EMA · European Union
busulfan — EMA regulatory status
busulfan (MYLERAN) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- MYLERAN
- Originator
- Lacuna Pharma Pty Ltd
- Mechanism
- DNA inhibitor
- Target
- DNA
- 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: DNA inhibitor. Target: DNA. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 21 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 | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 2019/2894 | Phase 3 | George Institute for | 2024-514917-36-00 |
| ALL SCTped FORUM | Phase 3 | George Institute for | 2024-512657-24-00 |
| Busulfan (BU) | Phase 3 | First People's Hospital | NCT03733327 |
| CTX001-111 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-516894-57-00 |
| DAUNORUBICIN for Favorable-intermediate-risk Acu… | Phase 3 | Telethon Foundation | 2023-510433-29-00 |
| FEDR-MF-002 | Phase 3 | Celgene | 2024-511972-33-00 |
| MDS0519 | Phase 3 | Telethon Foundation | 2023-510515-19-00 |
| MK-3543-006 | Phase 3 | MSD Merck Sharp | 2023-504865-21-00 |
| OTL-103-4 | Phase 3 | Telethon Foundation | 2024-517792-20-00 |
| OTL-203-02 | Phase 3 | ORCHARD THERAPEUTICS | 2022-500306-17-00 |
| VX21-CTX001-141 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-513349-35-00 |
| VX21-CTX001-151 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-513978-22-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12318427 | Methods and compositions for modulation of tau proteins | US |
| 12139517 | Modulators of chromosome 9 open reading frame 72 gene expression and uses thereof | US |
| 12043650 | Methods and compositions for modification of a cystic fibrosis transmembrane conductance regulator (CFTR) gene | US |
| 11981967 | Engineering AAV | US |
| 11859190 | Methods and compositions for regulation of transgene expression | US |
| 11845965 | Regulation of gene expression using engineered nucleases | US |
| 11827900 | Engineered target specific nucleases | US |
| 11793888 | Methods and compositions for engineering immunity | US |
| 11723952 | Methods and compositions for treating Huntington's Disease | US |
| 11690921 | Delivery of target specific nucleases | US |
| 11661612 | DNA-binding proteins and uses thereof | US |
| 11661611 | Genetic modification of cytokine inducible SH2-containing protein (CISH) gene | US |
Related hubs
FAQ
What is the EMA approval status of busulfan?
busulfan currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get busulfan 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 busulfan?
This spoke lists 21 published programs associated with busulfan in our pipeline index.