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Ofatumumab 300
Ofatumumab 300 is a Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 2 development.
Ofatumumab is a binding agent that targets the B-lymphocyte antigen CD20. It is used to treat conditions such as Chronic Lymphocytic Leukemia (CLL) and Relapsed or Refractory Chronic Lymphocytic Leukemia.
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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). -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Ofatumumab 300 |
|---|---|
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL (PHASE2)
- Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (NA)
- Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy (PHASE2)
- Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide (PHASE1, PHASE2)
- Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma (PHASE1)
- Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant (PHASE2)
- Ofatumumab & Ibrutinib + Allogeneic Bone Marrow Transplant or Consolidation in High Risk Chronic Lymphocytic Leukemia (PHASE2)
- B-cell Depletion in Offspring to Women With MS Under Immunomodulatory Treatment
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:
- Ofatumumab 300 CI brief — competitive landscape report
- Ofatumumab 300 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Ofatumumab 300
What is Ofatumumab 300?
Who makes Ofatumumab 300?
What development phase is Ofatumumab 300 in?
Related
- Manufacturer: GlaxoSmithKline — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing