Drugs / Panobinostat
last change Oct 2025 re-read 2 minutes ago

Panobinostat

Small molecule

Developed for
plasma cell myeloma · acute myeloid leukemia · myelodysplastic syndrome · breast cancer · cancer · diffuse large B-cell lymphoma · Hodgkins lymphoma · non-small cell lung carcinoma
+89 more · primary myelofibrosis · diffuse intrinsic pontine glioma · primary cutaneous T-cell lymphoma · prostate cancer · adult T-cell leukemia/lymphoma · angioimmunoblastic T-cell lymphoma · chronic lymphocytic leukemia/small lymphocytic lymphoma · chronic myelomonocytic leukemia · colorectal cancer · extranodal nasal NK/T cell lymphoma · graft versus host disease · hepatosplenic T-cell lymphoma · HIV infectious disease · leukemia · mantle cell lymphoma · melanoma · non-Hodgkin lymphoma · renal cell carcinoma · Waldenstrom macroglobulinemia · acquired polycythemia vera · anaplastic large cell lymphoma · Burkitt lymphoma · chronic myeloid leukemia · classic Hodgkin lymphoma · female breast carcinoma · glioma · head and neck cancer · hormone-resistant prostate carcinoma · lung cancer · lymphoblastic lymphoma · lymphoma · malignant glioma · MALT lymphoma · mycosis fungoides and variants · myelofibrosis · nodal marginal zone B-cell lymphoma · peripheral T-cell lymphoma, not otherwise specified · post-transplant lymphoproliferative disease · small cell lung carcinoma · soft tissue sarcoma · splenic marginal zone lymphoma · acute lymphoblastic leukemia · adult nodular lymphocyte predominant Hodgkin lymphoma · ALK-negative anaplastic large cell lymphoma · ALK-positive anaplastic large cell lymphoma · atypical teratoid rhabdoid tumor · B-cell adult acute lymphocytic leukemia · brain cancer · cancer of unknown primary site · childhood acute lymphoblastic leukemia · childhood acute myeloid leukemia · chordoma · chronic graft versus host disease · clear cell renal carcinoma · enteropathy-associated T-cell lymphoma · Epstein-Barr virus-related tumor · esophageal cancer · essential thrombocythemia · gastric cancer · glioblastoma · hematopoietic and lymphoid system neoplasm · hepatocellular carcinoma · HER2 positive breast carcinoma · Hodgkin's lymphoma, lymphocytic depletion · Hodgkin's lymphoma, mixed cellularity · malignant pancreatic neoplasm · medulloblastoma · meningioma · mesothelioma · metastatic malignant neoplasm in the brain · metastatic melanoma · neoplasm · neuroendocrine neoplasm · nodular sclerosis classical Hodgkin lymphoma · non-secretory plasma cell myeloma · plasma cell neoplasm · primary central nervous system lymphoma · primary cutaneous T-cell non-Hodgkin lymphoma · rectal cancer · refractory plasma cell neoplasm · sickle cell disease · skin cancer · small intestine lymphoma · T-cell adult acute lymphocytic leukemia · T-cell leukemia · thalassemia · thyroid gland carcinoma · triple-negative breast carcinoma · liver cancer
Investigated by
Novartis Pharmaceuticals · Novartis · National Cancer Institute (NCI) · M.D. Anderson Cancer Center · SCRI Development Innovations, LLC · Dana-Farber Cancer Institute
+100 more · H. Lee Moffitt Cancer Center and Research Institute · Genentech, Inc. · Massachusetts General Hospital · SecuraBio · Brigham and Women's Hospital · City of Hope Medical Center · University of California, San Francisco · Amgen · Beth Israel Deaconess Medical Center · Celgene Corporation · Emory University · Mayo Clinic · Midatech Pharma US Inc. · Onyx Therapeutics, Inc. · Roswell Park Cancer Institute · Southern Europe New Drug Organization · St. Jude Children's Research Hospital · Translational Research in Oncology · University of Wisconsin, Madison · AIDSfonds · Aarhus University Hospital · Abdullah Khan · Abdullah Kutlar · Ahmad Tarhini · Ajai Chari · Alliance for Clinical Trials in Oncology · Anand Jillella · Anne Beaven, MD · Armando Santoro, MD · Australian & New Zealand Children's Haematology/Oncology Group · Board of Regents, State of Louisiana · Cancer Trials Ireland · Centre Leon Berard · Deric M Park MD · Duke University · Eisai Inc. · Erasmus Medical Center · Fondazione Italiana Linfomi - ETS · Goethe University · HOVON Foundation · Herbert Hurwitz · Hoffmann-La Roche · Holden Comprehensive Cancer Center · Jason Valent · Johann Wolfgang Goethe University Hospital · John Mascarenhas · Luca Szalontay · Masonic Cancer Center, University of Minnesota · Medical University of South Carolina · Midatech Pharma plc · Millennium Pharmaceuticals, Inc. · Monash University · Muhammad Furqan · Multiple Myeloma Research Consortium · Myeloma UK · NYU Langone Health · National Cancer Centre, Singapore · National Health and Medical Research Council, Australia · Neurological Surgery, P.C. · Northwestern University · OHSU Knight Cancer Institute · Ohio State University Comprehensive Cancer Center · Oncotherapeutics · Oregon Health and Science University · Oslo University Hospital · PETHEMA Foundation · Pacific Pediatric Neuro-Oncology Consortium · Patrick Y. Wen, MD · Pediatric Brain Tumor Consortium · Peter MacCallum Cancer Centre, Australia · Polish Adult Leukemia Group · Prof Jamie Cavenagh · Quebec Clinical Research Organization in Cancer · Ronald Hoffman · all 106 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Farydak 2015-08-28 europa.eu

Trials 146 · started per year

today
EU approved 2015
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2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT04315064 Apr 2020 → May 2023 medulloblastoma The University of Texas Health Science Center, Houston Completed No outcome recorded
Phase 0 NCT00993642 Sep 2009 → Sep 2010 breast cancer Tulane University Health Sciences Center Withdrawn No outcome recorded
Phase 160 trials
Phase 1 NCT05774886 May → Sep 2023 female breast carcinoma, triple-negative breast carcinoma Dana-Farber Cancer Institute Withdrawn No outcome recorded
Phase 1 NCT04956302 Sep 2021 → Jun 2022 plasma cell myeloma Abdullah Khan Terminated No outcome recorded
Phase 1 NCT04341311 Aug 2020 → Feb 2024 diffuse intrinsic pontine glioma Dana-Farber Cancer Institute Terminated No outcome recorded
Phase 1 NCT03878524 Apr → Dec 2020 acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 OHSU Knight Cancer Institute Terminated No outcome recorded
Phase 1 NCT04264143 Mar 2020 → Apr 2022 diffuse intrinsic pontine glioma Luca Szalontay Completed No outcome recorded
Phase 1 NCT03982134 Sep 2019 → May 2021 melanoma, non-small cell lung carcinoma Muhammad Furqan Withdrawn No outcome recorded
Phase 1 NCT02890069 Oct 2016 → Feb 2022 colorectal cancer, non-small cell lung carcinoma, renal cell carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02717455 Jun 2016 → Feb 2022 glioma Pediatric Brain Tumor Consortium Completed No outcome recorded
Phase 1 NCT02676323 May 2016 → Apr 2018 acute myeloid leukemia, myelodysplastic syndrome St. Jude Children's Research Hospital Terminated No outcome recorded
Phase 1 NCT02032810 Jan 2014 → Sep 2017 melanoma, skin cancer H. Lee Moffitt Cancer Center and Research Institute Completed No outcome recorded
Phase 1/227 trials
Phase 1/2 NCT06240520 Apr 2024 → May 2025 HIV infectious disease Erasmus Medical Center Unknown No outcome recorded
Phase 1/2 NCT03566199 May 2018 → Mar 2021 diffuse intrinsic pontine glioma Sabine Mueller, MD, PhD Completed No outcome recorded
Phase 1/2 NCT02802163 Jun 2017 → Sep 2020 plasma cell myeloma H. Lee Moffitt Cancer Center and Research Institute Withdrawn No outcome recorded
Phase 1/2 NCT02471430 May 2016 → Aug 2022 HIV infectious disease Massachusetts General Hospital Completed No outcome recorded
Phase 1/2 NCT02057640 May 2014 → May 2018 plasma cell myeloma Jason Valent Completed No outcome recorded
Phase 1/2 NCT01693601 Jan 2013 → May 2018 myelofibrosis John Mascarenhas Completed No outcome recorded
Phase 1/2 NCT02145715 Jan 2013 → Jul 2015 plasma cell myeloma Prof Jamie Cavenagh Unknown No outcome recorded
Phase 1/2 NCT01680094 Sep 2012 → Sep 2013 HIV infectious disease University of Aarhus Completed No outcome recorded
Phase 1/2 NCT01496118 Dec 2011 → Dec 2020 plasma cell myeloma SCRI Development Innovations, LLC Completed No outcome recorded
Phase 1/2 NCT01169636 Jan 2011 → May 2017 Hodgkins lymphoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 251 trials
Phase 2 NCT05725200 Sep 2022 → Dec 2038 expected colorectal cancer Oslo University Hospital Recruiting No outcome recorded
Phase 2 NCT03632317 Oct 2019 → Oct 2025 diffuse intrinsic pontine glioma University of Michigan Rogel Cancer Center Withdrawn No outcome recorded
Phase 2 NCT04897880 Jan 2019 → May 2024 atypical teratoid rhabdoid tumor, brain cancer Australian & New Zealand Children's Haematology/Oncology Group Terminated No outcome recorded
Phase 2 NCT03256045 Feb 2018 → Feb 2021 plasma cell myeloma University of Washington Terminated No outcome recorded
Phase 2 NCT02961816 Jun 2017 → Jun 2021 lymphoma M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 2 NCT02756663 Dec 2016 → Feb 2021 plasma cell myeloma Novartis Pharmaceuticals Withdrawn No outcome recorded
Phase 2 NCT02518750 Nov 2016 → Mar 2018 T-cell leukemia, acute lymphoblastic leukemia St. Jude Children's Research Hospital Terminated No outcome recorded
Phase 2 NCT02654990 Apr 2016 → Oct 2019 plasma cell myeloma pharmaand GmbH Completed No outcome recorded
Phase 2 NCT02588339 Mar 2016 → Dec 2018 graft versus host disease H. Lee Moffitt Cancer Center and Research Institute Completed No outcome recorded
Phase 2 NCT02506959 Sep 2015 → Jun 2024 plasma cell leukemia, plasma cell myeloma, plasmacytoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 33 trials
Phase 3 NCT04326764 Jul 2018 → Feb 2023 acute myeloid leukemia, myelodysplastic syndrome Goethe University Terminated No outcome recorded
Phase 3 NCT01034163 Jun 2010 → May 2012 Hodgkins lymphoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01023308 Dec 2009 → Jul 2015 plasma cell myeloma Novartis Pharmaceuticals Completed No outcome recorded
Phase 41 trial
Phase 4 NCT02386800 Mar 2015 → Sep 2027 expected acquired polycythemia vera, acute myeloid leukemia, graft versus host disease, primary myelofibrosis +1 Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase not stated2 trials
NCT02204553 plasma cell myeloma Novartis Pharmaceuticals No longer available No outcome recorded
NCT02568943 plasma cell myeloma Novartis Pharmaceuticals No longer available No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT04804709 Background Jul 2021 → Mar 2022 diffuse midline glioma, H3 K27M-mutant Columbia University Terminated No outcome recorded
Phase 1 NCT00873002 Comparator Mar 2009 → May 2010 liver cancer Case Comprehensive Cancer Center Terminated No outcome recorded
Phase 21 trial
Phase 2 NCT02722941 Comparator Jun 2016 → Jun 2020 plasma cell myeloma H. Lee Moffitt Cancer Center and Research Institute Completed No outcome recorded

Press releases naming this drug 4 releases

DateIssuerRelease
2015-09-04 Novartis Pharmaceuticals Novartis receives EU approval for Farydak®, the first in its class of anticancer agents approved for patients with multiple myeloma novartis.com
2015-06-26 Novartis Pharmaceuticals Novartis drug Farydak® recommended by CHMP for EU approval to treat multiple myeloma, providing patients a new mechanism of action novartis.com
2015-06-12 Novartis Pharmaceuticals Novartis data at EHA show increased PFS benefit of Farydak® in new subgroup of patients with previously treated multiple myeloma novartis.com
2015-02-23 Novartis Pharmaceuticals Novartis receives FDA approval of Farydak®, the first HDAC inhibitor for patients with multiple myeloma novartis.com

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 153 sources stand behind the page.

FieldValueCited text
Known as panobinostat “In this randomized phase 2 study, we evaluated the response rate and toxicity of panobinostat, a pan-HDI administered 30 mg orally 3 times weekly, with or without rituximab, in...” PMID 27166360 May 2016
109

“The purpose of this Phase I study is to find the maximum tolerated dose of MTX110 (a water-soluble Panobinostat nanoparticle formulation) and Gadolinium that can be given...” NCT04264143

Panobinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer...” NCT01440582

“This study comprises of a dose-escalation and dose expansion phase and will determine the maximum tolerated dose of oral Panobinostat on a continuous schedule in adult in...” NCT00532389

“A phase II non-randomized single arm trial of oral panobinostat (LBH589) was conducted in patients with low or intermediate-1 risk myelodysplastic syndrome (MDS).” PMID 22072492 Nov 2011

“Enrolled patients will receive 4 infusions per week of panobinostat (MTX110; 0.25 ml of 300 μM = 26.2 μg), per infusion into the ventricular access device” NCT04315064

Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds.” NCT01007968

“LBH589 (Panobinostat) is a new pill that works by blocking a special group of proteins called histone deacetylases (HDACs).” NCT01055795

“i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel” NCT00788931

“Tazemetostat, Panobinostat, Olaparib, Capecitabine” NCT05774886

Panobinostat is an oral pan-deacetylase inhibitor” PMID 23950178 Aug 2013

NCT01651039

NCT01463046

NCT01023308

NCT01884428

NCT01245179

NCT02032810

NCT00901147

NCT00490776

NCT01034163

NCT01528501

NCT00594230

NCT00425555

NCT01693601

NCT00699296

NCT02722941

NCT02961816

NCT00997399

NCT01242774

NCT02756663

NCT03878524

NCT01582009

NCT00880269

NCT00738751

NCT01523834

NCT01105312

NCT00918333

NCT02204553

NCT00985946

NCT01658241

NCT05725200

NCT04341311

NCT01261247

NCT03256045

NCT03632317

NCT01965353

NCT01680094

NCT02471430

NCT01159418

NCT01282476

NCT01169636

NCT01433445

NCT00667862

NCT00878904

NCT02506959

NCT01613976

NCT00777049

NCT01496118

NCT01160731

NCT00848523

NCT02057640

NCT02568943

NCT02676323

NCT00686218

NCT03566199

NCT00931762

NCT04897880

NCT01549431

NCT00670553

NCT01802879

NCT02518750

NCT01324635

NCT00993642

NCT00840346

NCT01115036

NCT00743288

NCT01321346

NCT04956302

NCT00925132

NCT00567879

NCT00967044

NCT03982134

NCT02588339

NCT01055483

NCT00873002

NCT01336842

NCT04804709

NCT01451268

NCT01005797

NCT01504776

NCT01056601

NCT06240520

NCT01238965

NCT00777335

NCT01460940

NCT02386800

NCT01301807

NCT00891033

NCT01111526

NCT00962507

NCT02145715

NCT02290431

NCT02890069

NCT00878436

NCT00946647

NCT00723203

NCT00742027

NCT02654990

NCT02802163

NCT04326764

Known as Farydak Farydak (panobinostat lactate)/Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Velcade (bortezomib)/dexamethasone (FDVd)” NCT04956302
Known as LBH581 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01222936
Known as LBH589 “An Expanded Treatment Protocol of Panobinostat (LBH589) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma Who Have Had at Least One Prior Line...” NCT02204553
60

“A Phase I Study of LBH589 (Panobinostat) in Combination With External Beam Radiotherapy for the Treatment of Prostate Cancer, Esophageal Cancer and Head and Neck Cancer” NCT00670553

“This summary will use Panobinostat (LBH589) in patients with neuroendocrine tumors to see how the patient's tumor responds to panobinostat.” NCT00985946

“Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds.” NCT00997399

“Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds.” NCT01007968

“Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.” NCT02290431

“i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel” NCT00788931

“A Phase I Trial of Panobinostat (LBH589) and Epirubicin in Patients With Solid Tumor Malignancies” NCT00878904

“A Phase IB Study of the Histone Deacetylase Inhibitor Panobinostat (LBH589) Given Orally” NCT01159418

“Each patient will receive panobinostat (LBH589) and letrozole.” NCT01105312

“Pan-DAC Inhibitor Panobinostat (LBH589)” NCT01160731

“Panobinostat (LBH589), Sorafenib” NCT01005797

“Panobinostat (LBH589)” NCT01111526

“Panobinostat (LBH589)” NCT01528501

“Panobinostat (LBH589)” NCT00532389

“Panobinostat (LBH589)” NCT00993642

“Panobinostat (LBH589)” NCT00738751

“Panobinostat (LBH589)” NCT00946647

“Panobinostat - LBH589NCT00777335

“Panobinostat/LBH589NCT00880269

LBH589NCT01194908

NCT00532675

NCT00621244

NCT02717455

NCT00550199

NCT00556088

NCT01175109

NCT00907179

NCT00823290

NCT01028313

NCT00690677

NCT00570284

NCT01034657

NCT01032148

NCT01055795

NCT00663832

NCT01136499

NCT00503451

NCT00939159

NCT01194908

NCT00958022

NCT00449761

NCT01013597

NCT00632489

NCT00445068

NCT01341834

NCT00472368

NCT01090973

NCT00535951

NCT00493766

NCT00978432

NCT00412997

NCT01065467

NCT00691938

NCT01298934

NCT00550277

NCT00859222

NCT00739414

NCT00451035

NCT00936611

NCT00419536

Known as LBH589 (Panobinostat) LBH589 (Panobinostat)NCT01496118
Known as LBH589B “panobinostat/LBH589BNCT01055483
Known as MTX110 “The purpose of this Phase I study is to find the maximum tolerated dose of MTX110 (a water-soluble Panobinostat nanoparticle formulation) and Gadolinium that can be given...” NCT04264143
2

“Enrolled patients will receive 4 infusions per week of panobinostat (MTX110; 0.25 ml of 300 μM = 26.2 μg), per infusion into the ventricular access device” NCT04315064

“Panobinostat nanoparticle formulation MTX110NCT03566199

Known as PAN “histone deacetylase inhibitor panobinostat (PAN)” PMID 28905323 Sep 2017
Known as Panobinostat Lactate “Farydak (panobinostat lactate)/Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Velcade (bortezomib)/dexamethasone (FDVd)” NCT04956302
Known as PNB “DESIGN: Here we evaluate the impact of in-vivo administration of vorinostat (VOR) and panobinostat (PNB) during clinical trials on natural killer (NK) cell function and phenotype.” PMID 30830886 Mar 2019
Action Inhibit “Panobinostat is a potent, oral pan-deacetylase inhibitor (pan-DACi) that increases the acetylation of proteins involved in multiple oncogenic pathways.” PMID 22981498 Sep 2012
Modality Small molecule “Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds.” NCT00997399
Route Oral “LBH589 Administered Orally” NCT00412997