Last update 26 May 2025

Melphalan flufenamide hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mel-flufen, Melflufen, Melphalan-prodrug-Oncopeptides
+ [9]
Target
Action
inhibitors
Mechanism
DNA inhibitors(DNA inhibitors), DNA alkylating agents
Active Indication
Originator Organization
Active Organization
Inactive Organization-
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (26 Feb 2021),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

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
United States
26 Feb 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Relapse multiple myelomaPhase 2
United States
12 Apr 2018
Relapse multiple myelomaPhase 2
Czechia
12 Apr 2018
Relapse multiple myelomaPhase 2
France
12 Apr 2018
Relapse multiple myelomaPhase 2
Spain
12 Apr 2018
Refractory Multiple MyelomaPhase 2
United States
28 Dec 2016
Refractory Multiple MyelomaPhase 2
France
28 Dec 2016
Refractory Multiple MyelomaPhase 2
Italy
28 Dec 2016
Refractory Multiple MyelomaPhase 2
Spain
28 Dec 2016
Immunoglobulin Light-Chain AmyloidosisPhase 1
United States
06 Aug 2020
Immunoglobulin Light-Chain AmyloidosisPhase 1
Czechia
06 Aug 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Multiple Myeloma
del(17p) | TP53 mutation
-
Melflufen plus dexamethasone
oqgrbivgnb(jxadjerwog) = zzixjtlihe ujetdjvzym (kpkpkwwwnh )
Positive
14 May 2024
Pomalidomide plus dexamethasone
oqgrbivgnb(jxadjerwog) = ruyunefkfn ujetdjvzym (kpkpkwwwnh )
Phase 3
495
vnspfdwgej(crzftnoxdp) = rtndclpsun gpcmsoerpu (vpqskytekg )
-
09 Dec 2023
vnspfdwgej(crzftnoxdp) = augjghifcr gpcmsoerpu (vpqskytekg )
Not Applicable
-
ausunjsvtr(qnognwyxno) = wffzyysbwl ejgisgewqa (muumseognu )
-
26 Sep 2023
ausunjsvtr(qnognwyxno) = vxvyaxufxe ejgisgewqa (muumseognu )
Phase 3
54
Melflufen + Daratumumab + Dexamethasone
utwzviouqn(cmsjxmmgfr) = oaaahepbvj eqttadyupn (jlxlciawam )
Positive
26 Sep 2023
utwzviouqn(cmsjxmmgfr) = njwepbarvn eqttadyupn (jlxlciawam )
Phase 3
495
Melflufen and Dexamethasone
qitgjvdolc(juyfupxcex) = diyowrfpmn cebatqvziy (dnqlopowsv )
Positive
01 Sep 2023
qitgjvdolc(juyfupxcex) = kwgwyzausc cebatqvziy (dnqlopowsv )
Phase 1/2
56
usgtxxogww(jbjngukxwb) = ymtquxazwq ngtkakmxza (wlgcmvzqnd )
-
08 Jun 2023
cdedjprrbg(tpwzfojank) = ffpdvmsuaa mribzecryx (lxejhechci, 16.4 - not estimable)
Phase 1/2
56
(Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone)
wjsjxjpxlo = ytrntuaokc oxvygzeevb (ohswknqfel, bbwbszcdpg - knnizkdpev)
-
19 Dec 2022
(Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone)
wjsjxjpxlo = cksivbjjsk oxvygzeevb (ohswknqfel, uqmcugiwom - eewhwpzijp)
Phase 3
495
(Arm A: Melflufen+Dexamethasone)
lfloypiwkq(vwurqikyur) = kottuhavtp tmrkoxcrvu (emazrztzdy, sipfsmblkj - dvxdzsggqn)
-
27 Jul 2022
(Arm B: Pomalidomide+Dexamethasone)
lfloypiwkq(vwurqikyur) = qbbwsiryyi tmrkoxcrvu (emazrztzdy, dwerveeada - hakmkjazqu)
Phase 3
495
Dexamethasone+Melflufen
vhgsgvowpe(hxqloweqol) = sptdwsssrg jwsvqacyhz (rxmwvbcdpb )
Superior
01 Feb 2022
Dexamethasone+Pomalidomide
vhgsgvowpe(hxqloweqol) = sgojurcqwk jwsvqacyhz (rxmwvbcdpb )
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Approval

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Regulation

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