TGA / PMDA / NMPA · Asia-Pacific
dose — TGA / PMDA / NMPA regulatory status
dose 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: 243 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 |
|---|---|---|---|
| 217848 | Phase 3 | GSK Glaxo Smith | 2023-510196-59-00 |
| 608 dose | Phase 3 | Sunshine Guojian Pharmaceutical | NCT07261644 |
| ALKS 9072, Low Dose | Phase 3 | Alkermes Pharma Ireland | NCT01895452 |
| CLI-05993AA5-06 | Phase 3 | Chiesi Farmaceutici S.p.A | 2024-514248-95-00 |
| Dose | Phase 3 | United Therapeutics Europe | NCT04349176 |
| GWP42003-P 20 mg/kg/Day Dose | Phase 3 | Jazz Pharmaceuticals Ireland | NCT02091375, NCT02224690 |
| Guselkumab Dose 1 | Phase 3 | Janssen Cilag International | NCT03466411 |
| High Dose Colchicine (4.8 mg total dose) | Phase 3 | Takeda | NCT00506883 |
| Intermediate-dose Cytarabine in Combination with Venetoclax | Phase 3 | First People's Hospital | NCT06990321 |
| KY2025-328-02 | Phase 3 | First People's Hospital | NCT07604350 |
| Ketanest-S 25 Multi-dose for Non-psychotic therapy resistant… | Phase 3 | Disc Medicine | 2024-517485-42-00 |
| Methadone (100% dose) | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT05459402 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026117667 | DOSES DE TITRATION DE MARIDEBART CAFRAGLUTIDE | WO |
| 12415794 | Pyridazinone compounds and uses thereof | US |
| 12404313 | GDNF fusion polypeptides and methods of use thereof | US |
| 12364737 | Activin receptor type IIA variants and methods of use thereof | US |
| 12350313 | Activin receptor type IIa variants and methods of use thereof | US |
| 12269858 | Activin receptor type IIB variants and methods of use thereof | US |
| 12240831 | Pyridazinone compounds and uses thereof | US |
| 12240833 | Pyridazinone compounds and uses thereof | US |
| 12084350 | Allotrope of carbon having increased electron delocalization | US |
| 12012395 | Pyridazinone compounds and uses thereof | US |
| 2022263543 | Pharmaceutical compositions comprising sorbitan esters | AU |
| 11933866 | Magnetic resonance maps for analyzing brain tissue | US |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of dose?
dose 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 dose 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 dose?
This spoke lists 243 published programs associated with dose in our pipeline index.