- Route: Oral
- Indication: Obesity
- Regulatory Status (U.S.): Approved (generic formulation, ANDA209464, Zydus Pharms USA Inc.)
- Patent Status: Not yet disclosed
- First Approval: Not yet disclosed
obesity disorder
Also known as: obesity, obesity disease
Overview
A disorder involving an excessive amount of body fat.
Treatment landscape
ClinicalTrials.gov lists 50 registered studies for Obesity (Disorder) (AACT aggregate).
Phase breakdown: NA (46), PHASE4 (3), PHASE3 (1)
Common investigational therapies:
- Tirzepatide
- Placebo
- Semaglutide Pen Injector
- Semaglutide
- Gradual dose reduction of semaglutide
- Abrupt cessation of semaglutide
- GLP-1 Receptor Agonists
- GLP-1 Therapy
- Semaglutide (SEMA)
- Metoclopramide
Disease data sourced from MONDO Disease Ontology (MONDO:0011122), Orphanet — obesity disorder, NCT03412149, NCT06787001, NCT06852391, NCT06881485, NCT06911918, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 3TBD
Phase 3 development ongoing
Lorcaserin hydrochloride program in Phase 3 clinical development for obesity indication.
- Terminated2021-06-10
Program terminated
Bright Minds Biosciences Inc. terminated the lorcaserin Phase 3 development program.
Competitive landscape
The obesity therapeutic market includes multiple approved small-molecule agents and emerging biologic approaches. Established competitors include Mysimba (naltrexone/bupropion combination, Disc Medicine), semaglutide-based products including Wegovy (NovoThirteen), and tirzepatide (Mounjaro, The George Institute). Emerging therapies include cagrilintide and semaglutide combinations (NovoThirteen). The competitive set also encompasses off-label use of agents such as pioglitazone (Takeda) and various other small-molecule therapeutics. Lorcaserin's competitive position is complicated by the termination of Bright Minds Biosciences' Phase 3 program in 2021, despite the availability of a generic formulation through Zydus Pharms USA Inc. The market has increasingly favored GLP-1 receptor agonists and dual/triple agonist therapies, which may have influenced the sponsor's decision to discontinue development. The competitive landscape reflects a shift toward incretin-based therapies and combination approaches, positioning newer agents ahead of traditional small-molecule monotherapies in clinical development pipelines.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| ESOMEPRAZOLE, ESOMEPRAZOLE | Fondazione Telethon ETS | small_molecule | approved |
| Pioglitazone | Takeda | small_molecule | approved |
| RIMEGEPANT , Capsaicin | Disc Medicine | small_molecule | approved |
| Simvastatin | Hospital Authority, Hong Kong | small_molecule | approved |
| Sulfato de Magnesio Altan 150 mg/ml solución inyectable y para perfusión EFG, LIDOCAINE HYDROCHLORIDE, Dexdor 100 micrograms/ml concentrate for solution for infusion, KETOLAR 50 mg/ml solución inyectable. | The George Institute | small_molecule | approved |
| Candesartan and Hydrochlorothiazide | Takeda | small_molecule | approved |
| Mysimba 8 mg/90 mg prolonged-release tablets | Disc Medicine | small_molecule | approved |
| Semaglutide B 3.0 mg/ml PDS290 | Disc Medicine | small_molecule | approved |
| Wegovy 0.25 mg FlexTouch solution for injection in pre-filled pen, Wegovy 1 mg FlexTouch solution for injection in pre-filled pen, Wegovy 0.5 mg FlexTouch solution for injection in pre-filled pen, Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen, Wegovy 1.7 mg FlexTouch solution for injection in pre-filled pen | NovoThirteen | small_molecule | approved |
| cagrilintide, Placebo + Placebo, semaglutide, cagrilintide, cagrilintide semaglutide, semaglutide, semaglutide, semaglutide, cagrilintide semaglutide, semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide, cagrilintide | NovoThirteen | small_molecule | approved |
| Mounjaro 5 mg solution for injection in pre-filled pen, Mounjaro 2.5 mg solution for injection in pre-filled pen | The George Institute | small_molecule | approved |
| Semaglutide | United Therapeutics Europe Ltd | small_molecule | approved |
| SIBUTRAMINE | — | Monoamine transporter inhibitor | Approved |
| SETMELANOTIDE ACETATE | — | Melanocortin receptor 4 agonist | Approved |
| SETMELANOTIDE | — | Melanocortin receptor 4 agonist | Approved |
| RIMONABANT | — | Cannabinoid CB1 receptor antagonist | Approved |
| PHENTERMINE HYDROCHLORIDE | — | Norepinephrine transporter releasing agent | Approved |
| PHENTERMINE | — | Norepinephrine transporter releasing agent | Approved |
| PHENDIMETRAZINE TARTRATE | — | Norepinephrine transporter inhibitor | Approved |
| ORLISTAT | — | Pancreatic lipase inhibitor | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
United States: Lorcaserin hydrochloride is approved as a generic formulation under ANDA209464 by Zydus Pharms USA Inc., indicating FDA approval via the abbreviated new drug application pathway and bioequivalence to a reference-listed drug. The approval status confirms the drug is marketed in the U.S.; however, the reference-listed drug approval date and original sponsor are not disclosed in available records.
- FDA Status: Approved (generic, ANDA209464, Zydus Pharms USA Inc.)
- EMA Status: Not yet disclosed
- PMDA (Japan) Status: Not yet disclosed
- NMPA (China) Status: Not yet disclosed
Clinical evidence summary
Key questions answered
What is lorcaserin hydrochloride used for?
Lorcaserin hydrochloride is a small-molecule oral therapeutic developed for the treatment of obesity.
Is lorcaserin hydrochloride approved by the FDA?
Yes, lorcaserin hydrochloride is approved in the United States as a generic formulation under ANDA209464 by Zydus Pharms USA Inc.
Who is developing lorcaserin hydrochloride?
Bright Minds Biosciences Inc. is the sponsor of the lorcaserin program; however, the Phase 3 program was terminated in June 2021. A generic formulation is marketed by Zydus Pharms USA Inc.
What is the mechanism of action of lorcaserin hydrochloride?
The specific mechanism of action for lorcaserin hydrochloride has not been disclosed in available records.
How is lorcaserin hydrochloride administered?
Lorcaserin hydrochloride is administered orally.
What is the current development status of lorcaserin hydrochloride?
The Phase 3 development program sponsored by Bright Minds Biosciences Inc. was terminated as of June 10, 2021. A generic formulation remains approved and marketed in the United States.
What clinical trials support lorcaserin hydrochloride?
Clinical trial NCT02412631 is associated with the lorcaserin program; however, detailed trial design, results, and outcomes have not been disclosed in available records.
What is the internal code for the lorcaserin program?
The internal code for the lorcaserin program is 15-005230.
Does lorcaserin hydrochloride have any development partners?
No development partner information has been disclosed for Bright Minds Biosciences' lorcaserin program.
What competitors exist in the obesity treatment market?
Competitors include semaglutide-based products (Wegovy), tirzepatide (Mounjaro), Mysimba (naltrexone/bupropion), and emerging dual/triple agonist therapies such as cagrilintide combinations.
Why was the lorcaserin Phase 3 program terminated?
The specific reason for termination has not been disclosed; however, competitive pressures from GLP-1 receptor agonists and emerging dual/triple agonist therapies likely influenced the sponsor's decision.
Is lorcaserin hydrochloride approved outside the United States?
Regulatory approval status in the European Union, Japan, and China has not been disclosed in available records.
What is the therapeutic class of lorcaserin hydrochloride?
The therapeutic class for lorcaserin hydrochloride has not been disclosed in available records.
Who manufactures the approved generic formulation of lorcaserin hydrochloride?
Zydus Pharms USA Inc. manufactures the approved generic formulation under ANDA209464.
What is the molecular target of lorcaserin hydrochloride?
The specific molecular target for lorcaserin hydrochloride has not been disclosed in available records.
When was the lorcaserin program first disclosed?
The first disclosure date for the lorcaserin program has not been disclosed in available records.
Entity relationship graph
lorcaserin → Drug → Target → Indication → Company → Trials → Competitors
Drugs
Molecular targets
Companies
Indication
Trials
Competitors
- ESOMEPRAZOLE, ESOMEPRAZOLE
- Pioglitazone
- RIMEGEPANT , Capsaicin
- Simvastatin
- Sulfato de Magnesio Altan 150 mg/ml solución inyectable y para perfusión EFG, LIDOCAINE HYDROCHLORIDE, Dexdor 100 micrograms/ml concentrate for solution for infusion, KETOLAR 50 mg/ml solución inyectable.
- Candesartan and Hydrochlorothiazide
- Mysimba 8 mg/90 mg prolonged-release tablets
- Semaglutide B 3.0 mg/ml PDS290
- Wegovy 0.25 mg FlexTouch solution for injection in pre-filled pen, Wegovy 1 mg FlexTouch solution for injection in pre-filled pen, Wegovy 0.5 mg FlexTouch solution for injection in pre-filled pen, Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen, Wegovy 1.7 mg FlexTouch solution for injection in pre-filled pen
- cagrilintide, Placebo + Placebo, semaglutide, cagrilintide, cagrilintide semaglutide, semaglutide, semaglutide, semaglutide, cagrilintide semaglutide, semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide, cagrilintide
- Mounjaro 5 mg solution for injection in pre-filled pen, Mounjaro 2.5 mg solution for injection in pre-filled pen
- Semaglutide
- SETMELANOTIDE ACETATE
- SETMELANOTIDE
- RIMONABANT
- PHENTERMINE HYDROCHLORIDE
- PHENTERMINE
- PHENDIMETRAZINE TARTRATE
- ORLISTAT
Analyst insights
Strategic Implications: The termination of Bright Minds Biosciences' Phase 3 program in June 2021 represents a strategic exit from obesity development despite the existence of an approved generic formulation. This decision likely reflects market dynamics, competitive pressures from GLP-1 receptor agonists and emerging dual/triple agonist therapies, or portfolio prioritization by the sponsor.
Competitive Implications: Lorcaserin's development termination underscores the competitive challenges facing traditional small-molecule monotherapies in obesity treatment. The market has shifted toward incretin-based and multi-target agonist approaches, which have demonstrated superior efficacy in recent trials. The availability of a generic formulation through Zydus Pharms USA Inc. suggests the reference-listed drug may have faced market challenges or patent expiration, contributing to the sponsor's decision to discontinue further development.
Future Catalysts: No future development milestones are expected for Bright Minds Biosciences' lorcaserin program. The generic formulation availability through Zydus Pharms USA Inc. may continue to generate modest revenue in the U.S. market, but clinical advancement is not anticipated.
- Competitive pressure from semaglutide and tirzepatide therapies likely influenced termination decision
- Generic availability suggests limited differentiation in obesity market
- No additional regulatory or clinical catalysts anticipated for this program
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is lorcaserin hydrochloride?
- Oral small-molecule therapeutic for obesity developed by Bright Minds Biosciences Inc.
- Is it FDA approved?
- Yes, approved as generic formulation (ANDA209464) by Zydus Pharms USA Inc.
- What indication?
- Obesity
- What is the sponsor?
- Bright Minds Biosciences Inc. (Phase 3 program terminated June 2021)
- What is the route of administration?
- Oral
- What is the modality?
- Small molecule
- What is the current development status?
- Phase 3 program terminated; generic formulation approved and marketed in U.S.
- What is the mechanism of action?
- Not yet disclosed in available records
- What is the molecular target?
- Not yet disclosed in available records
- Does it have a development partner?
- No partner information disclosed
- What is the internal code?
- 15-005230
- What clinical trial is associated?
- NCT02412631 (details not disclosed)
- Who manufactures the approved formulation?
- Zydus Pharms USA Inc.
- What is the ANDA number?
- ANDA209464
- When was the program terminated?
- June 10, 2021
- What are key competitors?
- Semaglutide (Wegovy), tirzepatide (Mounjaro), Mysimba, cagrilintide combinations
- Is it approved in Europe?
- Approval status in EMA not yet disclosed
- Is it approved in Japan?
- Approval status in PMDA not yet disclosed
- Is it approved in China?
- Approval status in NMPA not yet disclosed
- What is the therapeutic class?
- Not yet disclosed in available records
- What is the patent status?
- Not yet disclosed in available records
- When was it first disclosed?
- First disclosure date not yet disclosed
- What is the projected peak sales?
- Not yet disclosed in available records
- What is the consensus position?
- Not yet disclosed in available records
- Is there a license agreement?
- No license type information disclosed
Evidence & sources
- ClinicalTrials.gov NCT02412631 (clinicaltrials)
- lorcaserin hydrochloride US status (fda)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0011122) (mondo)
- Orphanet — obesity disorder (orphanet)
- NCT03412149 (clinicaltrials_gov)
- NCT06787001 (clinicaltrials_gov)
- NCT06852391 (clinicaltrials_gov)
- NCT06881485 (clinicaltrials_gov)
- NCT06911918 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.