Belinostat — drug · CancerIndex

Regulatory

Approvals (1)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma	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 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor 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. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.( 1 )accelerated	approved	Jul 3, 2014	openfda

Data updated 3 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	8	4	2	49	1	US	Jul 3, 2014	2005-01
Non-Hodgkin Lymphoma	Approved	Phase 3	5	3	2	18	1	US	Jul 3, 2014	2005-01
Malignant Liver Neoplasm	Phase2	Phase 2	1	0	0	2	0	—	—	2006-05
Leukemia	Phase2	Phase 2	0	0	0	6	0	—	—

Curated evidence

Clinical evidence (2)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–2 of 2 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
UGT1A1 UGT1A1*281
Belinostat	Malignant Neoplasm

Clinical trials

Trials with this intervention (49)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–49 of 49 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06406465	A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity	recruiting	Phase 2	60	National Cancer Institute (NCI)NIH	1	Sep 29, 2026	clinicaltrials
NCT06561048	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