TGA / PMDA / NMPA · Asia-Pacific
extended-release — TGA / PMDA / NMPA regulatory status
extended-release 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: NMPA clinical trials.
Status snapshot
- Status
- NMPA clinical trials
- Structured fields
- 4
Regional decision snapshot — NMPA: clinical trials.
Linked evidence on this spoke: 38 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 |
|---|---|---|---|---|
| NMPA | China | clinical trials | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Aceneuramic Acid Extended-Release Tablets | Phase 3 | Ultragenyx UK | NCT02736188 |
| Delayed and extended release mesalazine | Phase 3 | Takeda | NCT00503243 |
| Extended Release Buprenorphine | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT04345718 |
| Extended Release Naltrexone | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT01908062 |
| Extended-release Guanfacine Hydrochloride | Phase 3 | Takeda | NCT01081132, NCT01081145 |
| Pramipexol Extended Release | Phase 3 | Boehringer Ingelheim | NCT00479401 |
| ROR-PH-301 | Phase 3 | United Therapeutics Europe | 2023-509304-16-00 |
| Rosiglitazone Extended Release 2mg | Phase 3 | GSK Glaxo Smith | NCT00348140 |
| SPD476-302 | Phase 3 | Takeda | NCT00548574 |
| SPD476-314 | Phase 3 | Takeda | NCT00545103 |
| SPD503-318 | Phase 3 | Takeda | NCT01500694 |
| Zolpidem extended-release | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT01685073 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12233166 | Extended release compositions comprising pyridostigmine | US |
| 11911515 | Extended release compositions comprising pyridostigmine | US |
| 11672762 | Onapristone extended-release compositions and methods | US |
| 11666536 | Extended release compositions comprising pyridostigmine | US |
| 11564888 | Extended release compositions comprising trihexyphenidyl | US |
| 11478430 | Implantable medical devices for extended release of therapeutic agents | US |
| 11478425 | Extended release compositions comprising pyridostigmine | US |
| 11229606 | Extended release compositions comprising pyridostigmine | US |
| 10786461 | Onapristone extended-release compositions and methods | US |
| 10688056 | Implantable medical devices for extended release of therapeutic agents | US |
| 10045943 | Implantable medical devices for extended release of therapeutic agents | US |
| 9636305 | Antiemetic extended release solid dosage forms | US |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of extended-release?
extended-release currently shows 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 extended-release 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 extended-release?
This spoke lists 38 published programs associated with extended-release in our pipeline index.