TGA / PMDA / NMPA · Asia-Pacific
tetrabenazine — TGA / PMDA / NMPA regulatory status
tetrabenazine (INOVA PHARMACEUTICALS (AUSTRALIA) PTY LTD) 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: TGA approved.
Status snapshot
- Status
- TGA approved
- Brand
- INOVA PHARMACEUTICALS (AUSTRALIA) PTY LTD
- Originator
- Lacuna Pharma Pty Ltd
- Mechanism
- Synaptic vesicular amine transporter inhibitor
- Target
- Synaptic vesicular amine transporter
- Structured fields
- 8
Sponsor / originator context: Lacuna Pharma 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: Synaptic vesicular amine transporter inhibitor. Target: Synaptic vesicular amine transporter. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — TGA: approved.
Linked evidence on this spoke: 7 published clinical programs and 1 related patent record. 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 |
|---|---|---|---|---|
| TGA | Australia | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Deutetrabenazine | Phase 3 | Teva Pharma | NCT04713982 |
| (+)-α-DIHYDROTETRABENAZINE | Phase 2 | Anaxis Pharma | 2024-519105-35-00 |
| (+)-α-DIHYDROTETRABENAZINE | Phase 2 | Anaxis Pharma | 2023-509518-12-01 |
| (+)-α-DIHYDROTETRABENAZINE, ADE513 placebo | Phase 2 | Anaxis Pharma | 2024-516852-17-00 |
| Deutetrabenazine 6 MG | Phase 2 | Teva Pharma | NCT04173260 |
| Deutetrabenazine | Approved | Teva Pharma | NCT07601516 |
| Deutetrabenazine Oral Capsule | Approved | Teva Pharma | NCT06997198 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 8562949 | Radiolabeled dihydrotetrabenazine derivatives and their use as imaging agents | US |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of tetrabenazine?
tetrabenazine currently shows TGA approved 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 tetrabenazine 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 tetrabenazine?
This spoke lists 7 published programs associated with tetrabenazine in our pipeline index.