TGA / PMDA / NMPA · Asia-Pacific
valsartan — TGA / PMDA / NMPA regulatory status
valsartan (DILART) 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 · NMPA clinical trials.
Status snapshot
- Status
- TGA approved · NMPA clinical trials
- Brand
- DILART
- Originator
- Alphapharm Pty Ltd
- Mechanism
- Type-1 angiotensin II receptor antagonist
- Target
- Type-1 angiotensin II receptor
- Structured fields
- 10
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; NMPA: clinical trials.
Linked evidence on this spoke: 6 published clinical programs and 2 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
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| APHP230833 | Phase 3 | PARItec | 2023-508798-94-00 |
| LCZ696 (sacubitril/valsartan) | Phase 3 | Novartis India | NCT02924727 |
| Sacubitril-Valsartan | Phase 3 | Chinese Academy of | NCT04912167 |
| CXXB750A12201 | Phase 2 | Novartis India | 2023-504678-39-00 |
| Randomized for not applicable (submitted trial is bioavailability) | Phase 1 | Anaxis Pharma | 2025-523054-14-00 |
| TKC202505 | Unknown | University of Hong | NCT07458880 |
Related patents
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of valsartan?
valsartan currently shows TGA approved · NMPA clinical trials 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 valsartan 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 valsartan?
This spoke lists 6 published programs associated with valsartan in our pipeline index.