Belinostat

Beleodaq is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins.

• Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )].ICD-10: C85.90

• None None.contraindicated

Recommended dosage of Beleodaq is 1,000 mg/m 2 administered over 30 minutes by intravenous infusion once daily on days 1 through 5 of a 21-day cycle. Cycles can be repeated until disease progression or unacceptable toxicity. ( 2.1 ) Treatment discontinuation or interruption with or without dosage reductions by 25% may be needed to manage adverse reactions ( 2.2 ) Reduce dosage in patients with moderate hepatic or renal impairment. ( 2.3 , 2.4 , 8.6 , 8.7 ) Avoid use in patients with severe hepatic or renal impairment. ( 2.3 , 2.4 , 8.6 , 8.7 ) Modify dosage in patients known to be homozygous for the UGT1A1*28 allele. ( 2.5 ) See the full prescribing information for preparation and administration instructions. ( 2.7 ) 2.1 Recommended Dosage The recommended dosage of Beleodaq is 1,000 mg/m 2 administered over 30 minutes by intravenous infusion once daily on Days 1 through 5 of a 21-day cycle. Cycles can be repeated every 21 days until disease progression or unacceptable toxicity. 2.2 Dosage Modification for Hematologic and Non-Hematologic Toxicities Table 1 displays the recommended Beleodaq dosage modifications for hematologic and non-hematologic toxicities. Base dosage adjustments for thrombocytopenia and neutropenia on platelet and absolute neutrophil nadir (lowest value) counts in the preceding cycle of therapy. • Absolute neutrophil count (ANC) should be greater than or equal to 1 x 10 9 /L and the platelet count should be greater than or equal to 50 x 10 9 /L prior to the start of each cycle and prior to resuming treatment following toxicity.

Hematologic Toxicity : Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia: Monitor blood counts and modify dosage for hematologic toxicities. ( 2.2 , 5.1 ) Infection : Serious and fatal infections (e.g., pneumonia and sepsis) ( 5.2 ) Hepatotoxicity : Beleodaq may cause hepatic toxicity and liver function test abnormalities. Monitor liver function tests and omit or modify dosage for hepatic toxicities. ( 2.2 , 5.3 ) Tumor lysis syndrome : Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions ( 5.4 ) Gastrointestinal Toxicity : Nausea, vomiting and diarrhea occur with Beleodaq and may require antiemetic and antidiarrheal medications ( 5.5 ). Embryo-Fetal Toxicity : Can cause fetal harm. ( 5.6 ) 5.1 Hematologic Toxicity Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary [see Dosage and Administration ( 2.2 ) and Adverse Reactions( 6.1 )] . 5.2 Infections Serious and sometimes fatal infections, including pneumonia and sepsis, have occurred with Beleodaq. Do not administer Beleodaq to patients with an active infection. Patients with a history of extensive or intensive chemotherapy may be at higher risk of life threatening infections [see Adverse Reactions ( 6.1 )]. 5.3 Hepatotoxicity Beleodaq can cause fatal hepatotoxicity and liver function test abnormalities [see Adverse Reactions ( 6.1 )] . Monitor liver function tests before treatment and before the start of each cycle.

The following clinically significant adverse reactions are described in more detail in other sections of the prescribing information. • Hematologic Toxicity [see Warnings and Precautions ( 5.1 )] • Infection [see Warnings and Precautions ( 5.2 )] • Hepatotoxicity [see Warnings and Precautions ( 5.3 )] • Tumor Lysis Syndrome [see Warnings and Precautions ( 5.4 )] • Gastrointestinal Toxicity [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (>25%) are nausea, fatigue, pyrexia, anemia, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Beleodaq may not reflect the rates observed in practice. Adverse Reactions in Patients with Peripheral T-Cell Lymphoma The safety of Beleodaq was evaluated in 129 patients with relapsed or refractory PTCL in the single arm clinical trial in which patients were administered Beleodaq at a dosage of 1,000 mg/m 2 administered over 30 minutes by IV infusion once daily on Days 1 through 5 of a 21-day cycle [see Clinical Studies ( 14 ) ] . The median duration of treatment was 2 cycles (range 1 – 33 cycles). The most common adverse reactions observed in the trial of patients with relapsed or refractory PTCL treated with Beleodaq were nausea, fatigue, pyrexia, anemia, and vomiting [see Clinical Studies ( 14 ) ] .

Lactation: Advised not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, Beleodaq can cause teratogenicity and/or embryo-fetal lethality because it is genotoxic and targets actively dividing cells [see Clinical Pharmacology ( 12.1 ) and Nonclinical Toxicology ( 13.1 )] . There are no available data on Beleodaq use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. No animal reproduction studies were conducted with Beleodaq. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of belinostat in human milk, the effects on the breastfed child, or the effects on milk production.

Metabolism

The pharmacokinetic characteristics of belinostat were analyzed from pooled data from phase 1/2 clinical studies that used doses of belinostat ranging from 150 to 1200 mg/m 2 (0.15 to 1.2 times the approved recommended dosage). Distribution The mean belinostat volume of distribution approaches total body water, indicating that belinostat has limited body tissue distribution.

No specific information is available on the treatment of overdosage of Beleodaq. There is no antidote for Beleodaq and it is not known if Beleodaq is dialyzable. If an overdose occurs, general supportive measures should be instituted as deemed necessary by the treating physician. The elimination half-life of belinostat is 1.1 hours [see Clinical Pharmacology ( 12.3) ] .

• Jul 3, 2014NDANDA206256Acrotech Biopharma

1. 1Disease Progression7021%
2. 2Nausea5416%
3. 3Anaemia4212%
4. 4Death4112%
5. 5Vomiting4012%
6. 6Dyspnoea3510%
7. 7Fatigue319.1%
8. 8Platelet Count Decreased298.5%
9. 9Constipation257.4%
10. 10Diarrhoea236.8%
11. 11Neutrophil Count Decreased236.8%
12. 12White Blood Cell Count Decreased236.8%
13. 13Neutropenia216.2%
14. 14Pneumonia195.6%
15. 15Pain185.3%

The 10 most recently updated of 56 ClinicalTrials.gov registrations naming Belinostat as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
  Recruiting · Phase 2 · Interventional · 60 enrolled · National Cancer Institute (NCI)
  NCT06406465updated 2026-06-12
• Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma
  Active not recruiting · Phase 2 · Interventional · 19 enrolled · National Cancer Institute (NCI)
  NCT04340843updated 2026-06-01
• Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment
  Active not recruiting · Phase 1 · Interventional · 48 enrolled · National Cancer Institute (NCI)
  NCT05627245updated 2026-05-13
• Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma
  Active not recruiting · Phase 1 · Interventional · 9 enrolled · University of Utah
  NCT05154994updated 2026-05-07
• Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
  Recruiting · Phase 3 · Interventional · 150 enrolled · Corvus Pharmaceuticals, Inc.
  NCT06561048updated 2026-04-08
• Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma
  Active not recruiting · Phase 2 · Interventional · 7 enrolled · H. Lee Moffitt Cancer Center and Research Institute
  NCT05170334updated 2026-04-06
• Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma
  Completed · Phase 2 · Interventional · 15 enrolled · University of Miami
  NCT02737046updated 2026-03-10
• Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
  Terminated · Phase 1 · Interventional · 18 enrolled · National Cancer Institute (NCI)
  NCT03772925updated 2026-03-03
• Phase I Trial of AZD1775 and Belinostat in Treating Patients With Relapsed or Refractory Myeloid Malignancies or Untreated Acute Myeloid Leukemia
  Terminated · Phase 1 · Interventional · 20 enrolled · National Cancer Institute (NCI)
  NCT02381548updated 2026-01-30
• Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
  Recruiting · Phase 2 · Interventional · 50 enrolled · University of Virginia
  NCT04747236updated 2026-01-21

CPIC-curated drug–gene pairs for Belinostat. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• UGT1A1CPIC B (provisional)FDA label: Actionable PGx

Frequently asked questions

How does Belinostat work?

Beleodaq is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins.

What is Belinostat used for?

According to FDA labeling, Belinostat carries indications including: Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Belinostat?

Belinostat is classified as Histone deacetylase (HDAC) inhibitors, Histone Deacetylase Inhibitor, Histone Deacetylase Inhibitors, Increased Cellular Death.

What are the brand names for Belinostat?

Belinostat is marketed under brand names including Beleodaq.

What are the contraindications for Belinostat?

Belinostat labeling lists contraindications including: None None.. Always consult the full prescribing information and a clinician.