BELEODAQ

LOE ApproachingSM

belinostat

NDAINTRAVENOUSPOWDERPriority Review
Approved
Jul 2014
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
10

Mechanism of Action

Histone Deacetylase Inhibitors

Pharmacologic Class:

Histone Deacetylase Inhibitor

Clinical Trials (5)

NCT06072131Phase 3Recruiting

To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL

Started Oct 2023
NCT05170334Phase 2Active Not Recruiting

Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma

Started Dec 2021
7 enrolled
Metastatic Uveal Melanoma
NCT04315233Phase 1Recruiting

Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

Started May 2021
34 enrolled
Metastatic Breast CancerRecurrent Ovarian Carcinoma
NCT04703920Phase 1Completed

Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer

Started Mar 2021
26 enrolled
Metastatic Breast CancerMetastatic Castration-resistant Prostate CancerMetastatic Ovarian Carcinoma+1 more
NCT04315155Phase 1Withdrawn

Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation

Started Oct 2020
0
Metastatic Adenocarcinoma

Loss of Exclusivity

LOE Date
Oct 27, 2027
20 months away
Patent Expiry
Oct 27, 2027

Patent Records (2)

Patent #ExpiryTypeUse Code
6888027
Aug 10, 2026
SubstanceProduct
U-1544
8835501
Oct 27, 2027
Product