Romidepsin

Drug Profile

Romidepsin

Alternative Names: Depsipeptide; FK 228; FR 901228; Istodax; NSC 630176; NSC 630176D

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Astellas Pharma
  • Developer Celgene Corporation; Lymphoma Academic Research Organisation; University of Birmingham; University of California at San Francisco; University of Texas M. D. Anderson Cancer Center
  • Class Antineoplastics; Cytostatic antibiotics; Depsipeptides; Small molecules
  • Mechanism of Action Histone deacetylase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Peripheral T-cell lymphoma; Cutaneous T cell lymphoma
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Cutaneous T cell lymphoma; Peripheral T-cell lymphoma
  • Phase I/II T cell lymphoma; T-cell leukaemia
  • Phase I Haematological malignancies
  • Discontinued Multiple myeloma; Pancreatic cancer; Prostate cancer; Renal cell carcinoma

Most Recent Events

  • 05 May 2016 Celgene suspends enrolment in a phase I/II clinical trial for Breast cancer (newly diagnosed; combination therapy; metastatic disease) in USA (IV) (NCT01938833)
  • 15 Mar 2016 Biomarkers information updated
  • 01 Oct 2015 Phase-I/II clinical trials in T-cell lymphoma and leukaemia (Combination therapy) in USA (IV)
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