Drugs / Romidepsin
Romidepsin
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | ISTODAX | — | 2011-06-16 – 2021-07-30 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Istodax | — | 2013-02-12 | europa.eu ↗ |
| Approved | US (FDA) | ISTODAX | — | 2009-11-05 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2021-08-02 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Statement on Istodax® (romidepsin) Relapsed/Refractory Peripheral T-cell Lymphoma U.S. Indication bms.com ↗
Based on this outcome, Bristol Myers Squibb made the decision to withdraw the PTCL indication from the U.S. market. |
| 2018-05-03 | Verastem, Inc. | Results Verastem Oncology Reports on Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma Opportunity, Landscape and Advancements in Pre-Commercial Initiatives at Analyst and Investor Day verastem.com ↗ |
| 2017-12-11 | Verastem, Inc. | Results Verastem Announces the Presentation of Phase 1 Duvelisib Combination Data in T-Cell Lymphomas at the ASH 2017 Annual Meeting verastem.com ↗
Combination of Duvelisib and Romidepsin Achieves 60% Overall Response Rate Including a 27% Complete Response Rate in these patient populations |
| 2016-06-09 | Bionor Immuno AS | Results The peer-reviewed and highly recognized journal ‘The Lancet HIV’ has accepted the results of the REDUC Part B trial for publication bionorholding.com ↗
Bionor Pharma ASA (Bionor) (OSE:BIONOR), announced today that the positive results from the clinical trial REDUC Part B (BPC01-001) will be published for the first time in the peer-reviewed and highly recognized journalThe Lancet HIV. |
| 2016-02-23 | Bionor Immuno AS | Results The final assay in Bionor’s REDUC trial for measuring latent HIV reservoir, Integrated HIV DNA, supports the Shock & Kill approach using Vacc-4x and romidepsin bionorholding.com ↗
With the results of this assay showing a mean 13% non-statistically significant (p=0.271) reduction, the direction of all three assays is consistent. |
| 2015-11-17 | Bionor Immuno AS | Regulatory Bionor files first clinical trial application for BIOSKILL bionorholding.com ↗
Bionor Pharma ASA (OSE:BIONOR) today announced the submission of a clinical trial application (CTA) to the Danish Medicines Agency requesting approval to initiate BIOSKILL in Denmark. |
| 2015-09-18 | Bionor Immuno AS | Results Results of the REDUC study Part A published in the journal PLoS Pathogens bionorholding.com ↗
Romidepsin safely increased the level of virus measured in the blood stream such that it became readily detectable using standard commercial assays. |
| 2015-05-04 | Bionor Immuno AS | Results Bionor announces promising results from an interim analysis of the functional cure HIV study REDUC Part B bionorholding.com ↗
The interim analysis announced today re-confirms that administration of romidepsin leads to activation of the virus in infected CD4+ T cells. |
| 2014-07-29 | Bionor Immuno AS | Results Bionor Pharma’s REDUC trial – Highlight of the 2014 AIDS conference bionorholding.com ↗
The trial demonstrated that Romidepsin successfully increased the virus production in HIV-infected cells between 2.1 and 3.9 times above normal |
| 2014-07-22 | Bionor Immuno AS | Results First Evidence that Romidepsin “Kicks” HIV out of Reservoirs bionorholding.com ↗
The treatment successfully reactivated HIV transcription in all 6 patients within a few hours following each romidepsin administration followed by a decrease between day 3 and 7 day post-infusion. |
| 2014-05-11 | Bionor Immuno AS | Results Bionor Pharma Announces Successful Completion of Part A of REDUC Study; First Evidence that Romidepsin “Kicks” HIV out of Reservoirs bionorholding.com ↗
Treatment with 5mg/m2 of romidepsin was successfully able to reactivate HIV in 6 patients while on conventional HIV medication cART. |
| 2014-02-27 | Bionor Immuno AS | Regulatory Bionor Pharma Announces Approval of REDUC Trial bionorholding.com ↗
Bionor Pharma ASA announces that the Company has received approval from the Danish Regulatory Agency for its REDUC trial. |
All press releases naming this drug 13 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 104 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | romidepsin | “Romidepsin (NSC 630176, FR901228, FK228, formerly referred to as depsipeptide) is a histone deacetylase inhibitor with potent cytotoxic activity against human tumor cell lines...” NCT00048334 ↗86“Romidepsin (dose escalation) Starting dose: 12mg/ms iv day +1 and +8” NCT02223208 ↗ “Pentostatin, Romidepsin, Ruxolitinib” NCT02788201 ↗ “Regorafenib Romidepsin Ruxolitinib” NCT02551718 ↗ |
| Known as | CHROMADAX | ChEMBL registry synonym — accepted as the source's own label CHEMBL343448 ↗ |
| Known as | CYCLIC (1.FWDARW.2)-DISULFIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL343448 ↗ |
| Known as | CYCLIC PEPTIDE DERIV.(E)-(1S,4S,10S,21R)-7-[(Z)-ETHYLIDENE]-4,21-DIISOPROPYL-2- OXA-12,13-DITHIA-5,8,20,23- TETRAAZABICYCLO[8.7.6]TRICOS-16-ENE-3,6,9,19,22-PENTONEL-VALINE | ChEMBL registry synonym — accepted as the source's own label CHEMBL343448 ↗ |
| Known as | depsipeptide | “Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC
630176), in patients with refractory neoplasms.” PMID 11895901 ↗ Mar 200211“Romidepsin (depsipeptide or FK228) is a histone deacetylase inhibitor, one of a new class of agents active in T-cell lymphoma.” PMID 21355097 ↗ Feb 2011 “romidepsin (depsipeptide, FK228)” NCT00106431 ↗ “depsipeptide (romidepsin)” NCT00091195 ↗ |
| Known as | DEPSIPEPTIDEANTIBIOTIC FR 901228ROMIDEPSINROMIDEPSINAPI0005301FK228OXA-12,13-DITHIA-5,8,20,23-TETRAZABICYCLO[8.7.6]TRICOSANE | ChEMBL registry synonym — accepted as the source's own label CHEMBL343448 ↗ |
| Known as | FK228 | “A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of Depsipeptide (FK228) in Patients That Have Completed a Prior Clinical Study With Depsipeptide.” NCT00299351 ↗5“Romidepsin (depsipeptide or FK228) is a histone deacetylase inhibitor, one of a new class of agents active in T-cell lymphoma.” PMID 21355097 ↗ Feb 2011 “histone deacetylase (HDAC) inhibitor Depsipeptide FK228 (DP).” NCT00037817 ↗ “romidepsin (depsipeptide, FK228)” NCT00106431 ↗ |
| Known as | FR901228 | “the histone deacetylase (HDAC) inhibitor Depsipeptide FR901228 (DP) mediates cell cycle arrest and apoptosis in cultured lung and esophageal cancer, and malignant pleural...” NCT00094978 ↗4“Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC 630176), in patients with refractory neoplasms.” PMID 11895901 ↗ Mar 2002 “Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15.” NCT00085527 ↗ “Romidepsin (FR901228)” NCT01445340 ↗ |
| Known as | FR901288 | “Determine objective response rate in patients with locally advanced or metastatic neuroendocrine tumors treated with FR901288 (romidepsin).” NCT00084461 ↗ |
| Known as | Istodax | “A Phase IB/II Study of Escalating Doses of Romidepsin (Istodax®) in Association With CHOP” NCT01280526 ↗ |
| Known as | N-(3-HYDROXY-7-MERCAPTO-1-OXO-4-HEPTENYL)VALYL- CYSTEINYL-2,3-DIDEHYDRO-2- AMINOBUTANOYL-,.XI.-LACTONE | ChEMBL registry synonym — accepted as the source's own label CHEMBL343448 ↗ |
| Known as | NSC-630176 | “Romidepsin (NSC 630176, FR901228, FK228, formerly referred to as depsipeptide) is a histone deacetylase inhibitor with potent cytotoxic activity against human tumor cell lines...” NCT00048334 ↗2“Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC 630176), in patients with refractory neoplasms.” PMID 11895901 ↗ Mar 2002 “Phase II trial of romidepsin (NSC-630176)” PMID 18941712 ↗ Oct 2008 |
| Known as | NSC754143 | ChEMBL registry synonym — accepted as the source's own label CHEMBL343448 ↗ |
| Known as | RMD | “histone deacetylase inhibitor (HDACi) romidepsin (RMD) as latency-reversing agent” PMID 34750296 ↗ Mar 2022 |
| Known as | ROMIDEPSIN (FK228 ,DEPSIPEPTIDE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL343448 ↗ |
| Known as | ROMIDEPSINA | ChEMBL registry synonym — accepted as the source's own label CHEMBL343448 ↗ |
| Known as | ROMIDEPSINE | ChEMBL registry synonym — accepted as the source's own label CHEMBL343448 ↗ |
| Action | Inhibit | “histone deacetylase inhibitor” NCT00007345 ↗ |
| Modality | Peptide | “romidepsin (depsipeptide)” NCT00098813 ↗ |
| Route | Intravenous | “intravenously” NCT00007345 ↗ |