Last reviewed · How we verify
candsartan cilexetil
candsartan cilexetil is a Angiotensin II Receptor Blocker (ARB) Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development.
Blocks angiotensin II type 1 (AT1) receptors, preventing vasoconstriction and aldosterone release to lower blood pressure.
Candesartan cilexetil is a small molecule used to treat hypertension and pediatric hypertension. It is administered as part of a clinical study to evaluate its efficacy, safety, and pharmacokinetics in hypertensive pediatric subjects aged 6 to 17 years.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | candsartan cilexetil |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Angiotensin II Receptor Blocker (ARB) |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Candesartan cilexetil is a prodrug that is rapidly converted to its active form, candesartan, during absorption. Candesartan selectively blocks AT1 receptors, preventing angiotensin II from binding and causing vasoconstriction, aldosterone secretion, and sympathetic activation, resulting in decreased blood pressure and reduced cardiovascular strain.
Approved indications
Common side effects
Key clinical trials
- Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age (PHASE3)
- Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age (PHASE3)
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:
- candsartan cilexetil CI brief — competitive landscape report
- candsartan cilexetil updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about candsartan cilexetil
What is candsartan cilexetil?
How does candsartan cilexetil work?
Who makes candsartan cilexetil?
What drug class is candsartan cilexetil in?
What development phase is candsartan cilexetil in?
Related
- Drug class: All Angiotensin II Receptor Blocker (ARB) drugs
- Manufacturer: AstraZeneca — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing