NCT06970405
- Objective
- Not yet disclosed.
- Design
- Not yet disclosed.
- Participants
- Not yet disclosed.
- Primary endpoint
- Not yet disclosed.
- Results
- Results not yet reported; trial terminated with program discontinuation.
pharma · Diabetic Macular Edema · Hypercholesterolemia · REGN
Regeneron UK
Regeneron UK Limited
Regeneron UK is a pharma organization headquartered in Tarrytown, USA. It trades on NYSE under ticker REGN. Primary therapeutic focus areas include Diabetic Macular Edema, Hypercholesterolemia, Asthma, Macular Degenerati
Tarrytown, USA HQ
16,715 Employees
Public company Type
REGN · NYSE Ticker
Company details
- Status
- Public
- HQ
- Tarrytown, USA
- Employees
- 16,715
- Programs
- 493
- Drugs
- 98
- Patents
- 837
Garetosmab
Phase 1 · small molecule · Obesity
Garetosmab (internal code R2477-OB-2470) is a small-molecule therapeutic candidate developed by Regeneron UK Limited for the treatment of obesity. The program is currently in Phase 1 clinical development and has been terminated as of September 17, 2025. The drug's mechanism of action and specific molecular target have
Internal code R2477-OB-2470
At a glance
- Sponsor
- Regeneron UK Limited
- Phase
- Phase 1
- Modality
- small_molecule
- Indication
- Obesity
- Status
- terminated
- Trials
- 1
Executive summary
Garetosmab (internal code R2477-OB-2470) is a small-molecule therapeutic candidate developed by Regeneron UK Limited for the treatment of obesity. The program is currently in Phase 1 clinical development and has been terminated as of September 17, 2025. The drug's mechanism of action and specific molecular target have not been disclosed. Regeneron's development strategy for this asset involved early-stage clinical evaluation, as evidenced by the Phase 1 trial registration (NCT06970405). The termination of the program represents a strategic decision by the sponsor to discontinue further development efforts. No regulatory submissions or approvals have been disclosed for this candidate. The competitive obesity therapeutics landscape includes both approved small-molecule agents and biologics from multiple sponsors, though many listed competitors appear to represent off-label or repurposed indications rather than obesity-specific approvals.
Why this program matters
Obesity represents a significant unmet medical need globally, with limited pharmacological treatment options approved for chronic weight management. The obesity therapeutics market has expanded substantially with the recent commercial success of GLP-1 receptor agonists, creating both opportunities and competitive pressures for novel mechanisms. Garetosmab's small-molecule modality would have offered a potentially differentiated approach compared to injectable biologics, potentially addressing patient preferences for oral administration and accessibility. The termination of this program suggests that Regeneron's internal evaluation determined the candidate did not meet efficacy, safety, or commercial viability thresholds during early clinical assessment. The competitive landscape for obesity treatment includes approved agents across multiple mechanistic classes, indicating an active and crowded market. Understanding why Regeneron terminated this asset provides insight into the clinical and commercial hurdles facing novel obesity therapeutics in the current environment.
Drug intelligence
Drug Class: Small-molecule therapeutic candidate for obesity.
Modality: Small molecule.
Mechanism of Action: Not yet disclosed.
Molecular Target: Not yet disclosed.
Route of Administration: Not yet disclosed.
Related Therapies: The competitive landscape includes approved small-molecule obesity agents such as Mysimba (naltrexone/bupropion combination), as well as GLP-1 receptor agonists and other metabolic modulators.
Patent Status: Not yet disclosed.
First Approval: Not applicable; program terminated in Phase 1.
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 12025-09-17
Program Terminated
Garetosmab development terminated as of September 17, 2025, following Phase 1 clinical evaluation.
Competitive landscape
The obesity therapeutics landscape includes multiple approved small-molecule agents and biologics. Among the competitors listed, Mysimba (naltrexone/bupropion prolonged-release tablets) represents an established approved combination therapy for chronic weight management. Simvastatin and pioglitazone are approved agents with metabolic effects, though their primary indications differ from obesity. Mounjaro (tirzepatide) solution for injection, developed by Eli Lilly and referenced here through The George Institute, represents a major competitive force in the obesity market as a GLP-1/GIP receptor agonist. Semaglutide formulations similarly represent the dominant GLP-1 agonist class. The competitive set also includes various other small-molecule agents with diverse mechanisms, suggesting a fragmented market with multiple therapeutic approaches. Garetosmab's termination indicates that the small-molecule approach did not achieve sufficient differentiation or clinical benefit to justify continued development against this competitive backdrop, particularly given the commercial dominance of GLP-1 and GLP-1/GIP agonists in recent years.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| Simvastatin | Hospital Authority, Hong Kong | small_molecule | approved |
| Pioglitazone | Takeda | small_molecule | approved |
| Semaglutide B 3.0 mg/ml PDS290 | Disc Medicine | small_molecule | approved |
| Mounjaro solution for injection in pre-filled... for Obesity | The George Institute | small_molecule | approved |
| ESOMEPRAZOLE, ESOMEPRAZOLE | Fondazione Telethon ETS | small_molecule | approved |
| Candesartan and Hydrochlorothiazide | Takeda | small_molecule | approved |
| NN9838-4968 | NovoThirteen | small_molecule | approved |
| Intravenous Ibuprofen | CUMBERLAND PHARMACEUTICALS INC | small_molecule | approved |
| NN9536-7752 | NovoThirteen | small_molecule | approved |
| ANGELO | The George Institute | small_molecule | approved |
| Mysimba 8 mg/90 mg prolonged-release tablets | Disc Medicine | small_molecule | approved |
| RIMEGEPANT , Capsaicin | Disc Medicine | 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
FDA Status: Not yet disclosed. No regulatory submissions or approvals reported.
EMA Status: Not yet disclosed.
PMDA (Japan) Status: Not yet disclosed.
NMPA (China) Status: Not yet disclosed.
Development Status: Program terminated in Phase 1; no regulatory pathway advancement disclosed. The termination prior to Phase 2 initiation suggests the sponsor did not pursue formal regulatory engagement or pre-clinical regulatory guidance for this asset.
Clinical evidence summary
Key questions answered
What is Garetosmab used for?
Garetosmab was being developed as a small-molecule therapeutic candidate for the treatment of obesity. The program has been terminated and is not in active development.
Who manufactures Garetosmab?
Garetosmab is developed by Regeneron UK Limited. The program has been terminated as of September 2025.
Is Garetosmab approved by the FDA?
No. Garetosmab was terminated in Phase 1 development and has not been submitted to or approved by the FDA or any other regulatory authority.
What is the mechanism of action of Garetosmab?
The mechanism of action of Garetosmab has not been disclosed in available sources.
What is the molecular target of Garetosmab?
The specific molecular target of Garetosmab has not been disclosed.
What clinical trials support Garetosmab?
Garetosmab was associated with Phase 1 trial NCT06970405. Trial details and results have not been disclosed; the trial was terminated with the program discontinuation.
What is the internal code for Garetosmab?
The internal code for Garetosmab is R2477-OB-2470.
When was Garetosmab terminated?
Garetosmab was terminated on September 17, 2025, while in Phase 1 development.
What is the route of administration for Garetosmab?
The route of administration for Garetosmab has not been disclosed.
Does Garetosmab have any development partners?
No development partner has been disclosed for Garetosmab. Regeneron UK Limited is listed as the sole sponsor.
What competitors exist in the obesity treatment market?
Approved competitors in obesity treatment include Mysimba (naltrexone/bupropion), GLP-1 agonists such as semaglutide and tirzepatide (Mounjaro), and various other small-molecule and biologic agents.
Why was Garetosmab terminated?
The specific reasons for termination have not been disclosed by Regeneron. The decision to discontinue a Phase 1 program typically reflects insufficient clinical efficacy, safety concerns, or strategic reprioritization.
What is the development phase of Garetosmab?
Garetosmab was in Phase 1 development when the program was terminated in September 2025.
Is Garetosmab a small molecule or biologic?
Garetosmab is classified as a small-molecule therapeutic candidate.
What is the patent status of Garetosmab?
Patent information for Garetosmab has not been disclosed.
Are there any label expansions planned for Garetosmab?
No label expansions are planned or applicable, as Garetosmab has been terminated and is not approved for any indication.
Entity relationship graph
Garetosmab → Drug → Target → Indication → Company → Trials → Competitors
Companies
Indication
Trials
Competitors
- Simvastatin
- Pioglitazone
- Semaglutide B 3.0 mg/ml PDS290
- Mounjaro solution for injection in pre-filled... for Obesity
- ESOMEPRAZOLE, ESOMEPRAZOLE
- Candesartan and Hydrochlorothiazide
- NN9838-4968
- Intravenous Ibuprofen
- NN9536-7752
- ANGELO
- Mysimba 8 mg/90 mg prolonged-release tablets
- RIMEGEPANT , Capsaicin
- SETMELANOTIDE ACETATE
- SETMELANOTIDE
- RIMONABANT
- PHENTERMINE HYDROCHLORIDE
- PHENTERMINE
- PHENDIMETRAZINE TARTRATE
- ORLISTAT
Analyst insights
Strategic Implications: Regeneron's termination of Garetosmab reflects the challenging competitive environment for novel obesity therapeutics. The decision to discontinue a Phase 1 program suggests early clinical or translational data did not support advancement, or that internal strategic prioritization favored other assets.
Competitive Implications: The termination underscores the market dominance of GLP-1 and GLP-1/GIP receptor agonists in obesity treatment. Small-molecule programs must demonstrate clear mechanistic or clinical advantages to justify continued investment against this backdrop. The crowded competitive landscape with multiple approved agents across different mechanisms creates high barriers to entry for novel candidates.
Future Catalysts: No future milestones are expected for this terminated program. Any future development would require a strategic decision by Regeneron to reinitiate the asset, which appears unlikely given the termination status.
Expected Milestones: None anticipated. The program has been discontinued.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is Garetosmab?
- Small-molecule obesity therapeutic candidate developed by Regeneron UK Limited; terminated in Phase 1 as of September 2025.
- Sponsor company?
- Regeneron UK Limited.
- Indication?
- Obesity.
- Development phase?
- Phase 1 (terminated September 17, 2025).
- Modality?
- Small molecule.
- Mechanism of action?
- Not yet disclosed.
- Molecular target?
- Not yet disclosed.
- Route of administration?
- Not yet disclosed.
- FDA approval status?
- Not approved; program terminated in Phase 1.
- EMA approval status?
- Not approved; program terminated in Phase 1.
- Development partner?
- No partner disclosed; Regeneron UK Limited is sole sponsor.
- License type?
- Not yet disclosed.
- Internal code?
- R2477-OB-2470.
- Clinical trial identifier?
- NCT06970405.
- Termination date?
- September 17, 2025.
- Peak sales projection?
- Not disclosed; program terminated.
- Consensus analyst position?
- Not yet disclosed.
- First disclosure date?
- Not yet disclosed.
- Lead investigator?
- Not yet disclosed.
- Expected next milestone?
- None; program terminated.
- Key competitors in obesity?
- Mysimba, semaglutide, tirzepatide (Mounjaro), and other approved small-molecule and biologic agents.
- Why was program terminated?
- Specific reasons not disclosed; typical Phase 1 termination reflects efficacy, safety, or strategic concerns.
Evidence & sources
- ClinicalTrials.gov NCT06970405 (clinicaltrials)
- 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.