Last reviewed · How we verify
TAK-536CCB
TAK-536CCB is a Angiotensin II receptor blocker/Calcium channel blocker combination Small molecule drug developed by Takeda. It is currently in Phase 3 development for Hypertension. Also known as: Fix-dose combination of Azilsartan and Amlodipine.
TAK-536CCB is a dual angiotensin II receptor blocker and calcium channel blocker combination designed to lower blood pressure through multiple mechanisms.
TAK-536CCB is a small molecule RAF serine/threonine protein kinase inhibitor used in the treatment of Essential Hypertension, specifically Grade I or II Essential Hypertension. It is administered as a tablet, either alone or in combination with other medications such as HCTZ 12.5 mg.
-
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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care. -
Big-pharma sponsor
+3.0pp
Takeda 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 | TAK-536CCB |
|---|---|
| Also known as | Fix-dose combination of Azilsartan and Amlodipine |
| Sponsor | Takeda |
| Drug class | Angiotensin II receptor blocker/Calcium channel blocker combination |
| Target | Angiotensin II type 1 receptor (AT1R); L-type calcium channels |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
The drug combines an ARB (angiotensin II receptor antagonist) component that blocks vasoconstriction and sodium retention with a calcium channel blocker component that reduces vascular smooth muscle contraction. This dual mechanism provides complementary antihypertensive effects with potential for improved efficacy and tolerability compared to monotherapy.
Approved indications
- Hypertension
Common side effects
- Dizziness
- Headache
- Peripheral edema
- Fatigue
Key clinical trials
- A Phase III Long-term Study of TAK-536TCH in Participants With Essential Hypertension (PHASE3)
- Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension. (PHASE2, 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:
- TAK-536CCB CI brief — competitive landscape report
- TAK-536CCB updates RSS · CI watch RSS
- Takeda portfolio CI
Frequently asked questions about TAK-536CCB
What is TAK-536CCB?
How does TAK-536CCB work?
What is TAK-536CCB used for?
Who makes TAK-536CCB?
Is TAK-536CCB also known as anything else?
What drug class is TAK-536CCB in?
What development phase is TAK-536CCB in?
What are the side effects of TAK-536CCB?
What does TAK-536CCB target?
Related
- Drug class: All Angiotensin II receptor blocker/Calcium channel blocker combination drugs
- Target: All drugs targeting Angiotensin II type 1 receptor (AT1R); L-type calcium channels
- Manufacturer: Takeda — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertension
- Also known as: Fix-dose combination of Azilsartan and Amlodipine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing