Istodax
(Romidepsin)ApprovedSmall molecule
TevaRomidepsin is used to treat certain types of cancer, specifically cutaneous T-cell lymphoma (a blood cancer affecting the skin) and peripheral T-cell lymphoma. It works by stopping cancer cells from growing and dividing.[2] Istodax is currently approved and in use across 25 indications[4].[1]
Istodax is one of 471 small molecule programs targeting HIV infection. It is currently in Approved.
25
Indications
77
Total Trials
9
Active Trials
470
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 25 indications
Competition
Competitive Landscape
706 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Istodax
TevaApproved
Zolymbus
AbbViePreclinical
Blenoxane
Bristol-Myers SquibbPreclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
Duragesic-100
CCephalon
Preclinical
Spravato
WWim Janssens
Preclinical
Cortef
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Duragesic
CCephalon
Preclinical
Feraheme
AAzurity Pharmaceuticals
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Lymphoma24 trials
Show 21 more trials
Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma
Withdrawn·—·Phase 1·NCT04233697
Cutaneous T-cell lymphoma6 trials
Show 3 more trials
Breast Cancer4 trials
Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer
Terminated·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1/2·NCT01938833·9 enrolled
Show 1 more trial
Safety and Efficacy2 trials
PTCL2 trials
Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL
Withdrawn·—·Phase 1·NCT02757248
37 more indications
Multiple Myeloma2 trials
Advanced Cancer2 trials
Relapsed or Refractory1 trial
Pancreatic Cancer1 trial
Recurrent1 trial
Metastatic Neuroendocrine Tumor1 trial
Myelodysplastic Syndrome1 trial
Treatment1 trial
Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART
Completed·—·Phase 2·NCT03041012·60 enrolled
Thyroid Cancer1 trial
Azacytidine1 trial
Soft Tissue Sarcoma1 trial
Advanced Solid Tumors1 trial
Graft Versus Host Disease1 trial
Acute Myeloid Leukemia1 trial
Metastatic Colorectal Cancer1 trial
Squamous Cell Carcinoma1 trial
Gastroesophageal Junction Cancer1 trial
Chronic Lymphocytic Leukemia1 trial
Allogeneic Stem Cell Transplantation1 trial
Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial
Colorectal Cancer1 trial
A Study of Enhancing Response to MK-3475 in Advanced Colorectal Cancer
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02512172·27 enrolled
Diffuse Large B-Cell Lymphoma1 trial
Myeloproliferative Disorder1 trial
Bladder Cancer1 trial
Anaplastic Large Cell Lymphoma1 trial
Regulatory
FDA Approval Timeline[5]
Nov 5, 2009
ISTODAX
NDA NDA022393
Mar 13, 2020
ROMIDEPSIN
NDA NDA208574
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Istodax drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Romidepsin. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]