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Belinostat Injection
Belinostat Injection is a Histone deacetylase (HDAC) inhibitor Small molecule drug developed by Acrotech Biopharma Inc.. It is currently in Phase 3 development for Peripheral T-cell lymphoma (PTCL), Cutaneous T-cell lymphoma. Also known as: Beleodaq®, PXD101.
Belinostat is a histone deacetylase (HDAC) inhibitor that blocks HDAC enzymes to promote histone acetylation, leading to altered gene expression and cancer cell death.
Belinostat is a histone deacetylase (HDAC) inhibitor that blocks HDAC enzymes to promote histone acetylation, leading to altered gene expression and cancer cell death. Used for Peripheral T-cell lymphoma (PTCL), Cutaneous T-cell lymphoma.
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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 | Belinostat Injection |
|---|---|
| Also known as | Beleodaq®, PXD101 |
| Sponsor | Acrotech Biopharma Inc. |
| Drug class | Histone deacetylase (HDAC) inhibitor |
| Target | Histone deacetylase (HDAC) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting histone deacetylases, belinostat increases acetylation of histone proteins, which opens chromatin structure and allows transcription of genes involved in cell cycle arrest and apoptosis. This mechanism is particularly effective in hematologic malignancies where epigenetic dysregulation drives tumor growth. The drug induces differentiation and death of cancer cells while sparing many normal cells.
Approved indications
- Peripheral T-cell lymphoma (PTCL)
- Cutaneous T-cell lymphoma
Common side effects
- Nausea
- Fatigue
- Vomiting
- Diarrhea
- Anemia
- Thrombocytopenia
- Infection
Key clinical trials
- To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL (PHASE3)
- Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer (PHASE1)
- A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies (PHASE1, PHASE2)
- A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies (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:
- Belinostat Injection CI brief — competitive landscape report
- Belinostat Injection updates RSS · CI watch RSS
- Acrotech Biopharma Inc. portfolio CI
Frequently asked questions about Belinostat Injection
What is Belinostat Injection?
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Related
- Drug class: All Histone deacetylase (HDAC) inhibitor drugs
- Target: All drugs targeting Histone deacetylase (HDAC)
- Manufacturer: Acrotech Biopharma Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Peripheral T-cell lymphoma (PTCL)
- Indication: Drugs for Cutaneous T-cell lymphoma
- Also known as: Beleodaq®, PXD101
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing