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AZILSARTAN
12.1 Mechanism of Action The active ingredients of Edarbyclor target two separate mechanisms involved in blood pressure regulation.
AZILSARTAN was discontinued before reaching advanced clinical trials. The drug was intended to treat high blood pressure. Its clinical significance is limited as it never progressed to a stage where it could be used to treat patients.
At a glance
| Generic name | AZILSARTAN |
|---|---|
| Target | Type-1 angiotensin II receptor, Type-1 angiotensin II receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | discontinued |
Mechanism of action
12.1 Mechanism of Action The active ingredients of Edarbyclor target two separate mechanisms involved in blood pressure regulation. Azilsartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II). Angiotensin II is the principle pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodi
Approved indications
- Hypertensive disorder
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Edarbyclor as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. WARNING: FETAL TOXICITY See full prescribing
Common side effects
- continuation because of adverse reactions
Drug interactions
- Renal clearance of lithium is reduced by diuretics
- Non-Steroidal Anti-Inflammatory Agents including
- Lithium Increases in serum lithium concentrations and
Key clinical trials
- A Two Cohort, Single-sequence, Parallel, Open Label, Multiple Oral Dosing Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of HUC2-565-A and HUC2-565-B in He (Phase 1)
- A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hyp (Phase 3)
- A Phase 3, Double-Blind, Randomized, Factorial, Efficacy and Safety Study of TAK 491 Plus Chlorthalidone Fixed-Dose Combination in Participants With Moderate to Severe Hypertension (Phase 3)
- A Randomized, Open Label, 2-Period, 2-Treatment, Cross-over Phase 1 Study to Evaluate the Bio-equivalence of Single Oral Dose of TAK-536 Pediatric Formulation and TAK-536 Commercial Formulation in Hea (Phase 1)
- A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-491 in Subjects With Mild to Moderate Uncomplicated Essential Hypertension (Phase 2)
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study (N/A)
- A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential Hypert (Phase 3)
- Effect of Azilsartan on the Incidence of Atrial Fibrillation in Patients With Hypertension Combined With Left Ventricular Hypertrophy (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AZILSARTAN CI brief — competitive landscape report
- AZILSARTAN updates RSS · CI watch RSS
- portfolio CI