TGA / PMDA / NMPA · Asia-Pacific
estriol — TGA / PMDA / NMPA regulatory status
estriol (OVESTIN) 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
- OVESTIN
- Originator
- Lacuna Pharma Pty Ltd
- Mechanism
- Estrogen receptor modulator
- Target
- Estrogen receptor
- 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: Estrogen receptor modulator. Target: Estrogen receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — TGA: approved.
Linked evidence on this spoke: 2 published clinical programs and 5 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 |
|---|---|---|---|---|
| TGA | Australia | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 9941 | Phase 2 | CNS Pharmaceuticals | NCT00302731 |
| Providence | Approved | George Institute for | 2025-521460-36-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 10406169 | Methods of monitoring estriol therapy | US |
| 10369158 | Pharmaceutical packaging for estriol therapy | US |
| 9168262 | Estriol therapy for multiple sclerosis and other autoimmune diseases | US |
| 8372826 | Estriol therapy for multiple sclerosis and other autoimmune diseases | US |
| 6936599 | Estriol therapy for multiple sclerosis and other autoimmune diseases | US |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of estriol?
estriol 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 estriol 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 estriol?
This spoke lists 2 published programs associated with estriol in our pipeline index.