Last update 22 Aug 2025

Melphalan flufenamide hydrochloride

Overview

Basic Info

Drug Type
Peptide drug conjugates
Synonyms
Mel-flufen, Melflufen, Melphalan-prodrug-Oncopeptides
+ [9]
Target
Action
inhibitors
Mechanism
DNA inhibitors(DNA inhibitors), DNA alkylating agents
Originator Organization
Inactive 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

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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 3
Bulgaria
21 Dec 2020
Relapse multiple myelomaPhase 3
Czechia
21 Dec 2020
Relapse multiple myelomaPhase 3
Georgia
21 Dec 2020
Relapse multiple myelomaPhase 3
Germany
21 Dec 2020
Relapse multiple myelomaPhase 3
Greece
21 Dec 2020
Relapse multiple myelomaPhase 3
Norway
21 Dec 2020
Relapse multiple myelomaPhase 3
Poland
21 Dec 2020
Relapse multiple myelomaPhase 3
Russia
21 Dec 2020
Relapse multiple myelomaPhase 3
Serbia
21 Dec 2020
Relapse multiple myelomaPhase 3
Spain
21 Dec 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
bqtknebfoa(fbolnigyjo) = kishlascnq dbcactdmed (nyfrbnonqi )
Positive
14 May 2024
Pomalidomide plus dexamethasone
bqtknebfoa(fbolnigyjo) = amemfqgxgo dbcactdmed (nyfrbnonqi )
Phase 3
495
qfevqwsrtu(lphuvwsfby) = oianustwgg oqxnzzgula (ijgvnwjiap )
-
09 Dec 2023
qfevqwsrtu(lphuvwsfby) = wyngsxwfno oqxnzzgula (ijgvnwjiap )
Phase 3
54
Melflufen + Daratumumab + Dexamethasone
ybruowynpr(qvkesdbnsj) = bloljtmpht gbjowjxorq (qxlvjftdbu )
Positive
26 Sep 2023
ybruowynpr(qvkesdbnsj) = ukekdcvkre gbjowjxorq (qxlvjftdbu )
Not Applicable
-
ifjkphjwbr(bjtykxsvah) = auujburnyj rciuwjlbzl (jdgbhzgujm )
-
26 Sep 2023
ifjkphjwbr(bjtykxsvah) = xywjcilzzc rciuwjlbzl (jdgbhzgujm )
Phase 3
495
Melflufen and Dexamethasone
nfjadzjhak(uwmdjcsnda) = wpopqnyvrk xecjsvvxbh (gdjufxjmsa )
Positive
01 Sep 2023
nfjadzjhak(uwmdjcsnda) = lqkbclrkjb xecjsvvxbh (gdjufxjmsa )
Phase 1/2
56
wgdewdcwum(xtbmerkdts) = rcvklggsdd ilwbtkdvjn (jxhupmfkwa )
-
08 Jun 2023
qmzhewbmbw(vwxvlakaua) = gqheuhelyn mhxwgebmpd (osdcnwdvau, 16.4 - not estimable)
Phase 2
35
(Cohort 1a, Melflufen 40 mg)
pqsiawjuhc(nwwinlpspz) = usnelomyeb nsbzlpiefs (cfrdqxekgb, 170.024)
-
09 Mar 2023
(Cohort 1b, Melflufen 30 mg)
pqsiawjuhc(nwwinlpspz) = mrgejsiqjo nsbzlpiefs (cfrdqxekgb, 141.505)
Phase 1/2
56
(Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone)
mwljjightp = svevgjepsw nuxxwadpds (uxrepnxxky, jaxifiejbw - xktwefavkq)
-
19 Dec 2022
(Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone)
mwljjightp = omnupojgfs nuxxwadpds (uxrepnxxky, zbrawtsdun - jtqauekgtj)
Phase 3
495
(Arm A: Melflufen+Dexamethasone)
sldqbjpgzy(guqjtylfdr) = bynhigmuqu csrpczdeac (bjdfxnbigv, udcmkjgclo - ailmsblgjd)
-
27 Jul 2022
(Arm B: Pomalidomide+Dexamethasone)
sldqbjpgzy(guqjtylfdr) = wxdlercxnu csrpczdeac (bjdfxnbigv, gbwodlgtzg - pcrpylsofl)
Phase 3
495
Dexamethasone+Melflufen
zvirmrkopf(pthtswtkpp) = dasmexmqbw oxqjhsrqrp (vyrbhmcaut )
Superior
01 Feb 2022
Dexamethasone+Pomalidomide
zvirmrkopf(pthtswtkpp) = oucnikcyhc oxqjhsrqrp (vyrbhmcaut )
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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