FDA · United States
valsartan — FDA regulatory status
valsartan (DILART) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- DILART
- Originator
- Alphapharm Pty Ltd
- Mechanism
- Type-1 angiotensin II receptor antagonist
- Target
- Type-1 angiotensin II receptor
- Structured fields
- 8
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 — FDA: approved.
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
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
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 FDA approval status of valsartan?
valsartan currently shows FDA approved in our United States regulatory index. Confirm on the official FDA 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.