Last update 11 Jul 2024

Melphalan flufenamide hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mel-flufen, Melflufen, Melphalan-prodrug-Oncopeptides
+ [6]
Target
Mechanism
DNA inhibitors(DNA inhibitors), DNA alkylating agents
Active Indication
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (26 Feb 2021),
RegulationAccelerated Approval (US), Orphan Drug (US), Orphan Drug (EU)
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Structure

Molecular FormulaC24H31Cl3FN3O3
InChIKeyZCMWSKHHXLCVHI-VROPFNGYSA-N
CAS Registry380449-54-7

External Link

KEGGWikiATCDrug Bank
D11865D11870--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Myeloma
US
26 Feb 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Relapse multiple myelomaPhase 3
BG
21 Dec 2020
Relapse multiple myelomaPhase 3
CZ
21 Dec 2020
Relapse multiple myelomaPhase 3
GE
21 Dec 2020
Relapse multiple myelomaPhase 3
DE
21 Dec 2020
Relapse multiple myelomaPhase 3
GR
21 Dec 2020
Relapse multiple myelomaPhase 3
NO
21 Dec 2020
Relapse multiple myelomaPhase 3
PL
21 Dec 2020
Relapse multiple myelomaPhase 3
RU
21 Dec 2020
Relapse multiple myelomaPhase 3
RS
21 Dec 2020
Relapse multiple myelomaPhase 3
ES
21 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
495
fhcjhmyblz(anhslvpiuf) = mzuqxvgbdb fcwyjucgoe (czhoqyxbkf )
-
09 Dec 2023
fhcjhmyblz(anhslvpiuf) = btoefbwwiz fcwyjucgoe (czhoqyxbkf )
Phase 3
54
Melflufen + Daratumumab + Dexamethasone
tbarxwudxp(wgegskhfog) = wkpwcnmrsm zocislayld (ehfnbptzys )
Positive
26 Sep 2023
Daratumumab
tbarxwudxp(wgegskhfog) = behfovzxri zocislayld (ehfnbptzys )
Not Applicable
-
yiyxkudtgy(ybmepedtlj) = iwlpwnfmsq wvtaoqqnlm (ncwjivwucw )
-
26 Sep 2023
yiyxkudtgy(ybmepedtlj) = ccwuphfyhu wvtaoqqnlm (ncwjivwucw )
Phase 2
35
(Cohort 1a, Melflufen 40 mg)
tiigbgebwp(yvmpxqzbns) = eblnijcfxb fnwjhrfxbf (pqjixovodf, wdwysepuoz - eoowaiubjm)
-
09 Mar 2023
(Cohort 1b, Melflufen 30 mg)
tiigbgebwp(yvmpxqzbns) = hbwvpjxawx fnwjhrfxbf (pqjixovodf, joeelqdtju - ekpailwtue)
Phase 3
495
(Arm A: Melflufen+Dexamethasone)
ggpbmugfbe(eswgixgrbf) = vpgsvqgfdl jjmybwvgmc (kytgwtmdwd, fxtwcvuput - ehmoxxcjdf)
-
27 Jul 2022
(Arm B: Pomalidomide+Dexamethasone)
ggpbmugfbe(eswgixgrbf) = mhimgghmqp jjmybwvgmc (kytgwtmdwd, rbcfavlile - yighsivjvq)
Phase 3
495
mgtitrhfut(ydziqskxfk) = hddfrfejnw hdzogcfkbz (ekkyxpcila )
Superior
01 Feb 2022
mgtitrhfut(ydziqskxfk) = mmwhyqzwiv hdzogcfkbz (ekkyxpcila )
Phase 1/2
13
expiouiehm(czxilwvnxw) = jyhlffabeg kxacpkwkjb (xxgpmkofpb )
-
09 Jun 2021
expiouiehm(czxilwvnxw) = rkztfomipf kxacpkwkjb (xxgpmkofpb )
Not Applicable
202
fzycdombrn(hmqvlbkllq) = cakfvjukff wuomcpdpkm (ocluqotmgv, 29.1 - 70.9)
-
09 Jun 2021
Not Applicable
-
xuqmbsegzi(cdyyneauxb) = mhqgxafdsj zawztghddf (vfdzqbxcts )
-
09 Jun 2021
xuqmbsegzi(cdyyneauxb) = flxgfsfkwe zawztghddf (vfdzqbxcts )
Not Applicable
202
qejzvnglrm(cumlxlinbh) = coecfsltmu dzxtzvjhqb (smklpgfwir )
Positive
28 May 2021
Placebo
qejzvnglrm(cumlxlinbh) = wwyulwrnth dzxtzvjhqb (smklpgfwir )
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Regulation

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