TGA / PMDA / NMPA · Asia-Pacific
candesartan — TGA / PMDA / NMPA regulatory status
candesartan (ATACAND) regulatory status in the Asia-Pacific is tracked from public TGA / PMDA / NMPA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: TGA approved.
Status snapshot
- Status
- TGA approved
- Brand
- ATACAND
- Originator
- Alphapharm Pty Ltd
- Mechanism
- Type-1 angiotensin II receptor antagonist
- Target
- Type-1 angiotensin II receptor
- Structured fields
- 7
Sponsor / originator context: Alphapharm Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Type-1 angiotensin II receptor antagonist. Target: Type-1 angiotensin II receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — TGA: approved.
Linked evidence on this spoke: 11 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| TGA | Australia | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Candesartan | Phase 3 | Takeda | NCT00775840 |
| Candesartan Cilexetil | Phase 3 | Takeda | NCT00120003 |
| Candesartan and standard chronic heart disease therapy | Phase 3 | Takeda | NCT00843154 |
| candesartan | Phase 3 | Takeda | NCT00252694 |
| candesartan | Phase 3 | Takeda | NCT00252720 |
| candesartan cilexetil | Phase 3 | Takeda | NCT00252733 |
| CXXB750A12201 | Phase 2 | Novartis India | 2023-504678-39-00 |
| Candesartan with CBT | Phase 2 | BRIGHT MINDS BIOSCIENCES | NCT01938664 |
| Candesartan | Approved | Takeda | NCT00108706 |
| Candesartan and Hydrochlorothiazide | Approved | Takeda | NCT00775814 |
| Candesartan cilexetil and hydrochlorothiazide | Approved | Takeda | NCT01012479 |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of candesartan?
candesartan currently shows TGA approved in our Asia-Pacific regulatory index. Confirm on the official TGA / PMDA / NMPA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get candesartan regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to candesartan?
This spoke lists 11 published programs associated with candesartan in our pipeline index.