EMA · European Union
dinutuximab — EMA regulatory status
dinutuximab (UNITUXIN) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA withdrawn.
Status snapshot
- Status
- EMA withdrawn
- Brand
- UNITUXIN
- Originator
- United Therapeutics Europe Ltd
- Mechanism
- Disialoganglioside GD2 binding agent
- Target
- Disialoganglioside GD2
- Structured fields
- 8
Sponsor / originator context: United Therapeutics Europe 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: Disialoganglioside GD2 binding agent. Target: Disialoganglioside GD2. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: withdrawn.
Linked evidence on this spoke: 4 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 |
|---|---|---|---|---|
| EMA | European Union | withdrawn | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Dinutuximab | Phase 3 | United Therapeutics Europe | NCT03098030 |
| Dinutuximab | Phase 2 | Shanghai Medical College | NCT03794349 |
| Dinutuximab | Phase 2 | United Therapeutics Europe | NCT01767194 |
| Dinutuximab | Phase 1 | United Therapeutics Europe | NCT02573896, NCT03332667 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12383618 | Expression vector delivery system and use thereof for inducing an immune response | US |
| 12384820 | Griffithsin mutants | US |
| 12383500 | Nanoliposome compositions and methods of using the same | US |
| 12383554 | Compositions and methods to protect mammalian tissue against cold and other metabolic stresses | US |
| 12350274 | Nucleotide analogs | US |
| 12343432 | Encapsulated probiotic | US |
| 12336974 | Methods and compositions for preventing and treating auditory dysfunctions | US |
| 12325688 | Gingerenone A prodrugs as sensotherapeutics and methods of use | US |
| 12298315 | Systems and methods to identify and treat subjects at risk for obstetrical complications | US |
| 12286657 | Methods and compositions | US |
| 12281060 | Remodilins for airway remodeling and organ fibrosis | US |
| 12281336 | Chikungunya virus (CHIKV) virus-like particles (VLPS) comprising the C, E1, and E2 structural proteins | US |
Related hubs
FAQ
What is the EMA approval status of dinutuximab?
dinutuximab currently shows EMA withdrawn in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get dinutuximab 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 dinutuximab?
This spoke lists 4 published programs associated with dinutuximab in our pipeline index.