FDA · United States
azilsartan medoxomil — FDA regulatory status
azilsartan medoxomil (EDARBI) 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
- EDARBI
- Originator
- Takeda
- Mechanism
- Type-1 angiotensin II receptor antagonist
- Structured fields
- 7
Sponsor / originator context: Takeda. 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. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 7 published clinical programs and 12 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 |
|---|---|---|---|
| Azilsartan Medoxomil | Phase 3 | Takeda | NCT00362115, NCT00591253 |
| Azilsartan Medoxomil and amlodipine | Phase 3 | Takeda | NCT00591266 |
| Azilsartan medoxomil and olmesartan | Phase 3 | Takeda | NCT00696241 |
| Azilsartan medoxomil with or without add-on chlorthalidone | Phase 3 | Takeda | NCT00695955 |
| Azilsartan medoxomil/placebo | Phase 3 | Takeda | NCT01456169 |
| Azilsartan medoxomil (TAK-491) | Phase 1 | Takeda | NCT01078376 |
| Azilsartan Medoxomil | Approved | Takeda | NCT02517866, NCT02480764 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12421188 | Heterocyclic compound and use thereof | US |
| 12415782 | Heterocyclic compound and use thereof | US |
| 12409210 | CNS delivery of therapeutic agents | US |
| 12391760 | Method of treating primary sclerosing cholangitis | US |
| 12391765 | Methods and materials for assessing response to plasmablast- and plasma cell-depleting therapies | US |
| 12383587 | AAV triple-plasmid system | US |
| 12384770 | Heterocyclic compound | US |
| 12378256 | Heterocyclic compound | US |
| 12358879 | Heterocyclic compound | US |
| 12337020 | Bacteriophage compositions | US |
| 12319940 | Methods for purification of arylsulfatase A | US |
| 12290531 | Compositions targeting BCMA and methods of use thereof | US |
Related hubs
FAQ
What is the FDA approval status of azilsartan medoxomil?
azilsartan medoxomil 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 azilsartan medoxomil 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 azilsartan medoxomil?
This spoke lists 7 published programs associated with azilsartan medoxomil in our pipeline index.