FDA · United States
pioglitazone hydrochloride — FDA regulatory status
pioglitazone hydrochloride (PIOGLITAZONE HYDROCHLORIDE) 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
- PIOGLITAZONE HYDROCHLORIDE
- Originator
- Takeda
- Mechanism
- Peroxisome proliferator-activated receptor gamma agonist
- Target
- Peroxisome proliferator-activated receptor gamma
- Structured fields
- 8
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: Peroxisome proliferator-activated receptor gamma agonist. Target: Peroxisome proliferator-activated receptor gamma. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 64 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 |
|---|---|---|---|
| APHP230847 | Phase 3 | PARItec | 2023-509891-40-00 |
| Alogliptin and pioglitazone | Phase 3 | Takeda | NCT00286494, NCT00655863 |
| Alogliptin and pioglitazone | Phase 3 | Takeda | NCT01318070, NCT01318122 |
| CADET-PAD | Phase 3 | COLLEGIUM PHARMACEUTICAL | 2024-511894-32-00 |
| CLI-06657AA1-03 | Phase 3 | Chiesi Farmaceutici S.p.A | 2024-516735-27-00 |
| CT-L03-301 | Phase 3 | Celltrion Healthcare Australia | 2023-508924-36-00 |
| D20180102 | Phase 3 | PARItec | 2024-511867-27-00 |
| Lactose Placebo | Phase 3 | United Therapeutics Europe | NCT03582176 |
| Lactose monohydrate for Chronic low back pain | Phase 3 | Disc Medicine | 2024-514769-20-00 |
| MEDOPP545 | Phase 3 | Stemline Therapeutics (United | 2024-512926-27-00 |
| Metformin plus pioglitazone | Phase 3 | First People's Hospital | NCT05629806 |
| N-acetylgalactosamine 4-sulfatase | Phase 3 | BioMarin Pharmaceutical Australia | NCT00048620, NCT00048711 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12385026 | Stabilized alpha-galactosidase and uses thereof | US |
| 12268700 | 3-o-sulfo-galactosylceramide analogs as activators of type II NKT cells and uses thereof | US |
| 12194079 | Therapeutic regimen for the treatment of Fabry using stabilized alpha-galactosidase | US |
| 11396571 | Polymers including galactose based blocks and uses thereof | US |
| 11116823 | Treatment of α-galactosidase a deficiency | US |
| 10870842 | Stabilized alpha-galactosidase and uses thereof | US |
| 10744154 | Galactose-pronged polysaccharides in a formulation for antifibrotic therapies | US |
| 10280414 | Stabilized α-galactosidase and uses thereof | US |
| 10253294 | Galactose oxidase treatment of dendritic cells to improve their immunogenicity | US |
| 9796756 | Galactose cluster-pharmacokinetic modulator targeting moiety for siRNA | US |
| 9732333 | Nucleic acid construct for expression of alpha-galactosidase in plants and plant cells | US |
| 9708595 | Stabilized alpha-galactosidase and uses thereof | US |
Related hubs
FAQ
What is the FDA approval status of pioglitazone hydrochloride?
pioglitazone hydrochloride 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 pioglitazone hydrochloride 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 pioglitazone hydrochloride?
This spoke lists 64 published programs associated with pioglitazone hydrochloride in our pipeline index.