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Lymphodepletion
Lymphodepletion is a Small molecule drug developed by Universität Münster. It is currently in Phase 2 development. Also known as: fludarabine, Fludara, cyclophosphamide, Neostar.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Lymphodepletion |
|---|---|
| Also known as | fludarabine, Fludara, cyclophosphamide, Neostar, Cytoxan |
| Sponsor | Universität Münster |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (PHASE3)
- Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma (PHASE1)
- A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2) (PHASE1, PHASE2)
- Safety and Efficacy of OBX-115 in Advanced Solid Tumors (PHASE1, PHASE2)
- Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma (PHASE1)
- KRAS-Specific Autologous TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors (PHASE1)
- Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma (PHASE2)
- A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lymphodepletion CI brief — competitive landscape report
- Lymphodepletion updates RSS · CI watch RSS
- Universität Münster portfolio CI
Frequently asked questions about Lymphodepletion
What is Lymphodepletion?
Who makes Lymphodepletion?
Is Lymphodepletion also known as anything else?
What development phase is Lymphodepletion in?
Related
- Manufacturer: Universität Münster — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: fludarabine, Fludara, cyclophosphamide, Neostar, Cytoxan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing