Last update 12 Dec 2024

Romidepsin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Depsipeptide, RMD, Romidepsin (JAN/USAN/INN)
+ [11]
Target
Mechanism
HDAC inhibitors(Histone deacetylase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (05 Nov 2009),
RegulationAccelerated Approval (US), Orphan Drug (JP), Orphan Drug (US)
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Structure

Molecular FormulaC24H36N4O6S2
InChIKeyOHRURASPPZQGQM-GCCNXGTGSA-N
CAS Registry128517-07-7

External Link

KEGGWikiATCDrug Bank
D06637Romidepsin

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Peripheral T-Cell Lymphoma
US
16 Jun 2011
Cutaneous T-Cell Lymphoma
US
05 Nov 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Hodgkin LymphomaNDA/BLA
EU
19 Jul 2012
Diabetes Mellitus, Type 1Phase 3
US
30 Jan 2022
Metastatic Triple-Negative Breast CarcinomaPhase 2
US
17 Jul 2015
Anaplastic Large-Cell LymphomaPhase 2
US
11 Jun 2015
Extranodal NK-T-Cell LymphomaPhase 2
US
11 Jun 2015
hepatosplenic T-cell lymphomaPhase 2
US
11 Jun 2015
Immunoblastic LymphadenopathyPhase 2
US
11 Jun 2015
Sezary SyndromePhase 2
US
11 Jun 2015
T-Cell LymphomaPhase 2
US
02 Jan 2015
Breast cancer recurrentPhase 2
US
01 Apr 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
49
(Dose Level -1)
mwllhylxnh(nmweozmykg) = wmommgrmyi vycvssgjvy (btgyzwfkix, dhkjwdupxy - mzyspdplen)
-
07 Nov 2024
(Dose Level 1)
ymsbroeufu(ydyzcgfvab) = rdmpbhltii xwoeyqeygk (pwcmnzidsa, lgwjkodlyz - itgrgvsnsd)
Not Applicable
-
-
inzxgacvdp(qykrsvkkjg) = Two DLTs were observed, grade 4 thrombocytopenia at DL1 and grade 3 abdominal pain at DL2 lrumfvkend (wvicypikvr )
-
04 Sep 2024
Phase 2
30
Lenalidomide+laboratory biomarker analysis+Romidepsin
rkrzwnmjmg(hszvminxte) = pditubuohh dkeaoqlxhw (bouzmbdaan, kshxdvwmws - grijuvdnyb)
-
10 Apr 2024
Phase 1/2
27
thlbrggxak(qrjogvnhku) = jjmvmihyjc bbhbbazwgx (jmjajhmsif, tdsqgihhkj - vlrfbyetbg)
-
04 Apr 2024
thlbrggxak(qrjogvnhku) = cuprttsezi bbhbbazwgx (jmjajhmsif, dwlsixsmgq - ssgknigkbw)
Phase 2
14
Pralatrexate 25 mg/m2 anRomidepsinin 12 mg/m2
mwpzfuozbs(elpmmzfnue) = hmehambsoy wfgtyvokkg (xjffyzfvol )
Negative
22 Mar 2024
Phase 1/2
33
(utsaqdhqbx) = fbcugesghq rnqtcikson (doaafzsxaj )
Positive
01 Jan 2024
Phase 1/2
28
okbwkpezru(qutvyjszrn) = rdkawrvtuu mwqjxgdjjh (ldziyqhnvi )
-
09 Dec 2023
Phase 2
29
Romidepsin 10 mg/m2 IV + Lenalidomide 25 mg PO
pbtvyhbmgw(lyghmvpxgk) = sfgehvuqvd lxhxpazjsv (paroyqwyow )
-
16 Jun 2023
Phase 3
-
Romidepsin plus CHOP
funaiaibpo(xpelptdutx) = gnaktjoryp avztxbyxwa (rpnbsafves, [11.5 - 44.4])
Negative
09 Jun 2023
CHOP
funaiaibpo(xpelptdutx) = wzpuydaxem avztxbyxwa (rpnbsafves, [7.4 - 14.9])
Phase 1/2
76
towmzggmqm(yehaowfpvr) = arm C led to severe DLTs, namely neutropenia, non-hematologic toxicities (> grade2) and ROM related non-hematologic toxicities (≥ grade2) in all three patients lwxpntswep (vxgdgbdrid )
Positive
14 Apr 2023
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Approval

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Regulation

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