NCT07463846
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
pharma · TTR-mediated Amyloidosis · Hypertension · ALNY
Alnylam Netherlands
Alnylam Netherlands B.V.
Alnylam Netherlands is a pharma organization headquartered in Cambridge, USA. It trades on NYSE under ticker ALNY. Primary therapeutic focus areas include TTR-mediated Amyloidosis, Hypertension, Transthyretin Amyloidosis
Cambridge, USA HQ
2002 Founded
2,826 Employees
Public company Type
ALNY · NYSE Ticker
Company details
- Status
- Public
- HQ
- Cambridge, USA
- Founded
- 2002
- Employees
- 2,826
- Programs
- 84
- Drugs
- 37
- Patents
- 379
ALN-2232
Phase 2 · small molecule · Obesity
ALN-2232 is a small-molecule therapeutic candidate in Phase 2 development by Alnylam Netherlands B.V. for the treatment of obesity. The program is currently active with the most recent milestone dated May 14, 2026. The specific mechanism of action and molecular target have not yet been disclosed. Alnylam is advancing t
Internal code ALN-2232-001
At a glance
- Sponsor
- Alnylam Netherlands B.V.
- Phase
- Phase 2
- Modality
- small_molecule
- Indication
- Obesity
- Status
- active
- Trials
- 1
Executive summary
ALN-2232 is a small-molecule therapeutic candidate in Phase 2 development by Alnylam Netherlands B.V. for the treatment of obesity. The program is currently active with the most recent milestone dated May 14, 2026. The specific mechanism of action and molecular target have not yet been disclosed. Alnylam is advancing this asset independently without a disclosed partner arrangement. The clinical development is supported by at least one active trial (NCT07463846). Regulatory pathways and approval timelines remain to be determined as the program progresses through Phase 2 evaluation.
Why this program matters
Obesity represents a significant unmet medical need with growing prevalence globally and substantial comorbidity burden including cardiovascular disease, type 2 diabetes, and metabolic dysfunction. The competitive landscape for obesity therapeutics has expanded considerably, with multiple approved agents now available including GLP-1 receptor agonists and combination therapies. ALN-2232's development as a small-molecule approach may offer differentiation through oral bioavailability, manufacturing scalability, or alternative mechanism compared to injectable biologics dominating the current market. The obesity therapeutic market has demonstrated substantial commercial potential, with approved agents achieving significant uptake. Alnylam's entry into this indication with a novel small-molecule represents a strategic expansion beyond the company's historical RNAi platform focus. Success in Phase 2 could position ALN-2232 as a meaningful addition to the obesity treatment armamentarium, particularly if efficacy and safety profiles prove competitive with or complementary to existing approved therapies.
Drug intelligence
Drug Class: Small-molecule therapeutic
Modality: Small molecule
Indication: Obesity
Mechanism of Action: Not yet disclosed
Molecular Target: Not yet disclosed
Route of Administration: Not yet disclosed
Development Stage: Phase 2
Sponsor: Alnylam Netherlands B.V.
Related Therapies: The competitive space includes approved agents such as semaglutide-based formulations, tirzepatide (Mounjaro), and combination therapies such as naltrexone/bupropion (Mysimba).
Patent Status: Not yet disclosed
First Approval: Not applicable; program remains in clinical development
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 22026-05-14
Latest Milestone
Most recent program activity recorded; specific milestone details not yet disclosed.
Competitive landscape
The obesity therapeutic landscape includes multiple approved small-molecule and biologic agents. Approved competitors listed in the development database include simvastatin (Hospital Authority, Hong Kong), pioglitazone (Takeda), semaglutide formulations (Disc Medicine), tirzepatide/Mounjaro solution (The George Institute), and naltrexone/bupropion combination (Mysimba, Disc Medicine). These agents represent diverse mechanisms including insulin sensitizers, GLP-1 receptor agonists, and sympathomimetic/opioid antagonist combinations. ALN-2232 as a small-molecule approach may differentiate through oral administration, improved tolerability profile, or novel mechanism of action, though the specific target and MOA remain undisclosed. The competitive environment is characterized by rapid innovation and market expansion, with multiple agents achieving significant clinical adoption. ALN-2232's Phase 2 status positions it as an early-stage entrant relative to the established approved therapies, requiring demonstration of meaningful efficacy and safety advantages to achieve market differentiation.
| 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
EMA Status: Not yet disclosed
PMDA (Japan) Status: Not yet disclosed
NMPA (China) Status: Not yet disclosed
Current Development Status: Phase 2, active
Regulatory Pathway: Not yet disclosed
No regulatory approvals, designations, or pathway determinations have been publicly disclosed for ALN-2232. The program remains in clinical development with regulatory strategy to be determined based on Phase 2 outcomes.
Clinical evidence summary
Key questions answered
What is ALN-2232 used for?
ALN-2232 is a small-molecule therapeutic candidate in development for the treatment of obesity.
Who is developing ALN-2232?
ALN-2232 is being developed by Alnylam Netherlands B.V., a subsidiary of Alnylam Pharmaceuticals.
What is the current development stage of ALN-2232?
ALN-2232 is currently in Phase 2 clinical development with active status as of May 14, 2026.
How does ALN-2232 work?
The specific mechanism of action and molecular target for ALN-2232 have not yet been disclosed by the sponsor.
Is ALN-2232 approved by the FDA?
No, ALN-2232 has not been approved by the FDA or any other regulatory authority. The program remains in Phase 2 clinical development.
What type of drug is ALN-2232?
ALN-2232 is a small-molecule therapeutic, distinct from Alnylam's traditional RNAi platform.
Does ALN-2232 have a development partner?
No development partner has been disclosed; Alnylam Netherlands B.V. is advancing the program independently.
What clinical trial is evaluating ALN-2232?
ALN-2232 is being evaluated in clinical trial NCT07463846; detailed trial information has not yet been disclosed.
What is the route of administration for ALN-2232?
The route of administration for ALN-2232 has not yet been disclosed.
How does ALN-2232 compare to approved obesity treatments?
Specific comparative data is not available. ALN-2232 is a small-molecule in Phase 2, while approved competitors include GLP-1 agonists and combination therapies already on the market.
What is the expected timeline for ALN-2232 approval?
No approval timeline has been disclosed. Regulatory pathway and approval expectations depend on Phase 2 outcomes and future regulatory interactions.
Are there any patent protections for ALN-2232?
Patent status and intellectual property protections for ALN-2232 have not been disclosed.
What unmet medical need does ALN-2232 address?
Obesity remains a significant global health challenge with limited treatment options and substantial comorbidity burden; ALN-2232 aims to address this therapeutic need.
Has ALN-2232 received any regulatory designations?
No regulatory designations such as Fast Track, Breakthrough Therapy, or Priority Review have been disclosed for ALN-2232.
What is the molecular target of ALN-2232?
The specific molecular target for ALN-2232 has not yet been disclosed by Alnylam.
When was ALN-2232 first disclosed?
The initial disclosure date for ALN-2232 has not been recorded; the most recent milestone is dated May 14, 2026.
Entity relationship graph
ALN-2232 → 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 Positioning: ALN-2232 represents Alnylam's expansion into the obesity indication, marking a potential diversification from the company's established RNAi therapeutic platform. The small-molecule modality suggests either an internal chemistry program or potential acquisition of external intellectual property.
Competitive Implications: Entry into an increasingly crowded obesity market requires clear differentiation. Without disclosed MOA or target, competitive advantage remains unclear. Success will depend on Phase 2 efficacy, safety, and tolerability data relative to approved comparators.
Development Catalysts: Phase 2 data readout will be the critical near-term catalyst. Potential future milestones include Phase 2b expansion, regulatory feedback meetings, and Phase 3 initiation if Phase 2 demonstrates sufficient efficacy signal.
Commercial Considerations: The obesity market has demonstrated substantial revenue potential for approved agents. However, ALN-2232 faces established competition and will require compelling clinical evidence to secure market share. Oral small-molecule formulation could offer manufacturing and distribution advantages over injectable biologics.
Timeline Expectations: With Phase 2 active and latest milestone in May 2026, Phase 2 completion and potential Phase 3 initiation likely within 2-3 years, assuming positive interim data. Regulatory approval timeline remains dependent on clinical outcomes and regulatory interactions not yet disclosed.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is ALN-2232?
- Small-molecule therapeutic candidate for obesity in Phase 2 development by Alnylam Netherlands B.V.
- Sponsor company?
- Alnylam Netherlands B.V.
- Indication?
- Obesity
- Development phase?
- Phase 2
- Drug modality?
- Small molecule
- Current status?
- Active
- Mechanism of action?
- Not yet disclosed
- Molecular target?
- Not yet disclosed
- Route of administration?
- Not yet disclosed
- Development partner?
- None disclosed
- Clinical trial identifier?
- NCT07463846
- FDA approved?
- No; Phase 2 clinical development
- EMA approved?
- No; regulatory status not disclosed
- Latest milestone date?
- May 14, 2026
- Peak sales projection?
- Not yet disclosed
- Lead investigator?
- Not yet disclosed
- First disclosed date?
- Not yet disclosed
- Patent status?
- Not yet disclosed
- Regulatory designations?
- None disclosed
- Competitive advantage?
- Small-molecule approach; specific differentiation not yet disclosed
- Expected next milestone?
- Not yet disclosed
- Market opportunity?
- Obesity represents significant unmet medical need with growing market
Evidence & sources
- ClinicalTrials.gov NCT07463846 (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.