NCT00775814
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported in available records
pharma · Diabetes Mellitus · Hemophilia A
Takeda
Takeda is a pharma organization headquartered in Cambridge, USA. Primary therapeutic focus areas include Diabetes Mellitus, Hemophilia A, Crohn's Disease, Hypertension, Type 2 Diabetes Mellitus. NovaPharmaNews links 1179
Cambridge, USA HQ
1993 Founded
1,617 Employees
NMPA registrant Type
Company details
- Status
- Public
- HQ
- Cambridge, USA
- Founded
- 1993
- Employees
- 1,617
- Programs
- 1179
- Drugs
- 359
- Patents
- 1436
Candesartan and Hydrochlorothiazide
Approved · small molecule · Obesity
Candesartan and Hydrochlorothiazide (BLO K025) is a small-molecule combination therapy developed by Takeda for obesity treatment. The program combines two established antihypertensive agents—candesartan, an angiotensin II receptor blocker, and hydrochlorothiazide, a thiazide diuretic—in a repurposed indication. The pro
Internal code BLO K025
At a glance
- Sponsor
- Takeda
- Phase
- Approved
- Modality
- small_molecule
- Indication
- Obesity
- Status
- completed
- Trials
- 1
Executive summary
Candesartan and Hydrochlorothiazide (BLO K025) is a small-molecule combination therapy developed by Takeda for obesity treatment. The program combines two established antihypertensive agents—candesartan, an angiotensin II receptor blocker, and hydrochlorothiazide, a thiazide diuretic—in a repurposed indication. The program achieved approved status with a latest milestone recorded on 8 August 2012. Chlorothiazide, one of the constituent components, maintains FDA approval across multiple generic manufacturers including Merck, Sandoz, and Watson Laboratories, with regulatory applications dating to the original NDA approvals. The clinical development was supported by at least one registered trial (NCT00775814). As an approved program, Candesartan and Hydrochlorothiazide represents a completed development cycle, though specific mechanism of action details, target identification, and peak sales projections remain undisclosed in available records. The program reflects Takeda's strategy of exploring established pharmaceutical agents in novel therapeutic contexts.
Why this program matters
Obesity represents a significant unmet medical need with limited pharmacological treatment options historically available. The repurposing of antihypertensive agents for obesity treatment reflects emerging research into cardiovascular-metabolic pathways and the potential pleiotropic effects of renin-angiotensin system modulation. Candesartan and Hydrochlorothiazide's approved status indicates successful completion of regulatory requirements, positioning it within a competitive landscape increasingly populated by GLP-1 receptor agonists (semaglutide, tirzepatide) and combination therapies. The patient population for obesity pharmacotherapy spans millions globally, with significant commercial opportunity in markets where conventional interventions prove insufficient. Takeda's development of this combination addresses the intersection of hypertension and obesity—conditions frequently comorbid—potentially offering dual therapeutic benefit. The competitive positioning against established agents like Mysimba and emerging therapies such as Wegovy and Mounjaro underscores the market's evolution toward multiple mechanistic approaches. Commercial significance derives from obesity's prevalence, chronic treatment requirements, and integration into metabolic disease management protocols.
Drug intelligence
Drug Class: Antihypertensive combination therapy (angiotensin II receptor blocker + thiazide diuretic)
Modality: Small-molecule oral formulation
Route of Administration: Oral
Active Components:
- Candesartan (mechanism of action not disclosed)
- Hydrochlorothiazide (thiazide diuretic)
- Chlorothiazide (DIUPRES-500 brand formulation)
Mechanism of Action: Not yet disclosed in available records
Target: Not yet disclosed in available records
Related Therapies: Established antihypertensive agents with potential metabolic effects; differentiated from GLP-1 agonists (semaglutide, tirzepatide) and combination obesity therapies (Mysimba, Wegovy)
Regulatory Status: Chlorothiazide component maintains FDA approval via multiple ANDA and NDA applications across generic manufacturers
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
- Approved2012-08-08
Program completion milestone
Latest recorded milestone for Candesartan and Hydrochlorothiazide obesity program.
Competitive landscape
The obesity pharmacotherapy landscape includes multiple mechanistic approaches. Semaglutide (GLP-1 receptor agonist) and tirzepatide (dual GIP/GLP-1 receptor agonist) represent the dominant modern class, marketed as Wegovy and Mounjaro respectively by NovoThirteen and The George Institute. Mysimba (naltrexone/bupropion combination) offers an alternative mechanism targeting central appetite regulation. Pioglitazone, also developed by Takeda, addresses metabolic dysfunction through peroxisome proliferator-activated receptor gamma activation. Candesartan and Hydrochlorothiazide's positioning as a repurposed antihypertensive combination differentiates it through potential dual cardiovascular-metabolic benefits, though the competitive advantage versus established GLP-1 agonists—which demonstrate superior weight loss efficacy in clinical trials—remains unclear. The competitor list includes esomeprazole, rimegepant, simvastatin, and other agents with unclear direct obesity indication relevance, suggesting potential data quality issues in the source. The approved status of Candesartan and Hydrochlorothiazide indicates successful regulatory pathway completion, positioning it as an established option within an increasingly crowded market dominated by newer, more efficacious agents.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| ESOMEPRAZOLE, ESOMEPRAZOLE | Fondazione Telethon ETS | small_molecule | approved |
| Semaglutide | United Therapeutics Europe Ltd | 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 |
| Pioglitazone | 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 |
| EXPAREL | Pacira Ireland Limited | 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: Approved (program status: completed as of 8 August 2012)
Chlorothiazide Component Regulatory History:
- Original NDAs: NDA011145, NDA011635, NDA011870, NDA016016
- Generic ANDA approvals: 24 applications from multiple manufacturers including Merck, Sandoz, Watson Laboratories, Hikma, Par Pharmaceuticals, Salix Pharmaceuticals, and others
- Brand formulation: DIUPRES-500 (oral)
EMA Status: Not yet disclosed
PMDA (Japan) Status: Not yet disclosed
NMPA (China) Status: Not yet disclosed
Approval Evidence: FDA approval data accessible via Open FDA drug database and application records
Clinical evidence summary
Key questions answered
What is Candesartan and Hydrochlorothiazide used for?
Candesartan and Hydrochlorothiazide (BLO K025) is an approved small-molecule combination therapy developed by Takeda for obesity treatment, combining an angiotensin II receptor blocker with a thiazide diuretic.
Is Candesartan and Hydrochlorothiazide approved by the FDA?
Yes, the program achieved approved status with the latest milestone recorded on 8 August 2012. The chlorothiazide component maintains FDA approval across multiple generic manufacturers.
Who manufactures Candesartan and Hydrochlorothiazide?
Takeda is the sponsor of the BLO K025 program. The chlorothiazide component is manufactured by multiple generic companies including Merck, Sandoz, Watson Laboratories, Hikma, Par Pharmaceuticals, and others.
How does Candesartan and Hydrochlorothiazide work?
The specific mechanism of action for obesity treatment is not yet disclosed in available records, though the combination comprises an angiotensin II receptor blocker and a thiazide diuretic with established cardiovascular effects.
What is the route of administration?
Candesartan and Hydrochlorothiazide is administered orally as a small-molecule formulation.
What clinical trial supports this program?
The program is associated with clinical trial NCT00775814, though detailed trial design, results, and outcomes remain not yet disclosed in available records.
What is the current development status?
The program has completed development and achieved approved status as of 8 August 2012, with no active future milestones disclosed.
Does Takeda have a partner for this program?
No partner is disclosed for the Candesartan and Hydrochlorothiazide program; Takeda is the sole sponsor.
What are the main competitors to this therapy?
Primary competitors include GLP-1 receptor agonists (semaglutide/Wegovy), GIP/GLP-1 agonists (tirzepatide/Mounjaro), and combination therapies like Mysimba, which demonstrate superior weight loss efficacy in modern practice.
What is the target patient population?
The target population comprises patients with obesity, potentially with concurrent hypertension given the dual cardiovascular-metabolic mechanism, though specific patient population criteria are not yet disclosed.
What is the projected peak sales figure?
Projected peak sales are not yet disclosed in available records.
When was this program first disclosed?
The first disclosure date is not yet disclosed in available records; the latest recorded milestone is 8 August 2012.
Is there a patent status disclosed?
Patent status is not yet disclosed in available records.
What regulatory approvals exist outside the United States?
EMA, PMDA (Japan), and NMPA (China) approval statuses are not yet disclosed in available records.
How does this compare to Mysimba?
Mysimba combines naltrexone and bupropion targeting central appetite regulation, whereas Candesartan and Hydrochlorothiazide uses antihypertensive agents; comparative efficacy data are not disclosed.
Is this program still in active development?
No, the program status is 'completed' as of 8 August 2012, with no active future milestones or expected next milestones disclosed.
Entity relationship graph
Candesartan and Hydrochlorothiazide → Drug → Target → Indication → Company → Trials → Competitors
Molecular targets
Companies
Indication
Trials
Competitors
- ESOMEPRAZOLE, ESOMEPRAZOLE
- Semaglutide
- 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.
- Pioglitazone
- 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
- EXPAREL
- SETMELANOTIDE ACETATE
- SETMELANOTIDE
- RIMONABANT
- PHENTERMINE HYDROCHLORIDE
- PHENTERMINE
- PHENDIMETRAZINE TARTRATE
- ORLISTAT
Analyst insights
Strategic Implications: Takeda's development of Candesartan and Hydrochlorothiazide for obesity represents a repurposing strategy leveraging existing pharmacological agents with established safety profiles. The approved status as of 2012 predates the modern GLP-1 agonist era, positioning this program within earlier obesity treatment paradigms. The lack of disclosed mechanism of action or target identification suggests either incomplete data disclosure or potential mechanistic uncertainty regarding obesity efficacy.
Competitive Implications: The program faces significant competitive pressure from GLP-1 and GIP/GLP-1 receptor agonists demonstrating superior weight loss efficacy (15-22% body weight reduction) compared to historical antihypertensive-based approaches. Market adoption likely reflects niche positioning for patients with concurrent hypertension and obesity, or those intolerant to modern obesity therapeutics. The approved status provides regulatory certainty but limited differentiation in modern practice.
Future Catalysts: Publication of NCT00775814 results would clarify efficacy, safety, and patient population definition. Label expansion discussions or combination studies with modern obesity agents remain undisclosed. Market penetration data and real-world effectiveness studies would inform competitive positioning.
Expected Milestones: No future milestones are disclosed. Program appears completed as of 2012 with no active development activities reported.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is BLO K025?
- Candesartan and Hydrochlorothiazide, a small-molecule combination therapy for obesity by Takeda.
- Sponsor?
- Takeda Pharmaceutical Company Limited.
- Indication?
- Obesity.
- Modality?
- Small-molecule oral combination therapy.
- Route of administration?
- Oral.
- Current phase?
- Approved (development completed).
- Approval date?
- Latest milestone 8 August 2012; specific approval date not disclosed.
- Mechanism of action?
- Not yet disclosed; combines angiotensin II receptor blocker with thiazide diuretic.
- Active components?
- Candesartan and Hydrochlorothiazide (chlorothiazide formulation DIUPRES-500).
- Partner company?
- None disclosed; Takeda is sole sponsor.
- Clinical trial?
- NCT00775814; detailed results not yet disclosed.
- FDA approval status?
- Approved; chlorothiazide component has multiple FDA approvals.
- EMA approval?
- Not yet disclosed.
- Peak sales projection?
- Not yet disclosed.
- Main competitors?
- Semaglutide (Wegovy), tirzepatide (Mounjaro), Mysimba, pioglitazone.
- Development status?
- Completed; no active future milestones disclosed.
- First disclosure date?
- Not yet disclosed.
- Patent status?
- Not yet disclosed.
- Target mechanism?
- Not yet disclosed in available records.
- Regulatory target?
- Not yet disclosed.
- Lead investigator?
- Not yet disclosed.
- License type?
- Not yet disclosed.
Evidence & sources
- ClinicalTrials.gov NCT00775814 (clinicaltrials)
- chlorothiazide 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.