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SEL-212 low-dose
SEL-212 low-dose is a Monoclonal antibody Small molecule drug developed by Swedish Orphan Biovitrum. It is currently in Phase 3 development for Relapsed or refractory non-Hodgkin lymphoma.
SEL-212 is a monoclonal antibody targeting CD19.
SEL-212 is a treatment being studied for conditions such as chronic gout and hyperuricemia. The exact mechanism of SEL-212 is unknown, but it is being investigated in clinical trials for its safety and efficacy in treating these conditions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | SEL-212 low-dose |
|---|---|
| Sponsor | Swedish Orphan Biovitrum |
| Drug class | Monoclonal antibody |
| Target | CD19 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
SEL-212 is a novel, low-dose CD19-targeting monoclonal antibody designed to deplete malignant B cells in patients with relapsed or refractory non-Hodgkin lymphoma. By targeting CD19, SEL-212 aims to selectively eliminate cancer cells while minimizing harm to healthy cells.
Approved indications
- Relapsed or refractory non-Hodgkin lymphoma
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
Key clinical trials
- A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II (PHASE3)
- A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy (PHASE3)
- Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid (PHASE2)
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:
- SEL-212 low-dose CI brief — competitive landscape report
- SEL-212 low-dose updates RSS · CI watch RSS
- Swedish Orphan Biovitrum portfolio CI
Frequently asked questions about SEL-212 low-dose
What is SEL-212 low-dose?
How does SEL-212 low-dose work?
What is SEL-212 low-dose used for?
Who makes SEL-212 low-dose?
What drug class is SEL-212 low-dose in?
What development phase is SEL-212 low-dose in?
What are the side effects of SEL-212 low-dose?
What does SEL-212 low-dose target?
Related
- Drug class: All Monoclonal antibody drugs
- Target: All drugs targeting CD19
- Manufacturer: Swedish Orphan Biovitrum — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory non-Hodgkin lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing