FDA · United States
tetrabenazine — FDA regulatory status
tetrabenazine (INOVA PHARMACEUTICALS (AUSTRALIA) PTY LTD) 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
- 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 — FDA: 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 |
|---|---|---|---|---|
| FDA | United States | 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 FDA approval status of tetrabenazine?
tetrabenazine 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 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.