FDA · United States
ulipristal acetate — FDA regulatory status
ulipristal acetate (ELLAONE) 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
- ELLAONE
- Originator
- Teva Pharma GmbH
- Mechanism
- Progesterone receptor modulator
- Target
- Progesterone receptor
- Structured fields
- 8
Sponsor / originator context: Teva Pharma GmbH. 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: Progesterone receptor modulator. Target: Progesterone receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 20 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 |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 2023/3720 UMBRELLA | Phase 3 | George Institute for | 2023-503316-33-00 |
| Varicella Vaccine | Phase 3 | Sinovac Research and | NCT07473427 |
| Varicella Vaccine | Phase 3 | Sinovac Research and | NCT06314724 |
| Absorbable and moldable skull base support plate | Phase 2 | First People's Hospital | NCT07539792 |
| Anterior lamellar nanostructured artificial human cornea. | Phase 2 | Lxo Ireland Designated | NCT01765244 |
| Stellate Ganglion Block injection with ropivicane | Phase 2 | United Therapeutics Europe | NCT01629537 |
| 219728 | Phase 1 | GSK Glaxo Smith | 2023-508279-36-00 |
| Bilateral Cerebellar deep brain stimulation | Phase 1 | Shandong Topscience Biotech | NCT06303960 |
| CLI-01535AA7-04 | Phase 1 | Chiesi Farmaceutici S.p.A | 2023-510171-59-00 |
| CLI-01535AA9-03 | Phase 1 | Chiesi Farmaceutici S.p.A | 2024-514247-28-00 |
| Magellan® | Phase 1 | United Therapeutics Europe | NCT01843686 |
| Shigella sonnei 53G | Phase 1 | United Therapeutics Europe | NCT02816346 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026024938 | MÉTHODES DE RÉDUCTION DE LA TRANSMISSION INTRA-UTÉRINE D'UNE INFECTION À SALMONELLA DUBLIN | WO |
| 12419942 | Use of the Salmonella spp type III secretion proteins as a protective vaccination | US |
| 12390512 | Depolymerase capable of degrading extracellular polymeric substances of Klebsiella pneumoniae | US |
| 12203143 | Methods and kits to identify Klebsiella strains | US |
| 12071636 | Pasteurella multocida strains and vaccines having hyaC and nanP deletions | US |
| 11717542 | Using tumor-navigating Salmonella to modulate tumor metabolism | US |
| 11529312 | Francisella lipids as broad anti-inflammatory therapeutics and associated methods of use | US |
| 11519007 | Tumor-navigating, self-eradicating, trail-armed salmonella for precision cancer therapy | US |
| 11464843 | Use of the salmonella SPP type III secretion proteins as a protective vaccination | US |
| 11382897 | Therapeutic combination for treatment of cerebellar ataxia | US |
| 11364304 | Crosslinked micellar spherical nucleic acids | US |
| 11352447 | Gellan gum hydrogels, preparation, methods and uses thereof | US |
Related hubs
FAQ
What is the FDA approval status of ulipristal acetate?
ulipristal acetate 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 ulipristal acetate 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 ulipristal acetate?
This spoke lists 20 published programs associated with ulipristal acetate in our pipeline index.