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Betalutin
Betalutin is a Small molecule drug developed by Nordic Nanovector. It is currently in Phase 1 development. Also known as: Betalutin, lutetium (177Lu)-lilotomab satetraxetan.
Betalutin is a radiolabeled antibody used to treat various types of non-Hodgkin lymphoma, including relapsed follicular lymphoma and diffuse large B-cell lymphoma. It is administered in combination with lilotomab, a murine monoclonal antibody against CD37, and is labeled with the radioactive isotope lutetium-177.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Betalutin |
|---|---|
| Also known as | Betalutin, lutetium (177Lu)-lilotomab satetraxetan |
| Sponsor | Nordic Nanovector |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Anaemia
- Lymphocyte count decreased
- Diarrhoea
- Nausea
- Dysphagia
- Fatigue
- Oral candidiasis
- Neutrophil count decreased
- Blood lactate dehydrogenase increased
- White blood cell count decreased
- Platelet count decreased
- Blood calcium increased
Key clinical trials
- A Phase 1/2 Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (PHASE1, PHASE2)
- Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05) (PHASE1)
- Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL (PHASE1)
- Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02) (PHASE1)
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:
- Betalutin CI brief — competitive landscape report
- Betalutin updates RSS · CI watch RSS
- Nordic Nanovector portfolio CI
Frequently asked questions about Betalutin
What is Betalutin?
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Is Betalutin also known as anything else?
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What are the side effects of Betalutin?
Related
- Manufacturer: Nordic Nanovector — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Betalutin, lutetium (177Lu)-lilotomab satetraxetan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing